High Doses of B Vitamins Linked to INCREASED Lung Cancer in Male Smokers

MedicalResearch.com Interview with:

Theodore M. Brasky, PhD Research Assistant Professor The Ohio State University – James Comprehensive Cancer Center Columbus, OH 43201

Dr. Brasky

Theodore M. Brasky, PhD
Research Assistant Professor
The Ohio State University – James Comprehensive Cancer Center
Columbus, OH 43201

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Prior literature has been suggestive of both a protective and harmful effect of certain B vitamins on lung cancer risk. We wanted to examine the association of intakes of vitamins B6, folic acid (B9), and B12 from supplements –which are typically taken at very high doses– and lung cancer risk in a large, prospective study of 77,000 men and women living in Washington State. The study is unique as it was designed specifically to examine associations of dietary supplements with cancer occurrence. We found that men who took high doses of vitamin B6 and B12 from individual supplements over a long period of time (meaning, doses much higher than the US RDA and much greater than what one would receive from taking a multivitamin over the long term) were at nearly 2-fold increased risk of lung cancer compared to men who did not have B6 or B12 intake from any supplemental source. This finding of increased risk appeared to be specific to men who were current smokers. Among them, long term high-dose supplementation was associated with 3-4 fold increases in lung cancer risk. We observed no increased risk for any of the supplements – B6, B12, or folic acid – with lung cancer risk in women or women who smoked.

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Promising Study of Shorter Course of Radiation Therapy After Mastectomy

MedicalResearch.com Interview with:

Bruce G. Haffty, MD Professor and Chair, Department of Radiation Oncology Rutgers Cancer Institute of New Jersey Rutgers Robert Wood Johnson Medical School and Rutgers New Jersey Medical School

Dr. Haffty

Bruce G. Haffty, MD
Professor and Chair, Department of Radiation Oncology
Rutgers Cancer Institute of New Jersey
Rutgers Robert Wood Johnson Medical School and
Rutgers New Jersey Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Shorter courses of radiation for patients treated by lumpectomy are now commonly employed. For patients receiving radiation to the chest wall and lymph nodes after mastectomy, the standard 5 to 6 week course is used and shorter courses have not been adopted.

We initiated this trial of a shorter course of radiation to the chest wall and lymph nodes after mastectomy to test its feasibility, safety and outcome.
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70-Gene Signature Changes 50% of Breast Cancer Chemotherapy Advice

MedicalResearch.com Interview with:
Anne Kuijer, MD

Departments of Surgery and Radiology
University Medical Center Utrecht and
Thijs van Dalen, PhD
Department of Surgery
Netherlands Cancer Institute, Amsterdam

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In recent years it has become evident that clinicopathological factors fail to accurately determine prognosis in hormone receptor positive early stage breast cancer patients at intermediate risk of developing metastases. Gene-expression profiles, such as the 70-gene signature (MammaPrint) are therefore increasingly used for chemotherapy decision-making. In the current multicentre study we assessed the impact of 70-gene signature use on chemotherapy decisions in these patients. We demonstrated that, without the use of the 70-gene signature, half of patients was advised chemotherapy, which reflects the current controversy regarding chemotherapy benefit. Use of the 70-gene signature changed the chemotherapy advice in half of all patients and adherence to the 70-gene signature result was high.

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Shorter Term Precision Radiation Found Effective For Prostate Cancer

MedicalResearch.com Interview with:

Charles N Catton, MD, FRCPC Cancer Clinical Research Unit (CCRU) Princess Margaret Cancer Centre UHN

Dr. Catton

Charles N Catton, MD, FRCPC
Cancer Clinical Research Unit (CCRU)
Princess Margaret Cancer Centre
UHN 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Prostate cancer is a very common malignancy which is frequently treated with external beam radiotherapy. A typical standard treatment course can extend over 7.5-8.5 weeks.

The introduction of high-precision radiotherapy treatment techniques provided the opportunity to compress treatment courses by delivering fewer, but more intensive daily treatments. The concerns with giving fewer and larger daily treatments (hypofractionation) is that toxicity may increase and that cancer control may become worse.

This international randomized trial enrolled 1206 men with intermediate risk prostate cancer and compared a standard 8 week course of external beam radiation treatment with a novel hypofractionated treatment course that was given over 4 weeks. Cancer control as measured by PSA control and clinical evidence of failure, bowel and bladder toxicity and quality of life were compared.

At a median follow-up of 6 years the hypofractionated regimen was found to be non-inferior to the standard regimen for cancer control. There was no difference early or late bladder toxicity between the two treatments. There was slightly worse early bowel toxicity during and immediately after treatment with the hypofractionated regimen, but there was actually slightly less long-term bowel toxicity with this same regimen.

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Taking Testosterone Doesn’t Increase Prostate Cancer Risk

MedicalResearch.com Interview with:

Dr. Stacy Loeb, MD, MScDepartment of Urology, Population Health, and Laura and Isaac Perlmutter Cancer CenterNew York University, New York

Dr. Stacy Loeb

Dr. Stacy Loeb MD Msc
Assistant Professor of Urology and Population Health
New York University Langone Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The association between exposure to testosterone replacement therapy and prostate cancer risk is controversial.  The purpose of our study was to examine this issue using national registries from Sweden, with complete records on prescription medications and prostate cancer diagnoses.  Overall, we found no association between testosterone use and overall prostate cancer risk. There was an early increase in favorable cancers which is likely due to a detection bias, but long-term users actually had a significantly reduced risk of aggressive disease.

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Maternal Cancer During Pregnancy Linked To Stillbirths and Infant Mortality

MedicalResearch.com Interview with:

Donghao Lu. PhD student Department of Medical Epidemiology and Biostatistics Karolinska Institute

Dr. Donghao Lu

Donghao Lu PhD student
Department of Medical Epidemiology and Biostatistics
Karolinska Institute

MedicalResearch.com: What is the background for this study?

Response: Cancer during pregnancy is a rare event. Whether prenatal exposure to a maternal malignancy and its treatment during pregnancy impair fetal development and neonatal health is, however, of great clinical concern. The risks of fatal outcomes such as stillbirth and infant mortality, however, have rarely been successfully explored in pregnancies complicated with cancer, in either clinical or population-based studies.

MedicalResearch.com: What are the main findings?

Response: Maternal cancer diagnosed during pregnancy was associated with increased risk of stillbirth (Incidence Rate Ratio, IRR, 2.5; 95% CI, 1.2 to 5.0), mainly stillbirths assessed as small for gestational age (SGA), and with increased risk of preterm SGA births (relative risk 3.0; 95% CI, 2.1 to 4.4). Maternal cancer diagnosed during pregnancy or the year after pregnancy were associated with increased risks of both neonatal mortality (deaths within 0 to 27 days; IRR, 2.7; 95% CI, 1.3 to 5.6 and IRR, 2.0; 95% CI, 1.2 to 3.2, respectively) and preterm birth (IRR, 5.8; 95% CI, 5.3 to 6.5 and IRR, 1.6; 95% CI, 1.4 to 1.8, respectively). The positive association with preterm birth was due to iatrogenic instead of spontaneous preterm birth. Preterm birth explained 89% of the association of maternal cancer during pregnancy with neonatal mortality.

MedicalResearch.com: What should readers take away from your report?

Response: Maternal cancer diagnosed during pregnancy was associated with increased risks of stillbirths assessed as SGA and preterm SGA live birth, suggesting that cancer and its treatment during pregnancy may impair fetal growth. Maternal cancer diagnosed during or shortly after pregnancy was associated with an increased risk of neonatal mortality, largely attributable to iatrogenic preterm birth. Although stillbirth and neonatal death are rare outcomes, the absolute risks of SGA and preterm birth are not small in pregnancies complicated with cancer. Careful monitoring of fetal growth and cautious decision making on the choices as well as the timing of preterm delivery should therefore be reinforced in these pregnancies.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Sweden is among the high-income countries with the lowest stillbirth and infant mortality rates, and these rates have decreased over time in many populations. Future studies in other populations are warranted to confirm our findings. Our data have also highlighted several cancer types, such as blood cancer, ovarian cancer, and cervical cancer, which entail highly increased risk of SGA or preterm birth and might be worthy of further exploration. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Maternal Cancer During Pregnancy and Risks of Stillbirth and Infant Mortality

Donghao Lu, Jonas F. Ludvigsson, Karin E. Smedby, Katja Fall, Unnur Valdimarsdóttir, Sven Cnattingius, and Fang Fang

Journal of Clinical Oncology
DOI: 10.1200/JCO.2016.69.9439 Journal of Clinical Oncology – published online before print March 6, 2017

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Prostate Cancer: No Association Between Androgen Deprivation Therapy and Dementia

MedicalResearch.com Interview with:
Farzin Khosrow-Khavar, M.Sc. Ph.D. Candidate
Department of Epidemiology, Biostatistics and Occupational Health, McGill University
Center for Clinical Epidemiology – Jewish General Hospital
Montreal, QC 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Previous studies have shown an association between androgen deprivation therapy (ADT) and risk of dementia and Alzheimer’s disease. However, these studies had methodological limitations that may account for this positive association. Using appropriate study design and methodology, we found no association between androgen deprivation therapy and risk of dementia (including Alzheimer’s disease) in patients with prostate cancer. These results were consistent by cumulative duration of  androgen deprivation therapy use and by ADT modality.

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Losing Some Weight May Reduce Risk of Endometrial Cancer

MedicalResearch.com Interview with:

Juhua Luo, PhD Associate professor of epidemiology and biostatistics Indiana University School of Public Health

Dr. Juhua Luo

Juhua Luo, PhD
Associate professor of epidemiology and biostatistics
Indiana University School of Public Health

MedicalResearch.com: What is the background for this study?

Response: We already know obesity increases risk of endometrial cancer. However, information on whether weight loss reduces risk of endometrial cancer is limited.

MedicalResearch.com: What are the main findings?

Response: Women losing 5% or more weight reduced risk of getting endometrial cancer by 29%. This was observed for any weight loss but risk was even lower for obese women with intentional weight loss. Obese women intentionally losing their weights by 5% or more reduced risk of getting endometrial cancer by 56%.

MedicalResearch.com: What should readers take away from your report?

Response: Among post-menopausal women, intentional weight loss reduces risk of getting endometrial cancer, especially for obese women. Our findings suggest that weight loss in postmenopausal women may not be too late for potential health benefit.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Additional research on intentional weight loss in relation to risk for other obesity-related cancer types and for mortality from cancer or other diseases are needed.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Intentional Weight Loss and Endometrial Cancer Risk

Juhua LuoRowan T. ChlebowskiMichael HendryxThomas RohanJean Wactawski-WendeJ, Cynthia A. ThomsonAshley S. FelixChu Chen, …

JCO Jan 2017

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Cancer Susceptibility Gene Mutations in Individuals With Colorectal Cancer

MedicalResearch.com Interview with:
Matthew B Yurgelun, M.D

Instructor in Medicine, Harvard Medical School
Dana-Farber Cancer Institute

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It has long been known that hereditary factors play a key role in colorectal cancer risk. It is currently well-established that approximately 3% of all colorectal cancers arise in the setting of Lynch syndrome, a relatively common inherited syndrome that markedly increases one’s lifetime risk of colorectal cancer, as well as cancers of the uterus, ovaries, stomach, small intestine, urinary tract, pancreas, and other malignancies. Current standard-of-care in the field is to test all colorectal cancer specimens for mismatch repair deficiency, which is a very reliable means of screening for Lynch syndrome. The prevalence of other hereditary syndromes among patients with colorectal cancer has not been known, though other such factors have been presumed to be quite rare.

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Specialized Surveillance Clinic For Patients At High Risk of Melanoma Reduced Procedures and Costs

MedicalResearch.com Interview with:

Caroline Watts| Research Fellow

Dr. Caroline Watts

Caroline Watts| Research Fellow
Cancer Epidemiology and Prevention Research
Sydney School of Public Health
The University of Sydney 

MedicalResearch.com: What is the background for this study?

Response: A clinic for people at high risk of melanoma was established at the Royal Prince Alfred Hospital, Sydney in 2006 as part of a research project to look at the impact of surveillance regime which included regular full body skin examination supported by dermoscopy and total body photography at 6 monthly intervals. If a suspicious lesion was identified, the lesion was either removed or an image of the lesion was captured using digital dermoscopy and the patient returned in 3 months for review.

This study aimed to estimate the costs and benefits from a health system perspective associated with specialised surveillance compared with current routine care high risk people would receive in the community.  Continue reading

Depression Common in Lung Cancer and Linked To Mortality

MedicalResearch.com Interview with:

Donald R. Sullivan, M.D., M.A. Assistant Professor, Division of Pulmonary & Critical Care Medicine Oregon Health & Science University Investigator, VA Portland Health Care System

Dr. Donald Sullivan

Donald R. Sullivan, M.D., M.A.
Assistant Professor, Division of Pulmonary & Critical Care Medicine
Oregon Health & Science University
Investigator, VA Portland Health Care System

MedicalResearch.com: What is the background for this study?

Response: There is an inextricably link between physical and mental health, and all too often clinicians focus solely on the physical components of disease. A life-threatening diagnosis such as cancer often evokes significant psychological distress and lung cancer patients are at significantly risk. Up to 44% of lung cancer patients experience depression symptoms and 5-13% major depressive disorder, higher than most other cancers. Previous studies have demonstrated the development of depression or depression symptoms at lung cancer diagnosis can increase patient mortality, but there is a paucity of research exploring how longitudinal changes in depression symptoms impact patient outcomes.
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No Link Found Between Vasectomy and Developing or Dying From Prostate Cancer

MedicalResearch.com Interview with:

Eric Jacobs, PHD | Strategic Director, Pharmacoepidemiology American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303

Dr. Eric Jacobs

Eric Jacobs, PHD
Strategic Director, Pharmacoepidemiology
American Cancer Society, Inc.
250 Williams St.
Atlanta, GA 30303

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Vasectomy is a common, inexpensive, and very effective method of long-term birth control. However, in 2014, an analysis from a large epidemiologic cohort study, the Health Professionals Follow-Up Study, found that vasectomy was associated with about 10% higher overall risk of prostate cancer and about 20% higher risk of fatal prostate cancer. Together with other researchers at the American Cancer Society, I analyzed the association between vasectomy and fatal prostate cancer among more than 363,000 men in the Cancer Prevention Study II (CPS-II) cohort, age 40 and older, who were followed for up to 30 years. This is the largest prospective analysis of vasectomy and fatal prostate cancer to date. We also examined vasectomy and prostate cancer in a subset of about 66,000 CPS-II study participants who were followed for new diagnoses of prostate cancer.

We found no link between having had a vasectomy and risk of either developing or dying from prostate cancer.

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Genetic Determinants of Cisplatin Resistance in Patients With Advanced Germ Cell Tumors

MedicalResearch.com Interview with:

Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center

Dr. Darren Feldman

Darren R. Feldman, MD
Medical Oncologist
Memorial Sloan Kettering Cancer Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is limited knowledge as to why a minority of patients with advanced germ cell tumors are resistant to chemotherapy while the majority achieve complete responses. Patients with cisplatin-resistant disease require intensive salvage treatment and are at high risk of dying from their disease. We sought to determine whether certain genomic alterations within tumors might be associated with cisplatin-resistance in GCT. We also wanted to identify the spectrum of genomic alterations in this population which might represent novel targets for existing or new drug development in this disease.

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High SPF Sunscreen Use Linked To Lower Risk of Melanoma

MedicalResearch.com Interview with:

Reza Ghiasvand, PhD Postdoctoral fellow, Department of Biostatistics, Faculty of Medicine, University of Oslo. Oslo, Norway

Dr. Reza Ghiasvand

Reza Ghiasvand, PhD
Postdoctoral fellow,
Department of Biostatistics,
Faculty of Medicine,
University of Oslo.
Oslo, Norway

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: To date, findings from studies have been inconsistent. Some studies found a decreased risk of melanoma among sunscreen users, while others found no association or a higher risk of melanoma among sunscreen users. Several studies found that many sunscreen users do not apply sunscreens properly and do not reapply as recommended and stay longer in the sun after using sunscreen and as a result get sunburn and increase their risk of skin cancer.

Our findings suggest higher UV exposure among sunscreen users compared to nonusers. However, those who used sunscreen with high SPF had 33% lower risk of melanoma compared to users of low SPF sunscreens.

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One Size Fits All Strategy No Longer Works For Treatment of Ovarian Cancer

MedicalResearch.com Interview with:

Larissa A. Meyer, MD MPH F.A.C.O.G. Assistant Professor Dept of Gynecologic Oncology and Reproductive Medicine Houston, TX 77030-1362

Dr. Larissa Meyer

Larissa A. Meyer, MD MPH F.A.C.O.G.
Assistant Professor
Dept of Gynecologic Oncology and Reproductive Medicine
Houston, TX 77030-1362

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Despite the completion of two randomized controlled trials, controversy regarding the optimal approach for the treatment of advanced ovarian cancer remains. Our observational study highlights the importance of thoughtful selection of individuals for primary cytoreductive surgery for advanced ovarian cancer. Our results suggest that primary cytoreductive surgery may improve survival for patients with stage IIIC ovarian cancer who are likely to achieve an optimal cytoreduction, while neoadjuvant chemotherapy may be the preferred option for many women with stage IV ovarian cancer.

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Molecular Subtyping of Rectal Cancers Can Guide Prognosis, Treatment and Future Screening

MedicalResearch.com Interview with:

Y. Nancy You, MD, MHSc Associate Professor Section of Colorectal Surgery Department of Surgical Oncology Medical Director Familial High-risk Gastrointestinal Cancer Clinic University of Texas MD Anderson Cancer Center

Dr. Y. Nancy You

Y. Nancy You, MD, MHSc
Associate Professor
Section of Colorectal Surgery
Department of Surgical Oncology
Medical Director
Familial High-risk Gastrointestinal Cancer Clinic
University of Texas MD Anderson Cancer Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Despite the progress in the treatment of many cancers, colorectal cancer (CRC) remains the third most common and lethal cancer in the US. Over 130,000 people are expected to be diagnosed and over 50,000 patients will die from CRC this year. In the recent years, the most exciting development has been our understanding of the molecular complexity of CRC.

Currently, four major molecular subtypes of colorectal cancer are recognized. Our study focuses on the Consensus Molecular Subtype 1, which accounts for up to 15% of CRCs, and is characterized by a deficiency in DNA mismatch repair (dMMR), a high level of mutations (i.e. hypermutated), by instability in parts of the genome called microsatellites, and by strong immune activation. Prior to our study, patients with rectal cancer that belong to this molecular subtype have represented an unknown, in terms of their prognosis, and how the tumors respond to current treatments. More importantly, this molecular subtype harbor a genetic condition that can be transmitted within the family called “Lynch Syndrome”. So we designed our study to fill these gaps in our understanding that exist in this subtype of CRCs and to highlight key clinical care issues related to the caring for patients with a genetic syndrome.

The main findings are that rectal cancers belonging to this molecular subtype have favorable prognosis, respond well to standard chemoradiation, and are linked to Lynch Syndrome and should be treated at centers with expertise in hereditary cancer syndromes. Continue reading

Life Expectancy Greatly Improved for Patients Diagnosed with CML

MedicalResearch.com Interview with:
Hannah Bower, MSc
Department of Medical Epidemiology and Biostatistics
Karolinska Institutet
Stockholm, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Previously, if left untreated or with symptomatic treatment (up to the 1970’s), the median survival time of patients with chronic myeloid leukemia (CML) ranged between two and three years. Later, interferon alpha and allogeneic stem cell transplantation were introduced. However, improvements in survival were mainly seen in younger patients. Treatment with the tyrosine-kinase inhibitor (TKI) imatinib-mesylate (Glivec®, Gleevec®) began in Sweden in the early 2000 resulting in major survival improvements, with the exception of the old/very elderly.

We investigated if these improvements continued to 2013 and if improvements are now observed in the elderly via the life expectancy and the loss in expectation of life; the latter of these quantifies the change in the life expectancy due to a diagnosis of CML. The great improvements in life expectancy, especially in the youngest patients, translate into great reductions in the loss in expectation of life. The major factor contributing to the improvement in the elderly is likely the increasing use of TKIs.

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Older Breast Cancer Patients Much Less Likely to Receive 21-Gene Recurrence Score Testing

MedicalResearch.com Interview with:

Valentina Petkov, MD, MPH Health Scientist/Program Officer NIH/NCI/DCCPS/Surveillance Research Program

Dr. Petkov

Valentina Petkov, MD, MPH
Health Scientist/Program Officer
NIH/NCI/DCCPS/Surveillance Research Program

MedicalResearch.com: What is the background for this study?

Dr. Petkov: The number of breast cancer diagnoses is increasing in older patients because of increasing life expectancy and changing population demographics. Despite high incidence, little is known about breast cancer biology and outcomes in patients older than 70, which are often under-represented in clinical trials. The 21-gene Oncotype DX Breast Recurrence Score assay has been used in clinical practice to predict distant recurrence risk and chemotherapy benefit in lymph node negative, hormonal receptor positive (estrogen and/or progesterone receptor positive) invasive breast cancer since 2004. The goal of our study was to evaluate the role of the 21 gene assay in older patients at population level.

We used Surveillance Epidemiology and End Results (SEER) data. We included in the analysis 40,134 patients who were diagnosed with invasive breast cancer between 2004 and 2011, had negative nodes and their tumors were hormonal receptor positive and HER2 negative. Breast Cancer Specific Mortality (BCSM) was assessed at 5 years after diagnosis in patients with low risk (Recurrence Score <18), intermediate risk (Recurrence Score 18-30) and high risk (Recurrence Score >30).

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Primary Care Screening Detects Melanoma at Earlier Stage

Laura Ferris, M.D., Ph.D. Associate professor, Department of Dermatology University of Pittsburgh School of Medicine and Member of the Melanoma Program University of Pittsburgh Cancer Institute

Dr. Laura Ferris

MedicalResearch.com Interview with:
Laura Ferris, M.D., Ph.D.
Associate professor, Department of Dermatology
University of Pittsburgh School of Medicine and
Member of the Melanoma Program
University of Pittsburgh Cancer Institute

MedicalResearch.com: What is the background for this study?

Dr. Ferris: Rates of melanoma, the most dangerous form of skin cancer, are on the rise, and skin cancer screenings are one of the most important steps for early detection and treatment. Typically, patients receive skin checks by setting up an appointment with a dermatologist. UPMC instituted a new screening initiative, which was modeled after a promising German program, the goal being to improve the detection of melanomas by making it easier for patients to get screened during routine office visits with their primary care physicians (PCPs). PCPs completed training on how to recognize melanomas and were asked to offer annual screening during office visits to all patients aged 35 and older. In 2014, during the first year of the program, 15 percent of the 333,788 eligible UPMC patients were screened in this fashion.

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Acupuncture May Improved Hot Flashes in Breast Cancer Patients

MedicalResearch.com Interview with:
Giorgia Razzini, PhD

Unit of Medical Oncology Civil Hospital
Carpi Italy;

MedicalResearch.com: What is the background for this study? What are the main findings? 

Dr. Razzini: Hot flashes experienced by breast cancer patients is a significant clinical problem because there are few reliable treatment that are free of side effects and it sometime reduces compliance with endocrine therapy for prevention of cancer recurrence. Menopausal symtoms overall  heavily impact on quality of life..

Acclimat found that acupuncture combined with self-care for 3 months, is associated with significantly lower hot flash scores, compared to self-care alone ( advices on diet, physical exercise and psycoloigical support if needed).

Beneficial effects persisted up to 6 months follow-up. These effects were not associated with significant adverse events.

MedicalResearch.com: What should clinicians and patients take away from your report? 

Dr. Razzini:  Research suggests that breast cancer women do not receive adequate care for menopausal symptoms in the clinical practice of most oncology department. Our study showed that oncologists can offer them specific integrative management strategy for menopausal symptoms including acupuncture and enhanced self-care to women with breast cancer, particularly in younger women when treatment with hormonal treatment is recommended, in order to help women to stay on their therapy and improve their quality of life.
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Adding Ovarian Suppression to Tamoxifen Worsens Menopausal Symptoms in Early Breast Cancer Patients

MedicalResearch.com Interview with:

Karin Ribi, PhD, MPH Head of Quality of Life Office IBCSG International Breast Cancer Study Group Bern Switzerland

Dr. Karin Ribi

Karin Ribi, PhD, MPH
Head of Quality of Life Office
IBCSG
International Breast Cancer Study Group
Bern Switzerland 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Ribi: This study investigated the quality of life (QoL) outcomes for women in the Suppression of Ovarian Function (SOFT) trial. SOFT investigated the value of adding ovarian suppression (OFS) to tamoxifen and to determine the role of the aromatase inhibitor exemestane+OFS as adjuvant (post-surgery) therapies for hormone-sensitive early breast cancer. SOFT was conducted by the International Breast Cancer Study Group (IBCSG) in over 3000 premenopausal women from more than 500 centers worldwide. The primary analysis of SOFT compared tamoxifen alone with tamoxifen+OFS in over 2000 women, and showed that adding OFS to tamoxifen did not provide a significant benefit in the overall population of premenopausal women. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of OFS improved disease outcomes.[1]

With regard to the QoL main findings, patients on tamoxifen+OFS were more affected than patients on tamoxifen alone by hot flushes at 6 and 24 months, by loss of sexual interest and sleep disturbance at 6 months, and by vaginal dryness up to 60 months. Without prior chemotherapy, patients on tamoxifen alone reported more vaginal discharge over the 5 years than patients on tamoxifen+OFS. Symptom-specific treatment differences at 6 months were less pronounced in patients with prior chemotherapy. Changes in global QoL indicators from baseline were small and similar between treatments over the whole treatment period.
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Genetic Assay Oncotype Dx Helps Clarify Chemotherapy Decisions in HER2 Negative Breast Cancer

MedicalResearch.com Interview with:

Oleg Gluz, MD West German Study Group Breast Center Niederrhein Evangelical Hospital Bethesda Moenchengladbach, Germany

Dr. Oleg Gluz

Oleg Gluz, MD
West German Study Group
Breast Center Niederrhein
Evangelical Hospital Bethesda
Moenchengladbach, Germany

MedicalResearch.com: What is the background for this study?

Dr. Gluz: PlanB trial is a Phase III chemotherapy study performed in patients with clinically high risk HER2 negative breast cancer. After early amendement, Recurrence Score (Oncotype Dx) as a selection criterion for or against chemotherapy together with central pathology review were included into the study. Patients with very low RS of below 12 and up to 3 positive lymph nodes were recommended to omit chemotherapy based on the low genomic recurrence risk. Chemotherapy was omitted in about 15% of all patients.

For the first time we present prospective data comparing a genomical tool (Oncotype Dx) and an independent central pathology review for grade, ER, PR, and Ki-67 from a large phase III study combined with an exploratory analysis on early relapse risk.

MedicalResearch.com: What are the main findings?

Dr. Gluz: The study has two major findings:

We have found a significant discordance in risk assessment between prognostic tools (grade by local and central lab, Oncotype Dx, Ki-67).

Patients treated by endocrine therapy alone based on very low Recurrence Score had an excellent disease free survival of 97% after 3 years of follow up.

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Chemotherapy Plus Radiation Demonstrated Control of Liver Metastases in Colon Cancer

MedicalResearch.com Interview with:

Dr Guy van Hazel Clinical Professor of Medicine, School of Medicine and Pharmacology, University of Western Australia

Dr. Guy van Hazel

Dr Guy van Hazel
Clinical Professor of Medicine,
School of Medicine and Pharmacology,
University of Western Australia 

Medical Research: What is the background for this study? What are the main findings?

Dr. van Hazel: The SIRFLOX study is based on original work by Dr Bruce Gray and myself almost two decades ago, when we studied the combination of Selective Internal Radiation Therapy (SIRT) with Y-90 resin microspheres – which was absolutely new at the time – with hepatic artery chemotherapy. This study showed an increase in liver control with the addition of SIRT [Gray B et al. Ann Oncol 2001; 12: 1711–1720.].

We then proceeded to initiate a trial comparing systemic SIRT plus 5-FU/LV according to the Mayo Clinic regimen compared to the Mayo Clinic regimen alone, but unfortunately this had to be abandoned because new chemotherapy became available which made it unethical to offer the control arm. However, in those patients who were treated up to that point with SIRT plus 5-FU/LV [van Hazel G et al. J Surg Oncol 2004; 88: 78–85.] we did see a very high response rates compared to the control arm, with an impressive survival of 29 months. We subsequently did a phase l/ll study of modified FOLFOX6 with or without SIRT and again found very high response rates [Sharma R et al. J Clin Oncol 2007; 25: 1099–1106.].  This led us to launch the SIRFLOX study in 2007.

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Many Cancer Survivor Face Heart Elevated Disease Risk

MedicalResearch.com Interview with:

Saro H. Armenian, DO, MPH Associate Professor Departments of Pediatrics and Population Sciences City of Hope Comprehensive Cancer Center Director of the Childhood Cancer Survivorship Clinic Duarte, CA

Dr. Saro Armenian

Saro H. Armenian, DO, MPH
Associate Professor
Departments of Pediatrics and Population Sciences
City of Hope Comprehensive Cancer Center
Director of the Childhood Cancer Survivorship Clinic
Duarte, CA

 

 

Medical Research: What is the background for this study? What are the main findings?

Dr. Armenian: There are an estimated 14 million cancer survivors living in the U.S. today, and this number is expected to reach 19 million by 2024. Among these cancer survivors, nearly two-thirds will have survived more than five years beyond their cancer diagnosis, and two out of every five will be considered a ten-year survivor, contributing to a growing population of aging cancer survivors. Until now, very little was known about the cardiovascular health of adult long-term cancer survivors.

For the current study, we relied on diagnosis/procedures routinely recorded in a large integrative healthcare system that includes racially/ethnically and socioeconomically diverse members who are broadly representative of the residents in Southern California. Cardiovascular outcomes were captured from a wide variety of healthcare delivery settings (inpatient and outpatient, primary and sub-specialty care). Importantly, cancer survivors included in the current study continued to receive their primary and subspecialty care within this system well-beyond their initial cancer diagnosis (5- and 10-year retention rate: 81% and 70%, respectively), providing us with reliable population-based estimates of long-term cardiovascular disease (CVD) risk.

We found an up to 70% higher risk of CVD (ischemic heart disease, stroke, or cardiomyopathy/ heart failure) in patients diagnosed with breast, kidney, lung/bronchus, multiple myeloma, non-Hodgkin lymphoma, and ovarian cancer when compared with an age- sex- and zip-code matched non-cancer controls.

Cancer survivors who had multiple modifiable risk factors such as hypertension, diabetes, dyslipidemia were at highest risk of developing cardiovascular disease  later in life, irrespective of cancer diagnosis. Importantly, cancer survivors who developed CVD were significantly more likely to die from all causes when compared to cancer survivors who did not develop CVD. While the reasons for these findings are not clear, it is possible that the presence of CVD can markedly diminish treatment options or planned duration of therapy at the time of cancer recurrence, thus compromising the optimal long-term management of a cancer patient.
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Age at Primary Breast Cancer Affects Risk of Age at Primary Breast Cancer on Contralateral Breast Cancer Risk in BRCA1/2 Carriers

Dr. Marjanka Schmidt PhD Group Leader, Molecular Pathology Netherlands Cancer Institut

Dr. Schmidt

MedicalResearch.com Interview with:
Dr. Marjanka Schmidt PhD
Group Leader, Molecular Pathology
Netherlands Cancer Institute

Medical Research: What is the background for this study? What are the main findings?

Dr. Schmidt: BRCA1/2 mutation carriers who developed a primary breast cancer are thought to be at high risk to develop a contralateral breast cancer (breast cancer in the opposite breast). Our study is one of the first to provide unbiased risk estimates for young breast cancer patients with a pathogenic BRCA1/2 mutation. We also showed that age of onset of the first breast cancer is a predictor for the development of contralateral breast cancer in BRCA1/2 mutation carriers, but not in non-carriers.
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Androgen Deprivation Therapy May Raise Risk of Alzheimer’s Disease

Kevin T. Nead, MD, MPhil Dept. of Radiation Oncology Perelman School of Medicine University of Pennsylvania

Dr. Kevin Nead

MedicalResearch.com Interview with:
Kevin T. Nead, MD, MPhil
Dept. of Radiation Oncology
Perelman School of Medicine
University of Pennsylvania

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Nead: There are a growing number of studies suggesting that the use of  Androgen Deprivation Therapy (ADT)  may be associated with cognitive changes and some of these changes overlap with characteristic features of Alzheimer’s disease. In addition, low testosterone levels have been associated with Alzheimer’s disease risk and ADT lowers testosterone levels. Despite these findings, we could not identify any studies examining the association between ADT and Alzheimer’s disease risk. We therefore felt this study could make an important contribution in guiding future research to fully understand the relative risks and benefits of ADT.

We examined electronic medical record data from Stanford University and Mt. Sinai hospitals to identify a cohort of 16,888 patients with prostate cancer. We found that men with prostate cancer who received Androgen Deprivation Therapy were more likely to develop Alzheimer’s disease than men who did not receive  Androgen Deprivation Therapy. We also found that this risk increased with a longer duration of ADT. These results were consistent using multiple statistical approaches and separately at both Stanford and Mr. Sinai.

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MRI May Detect More Early Contralateral Breast Cancer But Not Prevent Advanced Disease

Shiyi Wang, MD, PhD Assistant Professor of Epidemiology (Chronic Diseases) Yale School of Public Health

Dr. Wang

MedicalResearch.com Interview with:
Shiyi Wang, MD, PhD

Assistant Professor of Epidemiology (Chronic Diseases)
Yale School of Public Health

Medical Research: What is the background for this study?

Dr. Wang: As magnetic resonance imaging (MRI) of the breast has become part of medical care, there is increasing concern that this highly sensitive test might identify health problems that otherwise would not have had an impact on the patient – so called “overdiagnosis”. However, even if MRI use leads to overdiagnosis, the main “theoretical” benefit of early detection by MRI is to prevent future advanced diseases, the prognosis of which is deleterious. A systematic literature review found that, compared to mammography and/or ultrasound, MRI had a 4.1% incremental contralateral breast cancer (breast cancer in the opposite breast) detection rate. At this point, the impact of MRI on long-term contralateral breast cancer outcomes remains unclear. 

Medical Research: What are the main findings?

Dr. Wang: Analyzing the Surveillance, Epidemiology, and End Results-Medicare dataset, we compared two groups of women who had breast cancer (one group receiving an MRI, and the other not) in terms of stage-specific contralateral breast cancer occurrences. We found that after five years, the MRI group had a higher detection rate of cancer in the opposite breast than the non-MRI group (7.2 % vs. 4.0%). Specifically, MRI use approximately doubles the detection rate of early stage contralateral breast cancer, but does not decrease the incidence of advanced stage contralateral breast cancer occurrences after a 5-year follow-up. Our results indicate that nearly half of additional breast cancers detected by the preoperative MRI were overdiagnosed, which means that many of these occult cancers not detected by MRI would not have become clinically evident over the subsequent 5 years. There was no evidence that MRI use was benefiting women because the rate of advanced cancer was similar in the MRI and the non-MRI groups.

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Menopausal Hormone Therapy May Raise Risk Of Basal Cell Carcinoma

MedicalResearch.com Interview with:
Elizabeth K. Cahoon, PhD
Radiation Epidemiology Branch
Division of Cancer Epidemiology and Genetics, National Cancer Institute
National Institutes of Health
Department of Health and Human Services
Bethesda, MD

Medical Research: What is the background for this study? What are the main findings?

Dr. Cahoon: Although basal cell carcinoma (BCC) is the most common cancer in the United States, there is relatively little research on risk factors since few population-based cancer registries do not capture information on this malignancy.

Sun exposure (in particular ultraviolet radiation) is the primary risk factor for basal cell carcinoma, but less is known about other factors that may affect this risk. A previous study found a relationship between menopausal hormone therapy (MHT) use and increased risk of BCC in a population of Danish women.

In our study we looked to see if factors related to estrogen exposure from multiple sources was associated with basal cell carcinoma risk in a large, nationwide, prospective study. These included use of oral contraceptives or menopausal hormone therapy, but also reproductive factors (like age at menarche and menopause).

We observed that women who experienced natural menopause later in life were more likely to develop basal cell carcinoma compared to women who had natural menopause at a younger age.

In addition, women who reported using menopausal hormone therapy for one year or longer were more likely to develop basal cell carcinoma compared to women who did not report MHT use.

Women who reported natural menopause and menopausal hormone therapy use for 10 or more years had the highest risk of basal cell carcinoma, compared to women with no menopausal hormone therapy use.
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Patients with Colon Cancer May Have Memory and Cognitive Impairments

Dr Janette Vardy  BMed (Hons), PhD, FRACP A.Prof of Cancer Medicine University of Sydney Medical Oncologist ,Concord Cancer Centre Concord Repatriation & General Hospital Concord, Australia

Dr. Vardy

MedicalResearch.com Interview with:
Dr Janette Vardy  BMed (Hons), PhD, FRACP

A.Prof of Cancer Medicine
University of Sydney
Medical Oncologist ,Concord Cancer Centre
Concord Repatriation & General Hospital
Concord, Australia 

Medical Research: What is the background for this study?

Dr. Vardy: Many patients complain that their memory and concentration is not as good after chemotherapy.  Most of the studies have been in younger women with breast cancer, and are often limited by small sample sizes and short term follow up.    This is the largest longitudinal cohort study assessing impacts of cancer and its treatment on cognitive function.

We evaluated changes in cognitive function in 289 men and women with localized colorectal cancer (CRC), comparing those who received chemotherapy to those who did not require chemotherapy, 73 with metastatic disease, and a group of 72 healthy controls.?The localized CRC patients were assessed at baseline (soon after diagnosis and prior to any chemotherapy), 6, 12 and 24 months.  The healthy controls and metastatic group were assessed at baseline, 6 and 12 months.  We also examined underlying mechanisms.

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How Often Should Patients With Familial Colorectal Cancer Risk Be Screened?

Hans F.A. Vasen, MD Department of Gastroenterology Leiden University Medical Center and  Netherlands Foundation for the Detection of Hereditary Tumours Leiden, the Netherlands

Dr. Vasen

MedicalResearch.com Interview with:
Hans F.A. Vasen, MD

Department of Gastroenterology
Leiden University Medical Center and
Netherlands Foundation for the Detection of Hereditary Tumours
Leiden, the Netherlands

Medical Research: What is the background for this study?

Dr. Vasen: People with familial colorectal cancer (CRC) have a 3-6 fold increased risk of
colorectal cancer. It has been estimated that about 2% of the population have familial CRC (about 2.7 million people in the US). Previous studies showed that colonoscopic surveillance reduces the CRC-mortality by >80%. In people with hereditary CRC, i.e., Lynch syndrome (10 fold increased risk of CRC), an intensive screening program with colonoscopy 1x/1-2 years, is recommended. In familialcolorectal cancer, the optimal screening program  is unknown.

Medical Research: What are the main findings?

Dr. Vasen: In this randomized trial with 528 individuals at risk for familial CRC, we compared screening intervals of 3 and 6 years. We found that patients had significant more high-risk adenomas (precursor lesions of CRC) at 6-years-follow-up compared to at 3-years-follow-up. However, because of the relatively low rate of high-risk adenomas at 6 years (7%) and the absence of colorectal cancer in the 6-years group, we consider a 6-year-interval safe.

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Most Terminally Ill Cancer Patients Not Aware Of Their Life Expectancy

Holly G. Prigerson, Ph.D. Irving Sherwood Wright Professor in Geriatrics Professor of Sociology in Medicine Director, Center for Research on End of Life Care Weill Cornell Medical College New York Presbyterian Hospital New York City, New YorkMedicalResearch.com Interview with:
Holly G. Prigerson, Ph.D.
Irving Sherwood Wright Professor in Geriatrics
Professor of Sociology in Medicine
Director, Center for Research on End of Life Care
Weill Cornell Medical College
New York Presbyterian Hospital
New York City, New York 10065

Medical Research: What is the background for this study? What are the main findings?

Dr. Prigerson: Research has revealed that a majority of terminally ill cancer patients do not realize that they are dying. We wanted to know if terminally ill patients would report wanting to know their life expectancy, how many oncologists shared their life expectancy estimate for the patient with them, and how that prognostic disclosure affected the patient’s accuracy.  We found that 71% of terminally ill cancer patients wanted to know their life expectancy, but only 17.6% were told it by their oncologist. Those who were told were much more realistic than those who were not told, about 17 months closer to their actual survival time from out baseline assessment.

Oncologists who shared the prognosis did not psychologically injure patients (eg make them significantly more anxious or depressed) nor was their relationship harmed.

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African American Women Have More Aggressive Breast Cancer Tumor Biology

Aditya Bardia MBBS, MPH Attending Physician, Massachusetts General Hospital Cancer Center, Assistant Professor, Harvard Medical School Boston, MA 02114MedicalResearch.com Interview with:
Aditya Bardia MBBS, MPH
Attending Physician, Massachusetts General Hospital Cancer Center,
Assistant Professor, Harvard Medical School
Boston, MA 02114

 

Medical Research: What is the background for this study? What are the main findings?

Response:  Multiple studies have consistently shown that African American women with cancer, including breast cancer, have worse outcomes than Caucasian counterparts. While socioeconomic issues, including access to care plays an important role, the contribution of tumor biology has been less clear.

In this study, utilizing exome sequencing data, we linked the racial distribution of primary breast cancer with tumor genotypic traits, including somatic mutations, gene-expression profiles and intra-tumor heterogeneity. We observed that in addition to having a higher prevalence of triple negative breast cancer than Caucasian women (something that has been documented in the literature), African American women had a significantly higher prevalence of TP53 mutations, TNBC basal-like 1 and mesenchymal stem-like tumors, and intratumor genetic heterogeneity, and all of which suggest more aggressive tumor biology, suggesting that differences in tumor genomic profile contribute, at least partly, to the known racial disparity in survival between African Americans and Caucasians breast cancer patients.

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Distance, Insurance and Number of Oncologists Limit Access To Chemotherapy

Anna Lin, MBA, PHD Senior Epidemiologist, Health Services Research American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303MedicalResearch.com Interview with:
Anna Lin, MBA, PHD
Senior Epidemiologist, Health Services Research
American Cancer Society, Inc.
250 Williams St.
Atlanta, GA 30303

Medical Research: What is the background for this study?

Dr. Lin: Evidence-based guidelines recommend the use of adjuvant chemotherapy in patients with Stage III colon cancer within 90 days of colectomy to improve disease-free and overall survival; however, a substantial proportion of patients do not receive this treatment.  Geographic access to care may be associated with receipt of chemotherapy but has not been fully examined.

Medical Research: What are the main findings?

Dr. Lin: The main findings of this study indicate that patients traveling more than 50 miles were less likely to receive adjuvant chemotherapy for Stage III node-positive colon cancer.  In addition, patients who had either no insurance or public (non-private) insurance and resided in areas with low density of oncologists were less likely to receive adjuvant chemotherapy.

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Electronic Messages Improved Timeliness of Cancer Diagnosis

Hardeep Singh, MD MPH Chief, Health Policy, Quality and Informatics Program, Houston Veterans Affairs Health Services Research Center for Innovations Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine Houston TX 77030
MedicalResearch.com Interview with:
Hardeep Singh, MD MPH
Chief, Health Policy, Quality and Informatics Program,
Houston Veterans Affairs Health Services Research Center for Innovations
Michael E. DeBakey Veterans Affairs Medical Center and
Baylor College of Medicine
Houston TX 77030

Medical Research: What is the background for this study? What are the main findings?

Dr. Singh: Missed or delayed diagnoses are among the most common patient safety concerns in outpatient settings, and measuring and reducing them is a high priority. Our computerized triggers scanned huge amounts of patient data in the electronic health record and flagged individuals at risk for delays in follow-up of cancer-related abnormal clinical findings.  Records of all patients flagged by the computerized trigger algorithm in the intervention group were reviewed to determine the presence of delay and if delay was confirmed, we communicated this information to their clinicians. We found that patients seeing clinicians who were notified of potential delays had more timely diagnostic evaluation for both prostate and colon cancer and more patients in the intervention part of the study had received diagnostic evaluation by the time we completed our final review.

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Music Therapy Reduced Anxiety During Ambulatory Breast Cancer Surgery

Jaclyn Bradley Palmer, MM, MT-BC University Hospitals Of Cleveland Cleveland, OHMedicalResearch.com Interview with:
Jaclyn Bradley Palmer, MM, MT-BC
University Hospitals Of Cleveland
Cleveland, OH

 Medical Research: What is the background for this study? What are the main findings?

Response: Patients awaiting breast cancer surgery may be understandably anxious. While pharmacologic intervention may reduce anxiety, higher doses of preoperative drugs can depress circulation and respiration, making alternative measures a particular interest. Music therapy is the clinical use of music interventions to accomplish individualized goals within a therapeutic relationship by a board-certified music therapist. While music in surgery has been researched under the label of “music therapy”, many of the studied investigations illicit recorded music provided by non-music therapy staff, making it truly “music medicine” practices instead. In this investigation, the effect of both live and recorded music therapy on anxiety, anesthesia requirements, recovery time and patient satisfaction were studied perioperatively. Breast cancer surgery patients were engaged in a brief music therapy session which consisted of one live or recorded preferred song choice, followed by discussion and processing of emotions. Compared to usual care, both live and recorded music therapy groups experienced significantly greater reductions in anxiety (p<.001) with point reductions of 27.5 (42.5%) and 26.7 (41.2%), respectively. During surgery, both music groups listened to music-therapist selected recorded, instrumental harp music, chosen for it’s evidence-based therapeutic value of smooth lines, consistent volumes and stable melodies. In measuring the amount of interoperative drug (propofol) needed to reach moderate sedation, the intraoperative music was not found to have an effect in this trial. Patient satisfaction was universally high in all three study groups. Those who received live music preoperatively were discharged an average of 12.5 minutes sooner than those who received recorded music preoperatively, although neither music group was dischanged significantly sooner than the control group. Subjective reactions to the music interventions relayed that music therapy in surgery was an enjoyable addition.

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Sexual Function Improved With Lidocaine Cream in Breast Cancer Survivors

Martha F. Goetsch, MD, MPH Oregon Health & Science University Portland, OR 97239MedicalResearch.com Interview with:
Martha F. Goetsch, MD, MPH
Oregon Health & Science University
Portland, OR 97239

MedicalResearch: What is the background for this study?

Dr. Goetsch: Women who are survivors of breast cancer now number about 3 million in the US.  Therapy for breast cancer is anchored in creating a state of postmenopause in which estrogen is eliminated from the system. One of the most difficult symptoms of lack of estrogen is dyspareunia, the term for pain with intercourse. The old term “vulvovaginal atrophy” has been changed to “genitourinary syndrome of menopause” by agreement of two specialty societies. Because of my focus in the gynecologic specialty of vulvar pain, I have felt that this menopausal symptom is more than a condition of atrophy.  Additionally, my clinical experience has led me to believe that the exquisite tenderness is located in the vulvar vestibule rather than in the vagina. The vestibule is the inner vulva or entryway before the vagina. This study was devised to answer these hypotheses.

I predicted that the population most likely to represent the worst examples of postmenopausal dyspareunia was the population of women who cannot use estrogen due to being survivors of breast cancer. I treated the problem as a pain problem rather than solely a problem of dryness.

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Long Term Survival After Breast Cancer Diagnosis Has Increased For All Age Groups

Mitchell H. Gail, M.D., Ph.D. Senior Investigator Biostatistics Branch Division of Cancer Epidemiology and Genetics National Cancer Institute National Institutes of Health Rockville MD 20850-9780MedicalResearch.com Interview with:
Mitchell H. Gail, M.D., Ph.D.

Senior Investigator
Biostatistics Branch
Division of Cancer Epidemiology and Genetics
National Cancer Institute National Institutes of Health
Rockville MD 20850-9780

Medical Research: What is the background for this study?

Dr. Gail: In the United States, breast cancer survival following diagnosis has been improving since the 1970s. We wanted to understand what might explain these shifts, to fully characterize the changes over time, and to explore whether tumor size and estrogen receptor status could help explain the  trends in age- and stage-specific breast cancer death rates after diagnosis.

We evaluated survival from breast cancer from the date of diagnosis of all women diagnosed with invasive breast cancer in the US SEER Cancer Registries between 1973 and 2010. We excluded women with ductal or lobular carcinoma in situ.  We analyzed separate age groups (<50, 50-69, 70+ years) and SEER stage of disease (local, regional, distant).

Medical Research: What are the main findings?

Dr. Gail: Between 1973 and 2010, breast cancer death rates after diagnosis in the United States have fallen for each age group of women diagnosed with local or regional stage disease, not only in the first five years after diagnosis, but also thereafter.  For women under age 70, rates also fell for women with distant disease.

Changes in tumor size or estrogen-receptor status do not explain much of the improvement among women under age 70 years, but do explain roughly half the improvement in 70+ year old women in the first five years after diagnosis. Continue reading

Younger Black Men With Breast Cancer Have Higher Mortality Rate

Helmneh Sineshaw, MD, MPH Senior Epidemiologist, Health Services Researcher American Cancer Society, Inc Atlanta, GA 30303MedicalResearch.com Interview with:
Helmneh Sineshaw, MD, MPH
Senior Epidemiologist, Health Services Researcher
American Cancer Society, Inc
Atlanta, GA 30303

MedicalResearch: What is the background for this study?

Dr. Sineshaw: Male breast cancer is a rare disease, and its incidence rate is increasing. Younger black men have a higher breast cancer incidence than their white counterparts. Although black/white disparities in treatment receipt and survival among women with breast cancer have been widely documented in the literature, there have been few similar studies in men with breast cancer. Previous studies were based on smaller sample size, older databases, or using data from elderly patients.

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Melanoma Survival Improved By Cancer-Killing Virus

Howard L. Kaufman, MD, FACS Rutgers Cancer Institute of New Jersey New Brunswick, NJMedicalResearch.com Interview with:
Howard L. Kaufman, MD, FACS
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

Medical Research: What is the background for this study? What are the main findings?

Response: The study clearly demonstrated that advanced melanoma patients achieved a significant improvement in both response rate and durable response rate with Talimogene laherparepvec, or T-VEC. T-VEC is the first oncolytic virus to show a clinical benefit in a randomized phase 3 clinical trial for the treatment of cancer. Patients who received T-VEC also had an improved progress-free and overall survival with nearly 11% obtaining a complete response. T-VEC is an oncolytic virus that mediates anti-tumor activity by directly killing injected tumor cells and by initiating a systemic immune response. Treatment was also associated with few side effects, which were mostly low grade fever, fatigue, chills, nausea and pain at the injection site.

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Pacritinib Improved Disease Control In Myelofibrosis and Reduced Need For Blood Transfusions

Ruben A. Mesa, MD, FACP Consultant Hematologist Chair, Division of Hematology & Medical Oncology Deputy Director, Mayo Clinic Cancer Center Professor of Medicine Mayo Clinic Cancer Center NCI Designated Comprehensive Cancer Center Scottsdale, AZMedicalResearch.com Interview with:
Ruben A. Mesa, MD, FACP
Consultant Hematologist
Chair, Division of Hematology & Medical Oncology
Deputy Director, Mayo Clinic Cancer Center
Professor of Medicine Mayo Clinic Cancer Center
NCI Designated Comprehensive Cancer Center
Scottsdale, AZ

Medical Research: What is the background for this study? What are the main findings?

Dr. Mesa: Myelofibrosis is a rare and chronic blood cancer associated with significantly reduced quality of life and shortened survival. In patients with this disease, spleen enlargement (splenomegaly) is a very common and debilitating symptom – and as the disease progresses, the body slows production of important blood cells.

The results presented at ASCO were from the PERSIST-1 study, which is a Phase 3 registration-directed trial designed to compare pacritinib — an investigational oral multikinase inhibitor with specificity for JAK2 and FLT3 – to best available therapy (exclusive of a JAK inhibitor) in patients with myelofibrosis — regardless of their platelet counts.  Data from this study showed that compared to best available therapy, pacritinib resulted in a significantly higher proportion of patients with spleen volume reduction and control of disease-related symptoms, regardless of platelet levels at the time of enrollment.

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Genomic Instability Biomarker May Help Predict Treatment Response In Triple Negative Breast Cancer

MedicalResearch.com Interview with:
Melinda L. Telli, M.D. Assistant Professor of Medicine Stanford University Division of Medical Oncology Stanford, CA
Melinda L. Telli, M.D.
Assistant Professor of Medicine
Stanford University
Division of Medical Oncology

Stanford, CA 94305-5826

Medical Research: What is the background for this study? What are the main findings?

Response: A major goal of this study was to explore a DNA damaging chemotherapy regimen in patients with newly diagnosed early-stage triple-negative or BRCA1/2 mutation-associated breast cancer. This was based on the hypothesis that these types of tumors are more responsive to DNA damaging therapeutics. A second major goal was to identify predictors of response to this platinum-based therapy among patients with sporadic triple-negative breast cancer (TNBC).

Overall, this study demonstrated that the non-anthracycline and non-taxane neoadjuvant regimen of gemcitabine, carboplatin and iniparib resulted in a 36% pathologic complete response rate (pCR). This compares favorably to pCR rates commonly observed with anthracycline and taxane-based regimens in this group of patients. The response rate was higher among triple-negative breast cancer patients with a germline BRCA1 or BRCA2 mutation (56%).

Given the hypothesis of underlying DNA repair defects in sporadic triple-negative breast cancer, we also evaluated a novel measure of genomic instability to detect the accumulation of changes in the genomic landscape of a tumor attributable to defective homologous recombination DNA repair. Homologous recombination deficiency was assessed by loss of heterozygosity (HRD-LOH) in pretreatment core breast biopsies. Very importantly, we found that the HRD-LOH assay was able to identify patients with sporadic TNBC lacking a BRCA1 or BRCA2 mutation, but with an elevated HRD-LOH score, who achieved a favorable pathologic response. Continue reading

Many Women With Breast Cancer Want to Discuss Genetic Testing

Dr. Reshma Jagsi MD, DPhil Associate Professor and Deputy Chair for Faculty and Financial Operations in the Department of Radiation Oncology at the University of Michigan Health System Research Investigator at the Center for Bioethics and Social Sciences in Medicine University of MichiganMedicalResearch.com Interview with:
Dr. Reshma Jagsi MD, DPhil
Associate Professor and Deputy Chair for Faculty and Financial Operations in the Department of Radiation Oncology at the University of Michigan Health System
Research Investigator at the Center for Bioethics and Social Sciences in Medicine
University of Michigan

Medical Research: What is the background for this study? What are the main findings?

Dr. Jagsi: We surveyed women diagnosed with breast cancer and found that many women were concerned about the genetic risk of developing other cancers themselves or of a loved one developing cancer.  Overall, 35 percent of the women we studied expressed a strong desire for genetic testing, but 43 percent of those did not have a relevant discussion with a health care professional. In addition, minority patients with a strong desire for testing were less likely to discuss it with a professional, even though studies show that minority patients are not at lower risk for these mutations.

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Integrated Health Care Reduced Racial Disparities in Colon Cancer Treatment

Kim F. Rhoads, MD, MS, MPH, FACS Assistant Professor of Surgery Director, Community Partnership Program Stanford Cancer Institute Unit Based Medical Director, E3 Surgery and Surgical Subspecialties Stanford University Stanford, Ca 94305MedicalResearch.com Interview with:
Kim F. Rhoads, MD, MS, MPH, FACS
Assistant Professor of Surgery
Director, Community Partnership Program
Stanford Cancer Institute Unit Based Medical Director, E3 Surgery and Surgical Subspecialties Stanford University Stanford, Ca 94305

Medical Research: What is the background for this study? What are the main findings?

Dr. Rhoads: Colon cancer is the 3rd most common cancer in US men and women and is the 2nd most common cause of cancer death. For at least 2 decades, minorities with colon cancer have suffered a 15-20% additional risk of death when compared with non-minority patients. Our study set out to understand the influence of the location where treatment was delivered and the quality of care received, on overall survival and racial disparities.

We examined more than 30,000 patients who were diagnosed and treated for colon cancer in California from 2001 through 2006.  Using cancer registry data linked to state level inpatient data and hospital information, we compared the rates of National Comprehensive Cancer Network (NCCN) guideline adherence and mortality by location of care and by race. We found that patients treated within an integrated health system (IHS) received NCCN guideline based care at higher rates than those treated outside the system—about 3% higher rates of surgery; and more than 20% higher rates of stage appropriate chemotherapy. The rates of guideline based care were nearly equal between the racial groups treated inside the IHS.  Propensity score matched comparisons revealed a lower risk of death for all patients and no racial disparities associated with treatment within the Integrated system.  For patients treated outside IHS, the disparity in mortality was explained by accounting for differences in receipt of evidence based care by race.

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New Mayo Model Better Predicts Breast Cancer Risk After Benign Biopsy

MedicalResearch.com Interview with:
Dr.  Amy C. Degnim MD Professor of Surgery Mayo Clinic, Rochester.Dr.  Amy C. Degnim MD
Professor of Surgery
Mayo Clinic, Rochester.

Medical Research: What is the background for this study? What are the main findings?

Dr. Hartmann: Approximately 1 million women in the US every year have a breast biopsy that shows benign findings. We have found that the specific features of the breast tissue seen under the microscope can help to predict the risk of breast cancer in the future.  We developed a mathematical formula to calculate breast cancer risk based on the features seen in the biopsy tissue (named the BBD-BC model).  We found that using these microscopic features provides more accurate predictions of risk than the previous standard- the Breast Cancer Risk Assessment Tool (BCRAT).

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Genetic Basis For Acute Lymphoblastic Leukemia Drug Toxicity Identified

MedicalResearch.com Interview with:
Jun J. Yang  Ph.D.

Assistant Member Dept. of Pharm. Sci.
St. Jude Children’s Research Hospital
Memphis, TN 38105

Medical Research: What is the background for this study? What are the main findings?

Dr. Yang: Mercaptopurine is highly effective in acute lymphoblastic leukemia (ALL) and essential for the cure of this aggressive cancer. However, it also has a narrow therapeutic index with common toxicities. Identifying genetic risk factors for mercaptopurine toxicity will help us better understand how this drug works and also potentially enable clinicians to individualize therapy based on patients’ genetic make-up (precision medicine).

In addition to confirming the role of TPMT, we have identified another important genetic risk factor (a genetic variation in a gene called NUDT15) for mercaptopurine intolerance. Patients carrying the variant version of NUDT15 are exquisitely sensitive and required up to 90% reduction of the normal dose of this drug. TPMT variants are more common in individuals of African and European ancestry, whereas NUDT15 variants are important in East Asians and Hispanics.

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Non-Small Cell Lung Cancer: Stereotactic Radiation Plus Chemo Improved Survival

Dr. Puneeth Iyengar (left) and Dr. Robert Timmerman

Dr. Puneeth Iyengar (left) and Dr. Robert Timmerman

MedicalResearch.com Interview with:
Dr. Puneeth Iyengar, MD, PhD
.
Assistant Professor Director of Clinical Research
Dept of Radiation Oncology Co-leader, Thoracic Disease Oriented Team Harold Simmons Cancer Center
UT Southwestern Medical Center  Dallas, TX

Medical Research: What is the background for this study? What are the main findings?

Response: Stage IV Non-small cell lung cancer (NSCLC) remains a disease of limited survival, in the range of one year for a majority of patients who historically have gone on to receive systemic therapy only. Disease in this patient population most often recurs in the sites of original gross disease. With greater understanding of the biology and patterns of failure that occur in stage IV NSCLC, it is becomingly increasingly obvious that there are subsets of patients, those with limited sites of metastatic disease, who may benefit with more aggressive local therapy in addition to systemic agents to effectuate longer progression free survival (PFS) and potentially overall survival (OS). Since failures of treatment occur most commonly in original gross deposits, local non-invasive therapy in the form of stereotactic body radiation therapy (SBRT) may offer a means to curtail the recurrences, perhaps as a way to shift the time to and patterns of failure.

To address these concepts, a multi institutional single arm phase II study was conducted at UT Southwestern Medical Center in Dallas and University of Colorado Medical Center. Twenty-four patients with limited metastatic NSCLC (fewer than or equal to six sites of disease including the primary) who had progressed through at least one systemic therapy regimen were treated with SBRT to all sites of gross disease and the EGFR inhibitor erlotinib with progression free survival the primary end point. The results of the study were very significant, with a PFS in this study cohort of 14.7 months, compared to historical ranges of 2-4 months, and an OS of 20.4 months, compared to historical ranges of 6-9 months for this same patient population. The SBRT treatments were found to be very safe and efficacious – only 3 out of 47 measurable lesions irradiated recurred with a concomitant shift in failure patterns from local to distant sites. As importantly, EGFR status was evaluated in 13 patient tumors, with none harboring the most common mutations. One could, therefore, predict that with a mutation enriched population, the combination of EGFR inhibitor and SBRT may have offered even greater PFS and OS benefits. Our observations also suggest that the SBRT treatments probably contributed the most to the dramatic PFS and OS outcomes.

These findings were published in the Journal of Clinical Oncology in the December 1, 2014 print issue with an accompanying editorial.

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Increased Risk Of Leukemia After Breast Cancer Treatment

MedicalResearch.com Interview with:
Dr. Judy Karp, Dr. Antonio Wolff and  Dr. Kala Visvanathan
Breast Cancer Program
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, MD 21287

Medical Research: What is the background for this study? What are the main findings?

Response: The background for this study was the clinical observation from the Johns Hopkins Leukemia Program that a significant number of women with newly diagnosed acute myeloid leukemia had a personal history for breast and/or ovarian cancers.  This observation led to our examination of the large NCCN breast cancer database in a multidisciplinary and multi-institutional study.  The overarching finding in our study is that the risk of developing some form of leukemia following chemotherapy with or without radiation therapy, while small, continues to increase over at least 10 years without a plateau and is roughly twice what we thought it to be from previous breast cancer studies.

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HER2+ Breast Cancer: Trastuzumab Increased Survival

dr_edith_perezMedicalResearch.com Interview with:
Edith A. Perez, MD
Mayo Clinic
Jacksonville, FL 32224

Medical Research: What are the main findings of the study?

Dr. Perez: Our joint analysis of two large prospective trials showed that adding one year of Trastuzumab to otherwise standard adjuvant chemotherapy significantly improved long term survival in women with resected HER2+ breast cancer.
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Comorbiditites Contribute To Unplanned Hospitalizations Among GI Cancer Patients

MedicalResearch.com Interview with:
Joanna-Grace M. Manzano, MD

Assistant Professor
Department of General Internal Medicine

Maria E. Suarez-Almazor, MD, PhD
Barnts Family Distinguished Professor
Chief, Section of Rheumatology &
Deputy Chair, Dept. of General  Internal Medicine
UT MD Anderson Cancer Center Houston, TX

Medical Research: What are the main findings of the study?

Response: Our study established that unplanned hospitalization among elderly patients with GI cancer are very common – 93 events per 100-person years.

Certain characteristics were found to have an increased risk for an unplanned hospitalization in our cohort, namely: older age, black race, advanced disease, higher comorbidity score, residing in poor neighborhoods and dual eligibility for Medicare and Medicaid. Esophageal and gastric cancer had the highest risk for unplanned hospitalization among all GI cancer types.

Some of the observed reasons for unplanned hospitalization were potentially preventable and related to the patient’s comorbid illness.
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Central Venous Catheters Raise Infection Risk in Cancer Patients

Allison Lipitz-Snyderman, PhD Assistant Attending Outcomes Research Scientist Center for Health Policy and Outcomes Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer Center New York, NY  10065MedicalResearch.com Interview with:
Allison Lipitz-Snyderman, PhD
Assistant Attending Outcomes Research Scientist
Center for Health Policy and Outcomes
Department of Epidemiology and Biostatistics
Memorial Sloan Kettering Cancer Center New York, NY  10065

Medical Research: What are the main findings of the study?

Dr. Lipitz-Snyderman: Long-term central venous catheters are used to administer intravenous fluids and treatments such as chemotherapy.  These catheters can also be a source of bloodstream infections which can be harmful to cancer patients.  However, this risk is not well understood.  In our study, we found that the use of these catheters was associated with an increased risk of infections for patients with cancer.  We used a population-based dataset, SEER-Medicare, to study this issue in older adult cancer patients.  This dataset allowed us to study patients treated in different institutions and follow them over time.
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