Gene Linked to Colon Cancer in Younger Patients Identified

MedicalResearch.com Interview with:

Valentine N. Nfonsam, MD, MS, FACSAssociate Professor of SurgeryProgram Director, General Surgery ResidencyColon and Rectal SurgeryDivision of Surgical OncologyUniversity of Arizona, Tucson

Dr. Nfonsam

Valentine N. Nfonsam, MD, MS, FACS
Associate Professor of Surgery
Program Director, General Surgery Residency
Colon and Rectal Surgery
Division of Surgical Oncology
University of Arizona, Tucson 

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

Response: The overall incidence of colon cancer in the United states has gone down in the last few decades. However, there has been a significant increase in the incidence of sporadic colon cancer is young patients (<50 years old). The etiology of this phenomenon is likely multi-factorial.

These young patients do present with more advanced disease and with aggressive features. We demonstrated in our study that the colon cancer tumor biology was different between young and older patients. We also singled out a particular gene, Cartilage oligomeric Matrix Protein (COMP) which was significantly over-expressed in young patients and demonstrated its role in cancer proliferation and metastasis and also its potential as a prognostic biomarker since we were able to detect it in plasma.

Continue reading

AI Poised to Revolutionize Radiation Therapy for Cancer

MedicalResearch.com Interview with:

Raymond H Mak, MDRadiation OncologyBrigham and Women's Hospital

Dr. Mak

Raymond H Mak, MD
Radiation Oncology
Brigham and Women’s Hospital

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

  • Lung cancer remains the most common cancer, and leading cause of cancer mortality, in the world and ~40-50% of lung cancer patients will need radiation therapy as part of their care
  • The accuracy and precision of lung tumor targeting by radiation oncologists can directly impact outcomes, since this key targeting task is critical for successful therapeutic radiation delivery.
  • An incorrectly delineated tumor may lead to inadequate dose at tumor margins during radiation therapy, which in turn decreases the likelihood of tumor control.
  • Multiple studies have shown significant inter-observer variation in tumor target design, even among expert radiation oncologists
  • Expertise in targeting lung tumors for radiation therapy may not be available to under-resourced health care settings
  • Some more information on the problem of lung cancer and the radiation therapy targeting task here:https://www.youtube.com/watch?v=An-YDBjFDV8&feature=youtu.be

Continue reading

“Magic Mouthwash” Can Decrease Mouth Pain from Radiation Therapy

MedicalResearch.com Interview with:

Robert C. Miller, MD, MS, MBADepartment of Radiation Oncology, Mayo Clinic, Jacksonville, FloridaUniversity of Maryland School of Medicine, Baltimore

Dr. Miller

Robert C. Miller, MD, MS, MBA
Department of Radiation Oncology, Mayo Clinic, Jacksonville, Florida
University of Maryland School of Medicine, Baltimore

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

Response: “Magic Mouthwash” is one of the most commonly prescribed medications for oral mucositis pain during cancer therapy, but there has not been good evidence in the past to support its use.

This trial is the first large randomized controlled trial to demonstrate that both “Magic” mouthwash and doxepin rinse reduce patient reported pain during cancer therapy.

Continue reading

Pediatric Melanoma Risk Increasing in Adolescents & Young Adults, Including in Non-Whites

MedicalResearch.com Interview with:

Susan M. Swetter, MDProfessor of DermatologyDirector, Pigmented Lesion & Melanoma ProgramPhysician Leader, Cancer Care Program in Cutaneous OncologyStanford University Medical Center and Cancer Institute

Dr. Swetter

Susan M. Swetter, MD
Professor of Dermatology
Director, Pigmented Lesion & Melanoma Program
Physician Leader, Cancer Care Program in Cutaneous Oncology
Stanford University Medical Center and Cancer Institute

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

Response: The Stanford Pigmented Lesion and Melanoma and Program and Pediatric Dermatology Division participated in the long-term management of children, adolescents and young adults (<25 years of age) with melanoma and atypical melanocytic neoplasms, including atypical Spitz tumors (ASTs) that may be histopathologically challenging to differentiate from true melanoma.

Over a 23-year period, we have observed increased racial-ethnic diversity in young patients with these diagnoses, especially in the presentation of young individuals with darker skin phenotypes and more clinically amelanotic (nonpigmented) lesions compared to patients with lighter skin.  Continue reading

Cervical Cancer Subtypes Vary Among Population Sectors

MedicalResearch.com Interview with:

Farhad Islami, MD PhD Scientific Director, Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303

Dr. Islami

Farhad Islami, MD PhD
Scientific Director, Surveillance Research
American Cancer Society, Inc.
Atlanta, GA 30303 

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

Response: Despite a continuous decline in cervical cancer incidence rates, earlier studies reported an increase in cervical adenocarcinoma incidence rates. However, those reports had major limitations, as they did not account for changes in hysterectomy prevalence and used cancer occurrence data covering only 10%-12% of the U.S. population (which may not be representative of the entire population, especially racial/ethnic minorities).

Further, the most recent study examined the trends by age and histology through 2010. We examined contemporary trends in cervical cancer incidence rates in the U.S. (1999-2015) by age, race/ethnicity, major histological subtypes, and stage at diagnosis using up-to-date nationwide data after accounting for hysterectomy prevalence.

Continue reading

RNA Genetic Testing Improves Analysis of Hereditary Cancer Genes

MedicalResearch.com Interview with:
Rachid Karam, PhD

Director, Ambry Translational Genomics Lab
Ambry Genetics 

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

Response: DNA genetic testing (DGT) for hereditary cancer genes is now a well accepted clinical practice; however, the interpretation of DNA variation remains a challenge to laboratories and medical providers.

RNA genetic testing (RGT) as a supplement to DGT is a means to clarify the clinical actionability of variants in hereditary cancer genes, improving our ability to accurately apply known strategies for cancer risk reduction.

Continue reading

Surgical Outcomes Found to be Better at ‘Brand Name’ than Affiliate Cancer Hospitals

MedicalResearch.com Interview with:

Daniel J. Boffa, MDAssociate Professor of Thoracic SurgeryYale School of Medicine

Dr. Boffa

Daniel J. Boffa, MD
Associate Professor of Thoracic Surgery
Yale School of Medicine

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

Response: Prominent cancer hospitals have been sharing their brands with smaller hospitals in the community.  We conducted a series of nationally representative surveys and found that a significant proportion of the U.S. public assumes that the safety of care is the same at all hospitals that share the same respected brand.  In an effort to determine if safety was in fact the same, we examined complex surgical procedures in the Medicare database.

We compared the chance of dying within 90 days of surgery between top-ranked hospitals, and the affiliate hospitals that share their brands.  When taking into account differences in patient age, health, and type of procedure, Medicare patients were 1.4 times more likely to die after surgery at the affiliate hospitals, compared to those having surgery at the top-ranked cancer hospitals.

Continue reading

How Many Cancer Patients Use Complementary or Alternative Medicine Treatments?

MedicalResearch.com Interview with:

Nina Niu Sanford, M.D. Assistant ProfessorUT Southwestern Department of Radiation OncologyDallas TX 75390

Dr. Niu Sanford

Nina Niu Sanford, M.D.
Assistant Professor
UT Southwestern Department of Radiation Oncology
Dallas TX 75390

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

Response: There has been increasing interest in use of complementary and alternative medicine in the oncology population – both in terms of its potential efficacy and harms.

The main finding of this study is that approximately 1/3 of cancer patients and survivors self-reported using complementary or alternative medicine over the past year, the most common being herbal supplements.

Of these patients, approximately 1/3 did not disclose to their physicians that they were doing so.

Continue reading

Does Vitamin D Supplementation Impact Relapse-Free Survival in GI Cancers?

MedicalResearch.com Interview with:
Mitsuyoshi Urashima MD, PhD, MPH
Professor of Molecular Epidemiology
Jikei University School of Medicine
Tokyo, JAPAN

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

Response: Serum levels of vitamin D, increase in response to exposure to sunlight, a vitamin D-rich diet, or vitamin D supplementation. In 1989, the risk of colon cancer was estimated to be 70% lower in people with serum vitamin D levels ≥ 20 ng/mL, compared with those < 20 ng/mL.

In a cohort study, higher vitamin D levels were associated with lower total cancer incidence and lower total cancer mortality, particularly digestive system cancer mortality. However, because of the studies’ observational nature, whether lower levels of vitamin D is merely a precursor to relapse and death or causally related to shorter survival cannot be determined.

To clarify this, a randomized, double-blind, placebo-controlled trial using vitamin D supplement was performed in patients with digestive tract cancer from esophagus to rectum; this is the first trial designed to evaluate the effect of vitamin D on survival of these patients.  Continue reading

Tracing Extrachromosomal DNA Inheritance Patterns in Glioblastoma Using CRISPR

MedicalResearch.com Interview with:

Eunhee Yi, Ph.D.Postdoctoral AssociateThe Jackson Laboratory

Dr. Yi

Eunhee Yi, Ph.D.
Postdoctoral Associate
The Jackson Laboratory

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

Response: Recurrence after therapy for glioblastoma (GBM) is unavoidable. There are substantial differences among the cells of GBM tumors in the abundance and types of genetic materials. This heterogeneity is a major driver of therapy failure and disease progression. We previously reported that extrachromosomal DNA (ecDNA) elements, which reside outside the linear genome and represent a mechanism to amplify and activate oncogenes, is a potential cause of the increasing genetic diversity in GBM. Our current study is focused on the development of a novel cytogenetic tool to visualize ecDNA to visualize the behavior of these elements in live cells. We have leveraged the unique properties of ecDNA to develop a CRISPR-based “ecDNA tracing toolbox (EDTB)”.  Continue reading

Surgery Beneficial to Some HER2+ Metastatic Breast Cancer Patients

MedicalResearch.com Interview with:

Sharon S. Lum, MD, FACSProfessor in the Department of Surgery-Division of Surgical Oncology Medical Director of the Breast Health CenterLoma Linda University HealthLoma Linda University School of Medicine

Dr. Lum

Sharon S. Lum, MD, FACS, Professor
Department of Surgery-Division of Surgical Oncology
Medical Director of the Breast Health Center
Loma Linda University Health
Loma Linda University School of Medicine 

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

Response: Anecdotally, we observed that many patients with advanced HER2+ breast cancer have had tremendous responses to the new targeted therapies and the oncologists were referring them back to surgeons for consideration of local regional therapy.

While traditionally surgeons have avoided operating on metastatic breast cancer patients due to the patient’s likelihood of dying from their metastatic disease, these HER2+ patients seemed to be doing so well that surgery might make sense. In our surgical oncology clinic, we seemed to be operating more on these patients. Since these patients seemed to be living longer, they might survive long enough for their primary tumor to become a problem for them.

However, we did not have any data to support doing surgery in these cases. Prior studies have demonstrated mixed results regarding the survival benefit from surgery for stage IV breast cancer patients, but these were completed prior to routine use of anti-HER targeted therapies, so we wanted to further examine the role of surgery in HER2+ stage IV breast cancer patients.

Continue reading

Massive Reduction in Cervical Cancer Among Vaccinated Young Women

MedicalResearch.com Interview with:

Dr. Tim PalmerHonorary Senior LecturerDepartment of PathologyUniversity of EdinburghEdinburgh, UK

Dr. Palmer

Dr. Tim Palmer
Honorary Senior Lecturer
Department of Pathology
University of Edinburgh
Edinburgh, UK 

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

Response: High risk HPV infection is the obligate cause of between 70 and 90% of cervical cancers, depending upon the country. The development of vaccines against the commonest hr-HPV types has the potential to reduce the burden of cervical cancer, especially in low and middle income countries that cannot afford screening programmes. Cervical cancer affects predominantly women in their 30s and is a major public health issue even in countries with well-established screening programmes. Scotland has had a successful immunisation programme since 2008, and women immunised at age 12 to13 have been screened since 2015. We can therefore demonstrate the effect of hr-HPV immunisation on the pre-invasive stages of cervical cancer.

Continue reading

Therapeutic HPV Vaccine Can Trigger Resolution of Virus and Cervical Cancer in Some CIN Patients

MedicalResearch.com Interview with:

Diane Harper, M.D., M.P.H., M.S.Professor of Family Medicine and Obstetrics and GynecologySenior Associate Director, Michigan Institute for Clinical and Health ResearchPhysician Director for Community Outreach, Engagement and Health Disparities,Rogel Cancer CenterMichigan Medicine

Dr. Harper

Diane Harper, M.D., M.P.H., M.S.
Professor of Family Medicine and Obstetrics and Gynecology
Senior Associate Director, Michigan Institute for Clinical and Health Research
Physician Director for Community Outreach, Engagement and Health Disparities,
Rogel Cancer Center
Michigan Medicine 

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

Response: There is no current cure for women with HPV infection that has progressed to CIN 2/3 disease. The only treatment is for the diseased cervix, and does not eliminate the risk of another CIN 2/3 from the HPV infection 15-20 years later.

This vaccine is made from a live virus that has 3 genes inserted:  human cytokine IL-2, and modified forms of HPV 16 E6 and E7 proteins. When the vaccine is injected subcutaneously, the proteins for HPV 16/E6 and E7 and the cytokine LI-2 proteins are made. These proteins trigger the immune response.  This is very different form imiquimod which is topical and not specific for HPV.

Continue reading

Cancer Drug Trials: Does Changing the Endpoint from Overall Survival Hasten the Approval Process?

MedicalResearch.com Interview with:

Emerson Chen, MDChief Fellow, Hematology-Oncology, PGY-6Oregon Health & Science University

Dr. Chen

Emerson Chen, MD
Chief Fellow, Hematology-Oncology, PGY-6
Oregon Health & Science University

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

Response: Many cancer drugs are approved annually giving the appearance of innovation; however, some drugs may have been approved because of a lower bar. Use of lesser endpoints like response rate (how tumor shrinks) and progression-free survival (how tumor has delayed growth) have been proposed to speed trials when compared against traditional endpoints like overall survival (how long patients might live).

Using published trials that led to cancer drug approval from 2006 to 2017, we estimated how long it would take to get each of these three endpoints across all cancer drugs and indications to see how much time we could save by using these weaker but faster endpoints.

We see that many trials using overall survival used less time than anticipated, and many trials using response rate or progression-free survival actually took quite a bit of time.  In part that is due to researchers needing to document the duration of the response. But, whatever the reason, the time to get each of the three endpoints is actually more similar than different, and we estimate that our current use of  these faster endpoints are saving us only 11 months compared to using only overall survival.

Continue reading

HPV Vaccination Rates Low Among Adults at High-Risk for HIV Infection

MedicalResearch.com Interview with:

Lisa T. Wigfall, PhD, MCHES(R)Assistant Professor, Health and KinesiologyTexas A&M

Dr. Wigfall

Lisa T. Wigfall, PhD, MCHES(R)
Assistant Professor, Health and Kinesiology
Texas A&M

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

Response: Human papilloma virus (or HPV) is a very common sexually transmitted infection that can cause some types of cancer. These include anal, cervical, oral, penile, vaginal, and vulvar cancers. Some people such as people who are HIV-positive and men who have sex with men have a greater risk for developing HPV-associated cancers. The risk of developing anal cancer is significantly higher for men who have sex with men who are also HIV-positive.

Our study included adults who were at risk for becoming HIV-positive, which included having unprotected anal sex.

Continue reading

Almost No Increase is Childhood Cancers Among Children Conceived by IVF

MedicalResearch.com Interview with:

Logan G. Spector, Ph.D.ProfessorSuzanne Holmes Hodder Chair in Pediatric Cancer ResearchDirector, Division of Epidemiology/Clinical ResearchDepartment of PediatricsUniversity of Minnesota

Dr. Spector

Logan G. Spector, Ph.D.
Professor
Suzanne Holmes Hodder Chair in Pediatric Cancer Research
Director, Division of Epidemiology/Clinical Research
Department of Pediatrics
University of Minnesota

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

Response: Since IVF has become commonplace in the last three decades there has been concern about its potential for affecting the health of children conceived this way.  We know, for instance, that pregnancies enabled by IVF have more difficulties, and there are more birth defects among offspring.  So for this study we wished to see if children conceived by IVF have a different risk of childhoood cancer.

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

Response: There is not an increased risk of most childhood cancers among children conceived by IVF.  A class of especially rare childhood cancers known as embryonal tumors, especially embryonal liver tumors, appeared slightly more likely among children conceived by IVF.   For these few cancers, even among children conceived by IVF, they remained very rare.  Overall these results should be reassuring to parents who have used IVF. 

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

Response: For the few, rare cancers that seemed to be associated with IVF it would be helpful to see if these childrens’ tumors differ from other childrens’ tumors.  It will also be necessary to continue to follow cohorts of children conceived by IVF to see if their cancer experience differs at older ages.

MedicalResearch.com: Is there anything else you would like to add?

Response: This research took the cooperation of the Society for Assisted Reproductive Technology and over a dozen state departments of health over many years, for which we are thankful.  No disclosures.

Citation:

Spector LG, Brown MB, Wantman E, et al. Association of In Vitro Fertilization With Childhood Cancer in the United States. JAMA Pediatr. Published online April 01, 2019. doi:10.1001/jamapediatrics.2019.0392

 

Apr 1, 2019 @ 4:24 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Exercise: A Non-Pharmaceutical “Drug” To Reduce Heart Disease in Breast Cancer Patients

MedicalResearch.com Interview with:

Christina M. Dieli-Conwright, PhD, MPH, FACSM, CSCSAssistant Professor of ResearchDirector, Integrative Center for Oncology Research in ExerciseDivision of Biokinesiology & Physical Therapy, Ostrow School of DentistryDepartment of Medicine, Keck School of MedicineUniversity of Southern CaliforniaLos Angeles, CA 90033

Dr. Dieli-Conwright

Christina M. Dieli-Conwright, PhD, MPH, FACSM, CSCS
Assistant Professor of Research
Director, Integrative Center for Oncology Research in Exercise
Division of Biokinesiology & Physical Therapy, Ostrow School of Dentistry
Department of Medicine, Keck School of Medicine
University of Southern California
Los Angeles, CA 90033 

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

Response: This study was designed to assess the effects of an aerobic and resistance exercise on metabolic dysregulation in sedentary, obese breast cancer survivors, however we further examined the effects on cardiovascular disease risk measured by the Framingham Risk Score, reported here.

Our findings indicated that exercise, indeed, reduces the risk of cardiovascular disease in this population.  Continue reading

Cancer Patients Use THC and CBD Differently Than Other Medical Marijuana Patients

MedicalResearch.com Interview with:

Arum Kim, MDAssistant professor of Medicine and Rehabilitation MedicineNYU School of MedicineDirector of the Supportive Oncology ProgramPerlmutter Cancer Center

Dr. Kim

Arum Kim, MD
Assistant Professor
Medicine and Rehabilitation Medicine
NYU School of Medicine
Director of the Supportive Oncology Program
Perlmutter Cancer Center

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

Response: There is increasing interest in medical marijuana and its applications for patients with cancers. Despite increasing access, little is known regarding doses of cannabinoids – specifically tetrahydrocannabinol (THC)  and cannabidiol (CBD), methods of drug delivery, and differences in patterns of use between cancer and non-cancer patients.

Continue reading

Opioid-Related Hospitalizations Among Cancer Patients are Rare

MedicalResearch.com Interview with:

Isaac Chua MDInstructor of Medicine at Harvard Medical SchoolBoston, Massachusetts

Dr. Chua

Isaac Chua MD
Instructor of Medicine at Harvard Medical School
Boston, Massachusetts 

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

Response: Opioids are routinely prescribed for cancer-related pain, but little is known about the prevalence of opioid-related hospitalizations for patients with cancer. Although opioid addiction among patients with cancer is estimated to be as high as 7.7%, our understanding of opioid misuse is based on small, preliminary studies.

In light of the wider opioid epidemic, oncologists and palliative care clinicians frequently balance providing patients with legitimate access to opioids while protecting them and the general public from the risks of prescribing these medications.

Continue reading

Tooth Loss Linked To Greater Risk of Pancreatic Cancer Among African American Women

MedicalResearch.com Interview with:

Dr. Julie Palmer

Dr. Palmer

Julie R. Palmer, ScD
Professor, Boston University School of Medicine
Associate Director, Slone Epidemiology Center at Boston University
Boston, MA 02118 

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

Response: Since 1995, 59,000 African American women from all regions of the U.S. have participated in a Boston University research study of the health of Black women.  Study participants complete mailed or online questionnaires every two years.

Our major goal is to identify modifiable risk factors for cancers and nonmalignant conditions that disproportionately affect African Americans (e.g., pancreatic cancer, early-onset breast cancer, type 2 diabetes, uterine fibroids).  The reasons for the higher incidence of pancreatic cancer in African Americans relative to non-Hispanic White women in the U.S. are unknown.

I was aware that several recent studies in predominantly White populations had observed a higher incidence of pancreatic cancer in those who had reported poor oral health and wondered whether the higher prevalence of poor oral health among African Americans could play a role in their higher incidence of pancreatic cancer.  We had already asked about gum disease, periodontal disease, and adult tooth loss in several rounds of data collection.

After rigorous analysis, we found that women who reported any adult tooth loss had about two times the risk of future development of pancreatic cancer compared with those who had no tooth loss and had never reported periodontal disease.

The estimated risk was even greater for those who had lost five or more teeth. A similar association was observed for reports of periodontal disease, but the association was not statistically significant.

Continue reading

Gain in Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer

MedicalResearch.com Interview with:

Rita Mehta, MD, HS Clinical Professor,Chao Family Comprehensive Cancer CenterUniversity of California School of Medicine, Irvine 

Dr. Mehta

Rita Mehta, MD, HS Clinical Professor,
Chao Family Comprehensive Cancer Center
University of California School of Medicine, Irvine 

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

Response: Most patients with HR-positive breast cancer become resistant to hormonal therapies like aromatase inhibitor-anastrozole over time, and downregulating estrogen receptor was identified as a mechanism for overcoming or delaying resistance to hormonal therapy in advanced HR-positive breast cancer. The prospective, randomized phase III S0226 trial, first reported by us in NEJM 2012, showed that the selective estrogen receptor degrader fulvestrant in combination with anastrozole significantly improved progression-free survival in 707 women with HR-positive metastatic breast cancer in first-line setting.

Treatment with the selective estrogen receptor degrader (SERD) fulvestrant achieved a clinically significant and meaningful improvement in overall survival in patients with hormone receptor (HR)-positive advanced breast cancer in first-line therapy, according to the final analysis of overall survival results from the S0226 study reported by us (Mehta et al. NEJM 2019)

  • Results showed that median overall survival improved by 7.8 months with anastrozole plus fulvestrant (median overall survival = 49.8 months) compared to anastrozole (median overall survival = 42.0 months).
  • The improvement was even greater in patients with endocrine naive disease, with an absolute improvement in median overall survival of 11.9 months.
  • No new safety signals were observed with longer follow-up. 

Continue reading

Genentech Submits New Drug Application to FDA for Venclexta Plus Gazyva for Untreated CLL with Co-Existing Medical Conditions

MedicalResearch.com Interview with:

Nancy Valente, M.D.VP of Global Hematology DevelopmentGenentech

Dr. Valente

Nancy Valente, M.D.
VP of Global Hematology Development
Genentech

Dr. Valenta discusses the announcement of the submission by Genentech of a supplemental New Drug Application to the FDA for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia  with co-existing medical conditions.

MedicalResearch.com: What is the background for this study?
What are the main findings of the Phase III CLL14 study? 

Response: We completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. CLL is the most common form of adult leukemia and more than 20,000 new cases will be diagnosed in the U.S. this year.

The sNDA is based on data from the Phase III CLL14 study, which evaluated fixed-duration Venclexta in combination with Gazyva in people with previously untreated CLL. Results showed this chemotherapy-free combination can help people with previously untreated CLL live significantly longer without their disease worsening (progression-free survival; PFS) compared to standard-of-care Gazyva plus chlorambucil.

The FDA is reviewing our application under the Real-Time Oncology Review (RTOR) pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.  Continue reading

The Word ‘Cancer’ Still Affects How Patients Feel About Their Disease, Even if Low Risk

MedicalResearch.com Interview with:

Peter R. Dixon, MDDepartment of Otolaryngology-Head & Neck SurgeryInstitute of Health Policy, Management and EvaluationUniversity of TorontoToronto, Ontario, Canada 

Dr. DIxon

Peter R. Dixon, MD
Department of Otolaryngology-Head & Neck Surgery
Institute of Health Policy, Management and Evaluation
University of Toronto
Toronto, Ontario, Canada 

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

Response: The word ‘cancer’ is often associated with an aggressive and lethal disease. Innovations in screening and diagnostic tests detect some ‘cancers’ that — even if left untreated — pose very low-risk of any symptoms, progression, or mortality. Still, many of these low-risk cancers are treated aggressively and those treatments can have harmful consequences and side-effects.

We were interested in determining how influential the word ‘cancer’ is in decisions made by patients about low-risk malignant neoplasms relative to other labels for the same disease.

Continue reading

Lung Cancer: AI Can Reduce False Positives on Low-Dose CT Screening

MedicalResearch.com Interview with:

Panayiotis (Takis) Benos, Ph.D.Professor and Vice Chair for Academic AffairsDepartment of Computational and Systems BiologyAssociate Director, Integrative Systems Biology ProgramDepartment of Computational and Systems Biology, SOM andDepartments of Biomedical Informatics and Computer ScienceUniversity of Pittsburgh

Dr. Benos

Panayiotis (Takis) Benos, Ph.D.
Professor and Vice Chair for Academic Affairs
Department of Computational and Systems Biology
Associate Director, Integrative Systems Biology Program
Department of Computational and Systems Biology, SOM and
Departments of Biomedical Informatics and Computer Science
University of Pittsburgh 

 

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

Response: Low-dose computed tomography (LDCT) scans is the main method used for early lung cancer diagnosis.  Early lung cancer diagnosis significantly reduces mortality.  LDCT scans identify nodules in the lungs of 24% of the people in the high-risk population, but 96% of these nodules are benign.  Currently there is no accurate way to discriminate benign from malignant nodules and hence all people with identified nodules are subjected to follow up screens or biopsies.  This increases healthcare costs and creates more anxiety for these individuals.  By analyzing a compendium of low-dose computed tomography scan data together with demographics and other clinical variables we were able to develop a predictor that offers a promising solution to this problem. 

Continue reading

Actinic Keratosis: What is the Best Treatment for Pre-Skin Cancers?

One example of actinic keratoses on hands DermNZ

MedicalResearch.com Interview with:
Maud Jansen, MD | Resident Dermatology | PhD candidate
Dermatologie, Maastricht

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

Response: Actinic keratosis is the most frequent premalignant skin disease in the white population and is caused by exposure to ultraviolet radiation. With a prevalence of 37.5% among whites 50 years of age or older, actinic keratosis is one of the most frequent reasons for patients to visit a dermatologist. If left untreated, actinic keratosis may develop into squamous cell carcinoma.

Current guidelines provide no clear recommendations about which treatment approach is preferred. Currently, the choice of treatment often depends on the preferences of patients and their treating physicians. Evidence from randomized trials with direct comparison between treatments and with long-term follow-up is scarce.

Frequently prescribed and studied field-directed treatment approaches are 5-fluorouracil cream, imiquimod cream, photodynamic therapy (PDT), and ingenol mebutate gel.

We investigated the effectiveness of these four frequently used field-directed treatments (for multiple lesions in a continuous area). Over 600 patients in four different hospitals (Maastricht UMC+, Zuyderland (Heerlen), VieCuri (Venlo and Venray) en Catharina (Eindhoven)participated in the study. Patients were randomly assigned to one of the four treatments.

The main result of our study was that we found that after 12 months of follow-up, 5% fluorouracil cream was the most effective treatment in the treatment of patients with multiple actinic keratosis lesions. Moreover, patient satisfaction and increase in health-related quality of life were highest in the 5-fluorouracil group. Continue reading