AACR, Author Interviews, Cancer Research, Pancreatic / 02.07.2018

MedicalResearch.com Interview with: [caption id="attachment_42909" align="alignleft" width="163"]Michael J. Pishvaian, MD, PhD Phase I Program Director Assistant Professor Lombardi Comprehensive Cancer Center Washington, DC 20007 Dr. Pishvaian[/caption] Michael J. Pishvaian, MD, PhD Phase I Program Director Assistant Professor Lombardi Comprehensive Cancer Center Washington, DC 20007 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Pancreatic cancer is a deadly disease and will soon be the second leading cause of cancer-related death. We have made some progress in the last few years....but despite this, patients with advanced, inoperable pancreatic cancer (which represents about 80% of pancreatic cancer patients) still only live 12 months, on average. We desperately need new therapies, AND to think "outside the box" for the treatment of pancreatic cancer. In that context, we have been learning that there are subgroups of patients with cancer whose tumors are particularly susceptible to certain therapies - either new therapies, or in some cases, approved therapies that would have not normally been used for that disease.  These specific patient subgroups with "actionable" findings have been identified through extensive genetic and molecular characterization of a patient's tumor. In the past there was a cynical perspective that pancreatic cancer did not harbor any "actionable" molecular abnormalities. We have now demonstrated that: 1) There are clearly and undeniably patients with pancreatic cancer whose tumors do indeed harbor "actionable" findings.  This represents at least 27% of pancreatic cancer patients, but may represent up to 50% as new therapies evolve.  These percentages are also highly consistent with similar publications in the pancreatic cancer field over the last few years; and 2) Importantly, we have been following our patients longitudinally for outcomes, and while it is still early, there is a statistically significant improvement in progression-free survival when a patient with a specific actionable molecular abnormality is treated with the appropriately "targeted" therapy.  This finding is also consistent with findings that have been observed in other cancer types.  
Author Interviews, Cancer Research, Endocrinology, JAMA, Pediatrics / 02.07.2018

MedicalResearch.com Interview with: “Cancer awareness” by Susan Roberts is licensed under CC BY 2.0Mette Vestergaard Jensen, MD Danish Cancer Society Research Center MedicalResearch.com: What is the background for this study? Response: Cancer survival rates have improved and it is necessary to explore the long-term consequences of cancer treatment. Adolescents and young adults with cancer are at risk for several therapy-related late effects; however, these have not been studied extensively. We investigatet the lifetime risks of endocrine late effects of cancer and cancer treatment in adolescent and young adult cancer s
Annals Internal Medicine, Author Interviews, Cancer Research, Kidney Disease, Radiology, Surgical Research / 30.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42704" align="alignleft" width="131"]Adam Talenfeld, M.D Assistant Professor of Radiology Weill Cornell Medical College Assistant Attending Radiologist New York-Presbyterian Hospital.  Dr. Talenfeld[/caption] Adam Talenfeld, M.D Assistant Professor of Radiology Weill Cornell Medical College Assistant Attending Radiologist New York-Presbyterian Hospital. MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know that renal function decreases as we age, and we know that decreased renal function is independently associated with increased mortality. This is why medical society guidelines recommend partial nephrectomy, which preserves kidney tissue and function, over radical nephrectomy for the treatment of the smallest kidney cancers, stage T1a tumors, which are under 4 cm diameter. Paradoxically, though, we know older patients are more likely than younger patients to receive radical nephrectomy for these smallest tumors, probably because it’s a simpler surgery than partial nephrectomy. Percutaneous ablation, focal tissue destruction using heat or cold emanating from the tip of a needle, is a newer, image-guided, minimally-invasive, tissue-sparing treatment for solid organ tumors. We wanted to test how well percutaneous ablation would compare to partial nephrectomy and radical nephrectomy for these smallest kidney cancers. We found that percutaneous ablation was associated with similar 5-year overall and cancer-specific survival compared to radical nephrectomy. At the same time, ablation was associated with significantly lower rates of new-onset chronic renal insufficiency and one-fifth as many serious non-urological complications than radical nephrectomy within 30 days of treatment. These were complications, such as deep venous thrombosis or pneumonia, that resulted in emergency department visits or new hospital admissions. The outcomes of percutaneous ablation compared with partial nephrectomy were somewhat less clear, though ablation was again associated with fewer perioperative complications.
Author Interviews, Cancer Research, Nutrition / 29.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42874" align="alignleft" width="200"]Ulrich Pfeffer, PhD Head of the Functional Genomics lab IRCCS AOU San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genova, Italy Dr. Pfeffer[/caption] Ulrich Pfeffer, PhD Head of the Functional Genomics lab IRCCS AOU San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genova, Italy  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Curcumin is well known as a dietary integrator and in alternative medicine. Many previous studies showed its anti-cancer and many other beneficial activities. We and others had shown that these activities rely on its ability to reduce inflammation, which is an important factor in cancer development. This activity had also been described in much detail. It appears that curcumin inhibits the master regulator of the inflammatory program, the so called Nuclear factor kappa B, NFκB. In the present study, we asked whether Curcumin also affects tumor cell metabolism and if so, how. We show that curcumin inhibits a central enzyme of the cell metabolism, the ATP-Synthase, that stands at the end of the chain that burns sugar and produces energy. In tumor cells, this also leads to the production of reactive oxygen species, ROS, that kill the cancer cell.
Author Interviews, Melanoma / 26.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42774" align="alignleft" width="200"]Eugene R. Semenov, MD, MA Washington University School of Medicine Dr. Semenov[/caption] Eugene R. Semenov, MD, MA Washington University School of Medicine MedicalResearch.com: What is the background for this study? Response: Melanoma is an aggressive type of skin cancer which has traditionally carried a poor prognosis. Over the past decade, many new therapies have become available that have improved long-term survival rates in patients with metastatic melanoma. However, these drugs have been associated with serious side effects, such as pancreatitis and hepatitis. Our goal was to study how melanoma diagnosis, disease stage, and treatment status impact patient quality of life (QoL).
Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, Duke, Immunotherapy, NEJM, Vaccine Studies / 26.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42746" align="alignleft" width="133"]Dr. Annick Desjardins, Assistant Professor of Medicine, photographed on October 2, 2013. Dr. Desjardins[/caption] Annick Desjardins, M.D., F.R.C.P.C. Associate Professor of Neurology Associate Professor of Neurosurgery Director of Clinical Research The Preston Robert Tisch Brain Tumor Center at Duke Duke University School of Medicine Durham, NC 27710 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The poliovirus receptor (CD155) is an onco-fetal cell adhesion molecule with widespread expression in all solid tumors and particularly in primary CNS tumors (adult and pediatric). Recombinant nonpathogenic polio–rhinovirus chimera (PVSRIPO) was generated by replacing a critical piece of the genetic information from the Sabin type 1 polio vaccine, making PVSRIPO incapable of harming or killing normal brain cells, but toxic/lethal in cancer cells. In preclinical models, it has been demonstrated that the infection of tumor cells, leads to the release of danger signals, which triggers a recruitment of dendritic/CD4/CD8 T cells and a destruction of tumor cells by anti-tumor T cells. The manuscript reports the results of the phase 1 trial of PVSRSIPO in recurrent WHO grade IV malignant glioma patients. Adult patients with recurrence of a single glioblastoma lesion, 1-5.5cm in dimension, in a non-eloquent area of the brain, were enrolled on study. PVSRIPO is injected slowly over 6.5 hours directly into the tumor via a small catheter inserted via a small bur hole. Once intratumoral injection is completed, the catheter is removed and patients are observed for localized tumor inflammation, followed by tumor contraction. A total of 61 patients were treated on study, 9 patients in a dose escalation phase and 52 in a dose expansion phase. Side effects observed were in relation to the localized inflammation of the tumor and depending on the cerebral functions in close proximity to the tumor: headaches, visual field changes, hemiparesis, etc. One patient experienced a brain hemorrhage at the time of catheter removal, which triggered right sided weakness and aphasia. The patient remained alive 57.5 months after PVSRIPO infusion at data cutoff of March 20th, 2018. Two on-study death were observed, a patient died from cerebral edema and seizures, which was later found to be due to tumor progression, and one patient died from the complications of an intracranial hemorrhage while receiving anticoagulation and bevacizumab. The median overall survival among all 61 patients who received PVSRIPO was 12.5 months (95% CI, 9.9 to 15.2), comparatively to 11.3 months (95% CI, 9.8 to 12.5) in a historical control group of patients treated at Duke and who would have met eligibility on trial, would have the trial been available to them. At 24 months, the survival plateaued in patients treated with PVSRIPO with an overall survival rate of 21% (95% CI, 11 to 33) at 24 months and 36 months in PVSRIPO treated patients, while overall survival in the historical control group continued to decline, with an overall survival rates of 14% (95% CI, 8 to 21) at 24 months and 4% (95% CI, 1 to 9) at 36 months in the historical control group. 
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JAMA / 26.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42572" align="alignleft" width="200"]Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women's Hospital Dr. Bishal Gyawali[/caption] Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: PD-1 inhibitors are an interesting class of cancer drugs with atypical response patterns in clinical trials. There is a lot of debate over cancer drugs that improve progression-free survival (PFS) – a surrogate measure of clinical benefit– without affecting patients’ overall survival (OS), but in some studies, PD-1 inhibitors appears to improve overall survival (OS) without affecting PFS. We therefore conducted a systematic review and meta-analysis of randomized trials of PD-1 inhibitors (nivolumab and pembrolizumab) to assess the effect of these drugs on OS versus PFS. We showed that PD-1 inhibitors do appear to improve OS more than PFS. 
ASCO, Author Interviews, Cancer Research, Technology / 22.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42660" align="alignleft" width="196"]Alexandra Urman, MPH Clinical Research Manager Clinical Development IBM Watson Health  Alexandra Urman[/caption] Alexandra Urman, MPH Clinical Research Manager Clinical Development IBM Watson Health  MedicalResearch.com: What is the background for this study?  Response: Cancer statistics show only 3-5% of cancer patients participate in clinical trials although up to 20% may be eligible. Dr. Tufia Hadad, a medical Oncologist at the Mayo Clinic in Rochester, Minnesota sought to address this issue and spearheaded a project conducted at the Rochester facility in collaboration with IBM Watson Health. The objective was to determine if the use of cognitive computing increased clinical trial enrollment and screening efficiency in the breast cancer clinic. Watson for Clinical Trial Matching (CTM) is a cognitive system which utilizes natural language processing to derive patient and tumor attributes from unstructured text in the electronic health record that can be further used to match a patient to complex eligibility criteria in trial protocols.
Author Interviews, Breast Cancer, Cancer Research, PLoS, Vitamin D / 22.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42650" align="alignleft" width="130"]Cedric F. Garland, Dr.P.H., F.A.C.E. Adjunct Professor Division of Epidemiology Department of Family Medicine and Public Health University of California San Diego La Jolla, California 92093-0620 Dr. Garland[/caption] Cedric F. Garland, Dr.P.H., F.A.C.E. Adjunct Professor Division of Epidemiology Department of Family Medicine and Public Health University of California San Diego La Jolla, California 92093-0620 MedicalResearch.com: What is the background for this study? Response: Studies mapping death rates from female breast cancer in the US, the former USSR and Canada by Drs. Edward Gorham, and Frank and Cedric Garland revealed for the first time in history that death rates from breast cancer tracked latitude where people lived. The rates were highest in the least sunny northern tier of states, lowest in the sunny southwest. This led these scientists to be the first to theorize that vitamin D prevents breast cancer” said study first author Sharon McDonnell.
AACR, Aging, Author Interviews, Cancer Research, Immunotherapy, Melanoma / 21.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42605" align="alignleft" width="200"]Ashani Weeraratna, Ph.D. The Ira Brind professor and Co-program leader of the Immunology, Microenvironment and Metastasis Program The Wistar Institute Member of Wistar’s Melanoma Research Center Philadelphia  Dr. Weeraratna[/caption] Ashani Weeraratna, Ph.D. The Ira Brind professor and Co-program leader of the Immunology, Microenvironment and Metastasis Program The Wistar Institute Member of Wistar’s Melanoma Research Center Philadelphia  MedicalResearch.com: What is the background for this study? What are the main findings?  Response:  This study shows for the first time that older patients, especially those who have had prior MAPKi therapy fare better than younger patients when treated with anti-PD1. We found that tumors in younger patients and younger mice have higher levels of Tregulatory cells, the cells that regulate other immune cells. This is not true systemically, only within the tumor microenvironment. We were surprised because we expected that, as with targeted therapy, older patients would have a poorer response to immunotherapy, given what we perceive as a poorer immune system in older patients. 
Alcohol, Author Interviews, Cancer Research, PLoS / 20.06.2018

MedicalResearch.com Interview with: “Alcohol” by zeevveez is licensed under CC BY 2.0Andrew Kunzmann Research Fellow Queen's Universit Belfast MedicalResearch.com: What is the background for this study?   Response: We decided to conduct this research because the messages about the health effects linked to light-moderate drinking are less consistent. Previous studies suggest that light-moderate drinking is linked to an increased risk of cancer but a lower risk of mortality than never drinking. The international guidelines around what constitutes drinking in moderation also differ, with UK guidelines now recommending intakes below 6 pints of beer or 175ml glasses of wine per week (equivalent to less than 1 per day) but other guidelines recommending intakes of 2 drinks or less per day. We wanted to see what the risk of getting either of these conditions (cancer or mortality) were to give a more comprehensive and less confusing message about the health effects of light-moderate drinking. This was part of a well-established collaboration between Queen’s University Belfast and the National Cancer Institute in the US. We used data from a cancer screening trial in the US that contained data on over 100,000 people from the US, who were free from cancer at the start of the study and who completed a questionnaire asking how much alcohol they consumed at different periods of their adult life. This was then linked to data over an average of 9 years after they completed the questionnaire to see which individuals developed cancer or died from any cause. We then assessed whether risk of cancer and mortality differed based on lifetime alcohol intakes after accounting for a number of other factors such as age, educational attainment, smoking and dietary intakes.
Author Interviews, Biomarkers, Cancer Research, JAMA, UCSD / 15.06.2018

MedicalResearch.com Interview with [caption id="attachment_42338" align="alignleft" width="120"]Aaron Goodman, MD Hematologist/Medical Oncologist Assistant Professor of Medicine UC San Diego Health Dr. Goodman[/caption] Aaron Goodman, MD Hematologist/Medical Oncologist Assistant Professor of Medicine UC San Diego Health  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Response rates to PD-1/PD-L1 blockade in solid tumors are reported at 10-20%.  Remarkably, response rates of 65% to 87% have been reported in patients with refractory classical Hodgkin lymphoma treated with checkpoint inhibitors. In nodular sclerosing Hodgkin lymphoma, amplification of the chromosomal region 9p24.1, which contains the genes PD-L1 (CD274), PDCD1LG2 (PD-L2)and JAK2, is directly correlated with increased expression of these proteins on Reed–Sternberg cells. Overall, 105 of 108 (97%) biopsies from patients with newly diagnosed classical Hodgkin lymphoma have increased PD-L1 and PDCD1LG2 copy numbers.  The prevalence and utility of PD-L1amplification as a response biomarker to PD-1/PD-L1 blockade is unknown in other tumors. We sought to determine the prevalence and utility of PD-L1 amplification as a response biomarker to PD-1/PD-L1 blockade in solid tumors. 
AHA Journals, Author Interviews, Cancer Research, Heart Disease, Smoking, Tobacco, Tobacco Research / 14.06.2018

MedicalResearch.com Interview with: “fathers day” by James Simkins is licensed under CC BY 2.0Jessica L. Fetterman, PhD Assistant Professor of Medicine Boston University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In our study, we studied endothelial cells, the cells that line the inside of the blood vessels. We collected endothelial cells from smokers both who use menthol and non-menthol cigarettes are impaired compared to non-smokers and we could make the non-smoker cells look like the endothelial cells of smokers by treating with menthol or eugenol (provides a clove spice-flavoring). To test a wider variety of commonly used flavoring additives, we treated cultured (outside of the body in a dish) endothelial cells with some of the most commonly used flavoring additives in tobacco products and at different concentrations/doses. We then evaluated the effects of flavoring additives by looking at measures of cell death, oxidative stress, inflammation, and the ability of the cells to produce nitric oxide, a cardio-protective chemical made by endothelial cells that is lost when the cells become damaged. We found that the flavoring additives used in tobacco products like e-cigarettes are toxic to the cells that line the blood vessels (endothelial cells). Our works suggests that the flavoring additives used in tobacco products may be harmful to the cardiovascular system.
ASCO, Author Interviews, Cancer Research, Radiation Therapy / 13.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42379" align="alignleft" width="150"]Jonathan Strosberg MD Moffitt Cancer Center Tampa, FL Dr. Strosberg[/caption] Jonathan Strosberg MD Moffitt Cancer Center, Tampa, FL MedicalResearch.com: What is the background for this study? Response: Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life. We assessed the impact of 177Lu-Dotatate treatment on time to deterioration in health-related quality of life in patients with advanced midgut neuroendocrine tumors in the NETTER-1 study.
Author Interviews, Cancer Research, Genetic Research, Nature, Prostate Cancer / 13.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42385" align="alignleft" width="174"]Fredrick R. Schumacher, PhD, MPH. Associate Professor, Department of Population & Quantitative Health Sciences Case Western Reserve University Cleveland Dr. Schumacher[/caption] Fredrick R. Schumacher, PhD, MPH. Associate Professor, Department of Population & Quantitative Health Sciences Case Western Reserve University Cleveland MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Our study examines the genetic underpinnings of prostate cancer initiation using technology to test variants across the genome. Our study focused on men of European ancestry and included over 80,000 men with prostate cancer and 60,000 men without disease. We discovered 63 novel genetic variants associated with prostate cancer risk, which increases our knowledge of prostate cancer genetic risk factors by more than 60%. A genetic risk score created from the combination of 163 new and known prostate cancer risk variants revealed men with the highest genetic risk score are nearly seven times more likely to develop disease compared to the average man. Additionally, men with the lowest genetic risk score have a 85% risk reduction of developing prostate cancer compared to the average. Lastly, these new discoveries uncover several biological mechanisms involved in the initiation of prostate cancer.
Annals Internal Medicine, Author Interviews, Cancer Research, HIV, Infections / 12.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42261" align="alignleft" width="200"]Lesley S. Park, PhD, MPH Instructor, Medicine- Primary Care and Population Health BioStanford Center for Population Health Sciences (PHS) Associate Director, Research and Data Strategy; Director, PHS Postdoctoral Fellowship Veterans Aging Cohort Study (VACS) Cancer Core Co-Director Dr. Lesley Park[/caption] Lesley S. Park, PhD, MPH Instructor, Medicine- Primary Care and Population Health BioStanford Center for Population Health Sciences (PHS) Associate Director, Research and Data Strategy; Director, PHS Postdoctoral Fellowship Veterans Aging Cohort Study (VACS) Cancer Core Co-Director MedicalResearch.com: What is the background for this study? What are the main findings?  Response: As the population of persons living with HIV/AIDS is aging, the overall burden of cancer is substantial and increasing; however, we have much to learn about the potential cancer prevention benefits of antiretroviral treatment (ART). Our study is the first to examine the effects of prolonged periods of viral suppression and potential cancer prevention benefits. While prior randomized clinical trials (RCTs) and observational studies have examined viral suppression and cancer risk, they mostly were limited to small numbers of cancer outcomes or were only focused on few specific cancer types. Our study demonstrated a benefit of the prevention of cancer development in AIDS-defining cancers (non-Hodgkin lymphoma, Kaposi sarcoma), which was expected, but also in some non-AIDS-defining cancer types (lung, larynx, melanoma, leukemia). 
Author Interviews, JAMA, MRI, Prostate Cancer / 11.06.2018

MedicalResearch.com Interview with: [caption id="attachment_32943" align="alignleft" width="180"]Lars Boesen MD PhD Department of Urology Herlev Gentofte University Hospital Herlev Dr. Boessen[/caption] Dr. Lars Boesen MD PhD Department of Urology Herlev Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The current standard of care in prostate cancer diagnosis includes untargeted transrectal ultrasound-guided biopsies for all biopsy-naïve men with clinically suspicion of prostate cancer. However, this strategy that practically has remained unchanged for decades has limited diagnostic accuracy as significant cancers are missed or under-graded and insignificant cancers are unintendedly detected by the random sampling leading to possible overtreatment. Multiparametric MRI in the diagnosis of prostate cancer has been studied extensively in recent years and has improved detection, localization, staging and risk stratification. It has been suggested that if multiparametric MRIs were used as a triage test prior to biopsies, a significant proportion of men might safely avoid prostate biopsies and the diagnostic ratio of significant vs. insignificant cancer could be improved compared to performing standard biopsies in all men. However, multiparametric MRIs are generally time-consuming (~40 min scan time), expensive and include intravenous contrast media. This reduces its feasibility for widespread clinical implementation in larger patient populations in the western community with its high PCa prevalence. The development of a simpler and faster (~15 min) biparametric MRI protocol using less scan sequences and circumvents intravenous contrast-media seems to preserve adequate diagnostic accuracy in a detection setting and could facilitate dissemination of prostate MRI as a triage test before any biopsy. Here we present a large prospective study that assesses the diagnostic accuracy of a novel biparametric MRI to rule out significant prostate cancer in N=1020 biopsy-naive men with clinically suspicion of prostate cancer. We found that a low suspicion biparametric MRI had a very high negative predictive value (97%) for ruling out significant cancer on confirmatory biopsies. Furthermore, bpMRI suspicion scores were strongly associated with prostate cancer detection rates and restricting biopsies (targeted plus standard) to men with suspicious biparametric MRIs meant 30% could avoid prostate biopsies, improved significant prostate cancer diagnosis by 11%, and reduced insignificant prostate cancer diagnosis by 40% compared to our current diagnostic approach – standard biopsies for all men with clinically suspicion of prostate cancer. 
Abuse and Neglect, Author Interviews, Breast Cancer, JAMA, MD Anderson / 08.06.2018

MedicalResearch.com Interview with: Naoto Tada Ueno, M.D., Ph.D., F.A.C.P. Executive Director, Morgan Welch Inflammatory Breast Cancer Research Program and Clinic Section Chief, Section of Translational Breast Cancer Research, Department of Breast Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TXNaoto Tada Ueno, M.D., Ph.D., F.A.C.P. Executive Director, Morgan Welch Inflammatory Breast Cancer Research Program and Clinic Section Chief, Section of Translational Breast Cancer Research, Department of Breast Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX   MedicalResearch.com: What is the background for this study? What are the main findings? Response: The best outcome of inflammatory breast cancer (IBC) is dependent on achieving a pathological completed response after neoadjuvant chemotherapy for primary inflammatory breast cancer, which is the most aggressive type of breast cancer. We have conducted extensive preclinical work, which showed that EGFR is a potential therapeutic targets of IBC. Based on this preclinical data, we have conducted a phase II study to determine the pathological complete response rate of panitumumab plus neoadjuvant chemotherapy for HER2 negative primary inflammatory breast cancer. 
Author Interviews, Brigham & Women's - Harvard, Dermatology, Environmental Risks, Melanoma, Transplantation / 08.06.2018

MedicalResearch.com Interview with: “Sunscreen” by Tom Newby is licensed under CC BY 2.0Rebecca Ivy Hartman, M.D Instructor in Dermatology Brigham and Women's Hospital Boston MA 02115 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Organ transplant recipients (OTR) are at 100-fold higher risk to develop certain skin cancers compared to the general population due to immunosuppression, and thus preventing skin cancer in this population is critical. Our study found that in a high-risk Australian OTR population, only half of patients practiced multiple measures of sun protection regularly. However, after participating in a research study that required dermatology visits, patients were over 4-times more likely to report using multiple measures of sun protection regularly. Patients were more likely to have a positive behavioral change if they did not already undergo annual skin cancer screening prior to study participation.
ASCO, Author Interviews, Cancer Research / 07.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42045" align="alignleft" width="130"]Axel Le Cesne, MD Institute de Cancerologie Gustave-Roussy Villejuif, France Dr. Le Cesne[/caption] Axel Le Cesne, MD Institute de Cancerologie Gustave-Roussy Villejuif, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: With the exception of a study in translocation-related sarcomas (TRS) (Kawai, TLO 2015), trabectedin was never compared to best supportive care (BSC) in a randomized study in patients with all STS histotypes. This trial required by French Health Authorities in 2014. The tumor control rate after 6 cycles of trabectedin is similar (30%) to previous study in French referral centers (T-DIS trial, Le Cesne, Lancet Oncol 2015) evaluating trabectedin in all subtypes of STS. As already reported, trabectedin was well tolerated with no cumulative toxicities This study met its first endpoint as a preplanned PFS analysis showed a significant improvement in median PFS with trabectedin  over BSC in patients with pretreated ASTS including multiple histologies (HR: 0.39). A major impact of trabectedin was observed in the L-STS cohort (liposarcomas and leiomyosarcomas) with a median PFS of 1.4 months in the BSC arm and 5.13 m (HR: 0.29, p<0.0001) in the trabectedin arm. respectively). The benefit observed with trabectedin in the L-STS cohort of patients is similar to those observed in the US trial in the same population (4.2 vs 1.5m for DTIC) (Demetri, JCO 2016) and in the Japanese trial mentioned above (5.8 vs 0.9m for BSC) (Kawai, TLO 2015) After the crossing over allowed by the protocol (trabectedin for patients progressing in the BSC arm), safety and efficacy profiles of trabectedin remains similar. We did not observe a difference in terms of OS between the two arms, probably due to the cross-over planned by the protocol. 
ASCO, Author Interviews, Breast Cancer, Brigham & Women's - Harvard / 06.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42225" align="alignleft" width="200"]Dr. Aditya Bardia  MD, MPH Assistant Professor, Medicine, Harvard Medical School Attending Physician, Medical Oncology Massachusetts General Hospital Dr. Bardia[/caption] Dr. Aditya Bardia  MD, MPH Assistant Professor, Medicine Harvard Medical School Attending Physician, Medical Oncology Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hormone receptor-positive (HR+)/ and human epidermal growth factor receptor 2-negative (HER2-) breast cancer is the most common sub-type of breast cancer. While metastatic HR+/HER2- breast cancer is initially treated with endocrine therapy-based combinations, including CDK 4/6 inhibitors, patients eventually have disease progression, but the response rate to standard chemotherapy is low (~10-15 percent, post-taxane setting). In particular, patients with visceral disease have a poor prognosis. In this trial, we evaluated the efficacy of sacituzumab govitecan in patients with metastatic HR+/HER2- breast cancer, who had measurable disease and had received prior therapies for metastatic breast cancer. We observed an overall response rate of 31 percent in a heavily pre-treated population (prior number of therapies for metastatic breast cancer = 5; number of patients with prior CDK 4/6 inhibitor use = 69 percent). The responses were durable (median duration of response = 7.4 months). Neutropenia was the main adverse event noted (grade 3 neutropenia = 42 percent), and two patients (3.7 percent) discontinued the clinical trial due to adverse events. The response rate in patients with visceral metastaseswas 27 percent. 
Author Interviews, Colon Cancer, Gastrointestinal Disease / 06.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42220" align="alignleft" width="128"]Anas Raed,MD Section of General Internal Medicine Augusta University Dr. Raed[/caption] Anas Raed, MD Section of General Internal Medicine Augusta University MedicalResearch.com: What is the background for this study? Response: Colorectal cancer (CRC) incidence and mortality rates have been decreasing in the US since mid 1980s, however, recent evidence shows that incidence and mortality rates of CRC in patients younger than 50 years have been increasing significantly. In spite of the increasing trend of colorectal cancer, routine screening of this population has not been addressed due to lack of evidence and cost-effectiveness. Administering screening colonoscopy for all individuals younger than 50 years might not be feasible and, therefore routine screening colonoscopy for specific age groups might reduce the disparity of the incidence in this disease.
ASCO, Author Interviews, Breast Cancer, Cancer Research / 05.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42161" align="alignleft" width="193"]Dr. Giuseppe Del Priore, MD, MPH Chief Medical Officer of Tyme Inc.  Dr. Del Priore[/caption] Dr. Giuseppe Del Priore, MD, MPH Chief Medical Officer of Tyme Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Metastatic breast cancer, sometimes also called “stage IV” or “advanced breast cancer,” is the most extensive stage of breast cancer. It is an invasive cancer that has spread to other parts of the body, most often bones, lungs, liver, and brain. The current standard of care for metastatic breast cancer is systemic drug therapies, such as hormone therapy, chemotherapy, targeted drugs or a combination of these.  Because they reach every cell in the body, they have side effects that can worsen the patient’s quality of life. Existing treatments cannot cure metastatic breast cancer and are palliative in intent. This presents a great unmet need and challenge in treating patients with metastatic breast cancer. SM-88 is a novel relatively non-toxic combination therapy that harnesses cancer’s unique cell metabolism and oxidative stress to selectively drive cancer cell death. Earlier studies with SM-88 therapy demonstrated its potential efficacy in breast and other metastatic cancers. In this current report, we assessed the efficacy of SM-88 in patients with metastatic breast cancer from the first in human “Phase 1” and compassionate use programs from 2012 to 2017. Data demonstrated the potential efficacy of SM-88 in metastatic breast cancer with favorable safety and quality of life profiles. In addition, there were no indications of cross-resistance based on hormone profile, previous treatments or metastatic site. This is an extremely important finding since most cancer deaths are due to resistance to subsequent therapies.  As predicted by the SM-88 mechanism of action, we could not detect this problem with SM-88 use.
ASCO, Author Interviews, Dermatology, Melanoma, Merck, University of Pittsburgh / 05.06.2018

MedicalResearch.com Interview with: [caption id="attachment_40044" align="alignleft" width="200"]This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification. This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.
CDC Image[/caption] Dr. Diwakar Davar, MD Assistant Professor of Medicine Division of Hematology/Oncology University of Pittsburgh  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The optimal surveillance strategy to detect recurrence in cutaneous melanoma remains elusive. Risk of recurrence increases with higher stage, and is especially high for patients with stage IIIC disease. Although consensus guidelines agree on surveillance imaging for high-risk (stage IIB-IIIC) MEL, there is no consensus regarding optimal frequency/modality in these patients. NCCN guidelines suggest chest radiography (CXR) at 6- to 12-month intervals for stage IA-IIA melanoma  patients; although this is controversial. There exists a great deal of practice variation in the surveillance of these patients.
ASCO, Author Interviews, Cancer Research, Hematology / 05.06.2018

MedicalResearch.com Interview with: PharmaMarDr. Javier Gómez García Senior Manager. Biostatistics and Data Management PharmaMar Madrid Area, Spain MedicalResearch.com: What is the background for this study? What are the main findings? Response: Multiple myeloma accounts for approximately 1 percent of all cancers and slightly more than 10 percent of all hematologic malignancies. At present, more than 80,000 new cases are reported worldwide each year, and the disease prevalence is increasing. Plitidepsin is a synthetic cyclic depsipeptide isolated from the marine tunicate Aplidium albicans targeting the proto-oncogene eEF1A2, which is over-expressed in multiple myeloma cells. In ADMYRE trial 255 relapsed and refractory multiple myeloma patients with at least three but not more than six prior regimens, including at least bortezomib and lenalidomide/thalidomide, were randomized at 2:1 ratio to receive plitidepsin 5 mg/m2 D1 and 15 plus DXM 40 mg D1, 8, 15 and 22 (P+DXM), or DXM 40 mg D1,8,15 and 22 (DXM) every four weeks. P+DXM met the primary endpoint, progression-free survival (PFS) assessed by an Independent Review Committee, showing a 35% risk reduction in the probability of progression or death. Indeed, a 20% risk reduction in the probability of death was also observed in spite of the fact that 44% of patients from control arm (DXM) switched to P+DXM arm after progression. Therefore, survival in the control arm might have been extended by the effect of plitidepsin, increasing the post progression survival and overestimating the survival observed in the control arm and consequently underestimating the actual difference between treatment arms. Several methods were used to assess the impact of crossover and the robustness of the results even when penalizations were applied; PharmaMar believes that strong evidence in terms of survival benefit in favour of P+DXM has been established. 
Author Interviews, Breast Cancer, Chemotherapy, JAMA / 05.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42177" align="alignleft" width="128"]Guy Jerusalem, MD, PhD CHU Sart Tilman Liege and Liege University Liege, Belgium Dr. Jerusalem[/caption] Dr. Guy Jerusalem, MD, PhD CHU Sart Tilman Liege and Liege University Liege, Belgium MedicalResearch.com: What is the background for this study? What are the main findings? Response: BOLERO-6 was conducted to fulfill postapproval regulatory commitments to the FDA and EMA to estimate treatment benefit with EVE + EXE vs EVE alone or CAP for ER+, HER2− ABC that had progressed on an NSAI. Everolimus plus exemestane has not previously been compared with everolimus alone or capecitabine in a randomized setting.Data describing everolimus alone are limited to a single phase 2 study of just 19 patients. Thus, the FDA deemed it important to ascertain the efficacy of everolimus alone for ER+ breast cancer, and to determine the contribution of exemestane to combination therapy with everolimus. Capecitabine is often the first chemotherapeutic agent given for ER+ breast cancer that has progressed on anti-estrogen therapy. It has a reported PFS of 4.1–7.9 months among patients with HER2-negative advanced breast cancer. However, it has a different safety profile to everolimus or exemestane, and a comparison of endocrine-based combination therapy with single-agent chemotherapy was yet to be conducted. The median PFS with EVE + EXE (8.4 months) was consistent with BOLERO-2 (7.8 months), and compared to EVE alone here (6.8 months) corresponded to an estimated 26% reduction of risk of disease progression or death (HR 0.74). A numerical median PFS difference was observed for CAP over EVE + EXE (9.6 vs 8.4 months), which may be attributed to various baseline characteristics favoring CAP and potential informative censoring. The median PFS with capacitabine was longer than expected based on previous trials. Interpretation of the results of BOLERO-6 must consider the limited sample size and open-label design. 
ASCO, Author Interviews, Pancreatic / 04.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42156" align="alignleft" width="160"]Dr. Marcus Smith Noel, MD University of Rochester James P. Wilmot Cancer Institute Strong Memorial Hospital Dr. Smith Noel[/caption] Dr. Marcus Smith Noel, MD University of Rochester James P. Wilmot Cancer Institute Strong Memorial Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pancreatic cancer outcomes are poor even despite improvement in the overall prognosis for many cancers. Early detection of pancreatic cancer is uncommon because early stage pancreatic cancer often has few symptoms. Unfortunately, most cases are diagnosed at more advanced stages, which is in part why the disease is so lethal. Current standard of care treatments are highly toxic and not effective long-term, as about 90% of patients diagnosed with advanced or metastatic pancreatic cancer do not survive a year. SM-88 is a relatively non-toxic novel combination therapy designed to utilize cellular metabolism and oxidative stress to drive cancer cell death. This therapy has previously demonstrated activity in various metastatic cancers, such as pancreatic cancer, and is currently being evaluated in an ongoing Phase II trial for metastatic pancreatic cancer. This study is a trial in progress report of Tyme’s Phase II trial in patients with metastatic cancer. The Phase II trial is designed as an open-label, multi-center study of SM-88 in patients with metastatic pancreatic cancer who have failed at least one prior line of therapy. In the first stage of the trial, 36 patients will be randomized 1:1 to receive a dose of either a currently utilized active regimen or a double dose per day of SM-88. Primary endpoints are overall response rate (ORR) and overall survival (OS). Secondary endpoints include progression-free survival (PFS), disease control rate, duration of response and time to subsequent treatment. The purpose of the first stage of the study is to analyze the safety, efficacy and pharmacokinetics of SM-88 in patients.  The selected dose of SM-88 will be continued into the second stage of the trial for approximately 81 additional patients.