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, ASCO18, 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, ASCO18, 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, ASCO18, 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, ASCO18, 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.
Author Interviews, Biomarkers, Prostate Cancer / 03.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42152" align="alignleft" width="142"]James T. Kearns, MD Clinical Fellow, Department of Urology University of Washington School of Medicine Seattle, WA  Dr. Kearns[/caption] James T. Kearns, MD Clinical Fellow, Department of Urology University of Washington School of Medicine Seattle, WA MedicalResearch.com: What is the background for this study? What are the main findings? Response: The effects of the USPSTF recommendation against prostate cancer screening had not been fully characterized among a younger population, particularly with respect to downstream effects such as prostate biopsy, prostate cancer diagnosis, and treatment for prostate cancer. We found that PSA testing decreased in the years surrounding the USPSTF recommendation, but we also found a larger proportionate decrease in prostate biopsy, prostate cancer diagnosis, and use of surgery or radiation for the treatment of prostate cancer.
Abbvie, ASCO, Author Interviews, Cancer Research, Leukemia / 03.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42144" align="alignleft" width="200"]Dr. Danelle James, Dr. James[/caption] Dr. Danelle James, M.D., M.A.S. Head of Clinical Science Pharmacyclics, an AbbVie Company MedicalResearch.com: What is the background for this study? What are the main findings? Response: CAPTIVATE is a Phase 2 study investigating IMBRUVICA (ibrutinib) plus VENCLEXTA (venetoclax) for the treatment of Chronic Lymphocytic Leukemia (CLL) in the first-line setting. It was designed to evaluate if remission with undetectable minimal residual disease (MRD) can provide treatment-naïve CLL/SLL patients with treatment holidays (a period of time when a patient is able to stop therapy). The study enrolled 164 patients with previously untreated CLL or SLL. In preclinical and ongoing clinical studies, we’ve seen complementary activities with this combination. The combination has also previously shown potential for deeper remissions, as well as potential for lower risk of tumor lysis syndrome with ibrutinib as the lead-in therapy. Early data from CAPTIVATE show promising activity for the combination in this patient population, with 77 percent of the first 30 patients achieving responses with no detectable MRD in the blood after only six cycles of the combination therapy. Approximately nine out of 10 of the first patients achieved undetectable MRD after 12 cycles of combination therapy (which were preceded by three cycles of single agent ibrutinib, for a total of 15 cycles of therapy). Specifically, 86 percent of the first 14 patients achieved undetectable MRD in the marrow and 93 percent in the peripheral blood.
Author Interviews, Cancer Research, Leukemia, Nature, University of Pennsylvania / 01.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42093" align="alignleft" width="148"]Dr. J Joseph Melenhorst, PhD Director, Product Development & Correlative Sciences laboratories (PDCS) Adjunct Associate Professor Penn Medicine Center for Cellular Immunotherapies University of Pennsylvania Dr. Melenhorst[/caption] Dr. J Joseph Melenhorst, PhD Director, Product Development & Correlative Sciences laboratories (PDCS) Adjunct Associate Professor Penn Medicine Center for Cellular Immunotherapies University of Pennsylvania MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by CLL and CAR T cells?  Response: We started treating patients with a form of blood cancer called CLL (chronic lymphocytic leukemia) using a form of gene therapy wherein we engineer the patient’s own immune cells – T cells – with a tumor targeting molecule: The CAR, which stands for chimeric antigen receptor. When we engineer the patient’s immune cells we use a vehicle, in this case virus, that inserts the payload – the CAR – into the patient’s DNA. The virus disappears, and the CAR stays. Where this CAR inserts itself is unpredictable, but we always get stably engineered cells. 
Author Interviews, Prostate, Prostate Cancer, Urology / 31.05.2018

MedicalResearch.com Interview with: [caption id="attachment_42036" align="alignleft" width="132"]Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM Dr. Saad[/caption] Dr. Fred Saad, MD FRCS Professor and Chief of Urology Director of GU Oncology Raymond Garneau Chair in Prostate Cancer University of Montreal Hospital Center (CHUM) Director, Prostate Cancer Research , Montreal Cancer Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patient Reported Outcomes (PRO) data from the Phase 3 SPARTAN study showed adding ERLEADA (apalutamide) to androgen deprivation therapy (ADT) for patients with nmCRPC who were asymptomatic and well, did not worsen or cause detriment to HRQoL when compared to the placebo.The percent of patients who felt “quite a bit” or “very much” bothered was low (<2–6 percent of patients in the apalutamide group and 0–6 percent of those in the placebo group), suggesting that ERLEADA treatment was generally well-tolerated. This outcome, coupled with the efficacy results seen in SPARTAN, suggest that apalutamide can be given to patients at risk of metastasis without worry about compounded side effects or negative HRQoL..
Author Interviews, J&J-Janssen, Prostate, Prostate Cancer, Urology / 30.05.2018

MedicalResearch.com Interview with: [caption id="attachment_42036" align="alignleft" width="132"]Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM Dr. Saad[/caption] Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM MedicalResearch.com: What is the background for this study? What are the main findings? Response: The SPARTAN study was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluated ERLEADA (apalutamide), a next-generation androgen signaling inhibitor, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who had a rapidly rising PSA (PSA doubling time ≤10 months). The post-hoc analysis presented at the American Urological Association (AUA) 2018 annual meeting showed in patients who received the treatment apalutamide while receiving continuous androgen deprivation therapy (ADT) significantly decreased the risk of PSA progression by 94 percent compared with the placebo group.
Author Interviews, Cancer Research, Gender Differences, Lung Cancer, NEJM, Smoking, Tobacco Research / 24.05.2018

MedicalResearch.com Interview with: “Woman smoking” by Pedro Ribeiro Simões is licensed under CC BY 2.0Ahmedin Jemal, DVM, PHD Scientific Vice President, Surveillance & Health Services Rsch American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Historically, lung cancer rates have been higher in men than women at all ages because of the substantially higher cigarette smoking prevalence in men. However, cigarette smoking prevalences over the past few decades have become similar between young men and women. Consistent with this pattern, we previously reported the convergence of lung cancer rates between young men and young women. In this paper, we examined the lung cancer incidence rates in young women versus young men in the contemporary cohorts. We found that the historically higher lung cancer incidence rates in young men than in young women have reversed in whites and Hispanics born since the mid-1960s. However, this emerging incidence patterns were not fully explained by sex difference in smoking prevalence as cigarette smoking prevalences among whites and Hispanics were not higher in young women than young men.
Author Interviews, JAMA, Melanoma, UCLA / 24.05.2018

MedicalResearch.com Interview with: Joann G. Elmore, MD, MPH Professor of Medicine David Geffen School of Medicine at UCLA Director of the UCLA National Clinician Scholars Program Affiliate Professor of Medicine, University of Washington School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In a recent study published in 2017 in the British Medical Journal, our team found that pathologists disagreed on their diagnoses of some melanocytic skin biopsy lesions and early stage invasive melanoma more than 50% of the time. This concerning level of disagreement was particularly true for diagnoses in the middle of the disease spectrum, such as atypical lesions and melanoma in situ.  For example, Figure 1 from this paper shows the diagnoses of 36 pathologists who interpreted the same glass slide of a skin biopsy using their own microscopes; the diagnoses ranged from a benign lesion to invasive melanoma. Since that study, the American Joint Committee on Cancer has released new guidelines for melanoma staging. Given this change, we wanted to examine whether the updated guidelines improved the reliability of melanoma diagnosis. We found that using the new guidelines improved the accuracy of pathologists’ diagnoses for invasive melanoma (Elmore J, et al, JAMA Network Open 2018). 
Author Interviews, Dermatology, Environmental Risks, Melanoma / 22.05.2018

MedicalResearch.com Interview with: “Sunscreen” by Tom Newby is licensed under CC BY 2.0Carla Burns, M.S. Environmental Working Group She is one of the coauthors of the 2018 Guide to Sunscreens.  MedicalResearch.com: What is the background for the EWG report?  Response: Environmental Working Group (EWG) published its first Sunscreen Guide in 2007. When we first started the guide, many sun protection products sold in the U.S. were not as safe and used misleading marketing claims. Throughout the years, EWG has continued to find that a common sunscreen ingredient, oxybenzone, poses a hazard to human health and the environment. Despite EWG’s efforts to draw attention to the health hazards associated with this ingredient over the last 12, oxybenzone remains widely used in chemical-based sunscreens. So, this year, we are ramping up our efforts to rid the market of this ingredient by launching a campaign to urge companies and consumers to go oxybenzone-free by 2020.
Author Interviews, Global Health, JAMA, Leukemia / 21.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41916" align="alignleft" width="125"]Andrew J. Cowan, MD Seattle Cancer Care Alliance Division of Medical Oncology University of Washington, Seattle Dr. Cowan[/caption] Andrew J. Cowan, MD Seattle Cancer Care Alliance Division of Medical Oncology University of Washington, Seattle MedicalResearch.com: What is the background for this study? What are the main findings?   Response: Multiple myeloma (MM) is a plasma cell neoplasm with substantial morbidity and mortality. A comprehensive description of the global burden of multiple myeloma is needed to help direct health policy, resource allocation, research, and patient care. Myeloma cases and deaths increased from 1990 to 2016, with middle-income countries contributing the most to this increase. Treatment availability is very limited in countries with low socioeconomic development.
Author Interviews, Infections, Leukemia, MD Anderson, Transplantation / 20.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41862" align="alignleft" width="125"] Dr-Roy F. Chemaly Dr. Chemaly[/caption] Roy F. Chemaly, MD, MPH F.A.C.P., F.I.D.S.A. Department of Infectious Diseases Infection Control and Employee Health Division of Internal Medicine MD Anderson Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: CytomegalovirusCMV infection is a common cause of morbidity and mortality in allo-HCT recipients. Evidence suggests that CMV infection has not only an enormous clinical burden, but a substantial economic burden as well. We conducted this study at MD Anderson to determine the economic and clinical burden of preemptive therapy (PET) for CMV infection. Between 2012 and 2015, 100 consecutive patients hospitalized at our institution for allo-HCT who experienced reactivation of CMV and were treated pre-emptively, were enrolled. The majority of patients were men (55%), who had underlying leukemia (73%), and underwent matched unrelated donor transplant (59%). At the time of hospitalization, most patients had acute GvHD (62%), and were on steroids (58%) within 30 days of CMV reactivation which occurred at a median of 32 days post-HCT (2 -174). A total of 192 episodes of PET occurred in the 100 allo-HCT recipients within 1 year post-HCT. PET consisted of ganciclovir (41%), foscarnet (40%), and valganciclovir (38%). IVIG was also used as adjunct therapy in 20% of episodes. Progression to Cytomegalovirus disease occurred in 4 patients (4%) and mainly affected the GI tract. Mean length of stay for patients treated with ganciclovir or foscarnet was 32 days (2-141) and 41 days (1-177), respectively. The average direct cost per patient admitted for PET was $126,038 ($7,866-$641,841) and the mean cost of CMV antiviral drug per hospitalization was $6,096 for IVIG, $2,410 for foscarnet, $836 for ganciclovir, and $780 for valganciclovir. Serious side effects from PET were observed in 35% of patients on ganciclovir and 12% of patients on foscarnet. Total direct cost per encounter was significantly higher in patients who had serious side effects from foscarnet. All-cause mortality was 59% at 1 year post-transplant.
Author Interviews, JAMA, Medical Imaging, Prostate Cancer, Technology / 17.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41807" align="alignleft" width="156"]Andrew J. Armstrong, MD ScM FACP Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology Associate Director for Clinical Research in Genitourinary Oncology Duke Cancer Institute Divisions of Medical Oncology and Urology Duke University Dr. Armstrong[/caption] Andrew J. Armstrong, MD ScM FACP Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology Associate Director for Clinical Research in Genitourinary Oncology Duke Cancer Institute Divisions of Medical Oncology and Urology Duke University MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Men with prostate cancer commonly develop bone metastases and undergo nuclear medicine bone scans. However, these scans are non-quantitative, and disease burden has been challenging to assess over time and to relate to clinical outcomes. We developed a software program and measurement called the automated bone scan index that essentially reads a standard of care nuclear bone scan, provides a quantitative metric, and demonstrate in a phase 3 trial that this aBSI is highly associated with clinical outcomes including survival, time to symptomatic progression, and prostate cancer specific survival. We accomplished this within a prospective phase 3 international trial of men with metastatic hormone resistant prostate cancer who were followed over a long period of time.  All bone scans were read and measured using the aBSI at baseline, and we found that the aBSI was highly prognostic.  This work validates prior smaller phase 2 BSI studies, and demonstrates both the feasibility and clinical utility for incorporating the aBSI into clinical practice to provide this important prognostic information to patients and providers.
Author Interviews, Cancer Research, J&J-Janssen, Leukemia / 17.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41804" align="alignleft" width="132"]Andrzej Jakubowiak, MD, PhD Professor of Medicine Director, Myeloma Program University of Chicago Dr. Jakubowiak[/caption] Andrzej Jakubowiak, MD, PhD Professor of Medicine Director, Myeloma Program University of Chicago MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by multiple myeloma?   Response: DARZALEX (daratumumab) in combination with VELCADE (bortezomib), melphalan and prednisone - VMP - received U.S. FDA approval for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). With this most recent approval, DARZALEX is now the first monoclonal antibody approved for newly diagnosed patients with this disease. Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow. Despite the introduction of new medicines over the last decade, which has led to significant improvements in outcomes for patients with multiple myeloma, multiple myeloma remains an incurable disease. In 2018, it is estimated that 30,700 people will be diagnosed and 12,770 will die from the disease in the United States.
Author Interviews, Dermatology, Education, JAMA, Melanoma / 17.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41796" align="alignleft" width="200"]SKINDER APP Image from SKINDER APP[/caption] Michael S. Kolodney, MD, PhD Section of Dermatology, Department of Medicine West Virginia University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Melanoma is easily curable if recognized early.   Dermatologists are good at spotting melanomas because they develop an innate sense of how melanomas appear after examining thousands of malignant and benign lesions.  In contrast, most medical students are relatively disadvantaged by their limited dermatology exposure. We felt that too little experience, rather than lack of knowledge of the rules, is the primary barrier to development of pattern-recognition and intuition as a reliable tool for melanoma diagnosis in non-experts.  To remedy this problem, we developed a novel web-based application to mimic the training of a dermatologist by teaching medical students intuitive melanoma diagnosis in a highly condensed period of time. Our application, which we call Skinder, teaches intuitive visual diagnosis of melanoma by quickly presenting the learner with thousands of benign and malignant skin lesions.  The user makes rapid binary decisions, by swiping right for benign or left for malignant, and receives instant feedback on accuracy. With this application, the learner can amass a mental repository of diagnostic experience in a short amount of time. To determine if intuitive visual diagnosis training is superior to a traditional rule-based approach, we compared our web-based application to a rules based approach, the publicly available INFORMED Skin Education Series. Medical students were tested on the ability top differentiate melanomas from benign pigmented lesions before and after training with either Skinder of the Informed Skin Education Series. The pre-test mean for the Skinder group was 75% correct, compared to 74.7% correct for the INFORMED group. The post-test mean for the skinder application group was 86.3% correct, compared to 77.5% correct for the INFORMED group which was highly signifcant.
Author Interviews, Biomarkers, Breast Cancer, Technology, University of Michigan / 16.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41768" align="alignleft" width="200"]Greg Thurber, PhD Assistant Professor Department of Chemical Engineering Assistant Professor Department of Biomedical Engineering University of Michigan  Dr. Thurber[/caption] Greg Thurber, PhD Assistant Professor Department of Chemical Engineering Assistant Professor Department of Biomedical Engineering University of Michigan  MedicalResearch.com: What is the background for this study? Response: Most current disease screening strategies rely on either blood tests, where the physician can obtain information on specific disease molecules but has no idea where they originated in the body, or anatomical imaging, where the physician can see changes in the structure of tissues but doesn’t have any molecular information. We wanted to develop a method that could provide both molecular information and an image of where these molecules were located. We know from decades of research in cancer that this is a molecular disease, so providing molecular information to the physician will help improve detection and diagnosis. Breast cancer screening provides an excellent opportunity to apply this approach to improve detection. Currently, estimates indicate that we are overspending $4 billion per year on the overdiagnosis and overtreatment of breast cancer because we cannot accurately determine which patients need treatment and which can be safely monitored with no intervention. Despite this problem with overdiagnosis, however, screening saves lives…we simply need a better way. Molecular imaging has the capability of providing both molecular information and the location within the body. However, most of these techniques are expensive and use ionizing radiation, meaning there is a small risk of actually causing cancer. This is not acceptable for screening large numbers of otherwise healthy patients. To avoid this risk and provide a safe, inexpensive, and relatively easy method for patients to undergo screening, we decided to develop near-infrared fluorescent imaging agents that can be taken as a pill. The goal is for the patient to simply take a pill a day or two before their visit, and then the physician shines near-infrared light on the breast tissue to detect tumors where they ‘light up’ by giving off a different color of light.
Author Interviews, Cancer Research, JAMA, Yale / 15.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41716" align="alignleft" width="171"]Jeremy O'Connor, MD Section of General Internal Medicine Department of Internal Medicine Postdoctoral Fellow, National Clinician Scholars Program Yale University Dr. O'Connor[/caption] Jeremy O'Connor, MD Section of General Internal Medicine Department of Internal Medicine Postdoctoral Fellow, National Clinician Scholars Program Yale University MedicalResearch.com: What is the background for this study?   Response: There has been a lot of enthusiasm for the use of novel therapies in cancer care, and in particular for novel anticancer agents known as immune checkpoint inhibitors. But very little is known about how quickly providers have adopted immune checkpoint inhibitors into clinical practice. Existing studies suggest, in fact, that the process of clinical adoption is slow, with conventional wisdom holding that it takes an average of 17 years for new evidence to change practice. Our study evaluated whether the adoption of novel therapies might be much faster in certain contexts with the early use of immune checkpoint inhibitors as a notable example.