ASCO Tag

17 Jul

Posted at 20:54h in Cancer Research, Immunotherapy, Vaccine Studies

MedicalResearch.com Interview with:

Toshiro Shirakawa, MD, PhD

Dean and Professor

Graduate School of Science, Technology and Innovation, Kobe University

[caption id="attachment_75056" align="alignleft" width="200"]Prof-toshiro_shirakawa Prof. Shirakawa[/caption] MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Shirakawa: Immune checkpoint inhibitors have significantly improved the treatment of metastatic urothelial cancer, but many patients eventually develop resistance, leaving limited therapeutic options. We developed B440, a first-in-human oral cancer vaccine using genetically engineered Bifidobacterium longum expressing the WT1 tumor-associated antigen, with the goal of enhancing tumor-specific cellular immunity through the gut immune system.

In this phase I study, B440 demonstrated a favorable safety profile with no dose-limiting toxicities. WT1-specific cellular immune responses were detected in half of the patients, and these patients showed a trend toward longer progression-free survival. As this was a small, single-arm phase I study, these findings should be considered exploratory and hypothesis-generating. For context on how immune checkpoint inhibitors have reshaped the treatment landscape for metastatic urothelial cancer, see this earlier overview of immunotherapy in the treatment of metastatic urothelial cancer.

13 Jun

Posted at 15:57h in Author Interviews, Cancer Research, HPV
MedicalResearch.com Interview with: [caption id="attachment_69031" align="alignleft" width="150"]Pragati Advani MD, MPH, DrPHAssistant Professor of Oncology, Department of Thoracic Surgery And on faculty with the Department of Cancer Prevention and Population Sciences Roswell Park Comprehensive Cancer Center Buffalo, NY Dr. Advani[/caption] Pragati Advani MD, MPH, DrPH Assistant Professor of Oncology, Department of Thoracic Surgery And on faculty with the Department of Cancer Prevention and Population Sciences Roswell Park Comprehensive Cancer Center Buffalo, NY MedicalResearch.com: What is the background for this study? Response: In oncology, a study of second primary malignancy (SPM) is an emerging field that is predominantly driven by our success in identifying and treating the first primary cancers (FPCs). HPV is responsible for nearly a third of all infectious agent-related FPCs (including cancer of the oropharynx, anus, vulva, vagina, cervix and penis). Advances in diagnostic and treatment methods have resulted in improved survivorship among these patients. However, they remain at risk for developing a SPM. No studies thus far had examined the risk of SPMs after HPV-associated FPCs, stratified by cancer site and gender.

05 Jun

Posted at 10:20h in ASCO, Author Interviews, Breast Cancer, Genetic Research
MedicalResearch.com Interview with: [caption id="attachment_61845" align="alignleft" width="125"]Rima Patel, MDAssistant Professor, Division of Hematology/Oncology The Tisch Cancer Institute Icahn School of Medicine at Mount Sinai Dr. Patel[/caption] Rima Patel, MD Assistant Professor, Division of Hematology/Oncology The Tisch Cancer Institute Icahn School of Medicine at Mount Sinai   MedicalResearch.com: What is the background for this study? Response: The 21-gene Oncotype DX Recurrence Score (RS) and 70-gene MammaPrint (MP) assays provide prognostic information for distant recurrence and are used to guide chemotherapy use in hormone receptor (HR)-positive, HER2-negative early breast cancer (EBC). Previous reports have demonstrated racial differences in the prognostic accuracy of the RS. In both the TAILORx and RxPONDER trials, Black women with low genomic risk (RS 0-25) had a higher recurrence risk than White women. In another study using the NCDB database, Black race was associated with worse overall survival in multivariate models including RS. The impacts of race/ethnicity on the MammaPrint assay are unknown.

05 Jun

Posted at 09:59h in ASCO, Author Interviews, Cancer Research, Race/Ethnic Diversity
MedicalResearch.com Interview with: [caption id="attachment_61813" align="alignleft" width="130"]Nina Bickell, MD, MPHAssociate Director of Community Engaged and Equity Research Co-Leader of the Cancer Prevention and Control Program Co-Director of the Center for Health Equity and Community Engaged Research The Tisch Cancer Institute Icahn School of Medicine at Mount Sinai Dr. Bickell[/caption] Nina Bickell, MD, MPH Associate Director of Community Engaged and Equity Research Co-Leader of the Cancer Prevention and Control Program Co-Director of the Center for Health Equity and Community Engaged Research The Tisch Cancer Institute Icahn School of Medicine at Mount Sinai   MedicalResearch.com: What is the background for this study? Response: Recruiting diverse patients to clinical trials is essential to advance cancer treatments, yet accrual remains low. Efficient recruitment requires the ability identify patients at treatment decision points and determine eligibility for open clinical trials – a time and personnel intensive undertaking. We developed an automated Regular Expressions technology to identify, classify and match patients to clinical trials and overcome the limitations of more resource-intensive technologies like Natural Language Processing (NLP). We created a screener, parser and matcher to: use the electronic health record to identify patients at treatment decision points based on progress notes and imaging reports and classify their cancer type, stage and receptor status; extract and categorize breast, liver and lung cancer trial data based on cancer type, stage, and receptor status from the National Cancer Institute's ClinicalTrials.gov database; pair eligible patients with relevant trials based on stage and receptor status.

26 Jun

Posted at 10:03h in AACR, Author Interviews, Biomarkers, Cancer Research, Colon Cancer
MedicalResearch.com Interview with: Guardant HealthVan Morris, M.D. Department of Gastrointestinal Medical Oncology Division of Cancer Medicine MD Anderson Center MedicalResearch.com: What is the background for this study? Response: Stage II colon cancer is diagnosed in approximately 25% of all colon cancer cases.  Oncologists do not have a reliable biomarker to identify patients who do or do benefit from adjuvant chemotherapy for this population of patients.  Circulating tumor DNA is shed by tumor cells as they die and harbors somatic mutations which distinguish its DNA from that of normal cells. Recently, circulating tumor DNA has shown great promise in distinguishing patients with colon cancer (as well as other solid tumors) that do or do not recur after surgery.  Here, patients who have detectable circulating tumor DNA - a surrogate for the presence of microscopic, minimal residual disease – inevitably recur, whereas the likelihood of recurrence is much lower for patients who do not have detectable ctDNA.

10 Apr

Posted at 16:19h in ASCO, Author Interviews, Cancer Research, Journal Clinical Oncology
MedicalResearch.com Interview with: [caption id="attachment_53818" align="alignleft" width="130"]Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY Dr. Galsky[/caption] Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Would you explain what is meant by switch maintenance immunotherapy? Response: For decades, platinum-based chemotherapy has been standard first-line treatment for metastatic urothelial (bladder) cancer. The standard approach to first-line chemotherapy is to administered approximately 6 cycles of treatment (in the absence of disease progression or prohibitive side effects), and then to stop treatment and monitor. Unfortunately, virtually all patients with metastatic disease will experience disease progression after stopping chemotherapy. However, we know that if we just continue the same platinum-based chemotherapy until progression of cancer (rather than stopping after ~6 cycles), the side effects continue to accumulate but the benefits plateau. Approximately 5 years ago, the first new systemic therapies were approved to treatment metastatic urothelial cancer in decades, immune checkpoint inhibitors (PD-1 or PD-L1 inhibitors). In fact, 5 PD-1/PD-L1 inhibitors have been approved by the FDA for the treatment of patients with metastatic urothelial cancer progressing despite prior platinum-based chemotherapy. Given that these drugs are non-cross resistant with chemotherapy in at least a subset of patients (i.e., they can provide benefit even when chemotherapy is no longer working), and because they are well tolerated by a large proportion of patients, a logical question is rather than waiting until cancer progresses after stopping first-line chemotherapy, what if we started immunotherapy immediately. Switch maintenance refers to switching from chemotherapy to a different class of drug (e.g., immunotherapy) and maintenance refers to trying to "maintain" the response achieved with initial chemotherapy.

13 Feb

Posted at 22:55h in ASCO, Author Interviews, Bayer, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_53162" align="alignleft" width="140"]Dr. Hong Dr. Hong[/caption] Dr. David S. Hong MD Deputy Chair Department of Investigational Cancer Therapeutics Division of Cancer MedicineThe University of Texas MD Anderson Cancer Center Houston, TX    MedicalResearch.com: What is the background for this study? What are the main findings?
  • A rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion is a primary oncogenic driver that causes TRK fusion cancer, which has been found in a variety of common tumor types, including GI cancers such as colon, cholangiocarcinoma, pancreatic, and appendiceal cancers. In patients with gastrointestinal (GI) cancer, including pancreatic cancer and colorectal cancer, NTRK gene fusions are estimated to have a frequency of ~0.3%.
  • Larotrectinib is an oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion. Under the brand name Vitrakvi®, it is the first and only approved TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion with approval in the US in 2018 and other worldwide markets in 2019.
  • At ASCO GI 2020, we presented results of a new analysis of the efficacy and safety of larotrectinib specifically in patients with TRK fusion with gastrointestinal cancers, which is an often underdiagnosed patient group. The subset included 14 adult patients with GI tumor types with NTRK gene fusions, including colon, cholangiocarcinoma, pancreas, appendix and hepatic; of the eight patients with colon cancer, seven were microsite instability (MSI)-high.
  • In this subset of patients, the overall response rate (ORR) was 43%. Additionally, median overall survival was 33.4 months at 19 months of follow-up (range 2.8–36.5), median progression-free free survival (PFS) was 5.3 months (range 2.2-9.0) and median time to response was 1.8 months (range 1.7-2.1). In colon cancer patients, the ORR was 50% and the median PFS ranged from 1.5+ to 16.7+ months. 

11 Feb

Posted at 14:48h in ASCO, Author Interviews, Bayer, Cancer Research
MedicalResearch.com Interview with: bayer-pharmaceuticalsDr. Kirhan Ozgurdal Global Medical Affairs Physician Oncology, Bayer MedicalResearch.com: What is the background for this study? What are the main findings?
  • Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis, oncogenesis, metastasis and tumor immunity. It is approved for the treatment of patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. The safety and effectiveness of regorafenib is being evaluated in patients with unresectable hepatocellular carcinoma (uHCC),a liver tumor not eligible for curative treatment approaches such as surgery, given the extent of disease.
  • Following the Phase 3 RESORCE trial, which showed that regorafenib significantly improves overall survival versus placebo in patients with uHCC who progressed on prior sorafenib therapy, we conducted an interim analysis (the first 500 of 1000 patients) of the global REFINE observational trial to evaluate the safety and effectiveness of regorafenib in uHCC in the real-world setting.
  • The REFINE study shows a more varied patient population than the Phase 3 RESORCE trial, including a higher proportion of patients with ECOG performance status ≥1, and a higher proportion with Child–Pugh B liver function.
  • The incidence of regorafenib-related grade ≥3 treatment-emergent adverse events were lower than that reported in the RESORCE trial, possibly indicating improved adverse event management with the use of regorafenib in clinical practice.
  • The median overall survival was longer than that reported in RESORCE, but the proportion of censored patients was high in this interim analysis; the median progression free survival was similar to that reported in RESORCE.

04 Oct

Posted at 13:48h in Author Interviews, Cancer Research, Genetic Research
MedicalResearch.com Interview with: [caption id="attachment_51722" align="alignleft" width="138"]Dr Ranjit Manchanda MD, MRCOG, PhD Professor & Consultant Gynaecological Oncologist NHS Innovation Accelerator (NIA) Fellow Integrated Academic Training Programme Director London Specialty School of Obstetrics & Gynaecology, Health Education England Cancer Research UK, Barts Centre | Queen Mary University of London Department of Gynaecological Oncology | Barts Health NHS Trust, Royal London Hospital London Dr. Manchanda[/caption] Dr Ranjit Manchanda MD, MRCOG, PhD Professor & Consultant Gynaecological Oncologist NHS Innovation Accelerator (NIA) Fellow Integrated Academic Training Programme Director London Specialty School of Obstetrics & Gynaecology, Health Education England Cancer Research UK, Barts Centre | Queen Mary University of London Department of Gynaecological Oncology | Barts Health NHS Trust, Royal London Hospital London  MedicalResearch.com: What is the background for this study? Response: Current national and international guidelines recommend genetic-testing (for BRCA genes) in women with breast cancer (BC) who fulfil recognised/established clinical criteria which are based on a history of cancer in the patient and family. However 50% of BRCA carriers do not fulfil these criteria. Thus the current  family-history or clinical-criteria based approach misses half the people at risk. Additionally only 20%-30% of patients eligible tend to get referred for and access BRCA testing. Newer genes like PALB2 which cause breast cancer have been identified and can also be tested for. Knowing a patient’s mutation status (carrier identification) can have a number of benefits. After unilateral breast cancer, mutations carriers can choose contralateral prophylactic-mastectomy (CPM) or preventative mastectomy of the second breast to reduce their risk of developing contralateral breast cancer. Additionally they can opt for surgical prevention for ovarian-cancer (OC). Cancer affected carriers may become eligible for novel drugs (like poly-adenosine-diphosphate-ribose-polymerase (PARP) inhibitors) and other precision-medicine based novel drug therapies through clinical trials. A major advantage of genetic-testing is enabling testing relatives of breast cancer mutation carriers, to identify unaffected relatives carrying mutations who can benefit from early diagnosis and cancer prevention. Testing everyone instead of being restricted by family history will identify many more mutation carriers and their family members who can benefit from precision prevention. A large proportion of these cancers are preventable in known unaffected mutations carriers.

01 Jun

Posted at 00:52h in ASCO, Author Interviews, Cancer Research, J&J-Janssen, NEJM, Prostate Cancer
MedicalResearch.com Interview with: [caption id="attachment_49474" align="alignleft" width="142"]Dr. Kim Chi. MDProfessor of MedicineMedical Oncologist and Medical Director at BC Cancer – VancouverUniversity of British Columbia,Principal Investigator of the TITAN Study. Dr. Kim Chi[/caption] Dr. Kim Chi. MD Professor of Medicine Medical Oncologist and Medical Director at BC Cancer – Vancouver University of British Columbia, Principal Investigator of the TITAN Study. MedicalResearch.com: What is the background for this study? Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history. Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS). 

25 Feb

Posted at 13:01h in ASCO, Author Interviews, Cancer Research, NEJM, Prostate Cancer
MedicalResearch.com Interview with: [caption id="attachment_47619" align="alignleft" width="180"]Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy Prof. Fizazi[/caption] Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy MedicalResearch.com: What is the background for this study? How does darolutamide differ from other medications for prostate cancer? Response: Despite recent treatment advances, there is still significant unmet need for new therapeutic options for men with non-metastatic castration-resistant prostate cancer (nmCRPC). In laymen’s terms, nmCRPC is cancer that has not spread beyond the prostate region; PSA levels are elevated, despite treatment with hormone therapy, and men with nmCRPC generally feel well and do not have symptoms. The unmet medical need is for treatments that achieve disease control and delay the spread of the cancer without impacting their daily lives or increasing the burden of disease with treatment side effects. While the current treatments in this space are effective in delaying onset of metastases, the side effects can be unpleasant and disruptive to men’s lives; particularly cognitive issues, seizures, impact on balance which may lead to falls and bone fractures, rash and hypertension. Furthermore, new treatment options that have limited interactions with medications typically used in this patient population are also important. 

22 Feb

Posted at 01:52h in ASCO, Author Interviews, Prostate Cancer
MedicalResearch.com Interview with: Kim Nguyen Chi, MD FRCPC Professor of Medicine, University of British Columbia Regional Medical Director, BC Cancer - Vancouver MedicalResearch.com: What is the background for this study? What are the main findings? Response: For over 70 years, androgen deprivation therapy (ADT) has been the main treatment therapy for metastatic prostate cancer patients. This Phase 3 final analysis study looked at adding abiraterone acetate and prednisone to ADT for patients with metastatic prostate cancer, with the primary objectives being to assess improvements in overall survival and radiographic progression-free survival. At the first interim analysis reported in 2017, both primary endpoints were met, and the study was unblinded and patients on the ADT and placebos arm crossed over to receive ADT with abiraterone and prednisone. This study is the final analysis reporting on overall survival. The study findings found abiraterone acetate and prednisone plus ADT continued to demonstrate an improvement in overall survival, hazard ratio (HR) = 0.66, meaning a 34% decrease in the risk of death associated with the use of ADT with abiraterone and prednisone. The median overall survival, which had not been reached before in the ADT with abiraterone and prednisone arm, was 53.3 months compared to 36.5 months for ADT plus placebo, prolonging median overall survival by 16.8 months.

23 Aug

Posted at 20:03h in Author Interviews, Biomarkers, Cancer Research, Journal Clinical Oncology, Lymphoma, Stanford
MedicalResearch.com Interview with: Dr. David Kurtz, MD/PhD, Instructor and Dr. Ash Alizadeh MD/PhD, Associate Professor Division of Oncology, Department of Medicine Stanford University Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This work investigates the utility of circulating tumor DNA - a type of liquid biopsy - in diffuse large B-cell lymphoma, the most common blood cancer in adults. Liquid biopsies are an emerging technology to track cancers from a simple blood draw. Here, using a cohort of over 200 patients from 6 centers across North America and Europe, we asked if circulating tumor DNA could be used to detect lymphoma in patients, and more importantly, could it be used to identify responders and non-responders. 

15 Mar

Posted at 00:00h in ASCO, Author Interviews, Prostate, Prostate Cancer, Urology
MedicalResearch.com Interview with: https://www.churchillpharma.com/ Paul Nemeth, Ph.D. Sr. Vice President, Regulatory Affairs, Clinical Development & Quality Assurance Churchill Pharmaceuticals LLC King of Prussia, PA 19406 MedicalResearch.com: What is the background for this study? Response: In the STAAR study, 53 patients with metastatic castration-resistant prostate cancer (mCRPC) were randomized to receive YONSA, an abiraterone acetate fine particle formulation 500 mg once daily in combination with 4 mg of methylpresnisolone twice daily or 1,000 mg daily of the originator abiraterone acetate (OAA) in combination with 5 mg of prednisone twice daily for a period of 84 days.  Previous studies in healthy volunteers under fasted conditions had shown that single oral doses of 500 mg of YONSA are bioequivalent to single oral doses of 1,000 mg OAA and that a background of 4 mg of methylprednisolone twice daily on a single oral dose of 500 mg of YONSA results in the same extent of absorption as a background of 5 mg of prednisone twice daily on a single oral dose of 1,000 mg of OAA. 

16 Feb

Posted at 01:05h in ASCO, Author Interviews, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_40100" align="alignleft" width="142"]Prof. Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center William M. Scholl Professor and Vice-Chair Department of Oncology and  Professor of Medicine Georgetown University Medical Cente Prof. Atkins[/caption] Prof. Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center William M. Scholl Professor and Vice-Chair Department of Oncology and Professor of Medicine Georgetown University Medical Center  MedicalResearch.com: What is the background for this study? Response: Prior studies combining programmed death-1 (PD-1) checkpoint inhibitors with tyrosine kinase inhibitors of the vascular endothelial growth factor (VEGF)-pathway have been characterized by excess toxicity precluding further development. We hypothesized that axitinib, a more selective VEGF inhibitor would combine safely with pembrolizumab (anti-PD-1) and yield antitumour activity in treatment-naïve patients with advanced renal cell carcinoma.

02 Feb

Posted at 12:16h in ASCO, Author Interviews, Biomarkers, Cancer Research, Gastrointestinal Disease
MedicalResearch.com Interview with: [caption id="attachment_39796" align="alignleft" width="200"]Dr. Ana Vivancos, Principal Investigator Cancer Genomics Group Vall d'Hebron Institute of Oncology (VHIO Barcelona  Dr. Ana Vivancos[/caption] Dr. Ana Vivancos PhD, Principal Investigator Cancer Genomics Group Vall d'Hebron Institute of Oncology (VHIO Barcelona  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study was designed to address a key issue in liquid biopsy testing: analytical sensitivity. We know that mutations in plasma of mCRC patients show a wide range in their allelic frequencies (0.01-90%), the biological basis for which remains unclear. We also know that around 35% of cases show very low mutant allele fractions (MAFs), < 1%, therefore highlighting the need of using high sensitivity techniques in the routine lab in order to properly detect mutations. We have compared two different testing methods that are being used in liquid biopsy: Digital PCR (OncoBEAM RAS test, BEAMing) with a limit of detection of 0.02% vs qPCR (Idylla ctKRAS test, Biocartis) with an analytical sensitivity of 1%. Our findings indicate that detection sensitivity decreases for the qPCR based method in cases with low MAF (<1%) and more so when MAF values are very low (<0.01%).

23 Jan

Posted at 14:29h in ASCO, Author Interviews, Colon Cancer, MD Anderson
MedicalResearch.com Interview with: [caption id="attachment_39506" align="alignleft" width="140"]Scott Kopetz, M.D., Ph.D., FACP Associate Professor Department of Gastrointestinal Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX Dr. Kopetz[/caption] Scott Kopetz, M.D., Ph.D., FACP Associate Professor Department of Gastrointestinal 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 BRAF mutation carries a very poor prognosis for patients with advanced colo-rectal cancer (CRC), and is particularly unresponsive after first-line therapy, so additional treatment options for these patients are needed. While treatment with a BRAF inhibitor alone has not been effective in treating this disease, combination therapies have shown promise and lead to the initiation of the BEACON study. The safety lead-in phase of the BEACON CRC trial was designed to assess the safety and tolerability of encorafenib, binimetinib  and cetuximab triplet combination prior to the Phase 3 randomized portion of the study. Thirty patients were treated in the safety lead-in and received the triplet combination (encorafenib 300 mg daily, binimetinib 45 mg twice daily, and cetuximab per label). Out of the 30 patients, 29 had a BRAFV600E mutation. Microsatellite instability-high (MSI-H) (resulting from defective DNA mismatch repair) was detected in only 1 patient. The triplet demonstrated good tolerability, supporting initiation of the randomized portion of the study. In addition, promising initial clinical activity was observed. In patients with the BRAFV600E mutation, the estimated median progression-free survival (mPFS) at the time of analysis was 8 months. The confirmed overall response rate (ORR) in patients with the BRAFV600E mutation was 48%, and 3 patients achieved complete responses (CR). Further, the ORR was 62% in the 16 patients (10/16) who received only one prior line of therapy. Additionally, the triplet combination was generally well-tolerated. Two patients discontinued treatment due to AEs with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue (4/30), urinary tract infection (3/30), increased aspartate aminotransferase (AST; 3/30) and increased blood creatine kinase (CK; 3/30).

03 Mar

Posted at 14:43h in ASCO, Author Interviews, Outcomes & Safety, Pharmacology, Prostate Cancer, University of Michigan
MedicalResearch.com Interview with: [caption id="attachment_32608" align="alignleft" width="128"]Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan Dr. Caram[/caption] Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan   MedicalResearch.com: What is the background for this study? Response: Abiraterone and enzalutamide are oral medications that were approved by the Food & Drug Administration in 2011 and 2012 to treat men with metastatic castration-resistant prostate cancer. Most men with advanced prostate cancer are over age 65 and thus eligible for Medicare Part D. We conducted a study to better understand the early dissemination of these drugs across the United States using national Medicare Part D and Dartmouth Atlas data.

01 Mar

Posted at 23:32h in ASCO, Author Interviews, Prostate Cancer, Radiation Therapy
MedicalResearch.com Interview with: [caption id="attachment_32573" align="alignleft" width="135"]Daniel A. Hamstra, MD PhD The Texas Center for Proton Therapy Irving, TX Dr. Hamstra[/caption] Daniel A. Hamstra, MD PhD Radiation Oncologist Beaumont Hospital Dearborn Michigan MedicalResearch.com: What is the background for the The SpaceOAR phase 3 trial study and the hydrogel spacer? Response: External beam radiation therapy is commonly used to treat men with prostate cancer. As part of this treatment, side effects can occur involving bowel, urinary, and sexual symptoms. This study was performed to test if an absorbable hydrogel placed between the prostate and rectum (using a simple outpatient procedure) could move the rectum away from the prostate and thus result in sparing of the rectum and decreased bowel toxicity. The study randomized 222 men and the three-year data were just published (The International Journal of Radiation Oncology Biology and Physics). With three years of follow-up, we saw that the spacer did improve the radiation plans and decreased both rectal toxicity and urinary toxicity.

07 Feb

Posted at 12:43h in Author Interviews, Cancer Research, Journal Clinical Oncology, Weight Research

MedicalResearch.com Interview with: [caption id="attachment_31782" align="alignleft" width="133"] Dr. Juhua Luo[/caption] Juhua Luo, PhD Associate professor of epidemiology and biostatistics Indiana University School of Public Health MedicalResearch.com: What is the background for this study? Response: We already know obesity increases risk of endometrial cancer. However, information on whether weight loss reduces risk of endometrial cancer is limited. MedicalResearch.com:...

21 Jan

Posted at 15:25h in ASCO, Author Interviews, Brigham & Women's - Harvard, Colon Cancer, Exercise - Fitness
MedicalResearch.com Interview with: [caption id="attachment_31331" align="alignleft" width="145"]Brendan John Guercio, M.D. Clinical Fellow in Medicine (EXT) Brigham and Women's Hospital Dr. Brendan Guercio[/caption] Brendan John Guercio, M.D. Clinical Fellow in Medicine (EXT) Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sedentary lifestyle is a known risk factor for the development of colon cancer and has been associated with increased disease recurrence and mortality in patients with early stage colorectal cancer. This is the first study to our knowledge to show an association between increased physical activity (i.e. non-sedentary lifestyle) and improved survival and progression-free survival in patients with metastatic colorectal cancer.

22 Sep

Posted at 11:54h in ASCO, Author Interviews, Cancer Research, Journal Clinical Oncology
MedicalResearch.com Interview with: [caption id="attachment_28253" align="alignleft" width="200"]Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center Dr. Darren Feldman[/caption] Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is limited knowledge as to why a minority of patients with advanced germ cell tumors are resistant to chemotherapy while the majority achieve complete responses. Patients with cisplatin-resistant disease require intensive salvage treatment and are at high risk of dying from their disease. We sought to determine whether certain genomic alterations within tumors might be associated with cisplatin-resistance in GCT. We also wanted to identify the spectrum of genomic alterations in this population which might represent novel targets for existing or new drug development in this disease.

02 Dec

Posted at 21:18h in ASCO, Author Interviews, Immunotherapy, Ovarian Cancer
[caption id="attachment_19783" align="alignleft" width="192"]Junzo Hamanishi M.D., Ph.D. Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine Assistant Professor Kyoto Japan Dr. Hamanishi[/caption] MedicalResearch.com Interview with: Junzo Hamanishi  M.D., Ph.D. Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine Assistant Professor Kyoto Japan Medical Research: What is the background for this study? Dr. Hamanishi: More than 70% of patients with advanced ovarian cancer who achieve remission ultimately relapse and there are few effective treatments for these patients. Because the development of new treatment strategies for these patients is urgently required, we have focused on and studied the potential of cancer cells to escape from host immunity with PD-1/PD-L1 immunosuppressive signal in the tumor microenvironment to find new treatment strategies to overcome this phenomenon, collaborating with Professor Honjo who discovered PD-1 since 2006. Therefore, we conducted a phase II clinical trial in 20 platinum-resistant, recurrent ovarian cancer patients to evaluate the safety and anti-tumor efficacy of anti-PD-1 antibody (nivolumab) with 2 cohort at a dose of 1 or 3 mg/kg (constituting two 10-patient cohorts). Medical Research: What are the main findings? Dr. Hamanishi: This study is the first investigator-initiated phase II clinical trial testing the safety and efficacy of nivolumab against platinum-resistant ovarian cancer. In the 20 patients in whom responses could be evaluated, the best overall response was 15%, including two patients with a durable complete response (3mg/kg cohort). The disease control rate in all 20 patients was 45%. The median progression-free survival was 3.5 months, with a median overall survival of 20.0 months. Especially in the 3 mg/kg cohort, two patients achieved a complete response, and disease stabilized in another two patients. The objective response rate in 3mg/kg cohort cohort was 20% and disease was controlled in 40% of the higher-dose group. In the four patients who demonstrated an antitumor response, responses were durable and evident. Grade 3 or 4 treatment-related adverse events (AE) occurred in eight out of 20 patients or 40% overall. However, the frequency of AEs were not different in 2 cohorts.

02 Dec

Posted at 18:35h in Author Interviews, Breast Cancer, Journal Clinical Oncology, MRI, Yale
[caption id="attachment_19717" align="alignleft" width="125"]Shiyi Wang, MD, PhD Assistant Professor of Epidemiology (Chronic Diseases) Yale School of Public Health Dr. Wang[/caption] MedicalResearch.com Interview with: Shiyi Wang, MD, PhD Assistant Professor of Epidemiology (Chronic Diseases) Yale School of Public Health Medical Research: What is the background for this study? Dr. Wang: As magnetic resonance imaging (MRI) of the breast has become part of medical care, there is increasing concern that this highly sensitive test might identify health problems that otherwise would not have had an impact on the patient – so called “overdiagnosis”. However, even if MRI use leads to overdiagnosis, the main “theoretical” benefit of early detection by MRI is to prevent future advanced diseases, the prognosis of which is deleterious. A systematic literature review found that, compared to mammography and/or ultrasound, MRI had a 4.1% incremental contralateral breast cancer (breast cancer in the opposite breast) detection rate. At this point, the impact of MRI on long-term contralateral breast cancer outcomes remains unclear.  Medical Research: What are the main findings? Dr. Wang: Analyzing the Surveillance, Epidemiology, and End Results-Medicare dataset, we compared two groups of women who had breast cancer (one group receiving an MRI, and the other not) in terms of stage-specific contralateral breast cancer occurrences. We found that after five years, the MRI group had a higher detection rate of cancer in the opposite breast than the non-MRI group (7.2 % vs. 4.0%). Specifically, MRI use approximately doubles the detection rate of early stage contralateral breast cancer, but does not decrease the incidence of advanced stage contralateral breast cancer occurrences after a 5-year follow-up. Our results indicate that nearly half of additional breast cancers detected by the preoperative MRI were overdiagnosed, which means that many of these occult cancers not detected by MRI would not have become clinically evident over the subsequent 5 years. There was no evidence that MRI use was benefiting women because the rate of advanced cancer was similar in the MRI and the non-MRI groups.

12 Oct

Posted at 14:40h in Author Interviews, Cancer Research, End of Life Care, Radiation Therapy
MedicalResearch.com Interview with: Dr. Kavita Vyas Dharmarajan M.D., M.Sc Assistant Professor Radiation Oncology Assistant Professor Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Medical Research: What is the background for this study? Dr. Vyas Dharmarajan: Forty to fifty percent of all patients having radiation therapy as part of cancer treatment are having the treatment for palliative reasons – meaning, not to cure the cancer but rather to alleviate or prevent symptoms caused by it. The most common reason for referral to a radiation oncologist in the setting of advanced cancer is for alleviation of pain or prevention of an impending fracture due to bone metastases. Radiation therapy is very effective at relieving pain; in fact, published response rates are about 60-80%. The standard treatment has been two weeks of radiation treatment, and this is a common treatment scheme followed by many radiation oncologists. This may be too long or burdensome for some patients given their overall state of illness, or other personal or logistical factors. Several large randomized trials have shown that shorter radiation courses, even as short as 1 fraction of treatment, can be just as effective as 10 fractions (or, two weeks) of treatment. However, literature suggests that these condensed approaches are underutilized by radiation oncologists. A major disadvantage of traditional 2-week courses of radiation is that patients who are very debilitated may be kept in the hospital to undergo this treatment. Some patients stop early because it is too burdensome. Moreover, some may not survive long enough after the treatment to appreciate its benefits. At Mount Sinai, we proposed an intervention that combined the technical expertise within radiation oncology with the whole-patient support services of palliative medicine into a service model led by a single radiation oncologist specializing in the care of advanced cancer patients and collaboration with experts in palliative care. The service model was meant to care for patients suffering from advanced cancer with the goal of improving the quality of care that these patients receive. About two years into the establishment of this new model, we assessed patient outcomes of pain improvement, length of hospitalization, utilization of palliative care services after radiation, treatment completion rates, and duration of treatments. To accomplish this study, we reviewed the charts of 336 consecutively treated patients who underwent radiation therapy at the Mount Sinai Hospital over the last 5 years. We compared the outcomes of the patients treated before the model was established in 2013 to those treated after the model was established. Medical Research: What are the main findings? Dr. Vyas Dharmarajan: We found large differences in quality of care for advanced cancer patients being treated for symptomatic bone metastases after establishment of our palliative radiation oncology consult service. The rate of short-course treatments (meaning 5 or fewer radiation fractions) rose from 26% to 61%, while the corresponding rate of traditional length treatments (meaning, treatments over 5 fractions) declined from 74% to 39%. Hospital length of stay declined by 6 days, from 18 to 12 days (median). We also found that more patients were finishing their treatments -- the proportion of treatments left unfinished halved, from 15% to 8%. More patients were accessing palliative care services within 30 days of finishing radiation, (34% vs. 49%). We did not see a significant change in the proportion of patients experiencing pain relief from the treatment. In fact, we saw a slight improvement (74% to 80%), but this was not a statistically significant increase. Medical Research: What should clinicians and patients take away from this report? Dr. Vyas Dharmarajan: Our study validates the importance of cohesive collaboration in cancer care. The palliative radiation oncology service model thrives at the Mount Sinai Hospital because of the unique and strong partnership between palliative care and radiation oncology departments. Yet, there are elements of palliative care practice that can transcend other disciplines including radiation oncology. These include eliciting and attending to goals, preferences, expectations, and concerns of patients and families being evaluated for treatment. Shorter treatment courses for advanced cancer patients are effective, and the implications of using such treatments goes beyond that of just finishing the treatment early. Patients treated within our service model were more likely to finish their treatment and spend 6 more days at home with their families. Clinicians should know that using such an approach did not compromise the efficacy of the treatment. Medical Research: What should patients know about your study? Dr. Vyas Dharmarajan: Patients should know that their voices, their preferences, and their goals matter when making decisions about palliative radiation treatment. My goal as a palliative radiation oncologist is to engage patients and their families to set realistic expectations and incorporate their goals and preferences into their treatment plans. By involving key players in this process, such as palliative care specialists, we can ensure that patients receive the best quality of care that treats the whole person, not just a tumor. Medical Research: What recommendations do you have for future research as a result of this study? Dr. Vyas Dharmarajan: Our study showed that making small changes to everyday practice in the real world can lead to large impacts on patient outcomes in a population of cancer patients who are often the sickest. Our next projects revolve around 1) how best to equip radiation oncologists with the skills needed to appropriately provide treatment and primary palliative care to advanced cancer patients, and 2) to empower patients and families to engage with their physicians in discussions about their treatment including their overall goals and preferences. Both of these concepts ultimately have direct impacts on treatment recommendations and treatment outcomes for advanced cancer patients and their families. Citation: upcoming Palliative Care abstract: A palliative radiation oncology consult service’s impact on care of advanced cancer patients with symptomatic bone metastases.MedicalResearch.com Interview with: Dr. Kavita Vyas Dharmarajan M.D., M.Sc Assistant Professor Radiation Oncology Assistant Professor Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Medical Research: What is the background for this study?  Dr. Vyas Dharmarajan: Forty to fifty percent of all patients having radiation therapy as part of cancer treatment are having the treatment for palliative reasons – meaning, not to cure the cancer but rather to alleviate or prevent symptoms caused by it. The most common reason for referral to a radiation oncologist in the setting of advanced cancer is for alleviation of pain or prevention of an impending fracture due to bone metastases. Radiation therapy is very effective at relieving pain; in fact, published response rates are about 60-80%. The standard treatment has been two weeks of radiation treatment, and this is a common treatment scheme followed by many radiation oncologists. This may be too long or burdensome for some patients given their overall state of illness, or other personal or logistical factors. Several large randomized trials have shown that shorter radiation courses, even as short as 1 fraction of treatment, can be just as effective as 10 fractions (or, two weeks) of treatment. However, literature suggests that these condensed approaches are underutilized by radiation oncologists. A major disadvantage of traditional 2-week courses of radiation is that patients who are very debilitated may be kept in the hospital to undergo this treatment. Some patients stop early because it is too burdensome. Moreover, some may not survive long enough after the treatment to appreciate its benefits. At Mount Sinai, we proposed an intervention that combined the technical expertise within radiation oncology with the whole-patient support services of palliative medicine into a service model led by a single radiation oncologist specializing in the care of advanced cancer patients and collaboration with experts in palliative care. The service model was meant to care for patients suffering from advanced cancer with the goal of improving the quality of care that these patients receive. About two years into the establishment of this new model, we assessed patient outcomes of pain improvement, length of hospitalization, utilization of palliative care services after radiation, treatment completion rates, and duration of treatments. To accomplish this study, we reviewed the charts of 336 consecutively treated patients who underwent radiation therapy at the Mount Sinai Hospital over the last 5 years. We compared the outcomes of the patients treated before the model was established in 2013 to those treated after the model was established. Medical Research: What are the main findings? Dr. Vyas Dharmarajan: We found large differences in quality of care for advanced cancer patients being treated for symptomatic bone metastases after establishment of our palliative radiation oncology consult service. The rate of short-course treatments (meaning 5 or fewer radiation fractions) rose from 26% to 61%, while the corresponding rate of traditional length treatments (meaning, treatments over 5 fractions) declined from 74% to 39%. Hospital length of stay declined by 6 days, from 18 to 12 days (median). We also found that more patients were finishing their treatments -- the proportion of treatments left unfinished halved, from 15% to 8%. More patients were accessing palliative care services within 30 days of finishing radiation, (34% vs. 49%). We did not see a significant change in the proportion of patients experiencing pain relief from the treatment. In fact, we saw a slight improvement (74% to 80%), but this was not a statistically significant increase.