Author Interviews, Cancer Research, COVID -19 Coronavirus, Leukemia / 06.12.2020

MedicalResearch.com Interview with: William Wood, MD Associate Professor of Medicine, Division of Hematology UNC School of MedicineWilliam Wood, MD Associate Professor of Medicine, Division of Hematology UNC School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the earliest days of the COVID-19 pandemic, there were concerns that individuals with cancer, and especially those with hematologic malignancies, could be at higher risk for adverse outcomes following COVID-19 infection than the general population. For this reason the ASH Research Collaborative developed a voluntary data collection registry in which providers or sites caring for patients with hematologic malignancies and COVID-19 infection provided de-identified data via an online data collection platform. We believe that our findings – that 20% of patients with blood cancers who had COVID-19 infection died, including 33% of those who required hospital or ICU level-care – indicate that patients with blood cancers are a medically vulnerable group when it comes to COVID-19. The risk of dying was highest in patients who were older, had more severe infection, opted to forego more intensive treatment, and/or had poorer prognosis before their COVID-19 infection, as determined by their treating clinicians (more…)
Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, JAMA, Yale / 26.11.2020

MedicalResearch.com Interview with: Lajos Pusztai, M.D, D.Phil. Professor of Medicine Director, Breast Cancer Translational Research Co-Director, Yale Cancer Center Genetics and Genomics Program Yale Cancer Center Yale School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: In HER2-positive early stage (stage I-II) breast cancer, several different preoperative (also called neoadjuvant) chemotherapy options exist, each of these is associated with a different rate of complete eradication of cancer from the breast and lymph nodes (called pathologic complete response or pCR). Patients who experience pCR have excellent long term survival. The complete response rates range from 20% to 80%, the rates are higher with regimens that include several different chemotherapy drugs and dual HER2 blockade. Unfortunately, these highly effective multi-drug treatment regimens are also more toxic and more expensive.  We also learned that patients who do not achieve pCR after preoperative therapy, have high rates of recurrence, but the recurrence rate can be improved by administering postoperative adjuvant therapy. These two observations together, (1) different regimens with different toxicities and costs resulting in different pCR rates, and (2) existence of effective postoperative therapies for patients with residual cancer after preoperative therapy, sets the stage for combining various pre- and post-operative treatment strategies. Starting with a shorter, less toxic and less expensive neoadjuvant regimen would allow a substantial minority (20-45%) of patients who archive pCR to be spared of longer and more toxic regimens, whereas those with residual disease could receive the remaining part of the currently most effective regimens post-operatively as adjuvant therapy. In this study we examined the cost effectiveness of different neoadjuvant followed by adjuvant treatment strategies from a healthcare payer perspective. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Genetic Research, Melanoma, Prostate Cancer / 23.11.2020

MedicalResearch.com Interview with: Saud H AlDubayan, M.D. Instructor in Medicine, Harvard Medical School Attending Physician, Division of Genetics, Brigham and Women's Hospital Computational Biologist, Department of Medical Oncology, Dana-Farber Cancer Institute Associate Scientist, The Broad Institute of MIT and Harvard  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The overall goal of this study was to assess the performance of the standard method currently used to detect germline (inhered) genetic variants in cancer patients and whether we could use recent advances in machine learning techniques to further improve the detection rate of clinically relevant genetic alterations. To investigate this possibility, we performed a head to head comparison between the current gold-standard method for germline analysis that has been universally used in clinical and research laboratories and a new deep learning analysis approach using germline genetic data of thousands of patients with prostate cancer or melanoma. This analysis showed that across all different gene sets that were tested, the deep learning-based framework was able to identify additional cancer patients with clinically relevant germline variants that went undetected by the standard method. For example, several patients in our study also had germline variants that are associated with an increased risk of ovarian cancer, for which the surgical removal of the ovaries (at a certain age) is highly recommended. However, these genetic alterations were only identified by the proposed deep learning framework.     (more…)
Author Interviews, Cancer Research / 10.11.2020

MedicalResearch.com Interview with: Brianna M. Jones, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: Oral tongue cancer has traditionally been a diagnosis associated with older age and habitual tobacco or alcohol use. However, in the past few decades there has been a disproportionate increase in oral tongue cancer in young patients, particularly in those without a prior history of significant alcohol or tobacco use. In the literature, these young patients without traditional risk factors seem to represent a distinct clinical entity with worse oncologic outcomes. The purpose of this study was to compare young patients (age ≤45) to older patients (>45) with oral tongue squamous cell carcinoma (OTSCC) without habitual smoking or drinking history.  (more…)
Author Interviews, Cancer Research, Colon Cancer / 05.11.2020

MedicalResearch.com Interview with: Hisham Hussan, MD, FACG The Ohio State University Wexner Medical Center  MedicalResearch.com: What is the background for this study? Response: Early-onset colorectal cancer (i.e., CRC diagnosed before 50 years of age) is predicted to rise to 10.9% of all colon and 22.9% of all rectal cancers by 2030. Some studies identified an association between early-onset CRC and obesity. By contrast, other studies found a similar body mass index (BMI) between adults with and without early-onset CRC. These conflicting findings are possibly due to weight loss from colorectal cancer that may obscure its relation to obesity. (more…)
Author Interviews, Cancer Research, Journal Clinical Oncology, University of Pittsburgh / 03.11.2020

MedicalResearch.com Interview with: Kristine Gade, MD Hematology/Oncology Fellow UPMC Hillman Cancer Center MedicalResearch.com: What is the background for this study? Would you briefly describe the “surprise question”?  Response:  Via Oncology Pathways, a cancer care platform used by UPMC and other institutions across the country, asks physicians to answer the surprise question – “Would I be surprised if this patient died in the next 12 months?” – whenever a new treatment plan is implemented.   This question has been widely adopted by many oncology and palliative care frameworks and has been shown to be modestly predictive of mortality in multiple studies.  We know that advanced cancer patients have a high utilization of the emergency department, even near end of life.  Our group wanted to see if we could use the results of the surprise question to easily and quickly communicate to emergency department providers the expected prognosis for our advanced cancer patients.  First, we set out to assess the surprise question’s ability to predict survival among our UPMC Hillman Cancer Center patients with select stage IV cancer diagnoses.   (more…)
Author Interviews / 14.10.2020

MedicalResearch.com Interview with: Chuan-Liang Xu, MD, PhD Changhai Hospital of Shanghai MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with urothelial carcinoma usually have to undergo lifelong cystoscopy for surveillance, because it recurred often. Cystoscopy is an examination which inserted a catheter with light and camera into the urethra and inspect the lining of the bladder. Cystoscopy is invasive and uncomfortable for the patients, and also cost a lot of money. Urothelial carcinoma is in direct contact with the urine, just like fish and water, and tumor cells might be flushed out by urine. Traditional method urine cytology is trying to find tumor cells in the urine by cytopathologist, but this method may miss up to 50 to 70% of tumor patient. So, the main purpose of our study is to establish a new non-invasive, and more accurate method to detect urothelial cancer by analyzing the chromosomal alterations from the urine exfoliated cells, and reduce the use of cystoscopy.  (more…)
Author Interviews, Cancer Research, HPV, Karolinski Institute, NEJM, Vaccine Studies / 30.09.2020

MedicalResearch.com Interview with: Dr. Jiayao Lei PhD Prof. Pär Sparén PhD Karolinski Institute MedicalResearch.com: What is the background for this study? Response: The efficacy and effectiveness of quadrivalent HPV (qHPV) vaccine protecting against HPV infection, genital warts and high-grade precancerous cervical lesions have been shown. However, there is lack of population-based studies in examining the association between HPV vaccine and invasive cervical cancer on individual level.  (more…)
Author Interviews, Cancer Research, ESMO / 21.09.2020

MedicalResearch.com Interview with: Guy Jerusalem MD PhD Medical Oncology, CHU Sart Tilman Liège and University of Liège Liège/BE MedicalResearch.com: What is the background for this study? Response: COVID-19 pandemic impacted healthcare systems globally and resulted in the interruption of usual care in many healthcare facilities exposing vulnerable cancer patients to significant risks. Our study aimed to evaluate the impact of this pandemic on cancer care worldwide. A 95 items survey was constructed and distributed worldwide by 20 oncologists from 10 of the most affected countries. 109 representatives from oncology centers in 18 countries filled out the survey between June 17 and July 14. (more…)
Author Interviews, Cancer Research / 17.09.2020

MedicalResearch.com Interview with: Dr. Arvin C. Dar, PhD Associate Professor Departments of Oncological Sciences & Pharmacological Sciences Tisch Cancer Institute Icahn School of Medicine at Mount Sinai Associate Director Mount Sinai Center for Therapeutic Discovery MedicalResearch.com: What is the background for this study? Response: We were interested in better understanding the mechanism of action for the drug trametinib. We wanted to understand how the drug actually works – even though its clinically approved, the drug was a ‘serendipitous discovery’ and originally found through phenotypic screens. (more…)
Author Interviews, Cancer Research, Dermatology, Pediatrics / 16.09.2020

MedicalResearch.com Interview with: Irene Lara-Corrales, MD Associate Professor of Pediatrics at the University of Toronto Staff physician in Pediatric Dermatology at the Hospital for Sick Children in Toronto, Canada She is a member of the Society for Pediatric Dermatology.   Christina Boull, MD Assistant Professor of Dermatology at the University of Minnesota Program Director for the Advanced Dermatology Medical Student Rotation Fellowship Director for the Pediatric Dermatology Fellowship     MedicalResearch.com: What is the background for this study? Response: We got involved in this project a couple of years ago when many members of the Pediatric Dermatology Research Alliance's (PeDRA) Skin Tumors and Reactions to Cancer Therapies (STARC) group started seeing many patients with skin toxicities given by targeted therapies.  We recognized that this was a new and growing area of skin concerns that pediatric dermatologists were starting to see. Being such a new field, and with little known about these medications, we thought it would be important to put our cases together and describe what we were seeing.   (more…)
Author Interviews, Biomarkers, Cancer Research / 20.08.2020

MedicalResearch.com Interview with: Dr. Alexey Aleshin, M.D., MBA Senior Medical Director Natera MedicalResearch.com: What is the background for this study? Response: Checkpoint inhibitor-based immunotherapies (ICI)  have changed the management of a range of cancers of diverse histologies. While these therapies are well tolerated and efficacious, only a minority (<20%) of patients respond to treatment or derive durable clinical benefit from them, highlighting the need for a pan-cancer biomarker that can predict response prior to, or shortly after, treatment initiation. With immune checkpoint inhibitors (ICIs) rapidly becoming a cornerstone of cancer therapy, early determination of response to ICI treatment can optimize patient benefit and minimize the risk of toxicities, while potentially reducing unnecessary treatment and costs to patients and payers. Additionally, due to the nature of immune checkpoint inhibition, atypical patterns of response have emerged. For instance, tumor pseudoprogression — a transient increase in tumor size due to the infiltration of immune cells, followed by delayed shrinkage — has been reported in as much as 10% of patients receiving ICI therapy. Distinguishing pseudoprogression from true progression is clinically important to avoid premature discontinuation of a treatment that may have future benefit, or delay the initiation of an alternative line of therapy. However, they are hard to differentiate using current imaging techniques. Our study published in Nature Cancer earlier this month, demonstrates that bespoke circulating tumor DNA (ctDNA) testing may be a valuable tool that sheds light on both of these issues. (more…)
Author Interviews, Cancer Research, Nature, Technology / 06.08.2020

MedicalResearch.com Interview with: Moritz Gerstung PhD Group Leader: Computational cancer biology EMBL-European Bioinformatics Institute MedicalResearch.com: What is the background for this study? Response: We have learned a lot in the last ten years about the molecular nature about various cancers thanks to the resources created by TCGA, ICGC and many other initiatives. Similarly, digital pathology has progressed hugely due to new AI algorithms. Yet it hasn’t been explored deeply how a cancer’s genetic makeup and its histopathological appearance are related. Here computers can be very helpful as they can process large amounts of digital microscopy slide images and test whether there are any recurrent histopathological patterns in relation to hundreds or thousands of genetic and other molecular abnormalities.  (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus, JAMA / 04.08.2020

MedicalResearch.com Interview with: Harvey W. Kaufman, MD, MBA, FCAP Senior Medical Director, Medical Informatics Quest Diagnostics Needham, MA  MedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has disrupted routine healthcare and in particular cancer screenings.  We documented the impact on patients who were newly identified by cancer in the early months of the pandemic by analysis of Quest Diagnostics data. MedicalResearch.com: What are the main findings?  Response: We saw a 46% decline in newly identified patients with six common types of cancer.  In accordance to healthcare recommendations, many patients didn’t receive mammograms, colonoscopies, low-dose CT scans, and avoided physician visits for minor complaints.  When these patients return, some will present with more advanced stages of cancer than they would have without the disruption of the pandemic.  (more…)
AACR, Author Interviews, Cancer Research / 16.07.2020

MedicalResearch.com Interview with: Radek Spisek MD PhD Charles University in Prague  MedicalResearch.com: What is the background for this study? Response: Immune cytokine IL-15 is a highly promising immuno-oncology target that mobilizes the two most important cell types driving anti-cancer immune responses: cytotoxic T cells and natural killer (NK) cells. Stimulating IL-15 receptors on these cells represents a potent and complementary mechanism to existing cancer treatments, such as PD-1 checkpoint inhibitors or monoclonal antibodies. Sotio is developing an IL-15 superagonist, SO-C101, as a potent immunotherapy for patients with cancer. This study examined SO-C101 in multiple tumor mouse models alone and in combination with PD-1 inhibition.  (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, Colon Cancer / 26.06.2020

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. (more…)
Author Interviews, Cancer Research, Leukemia / 16.06.2020

MedicalResearch.com Interview with: Courtney D. DiNardo, M.D., MSCE Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center MedicalResearch.com: What is the background for this study? Response: At this year’s virtual European Hematology Association (EHA) meeting, we are presenting late-breaking data from the Phase 3 VIALE-A trial. The randomized double-blind, placebo-controlled trial evaluated venetoclax in combination with azacitidine in previously-untreated patients with acute myeloid leukemia (AML) who are ineligible for standard induction therapy compared to azacitidine plus placebo.  (more…)
Author Interviews / 15.06.2020

MedicalResearch.com Interview with: Nicholas J. Vogelzang, MD, FASCO, FACP Medical Oncologist at Comprehensive Cancer Centers of Nevada Associate Chair, US Oncology Research Genitourinary Committee  MedicalResearch.com: What is the background for this study? Response: According to the American Cancer Society, prostate cancer is the second leading cause of cancer death in men in the U.S. New approaches are needed to target the androgen receptor (AR), a critical driver of metastatic castration resistant prostate cancer (mCRPC). Current agents work by decreasing androgen levels (abiraterone) or blocking androgen binding to AR (enzalutamide). Despite rapid and dramatic responses to standards of care, all patients with metastatic disease progress to the castration resistant state and their tumors continue to be dependent on the AR signaling axis.1 Study design:
  • “3 + 3” dose escalation; starting dose = 35 mg, orally, once daily with food
  • Dose increases dependent on toxicities
    • Range 25% to 100% based on severity of AEs
Inclusion criteria:
  • Men with mCRPC, regardless of AR status
  • At least two prior systemic therapies, at least one of which was abiraterone or enzalutamide
  • Disease progression on most recent therapy
    • Rising PSA or 2+ new lesions upon bone scan
Endpoints:
  • Primary:
    • Define the maximum tolerated dose and recommended phase 2 dose
  • Secondary:
    • Pharmacokinetics
    • Anti‐tumor activity (PSA50, RECIST criteria)
  • Exploratory:
    • Biomarkers
      • ctDNA mutational profiling
      • AR levels in optional paired biopsies
      • AR and AR‐ V7 levels in circulating tumor cells (CTCs) 
(more…)
ASCO, Author Interviews, Cancer Research / 12.06.2020

MedicalResearch.com Interview with: Alex Spira, MD, PhD, FACP Medical Oncologist Virginia Cancer Specialists and Chair of the US Oncology Research Executive Committee MedicalResearch.com: What is the background for this study? Would you explain what the conjugate consists of and what types of cancer it may target? What are the main findings? Response: The concept of the CX072 and CX2029 studies is that they use what’s called a probody molecule that gets broken down only at the tumor site. This is completely novel in that it helps diminish toxicity by not having less systemic absorption. In the case of CX2029, this target was previously undruggable, meaning the systemic toxicity was too high. By limiting it to activity at the tumor, that is significantly abated.   (more…)
ASCO, Author Interviews, Cancer Research, Colon Cancer / 04.06.2020

MedicalResearch.com Interview with: Salvatore Siena, MD Director, Falck Division of Medical Oncology Department of Hematology and Oncology, and Niguarda Cancer Center Grande Ospedale Metropolitano Niguarda, Milano, I Full Professor of Medical Oncology, Department of Oncology and Hemato-Oncology Università degli Studi di Milano   MedicalResearch.com: What is the background for this study? Response: There remains a significant unmet clinical need in treating patients with HER2 positive advanced colorectal cancer (CRC) who progressed on previous therapies. Exploratory clinical studies in CRC with HER2-amplification documented that patients with tumors with this molecular characteristic may benefit from HER2-targeted therapies  (reviewed in Siena S et al Ann Oncol 2018). In particular, the phase 1 DS8201-A-J101 dose-expansion study of the cohort of patients with HER2 expressing non-breast/non-gastric or HER2 mutant solid tumors who received the 6.4 mg/kg dose of T-DXd, there were 20 patients with CRC. In this studythe experimental drug T-DXd (trastuzumab deruxtecan) showed clinical benefit and manageable safety profile.
  • Investigator-assessed ORR (Objective Response Rate) of 15.0% (95% CI, 3.2-37.9), DCR (Disease Control Rate) of 80.0% (95% CI, 56.3-94.3), and median PFS (Progression Free Survival) of 4.1 months (95% CI, 2.1-5.9) was reported
  • Common TEAEs (Treatment Emergent Adverse Events) include gastrointestinal (low grade) and hematological, which is consistent with overall T-DXd safety profile across various tumors
  • ILD (Interstitial Lung Disease) was reported in 2 patients (Tsurutani et al. 2020)
Given the unmet need in the treatment of patients with HER2 positive advanced CRC who progressed on previous therapies and the clinical observations from the phase 1 DS8201-A-J101 study (see previous paragraph) , the phase 2 DESTINY-CRC01 trial was conducted to evaluate the efficacy and safety of T-DXd in patients with HER2 expressing CRC who were previously treated with at least 2 lines of therapy.  (more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Ovarian Cancer / 02.06.2020

MedicalResearch.com Interview with: Mark Sims US Franchise Head Women’s Cancer & DNA Damage Response AstraZeneca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: SOLO2 is a Phase III, randomized, double-blind, multicenter trial designed to determine the efficacy and safety of LYNPARZA tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent gBRCA-mutated (BRCAm) ovarian cancer. The trial included 295 patients with germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy and were in complete or partial response. The trial met its primary endpoint in October 2016, showing maintenance treatment with LYNPARZA significantly improved progression-free survival to a median of 19.1 months vs 5.5 months with placebo (a hazard ratio of 0.30; a 95% confidence interval of 0.22 to 0.41; a p value of <0.0001). (more…)
ASCO, Author Interviews, Cancer Research / 30.05.2020

MedicalResearch.com Interview with: Cardinale Smith, MD, PhD Associate Professor Medicine, Hematology and Medical Oncology and Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York  MedicalResearch.com: What is the background for this study? Response: Cancer patients are often hospitalized with complications from cancer and cancer treatment. Physical decline is common among hospitalized cancer patients and contributes to poorer outcomes including increased length of stay, excess days, readmissions and patient experiences.  Therefore, increased activity and mobilization during hospitalization are essential to prevent functional decline. Whereas previous research has focused on risk factors that limit mobility and interventions for enhancing mobility in well-functioning, community dwelling older adults, there have been limited interventions on the mobility of hospitalized cancer patients. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer / 30.05.2020

MedicalResearch.com Interview with: Francois-Clement Bidard, MD PhD Head of Breast Cancer Group, Institut Curie Professor of Med. Oncology, UVSQ/Paris MedicalResearch.com: What is the background for this study? Response: A timely question is how to optimize the endocrine therapy of ER+ HER2- metastatic breast cancers? Aromatase inhibitors (AI) are currently the standard of care in first line, in combination with CDK4/6 inhibitors. Mutations in the estrogen receptor gene (ESR1) can be detected in up to 40% of AI-resistant metastatic breast cancers, but no data was available in the current first line setting (AI combined to CDK4/6 inhibitor). This exploratory study of the first line PADA-1 study reports on the detection rate of ESR1 mutations in cell-free DNA from an “AI-sensitive” population (with no metastatic relapse during adjuvant AI therapy), before the start of therapy (at inclusion). As expected, we found a low prevalence of 3.2% in the general population (N=1,017 patients included). The prevalence of ESR1 mutations among subgroups appeared primarily driven by the type of adjuvant endocrine therapy: patients with prior exposure to adjuvant therapy with AI displayed the highest prevalence of ESR1 mutations (7.1%), followed by patients with no prior adjuvant endocrine therapy (mostly de novo stage IV; ESR1 mutation prevalence: 2.4%). Patients who received adjuvant endocrine therapy with no AI (e.g. tamoxifen only) had the lowest ESR1 mutation prevalence (1.2%). (more…)
ASCO, Author Interviews, Cancer Research, Electronic Records / 30.05.2020

MedicalResearch.com Interview with: Debra A. Patt, MD, PhD, MBA, FASCO Editor-in-chief of the Journal of Clinical Oncology - Clinical Cancer Informatics Medical oncologist at Texas Oncology, and US Oncology Research Breast Cancer Committee member MedicalResearch.com: What is the background for this study? Response: Cancer care is increasing in complexity with differentiation of cancer subtypes, new treatments, and treatment sequences and combinations.  Complying with evidence based therapy has become an increasing challenge.  We see that compliance with guideline based care across the country is highly variable. Our study evaluated an electronic health record based Clinical Decision Support System to facilitate compliance with evidence based guidelines--or pathways--to deliver care to adult patients with cancer. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 28.05.2020

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: The study examined networks that formed around hospitals that had been previously ranked in the top-50 by US News and World Report.  These top-ranked hospitals have shared their brand with hospitals in their network, which leads some people to believe that the care is the same at top-ranked hospitals and their affiliate hospitals.  We wanted to determine if outcomes after complex surgical procedures were truly the same at affiliate hospitals and top-ranked hospitals.  (more…)
ASCO, Author Interviews, Cancer Research / 19.05.2020

MedicalResearch.com Interview with: Dr. Jesus G. Berdeja, MD Director of Myeloma Research Sarah Cannon Nashville, TN MedicalResearch.com: What is the background for this study? Response: Despite many advances in the treatment of multiple myeloma in recent years, the majority of patients will progress through all available therapies and ultimately succumb to their disease.  Thus there is still a high unmet medical need. The Phase 1b/2 CARTITUDE-1 study evaluates the safety and efficacy of JNJ-4528, an investigational BCMA-directed CAR-T therapy, in the treatment of patients with relapsed or refractory multiple myeloma. Participants in this study have already tried approved therapies, and had received a median of five prior treatment regimens and their median overall survival is less than 12 months.  (more…)
Author Interviews, Diabetes, Genetic Research, Pancreatic / 15.05.2020

MedicalResearch.com Interview with: Dr. Núria Malats, MD PhD, Head of the Genetic and Molecular Epidemiology Group Spanish National Cancer Research Centre (CNIO)  MedicalResearch.com: What is the background for this study? Response: The high mortality of pancreatic cancer is a consequence of late diagnosis because of the absence of symptoms in the earliest stages, and defining risk populations is therefore crucial to be able to carry out diagnostic tests that reveal the presence of the tumour as early as possible. Diabetes and pancreatic cancer are connected because the pancreas secretes insulin; in diabetic people, this does not occur in a normal way. It is estimated that around 50% of patients with pancreatic cancer presents diabetes. But it is an outstanding challenge for researchers to figure out which is the cause and which is the consequence.  To conduct the study, the team used data from more than 3,500 persons from PanGenEU, a large European study involving centres from six countries, including Spain, and led by Malats, to analyse the relationship between multiple risk factors and pancreatic cancer. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc). (more…)
AACR, Author Interviews, Bayer, Cancer Research / 08.05.2020

MedicalResearch.com Interview with: David S Hong, M.D Department of Investigational Cancer Therapeutics Division of Cancer Medicine MD Anderson, University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. A variety of NTRK genes have been identified in various tumor types including fusions and non-fusions (e.g., amplifications, rearrangements, deletions, slice variants). In the analysis presented at AACR 2020, we sought to evaluate this pooled data to determine the efficacy of larotrectinib in patients with non-fusion alterations in NTRK genes.  (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, JAMA / 08.05.2020

MedicalResearch.com Interview with: Anurag K. Singh MD Professor of Oncology Director of Radiation Research Leader, Cell Stress and Biophysical Therapy Program Associate Dean Graduate Medical Education, Research Roswell Park Comprehensive Cancer Center Buffalo NY MedicalResearch.com: What is the background for this study? Response: More than 40% of women with hormone receptor-positive, HER2-negative early stage breast cancer with high recurrence scores (RS) have RS of 26-30. Optimal adjuvant systemic therapy in this subgroup remains unclear, and national guideline currently recommends either chemoendocrine therapy or endocrine therapy alone. In addition, the difference in overall survival of a patient with a RS 26-30 versus RS >30 is unclear.   (more…)