cancer research Tag

30 Apr

Posted at 12:09h in Author Interviews, Cancer Research, Nutrition
MedicalResearch.com Interview with: Sa Kan Yoo MD PhD Division of Developmental Biology and Regenerative Medicine Kobe University, Kobe, Japan MedicalResearch.com: What is the background for this study? Response: Cancer is often considered as a disease of “overgrowth”. But, many known “cancer genes” in fact induce cell death rather than cell growth. Because of this phenomenon, it requires involvement of many genes, not a single “cancer gene”, for cells to become cancer. Although this protective phenomenon that cancer genes induce cell death has been known, its exact mechanism has remained unclear. We tackled this problem using the fruit fly, found its mechanism and discovered a way to manipulate it by dietary nutrition.

25 Feb

Posted at 21:02h in Author Interviews, Cancer Research
MedicalResearch.com Interview with: group-picture Catharina Svanborg M.D., Ph.D. Professor at Lund University Department of Laboratory Medicine, Division of Microbiology, Immunology and Glycobiology Founder/Chairman of the Board at HAMLET Pharma MedicalResearch.com: What is the background for this study? Like many unexpected scientific developments, this finding was serendipitous. In our search for the molecular basis of host susceptibility to infection, we discovered that infection directly affects MYC levels. Gene expression analysis revealed that MYC itself was inhibited and that genes regulated by MYC were affected in children with acute kidney infection. Rapid reductions in MYC levels was further confirmed by infecting human kidney cells with the pathogenic E. coli bacteria isolated from patients with acute pyelonephritis, allowing us to formulate the hypothesis that bacteria regulate host MYC levels during acute infection and to investigate the mechanism leading to this inhibition. This work was conducted by the Laboratory Medicine group at Lund University in Sweden led by Professor Catharina Svanborg.

08 Jan

Posted at 14:03h in Author Interviews, Opiods, Pancreatic, PLoS
MedicalResearch.com Interview with: [caption id="attachment_56379" align="alignleft" width="200"]Faraz Bishehsari, MD, PhD Associate Professor of Medicine and Graduate College Director of the Translational Gastroenterology Unit Division of Digestive Diseases Rush University Medical Center Dr. Bishehsari[/caption] Faraz Bishehsari, MD, PhD Associate Professor of Medicine and Graduate College Director of the Translational Gastroenterology Unit Division of Digestive Diseases Rush University Medical Center MedicalResearch.com: What is the background for this study? Response: This study builds on recent population based studies where opium use was found to be possible risk factor for pancreatic cancer. Although opium use is not a common recreational habit in the United States, opioid use has been rising remarkably over the past decade. In fact, opioid misuse and overdose have evolved into a public health crisis here with increasing opioid prescription use and abuse over the past decade.

10 Dec

Posted at 16:14h in Author Interviews, Cancer Research, CDC, JAMA, Lung Cancer
MedicalResearch.com Interview with: David A. Siegel, MD, MPH Division of Cancer Prevention and Control US Centers for Disease Control and Prevention Atlanta, Georgia MedicalResearch.com: Why is it important to better understand the smoking histories (both current/former and never smokers) among lung cancer patients? Response: Knowledge of smoking status of patients diagnosed with lung cancer can help us understand how to best prevent, detect, and treat lung cancer in the future. More than 84% of women and 90% of men newly diagnosed with lung cancer had ever smoked cigarettes, and half of patients aged 20 to 64 years newly diagnosed with lung cancer were current cigarette smokers. These findings reinforce the importance of cigarette cessation and lung cancer screening. 1 out of every 8 people diagnosed with lung cancer had never smoked cigarettes, which reiterates the importance of learning more about their risk factors for lung cancer, which could impact prevention and treatment. 

06 Dec

Posted at 22:39h in Author Interviews, Cancer Research, COVID -19 Coronavirus, Leukemia
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

01 Dec

Posted at 12:32h in Author Interviews, Cancer Research, Genetic Research
MedicalResearch.com Interview with: [caption id="attachment_56006" align="alignleft" width="130"]Dr-Nina Bhardwaj Dr. Bhardwaj[/caption] Nina Bhardwaj MD PhD Director of Immunotherapy Tisch Cancer Institute Icahn School of Medicine at Mt Sinai Ward-Coleman Chair in Cancer Research Professor of Hematology and Oncology MedicalResearch.com: What is the background for this study? Response: Neoantigens are novel antigens expressed by tumors as a result of somatic mutations or frame shift mutations. They can be very immunogenic and consequently they are being incorporated into cancer vaccine platforms. In most cases it is necessary to determine each patient’s individual mutations and customize their vaccine antigens accordingly. We sought to identify shared mutations in cancer antigens which are deficient in DNA repair mechanisms namely microsatellite unstable tumors. These tumors have mutations in genes that normally are responsible for ensuring that DNA is properly replicated. Because these genes encode proteins that ensure proper repair around micro-satellite areas (which contain short repeated sequences of DNA and are present in similar regions from one person’s genome to the next), when they are mutated, these regions may not be repaired. Consequently due to nucleotide deletions and insertions one gets frame shift mutations which result in new protein expression which can be shared across tumors, as has been observed for a few regions. We therefore did a comprehensive study of a subset of tumors to determine the breadth of shared frame shift mutations.

03 Nov

Posted at 00:44h in Author Interviews, Cancer Research, Journal Clinical Oncology, University of Pittsburgh
MedicalResearch.com Interview with: [caption id="attachment_55817" align="alignleft" width="120"]Kristine Gade, MD Hematology/Oncology Fellow UPMC Hillman Cancer Center Dr. Gade[/caption] 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.  

14 Oct

Posted at 21:09h in Author Interviews
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. 

01 Oct

Posted at 19:09h in Author Interviews, Cancer Research, Prostate Cancer
[caption id="attachment_55541" align="alignleft" width="160"]Dr. Maha Hussain Dr. Hussain[/caption] MedicalResearch.com Interview with: Maha Hussain, MD, FACP, FASCO Genevieve Teuton Professor of MedicineDivision of Hem/Onc Deputy Director Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? Response: PROfound is an open-label international Phase III clinical trial which evaluated the efficacy and safety of Olaparib (Lynparza) versus enzalumatide or abiraterone and prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior treatment with NHA treatments (abiraterone and prednisone or enzalutamide) and have a qualifying tumor mutation in BRCA1/2, ATM or one of the other genes involved in the HRR pathway. The trial design included 2 cohorts; Cohort A included patients with BRCA1,2 or ATM and Cohort 2 included patients with 12 other HRR genes.

30 Sep

Posted at 21:38h in Author Interviews, Cancer Research, HPV, Karolinski Institute, NEJM, Vaccine Studies
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. 

17 Sep

Posted at 11:45h in Author Interviews, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_55413" align="alignleft" width="200"]Dr. Arvin C. Dar, PhD Assistant Professor of Oncological Sciences and Structural and Chemical Biology Icahn School of Medicine at Mount Sinai Dr. Dar[/caption] 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.

20 Aug

Posted at 22:21h in Author Interviews, Biomarkers, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_55158" align="alignleft" width="200"]Dr. Alexey Aleshin, M.D., MBA Senior Medical Director Natera Dr. Aleshin[/caption] 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.

06 Aug

Posted at 10:48h in Author Interviews, Cancer Research, Nature, Technology
MedicalResearch.com Interview with: [caption id="attachment_55045" align="alignleft" width="200"]Moritz Gerstung PhD Group Leader: Computational cancer biology EMBL-European Bioinformatics Institute Dr. Gerstung[/caption] 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. 

04 Aug

Posted at 16:18h in Author Interviews, Cancer Research, COVID -19 Coronavirus, JAMA
MedicalResearch.com Interview with: [caption id="attachment_55014" align="alignleft" width="200"]Harvey W. Kaufman, MD, MBA, FCAP Senior Medical Director, Medical Informatics Quest Diagnostics Needham, MA Harvey Kaufman[/caption] 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. 

22 Jul

Posted at 01:10h in Author Interviews, Breast Cancer, Cancer Research, Genetic Research, Ovarian Cancer
MedicalResearch.com Interview with: [caption id="attachment_54909" align="alignleft" width="200"]Prof Ranjit Manchanda MD, MRCOG, PhD Professor of Gynaecological Oncology & Consultant Gynaecological Oncologist Prof. Manchanda[/caption] Prof Ranjit Manchanda MD, MRCOG, PhD Professor of Gynaecological Oncology & Consultant Gynaecological Oncologist NHS Innovation Accelerator (NIA) Fellow Integrated Academic Training Programme Director London Specialty School of Obstetrics & Gynaecology, Health Education England Specialty Research Lead for Gynaecological Cancer, NIHR, North Thames Clinical Research Network Cancer Research UK, Barts Centre | Queen Mary University of London Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine | Charterhouse Square | London Department of Gynaecological Oncology | Barts Health NHS Trust, Royal London Hospital MedicalResearch.com: What is the background for this study? Response: Around 10–20% of ovarian cancers and 6% breast cancers overall are caused by inheritable BRCA1/BRCA2 mutations. Women carrying BRCA1/BRCA2 mutations have a 17–44% risk of ovarian cancer and 69–72% risk of breast cancer until age 80 years. Most of these cancers can be prevented in unaffected BRCA1/BRCA2 women carriers. Women can opt for a range of options including screening, preventive, and reproductive choices to minimise their risk. The current approach uses established clinical-criteria/family-history (FH) based a priori BRCA probability thresholds to identify high-risk individuals eligible for BRCA testing. However, this requires individuals and health practitioners to recognise and act on a significant FH. BRCA carriers, who are unaware of their FH, unappreciative of its risk/significance, not proactive in seeking advice, or lack a strong FH (small families/paternal inheritance/chance) get excluded. Over 50% BRCA carriers do not fulfil clinical criteria and are missed. Despite >25 years of BRCA testing and effective mechanisms for prevention, current guidelines and access to testing pathways remain complex and associated with a massive under-utilisation of genetic testing. Only 20% of eligible women have accessed/undergone genetic testing and our earlier analysis showed that 97% of BRCA carriers in the population remain unidentified. Current detection rates are inadequate to identify all BRCA carriers and even doubling detection rates will not work. Why should we wait for decades for people to develop cancer before identifying BRCA carriers and unaffected at-risk family members to offer prevention?. This highlights substantial missed opportunities for early detection and prevention. A new population testing approach can change this. Jewish population studies show this is feasible, acceptable, has high satisfaction (91–95%), significantly reduces anxiety, doesn’t harm psychological well-being or quality of life, and is extremely cost-effective. However, this has not been evaluated in the general population and in particular across different  countries or health systems. The potential applicability and scope for this approach transcends continents and countries. Additionally, for interventions to be sustainable, they need to be cost-effective and affordable. We have undertaken a cost-effectiveness analysis of population based BRCA testing compared with current standard clinical testing of women designated as high risk, across high income countries (UK/USA/Netherlands), upper-middle income countries (China/Brazil), and low-middle income country (India).

16 Jul

Posted at 21:22h in AACR, Author Interviews, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_54872" align="alignleft" width="151"]Radek Spisek MD PhD Charles University in Prague  Dr. Spisek[/caption] 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. 

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.

16 Jun

Posted at 13:43h in Author Interviews, Cancer Research, Leukemia
MedicalResearch.com Interview with: [caption id="attachment_54594" align="alignleft" width="140"]Courtney D. DiNardo, M.D., MSCE Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Dr. DiNardo[/caption] 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. 

15 Jun

Posted at 18:28h in Author Interviews
MedicalResearch.com Interview with: [caption id="attachment_54579" align="alignleft" width="200"]Nicholas J. Vogelzang, MD, FASCO, FACP Dr. Vogelzang[/caption] 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) 

13 Jun

Posted at 01:38h in ASCO, AstraZeneca, Author Interviews, Cancer Research, Melanoma
MedicalResearch.com Interview with: [caption id="attachment_54541" align="alignleft" width="200"]Dr-Yuanbin Chen Dr. Chen[/caption] Yuanbin Chen, MD, PhD Cancer & Hematology Centers of Western Michigan MedicalResearch.com: What is the background for this study? What are the main findings?
    • Response: The CASPIAN trial was a randomized, open-label, multi-center global Phase III trial in the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). The trial compared IMFINZI in combination with etoposide and either carboplatin or cisplatin chemotherapy, or IMFINZI and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone – the primary endpoint being overall survival (OS). After a median follow up of more than two years, the latest results for IMFINZI plus chemotherapy demonstrate a sustained and clinically meaningful OS benefit for patients with extensive-stage small cell lung cancer (ES-SCLC), maintaining a 25% reduction in the risk of death versus chemotherapy alone. Updated median OS was 12.9 months versus 10.5 for chemotherapy.
      • In a post-hoc analysis, 22.2% of patients treated with IMFINZI plus chemotherapy remained alive after 24 months, versus 14.4%, for chemotherapy alone.
      • Post-hoc analysis also showed that for IMFINZI plus chemotherapy, 11.0% of patients were alive and progression-free at 24 months versus 2.9% for chemotherapy alone.
      • IMFINZI plus chemotherapy maintained a high confirmed objective response rate (ORR) (68% versus 58%) and in a post-hoc analysis, duration of response (DoR) for IMFINZI at 24 months was 13.5% versus 3.9% for chemotherapy alone.
      • At 24 months, 12% of patients in the IMFINZI plus chemotherapy arm remained on IMFINZI treatment.]

13 Jun

Posted at 01:31h in ASCO, AstraZeneca, Author Interviews, Cancer Research, Lung Cancer, Yale
MedicalResearch.com Interview with: [caption id="attachment_54544" align="alignleft" width="160"]Roy S. Herbst, MD, PhD Ensign Professor of Medicine (Medical Oncology) Professor of Pharmacology Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research Yale Cancer Center Dr. Herbst[/caption] Roy S. Herbst, MD, PhD Ensign Professor of Medicine (Medical Oncology) Professor of Pharmacology Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research Yale Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings?
  • ADAURA is the first global trial for an EGFR tyrosine kinase inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of Stage IB, II, and IIIA EGFRm NSCLC. The results demonstrated unprecedented disease free survival (DFS) in the adjuvant treatment of these patients after complete tumor resection with curative intent. Osimertinib was assessed against placebo for a treatment duration of up to three years and then unblinded two years earlier than expected at the recommendation of the Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy during a planned safety analysis.
  • In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant (after surgery) treatment with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).
  • DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).

12 Jun

Posted at 09:56h in ASCO, Author Interviews, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_54509" align="alignleft" width="200"]Alex Spira, MD, PhD, FACP Medical Oncologist Virginia Cancer Specialists and Chair of the US Oncology Research Executive Committee Dr. Spira[/caption] 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.  

12 Jun

Posted at 09:47h in ASCO, Author Interviews, OBGYNE, Ovarian Cancer
MedicalResearch.com Interview with: [caption id="attachment_54506" align="alignleft" width="140"]Robert L. Coleman, MD, FACOG, FACS Chief Scientific Officer US Oncology Research Dr. Coleman[/caption] Robert L. Coleman, MD, FACOG, FACS Chief Scientific Officer US Oncology Research MedicalResearch.com: What is the background for this study? Response: For years, there has been general support for surgery in patients with recurrent ovarian cancer supported by reams of retrospective studies that suggest patients live longer if they have surgery preceding chemotherapy. Suggested hypotheses from these trials were that patients most likely to benefit from the procedure were those with good performance status (could tolerate the procedure), had long platinum-free interval (surrogate for potential for chemotherapy response) and those in whom all disease could be resected. Each of these are also characteristics that would portend a good prognostic cohort in general and would likely do better than other patients without these characteristics. So there was a strong selection bias in these retrospective surveys. Thus, the call for randomized trials. GOG-213 was launched in 2007 with 2 primary endpoints: 1. Determine the impact of adding bevacizumab to paclitaxel/carboplatin in patients with platinum-sensitive recurrent ovarian cancer, and 2. Determine if surgery increases overall survival.

04 Jun

Posted at 10:49h in ASCO, Author Interviews, Cancer Research, Colon Cancer
MedicalResearch.com Interview with: [caption id="attachment_54443" align="alignleft" width="200"]ASCO: Antibody-Drug Conjugate Shows Promise in HER2 Positive Advanced Colorectal Cancer Dr. Siena[/caption] 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. 

02 Jun

Posted at 19:24h in ASCO, AstraZeneca, Author Interviews, Breast Cancer, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_54437" align="alignleft" width="200"]Josefa Briceno, MD Medical Head, DDR/ADC Franchise AstraZenca Dr. Briceno[/caption] Josefa Briceno, MD Medical Head, DDR/ADC Franchise AstraZenca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In January 2018, the US FDA expanded the approved use of LYNPARZA to treat patients with HER2- negative metastatic breast cancer with germline BRCA mutations based on positive results from the Phase III OlympiAD trial, which demonstrated the benefit of LYNPARZA over standard of care in physician’s choice chemotherapy in this patient population. LUCY is a Phase IIIb interim analysis aimed to evaluate the clinical effectiveness and safety of LYNPARZA in a real-world setting and has been expanded to include a group of patients with somatic BRCA mutations. A total of 252 patients with HER2-negative metastatic breast cancer with germline BRCA mutations were enrolled in the open-label, single-arm, Phase IIIb study. Patients received a taxane and/or anthracycline in the (neo)adjuvant/metastatic setting, and ≤2 lines of chemotherapy. The primary end point of the study was investigator-defined progression-free survival (PFS), and secondary end points included overall survival, time to first subsequent therapy or death, and investigator-assessed clinical response rate. The interim analysis was planned to take place after 160 progression-free survival events. Overall, treatment lasted for a median of 7.9 months, and the median progression-free survival was 8.1 months (95% confidence interval of 6.9-8.7; 166 progression-free survival events). In addition, the median time to first subsequent therapy or death was 9.7 months (95% confidence interval of 8.7-11.1) and the investigator-assessed clinical response rate was 48.6% (95% confidence interval of 42.2-55.0). Adverse events of all grades were reported in >20% of patients were nausea, anemia, asthenia, vomiting, and fatigue. Grade ≥3 adverse events were reported in 24.6% of patients, and 4.4% of patients had an adverse event that led to treatment discontinuation.

30 May

Posted at 18:10h in ASCO, Author Interviews, Cancer Research
MedicalResearch.com Interview with: [caption id="attachment_54250" align="alignleft" width="130"]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  Dr. Smith[/caption] 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.

30 May

Posted at 18:07h in ASCO, Author Interviews, Biomarkers, Breast Cancer
MedicalResearch.com Interview with: [caption id="attachment_54388" align="alignleft" width="200"]Francois-Clement Bidard, MD PhD Head of Breast Cancer Group, Institut Curie Professor of Med. Oncology, UVSQ/Paris  Dr. Clement Bidard[/caption] 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%).

30 May

Posted at 12:08h in ASCO, Author Interviews, Cancer Research, Electronic Records
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.

28 May

Posted at 22:04h in ASCO, Author Interviews, Cancer Research, Leukemia, UC Davis
MedicalResearch.com Interview with: [caption id="attachment_54355" align="alignleft" width="150"]Dr-Brian A. Jonas Dr. Jonas[/caption] Brian A. Jonas, M.D., Ph.D. UC Davis Health System MedicalResearch.com: What is the background for this study? At this year’s American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) virtual meetings, we presented data on the rapidity and likelihood of response to venetoclax treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). We evaluated data from two clinical trials of venetoclax in combination with azacitidine, or decitabine (M14-358), or low-dose cytarabine (LDAC) (M14-387) in this patient population.