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Showing 6151 - 6200FDA Issues Guidance on Endpoints for Cancer Clinical Trials
This week, the U.S. Food and Drug Administration (FDA) issued a guidance titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. The guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the FDA to support effectiveness claims...
Adjuvant Trastuzumab Emtansine vs Trastuzumab in Patients With HER2-Positive Breast Cancer With Residual Disease After Neoadjuvant Therapy
As reported at the recent San Antonio Breast Cancer Symposium and in The New England Journal of Medicine by von Minckwitz et al, an interim analysis of the phase III KATHERINE trial has shown that adjuvant trastuzumab emtansine (T-DM1; Kadcyla) improved invasive disease–free survival vs...
Fixed-Duration Venetoclax Plus Rituximab in Relapsed or Refractory CLL
In patients with relapsed or refractory chronic lymphocytic leukemia (CLL), fixed-duration venetoclax -(Venclexta) combined with rituximab (Rituxan) reduced the risk of disease progression or death compared with standard-of-care bendamustine/rituximab, according to longer-term follow-up of the...
AI Technology for Digital Breast Tomosynthesis Receives FDA Clearance for Clinical Use
A deep-learning, cancer detection software built on artificial intelligence (AI) called ProFound AI received clearance by the U.S. Food and Drug Administration (FDA) for commercial sales and clinical use in the United States. The announcement was made in a news release from iCAD, Inc., a global...
Expert Point of View: Joseph C. Alvarnas, MD
“When people don’t respond [to chimeric antigen receptor (CAR) T-cell therapy] as well as they should, it may be that the T cells are depleted and functionally exhausted. The mechanism of exhaustion is in part mediated by checkpoint-related killing. By thwarting that process with pembrolizumab...
Disease-Free Survival With Letrozole vs Placebo After Aromatase Inhibitor–Based Therapy in Postmenopausal Breast Cancer
As reported by Mamounas et al in The Lancet Oncology, the phase III NRG Oncology/NSABP B-42 trial has shown no disease-free survival benefit with 5 years of letrozole (Femara) vs placebo after 5 years of aromatase inhibitor–based therapy in women with hormone receptor–positive...
Expert Point of View: Joseph C. Alvarnas, MD, and Henry Fung, MD
Commenting on the ibrutinib (Imbruvica)/chimeric antigen receptor (CAR) T-cell approach at a press conference, Joseph C. Alvarnas, MD, said: “Patients with CLL do not do as well on CAR T-cell therapy as those with B-cell acute lymphoblastic leukemia, and by combining ibrutinib with CAR T cells,...
Early Studies of Ibrutinib Plus CAR T-Cell Combination in Chronic Lymphocytic Leukemia
Researchers are combining chimeric antigen receptor (CAR) T-cell therapy with ibrutinib (Imbruvica) as a means of augmenting and deepening responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Two pilot studies presented at the 2018 American Society of Hematology...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 26, 2018, larotrectinib (Vitrakvi) was...
Controlling the Global Burden of Liver Cancer
The burden of mortality related to liver cancer is increasing worldwide. Prevention and control of viral hepatitis will be vital in combating this burden, but curbing the growing epidemic of obesity must also be seen as a key part of liver cancer prevention, according to Rosmawati Mohamed, MD, of...
Low-Dose CT Lung Screening: New Developments Support Increased Quality, More Data, Deep Learning
Two years ago, Rick Avila, MS, Chief Executive Officer (CEO) of Accumetra, LLC, was using rolls of Scotch tape as a research tool. The Scotch tape was a phantom, or reference object, and his company was working with computed tomography (CT) lung screening sites around the world to determine the...
Nuclear Excision Repair as a Possible Predictor of Early Relapse in Pediatric ALL
Researchers recently discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists may be able to determine the likelihood of early relapse (less than 3 years) in patients with acute lymphoblastic leukemia (ALL). These findings were published by...
First-Line Ibrutinib With or Without Rituximab vs Rituximab/Bendamustine in Older Patients With CLL
In a phase III trial reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine by Woyach et al, ibrutinib (Imbruvica) and ibrutinib/rituximab (Rituxan) were associated with superior progression-free survival vs...
Increased Risk for Breast Cancer After Childbirth May Last More Than 2 Decades
Although parity—time since most recent birth— is recognized as a protective factor against breast cancer, an analysis of data from 15 prospective cohort studies to assess breast cancer risk in relation to recent childbirth has found that compared to women of the same age who had never...
Cornelis Melief, MD, PhD, Receives 2018 ESMO Immuno-Oncology Award
The European Society for Medical Oncology (ESMO) has selected Cornelis Melief, MD, PhD, to receive the ESMO 2018 Immuno-Oncology Award in recognition of his work studying the interactions of the immune system with cancer. Dr. Melief is Professor Emeritus in Tumor Immunology at the Leiden...
CDC Foundation Launches Virtual Tool to Prevent Infections in Patients With Cancer
The Centers for Disease Control and Prevention (CDC) Foundation recently launched an educational tool using virtual human technology to improve patient-provider conversations about neutropenia as a side effect of chemotherapy. This new resource is part of the Preventing Infections in Cancer...
Expert Point of View: Carlos L. Arteaga, MD, Laura J. Esserman, MD, MBA, and Joseph Sparano, MD
“This study supports the use of neoadjuvant chemotherapy,” commented press conference moderator Carlos L. Arteaga, MD, of the Simmons Cancer Center at UTSouthwestern Medical Center in Dallas. “It did not matter whether patients received adjuvant therapy, as long as they had achieved a pathologic...
Association Between Pathologic Complete Response After Neoadjuvant Chemotherapy and Breast Cancer Outcomes
A large comprehensive patient-level meta-analysis showed that achieving pathologic complete response after neoadjuvant chemotherapy correlates with significantly improved event-free survival and overall survival in patients with localized breast cancer. These findings were particularly robust in...
Will the Trump Administration’s Plan to Reduce Cancer Drug Prices Work?
High drug prices are the number one health-care concern of many Americans. The average price of a cancer drug rose from less than $10,000/yr before 2000 to more than $170,000/yr in 2017.1-3 Between 1995 and 2013, the launch price of cancer drugs increased by 10% to 12% every year, and the average...
First-Line Ibrutinib/Rituximab Combination Shows Benefit for Younger Patients With CLL
First-line therapy with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to...
Expert Point of View: Eric P. Winer, MD, and Jame Abraham, MD
Commenting on the findings of the KATHERINE trial were Eric P. Winer, MD, Director of the Breast Oncology Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and the Thompson Senior Investigator in Breast Cancer Research andProfessor of Medicine at Harvard...
MURANO Trial Follow-up: MRD and Prognosis With Fixed Duration of Venetoclax/Rituximab in Relapsed or Refractory CLL
As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...
ESMO Immuno-Oncology 2018: Does Proton Pump Inhibitor Therapy Impact the Efficacy of Nivolumab Plus Ipilimumab?
Patients with melanoma receiving proton pump inhibitors for comorbidities derived approximately half the clinical benefit from immunotherapy consisting of nivolumab (Opdivo) plus ipilimumab (Yervoy) as patients receiving the same combination but not treated with proton pump inhibitors, according to ...
ESMO Immuno-Oncology 2018: MYSTIC: First-Line Durvalumab With or Without Tremelimumab in Metastatic NSCLC
First-line immunotherapy with durvalumab (Imfinzi) or the combination of durvalumab and tremelimumab does not improve overall survival in unselected patients with lung cancer, according to late-breaking results from the MYSTIC trial presented by Rizvi et al at the European Society for Medical...
ESMO Immuno-Oncology 2018: KEYNOTE-010: Long-Term Treatment With Pembrolizumab in Previously Treated NSCLC
Patients with previously treated, advanced non–small cell lung cancer (NSCLC) who received pembrolizumab (Keytruda) showed significantly longer overall survival (OS) compared to those treated with docetaxel, Herbst et al reported at the ESMO Immuno-Oncology Congress 2018 in Geneva,...
Radiotherapy Plus Cetuximab or Cisplatin in HPV-Positive Oropharyngeal Carcinoma
In a noninferiority phase III trial (NRG Oncology RTOG 1016) reported in The Lancet, Gillison et al found that radiotherapy plus cetuximab (Erbitux) was associated with poorer overall survival vs radiotherapy plus cisplatin in patients with human papillomavirus (HPV)-positive oropharyngeal...
ASCO and ESMO Publish Joint Assessment of Their Value Frameworks
To better understand the performance characteristics of ASCO’s Value Framework Net Health Benefit Score version 2 (ASCO-NHB v2) and the European Society for Medical Oncology’s (ESMO’s) Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1), ASCO and ESMO undertook a...
Pembrolizumab vs Standard of Care in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
In the phase III KEYNOTE-040 trial reported in The Lancet, Cohen et al found that pembrolizumab (Keytruda) was associated with a “clinically meaningful prolongation of overall survival” vs investigator’s choice of standard therapies in patients with previously treated recurrent or ...
Addition of Neoadjuvant Palbociclib to Letrozole in Estrogen Receptor–Positive Early Breast Cancer
In the phase II PALLET trial reported in the Journal of Clinical Oncology, Johnston et al found that the addition of neoadjuvant palbociclib (Ibrance) to letrozole increased rates of complete cell-cycle arrest, reduced apoptosis, and did not significantly improve clinical response rate in patients...
Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer
A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...
Does Tailored Lifestyle Feedback Given During Colorectal Cancer Screening Improve Disease-Preventive Behaviors?
A program that provided individually tailored lifestyle recommendations for patients undergoing screening for colorectal cancer helped encourage healthy behavior, according to results published by Knudsen et al in Cancer Epidemiology, Biomarkers & Prevention. “It is well known that...
Regorafenib in Previously Treated Metastatic Osteosarcoma
In a phase II trial reported in The Lancet Oncology, Duffaud et al found evidence of activity of regorafenib (Stivarga) in a cohort of adult patients with previously treated metastatic osteosarcoma. This noncomparative, double-blind trial involves 4 cohorts of patients, consisting of those with...
Apixaban Thromboprophylaxis in Patients With Cancer
In the Canadian phase III AVERT trial reported in The New England Journal of Medicine, Carrier et al found that the oral factor Xa inhibitor apixaban reduced the risk of venous thromboembolism vs placebo among intermediate- to high-risk ambulatory patients with cancer starting chemotherapy but was...
Aggressive Squamous Cell Carcinoma in Solid Organ Transplant Recipients
Squamous cell carcinoma (SCC) is the most frequently diagnosed cancer in recipients of a solid organ transplant. When organ transplant recipients are diagnosed with SCC, they are also at higher risk for a more aggressive disease course, metastasis, and death than the general population. Researchers ...
CIMRA Assay for Detection of Gene Variants in Lynch Syndrome
An international team of researchers has developed, calibrated, and validated a novel tool for identifying the genetic changes in Lynch syndrome genes that are likely to be responsible for causing symptoms of the disease. The results were published by Drost et al in Genetics in Medicine. ...
Addition of Veliparib to Cisplatin/Etoposide in Extensive-Stage SCLC
In the phase II ECOG-ACRIN 2511 trial reported in the Journal of Clinical Oncology, Owonikoko et al found that the addition of the poly (ADP ribose) polymerase (PARP) inhibitor veliparib to cisplatin/etoposide was associated with a modest but statistically significant improvement in...
Palbociclib Plus Fulvestrant in Advanced Breast Cancer: Overall Survival Analysis of PALOMA-3
An overall survival analysis of the PALOMA-3 trial reported by Turner et al in The New England Journal of Medicine found that the addition of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved survival among patients with hormone...
ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma
As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...
Alexander B. Pine, MD, PhD, on Practices and Preferences for Anticoagulant Therapy in Treating VTE
Alexander B. Pine, MD, PhD, of Yale School of Medicine, discusses a survey gathering data on health-care providers’ practices and preferences in using direct oral anticoagulant therapy to treat venous thromboembolism. Readers of The ASCO Post are invited to participate in this research by...
RSNA 2018: Breast Cancer Risk-Based Mammography Screening in Younger Women
A new, large-scale study of more than 5 million mammograms found that annual mammography screening beginning at age 30 may benefit women with at least 1 of 3 specific risk factors: dense breasts, a personal history of breast cancer, or a family history of breast cancer. The study was presented at...
Eicosapentaenoic Acid and Aspirin in Preventing Colorectal Adenomas
In a UK trial (seAFOod Polyp Prevention) reported in The Lancet by Hull et al, no differences in adenoma prevention were found after treatment with omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA), aspirin, both, or placebo in patients with high-risk findings on colonoscopy. On the...
Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer and Misdiagnosis of MSI or dMMR Status
In a study reported in JAMA Oncology, Cohen et al found evidence that primary resistance to immune checkpoint inhibitor treatment in metastatic colorectal cancer (CRC) can be explained in some cases by misdiagnosis of microsatellite instability (MSI) or defective mismatch repair (dMMR) status....
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Every Cancer Treatment Plan Is Different—Help Your Patients Learn About What to Expect
YOUR PATIENTS can be active partners in their treatment. Address patient concerns and questions about core types of treatment with affordable printed materials from ASCO Answers. Topics include oral chemotherapy, understanding immunotherapy, understanding blood test results, and much more. Many of ...
Calling ASCO Members: Join ASCO’s Research Survey Pool Today to Help Inform Research in Oncology
ASCO IS assembling a cohort of its members who are willing to participate in survey-based research projects of ASCO members for noncommercial purposes. The immense knowledge and experience of ASCO’s membership can help to accelerate the development of new insights that may help to improve cancer...
Role of Genomic Profiling in Younger Patients With Cancer
Although overall cancer survival rates continue to improve among all age groups in the United States—there are currently an estimated 15.5 million cancer survivors, and that number is expected to increase to 20.3 million by 20261—survival rates for adolescents and young adults with cancer (AYAs)...
Oncology Researcher Catherine J. Wu, MD, Always Knew She Wanted to Be a Doctor
Catherine J. Wu, MD, Professor at Dana-Farber Cancer Institute, was reared in a medical environment, which shaped her career path as a physician-scientist. “Both of my parents are physicians and were trained in internal medicine. Medicine was always part of my life as I grew up, and it seemed like...
Encorafenib and Binimetinib: A New Benchmark in Metastatic Melanoma Therapy?
IN JULY 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the oral BRAF inhibitor encorafenib (Braftovi) and the oral MEK inhibitor binimetinib (Mektovi) for BRAF V600E– or V600K– positive metastatic melanoma. The FDA approval was based on the results of the COLUMBUS...
Bladder Cancer: Strategies to Address Checkpoint Inhibitor Failure
CHECKPOINT INHIBITORS have rapidly become the standard of care as second-line treatment, and in some patients first-line treatment, of advanced bladder cancer. However, the majority of patients do not respond and eventually experience disease progression; these patients will need subsequent...
Shedding Light on Mechanisms of Resistance to Treatment of Metastatic Castration-Resistant Prostate Cancer
ONE OF the pressing issues in metastatic castration-resistant prostate cancer is the development of resistance to therapies directed at the androgen receptor (AR), such as enzalutamide (Xtandi) and abiraterone acetate (Zytiga). Research is ongoing to identify mechanisms of resistance in the hope of ...
