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Showing 15401 - 15450FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma
On February 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or...
Newly Discovered Mutation in BCL2 Protein Impacts Outcomes in Patients With Progressive CLL
INVESTIGATORS FROM Australia have identified a genetic mutation that causes resistance to the targeted drug venetoclax in patients with chronic lymphocytic leukemia (CLL), according to research presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition1 and...
First-Line Ibrutinib/Rituximab Combination Shows Benefit for Younger Patients With CLL
FIRST-LINE therapy with the combination of ibrutinib and rituximab 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 the late-breaking...
Large Single-Arm Trial of Hydroxyurea for Sickle Cell Anemia in Sub-Saharan Africa
THE LARGEST PROSPECTIVE trial of hydroxyurea for sickle cell anemia has shown that this treatment is feasible, accepted, well tolerated, and safe for children living in sub-Saharan Africa. Hydroxyurea has long been the standard of care for treating children with sickle cell anemia in developed...
Expert Point of View: Mrinal Patnaik, MBBS, and David P. Steensma, MD
Mrinal S. Patnaik, MBBS, Associate Professor of Internal Medicine and Oncology and a consultant in hematology at the Mayo Clinic, Rochester, commented on the MEDALIST trial for The ASCO Post. “Given its unique mode of action, relative ease of administration, and excellent tolerability,...
Luspatercept May Reduce the Need for Transfusion in Lower-Risk Myelodysplastic Syndromes
IN THE RANDOMIZED, double-blind, phase III MEDALIST trial, the experimental drug luspatercept significantly reduced the need for frequent red blood cell transfusions in patients with lower-risk myelodysplastic syndromes (MDS) and ring sideroblasts. With luspatercept, 37.8% of patients remained...
Front-Line Ibrutinib Improves Progression-Free Survival in Older Patients With Chronic Lymphocytic Leukemia
IN A PHASE III TRIAL reported during the Plenary Session at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition and published in The New England Journal of Medicine, single-agent ibrutinib and ibrutinib/rituximab were associated with superior progression-free survival vs...
Conference Highlights From the 2018 American Society of Hematology Annual Meeting & Exposition
In sunny San Diego, the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition welcomed nearly 30,000 attendees who were eager to present, learn, network, and cheer the joint achievements of many researchers. The packed meeting was filled with important information from...
Pembrolizumab in Combination With Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC
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 October 30, 2018, pembrolizumab in combination with...
Medicaid Enrollees Must Have Access to High-Quality Cancer Care, ASCO Writes in Comments to CMS
IN A COMMENT letter to the Centers for Medicare & Medicaid Services (CMS), ASCO urged the agency to ensure that every Medicaid enrollee with cancer can access the high-quality care needed to treat his or her disease. The comments were submitted in response to a proposed rule on Medicaid and the ...
CancerLinQ Leader Contributes to New BRCA Exchange to Inform Understanding of Cancer Risk
A new global resource that includes data on thousands of inherited variants in the BRCA1 and BRCA2 genes will help inform the understanding of cancer risk. Wendy Rubinstein, MD, PhD, FACP, FACMG, Deputy Medical Director of CancerLinQ, LLC, a wholly owned nonprofit subsidiary of ASCO, served as a...
Breaking Through: Researcher Supported by ASCO’s Conquer Cancer Foundation Earns ‘Advance of the Year’ for Rare Cancer Study
AT MEMORIAL SLOAN KETTERING Cancer Center, Mrinal M. Gounder, MD, led the first randomized, global trial for patients with desmoid tumors, a rare type of sarcoma. The trial: Patients with unresectable progressive desmoid tumors randomly received either a placebo or sorafenib. The results: Tumors...
JCO Fast Track Presubmission, Rapid Review Programs Shorten Publication Time
THE JOURNAL of Clinical Oncology’s (JCO) author-friendly submission programs are taking time off the publication process for health-care professionals. JCO’s quick review process programs, Fast Track Presubmission and Rapid Review, aim to make the journal submission and review process easier for...
ASCO Convenes Stakeholders to Build Consensus for a Clinical Trial Data-Sharing Policy Among Journals That Publish Clinical Cancer Research
Jeffrey M. Drazen, MD, Editor-in-Chief of The New England Journal of Medicine, wrote in a 2016 editorial, “Data Sharing and the Journal,” that “[W]e believe there is a moral obligation to the people who volunteer to participate in these trials to ensure that their data are widely and responsibly...
In Era of Immunotherapy, Radiation Therapy May Become Essential Component of Systemic Treatments of Cancer
“IN THIS era of immunotherapy, it is highly possible, and potentially probable, that radiation therapy may become not just a form of locoregional and palliative treatment, but an essential component of our systemic treatments of cancer,” according to Zachary S. Morris, MD, PhD, Vice-Chair,...
Immunotherapy for Head and Neck Cancer Expands, but Concerns Persist About Patient Selection and Toxicities
SOME PATIENTS with advanced head and neck cancer may achieve durable responses with immunotherapy, and recent trial results suggest first-line immunotherapy may increase survival among patients with recurrent or metastatic disease. However, concerns remain about selecting patients most likely to...
Update on FDA-Approved CAR T-Cell Products
AXICABTAGENE CILOLEUCEL (also known as CAR19) is an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the ...
Update on FDA-Approved CAR T-Cell Products
TISAGENLECLEUCEL IS an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1,2 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the 2018 American Society of...
FDA Approves Caplacizumab-yhdp for Acquired Thrombotic Thrombocytopenic Purpura
ON FEBRUARY 6, 2019, the U.S. Food and Drug AdministrationFDA approved caplacizumab-yhdp (Cablivi) injection, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP). “Patients with aTTP endure...
FDA Approves Split-Dosing Regimen of Therapy for Multiple Myeloma
ON FEBRUARY 12 , 2019, the U.S. Food and Drug Administration (FDA) approved a split-dosing regimen for daratumumab (Darzalex), providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. Daratumumab is a CD38-directed...
Highlights From the 2018 ASH Annual Meeting & Exposition
TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...
Expert Point of View: Carlos L. Arteaga, MD
CARLOS L. ARTEAGA, MD, Director of the Harold C. Simmons Comprehensive Cancer Center and Associate Dean of Oncology Programs at The University of Texas Southwestern Medical Center, Dallas, expressed some caution about the overall applicability of the findings of the PADDY trial. Primarily, he...
Prognostic Value of Disseminated Tumor Cells in Early Breast Cancer
IN THE PADDY TRIAL, involving more than 10,000 women with early invasive breast cancer, the presence of disseminated tumor cells at diagnosis or primary surgery was an independent prognostic factor for overall, disease-free, and distant disease–free survival. The study findings were presented at...
SABCS Presentations Offer New Data on Biomarkers and Novel Treatment Approaches in Early and Metastatic Breast Cancers
REPORTERS FOR The ASCO Post captured the following summaries of noteworthy studies presented at the 2018 San Antonio Breast Cancer Symposium. In HER2-Negative Metastatic Disease, CTCs Frequently HER2-Positive ALMOST HALF of all patients with HER2-negative metastatic breast cancer have circulating...
BRAF/MEK Targeting May Yield Benefit in Treating Biliary Tract Cancer
ROUTINE TESTING for BRAF V600E mutations in patients with biliary tract cancer may prove to be a good idea, based on the findings of a phase II study in which treatment with dabrafenib plus trametinib showed activity.1 The results suggest there may be a benefit to testing patients with biliary...
Expert Point of View: Michael J. Overman, MD
INVITED STUDY discussant Michael J. Overman, MD, Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, is a co-investigator on CheckMate 142, which led to the approval of another immunotherapy doublet—nivolumab plus ipilimumab—in patients...
Durvalumab and Tremelimumab Combination Active in Refractory Microsatellite-Stable Colorectal Cancer
THE COMBINATION of durvalumab and tremelimumab prolonged median overall survival by 2.5 months compared with best supportive care alone in patients with advanced treatment-refractory colorectal cancer. These findings, which are from the randomized phase II Canadian Cancer Trials Group (CCTG) CO.26...
How to Improve Care for Young Sexual and Gender Minority Cancer Survivors
IN 2017, ASCO issued its recommendations for addressing the oncology care needs of sexual and gender minority cancer survivors and the unique challenges they face.1 There are myriad reasons for cancer disparities in this population compared to heterosexual cisgender cancer survivors, including...
‘Curve 2’ and Oncology: What Those in Charge Don’t Understand … or Ignore
THERE IS little doubt that the U.S. health-care system is under assault from many directions.1 It is clear that the costs of health management are no longer sustainable, and the United States has one of the highest per capita health costs among the 36 member nations of the Organisation for...
Expert Point of View: Andrew X. Zhu, MD, PhD
ANDREW X. ZHU, MD, PhD, of Massachusetts General Hospital Cancer Center and Harvard Medical School, noted that Prep-02/ JSAP-05 is the first study to show the value of neoadjuvant chemotherapy in patients with resectable pancreatic adenocarcinoma. However, the findings are applicable only to Asian ...
Emerging Role for Neoadjuvant Treatment of Resectable Pancreatic Cancer
SEVERAL STUDIES presented at the 2019 Gastrointestinal Cancers Symposium evaluated the benefits of neoadjuvant treatment in patients with pancreatic cancer—and in patients deemed fully resectable, not just “borderline” resectable.1-3 Although the standard of care for resectable pancreatic ductal...
Expert Point of View: Mark Crowther, MD, MSc, FRCPC
Session moderator Mark Crowther, MD, MSc, FRCPC, Professor of Clinical Epidemiology and Biostatistics and Leo Pharma Chair in Thromboembolism Research at McMaster University, in Ontario, Canada, said that the results of the PAUSE study provide the most definitive evidence to date regarding how...
PAUSE Study Establishes Simple Approach to Perioperative Management of Direct Oral Anticoagulants
The largest study to date addressing the common problem of perioperative direct oral anticoagulant (DOAC) management has shown that patients with atrial fibrillation can safely stop taking their anticoagulant for 1 day before and after procedures with a low risk of bleeding and for 2 days before...
Crizanlizumab Improves Prevention of Vaso-occlusive Crises in Patients With Sickle Cell Disease
For the first time in more than 20 years, patients with sickle cell disease may have another treatment option to reduce painful vaso-occlusive crises, according to data presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition.1 Results of the phase II, randomized,...
Expert Point of View: Mark Crowther, MD, MSc, FRCPC
Moderator of the session, Mark Crowther, MD, MSc, FRCPC, Professor of Clinical Epidemiology and Biostatistics, Leo Pharma Chair in Thromboembolism Research at McMaster University, in Ontario, Canada, said that the CASSINI study represents a major advance in the management and prevention of a very...
Direct Oral Anticoagulants Show Reduced Risk of Venous Thromboembolism in Patients With Cancer
Results of a recent study suggest that direct oral anticoagulants can reduce the risk of thromboembolism in patients with cancer who are starting a new systemic therapy regimen, without significantly increasing the risk of major bleeding. Data presented at the 2018 ASH Annual Meeting &...
Pilot Study Tests Novel Approach to Gene Therapy for Sickle Cell Disease
Initial findings from a first-in-human trial have provided proof of principle for a groundbreaking approach to gene therapy for sickle cell disease, according to data presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition.1 Early results of genetic targeting of...
Low-Dose Rituximab Effective for Acquired Thrombotic Thrombocytopenic Purpura With Severe ADAMTS13 Deficiency
The results of a recent pilot study suggest that low-dose rituximab provides similar efficacy to standard-dose rituximab for the treatment of acquired thrombotic thrombocytopenic purpura (TTP), a finding that could point to potential cost savings for patients in the nonlymphoma setting. According...
J. Evan Sadler, MD, PhD, Expert in Blood-Clotting Disorders, Dies at 67
Pioneering hematologist J. Evan Sadler, MD, PhD, an expert in the study and treatment of blood-clotting disorders, died December 13, 2018, at his home in Clayton, Missouri, following a brief illness. He was 67. Dr. Sadler was the Director of Hematology, the Ira M. Lang Professor of Medicine, and a ...
Expert Point of View: Kenneth Shain, MD, PhD, and Vincent Rajkumar, MD
In interviews with The ASCO Post, Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, and Vincent Rajkumar, MD, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, commented on the findings of the MAIA trial. “The study shows that...
Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma: Outcomes From the MAIA Trial
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab to lenalidomide and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract presentation by Thierry...
FDA Pipeline: Priority Reviews in Solid Tumors and Lymphoma; Plus an sNDA in Acute Myeloid Leukemia
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
Report Says Health Systems Are Key to Improving Cancer Outcomes in the United States
A new report indicates that without a national effort to transform health-care delivery in the United States, many people will not benefit from the ongoing improvements in cancer care. These findings were published by Yabroff et al in CA: A Cancer Journal for Clinicians. The article is the fifth...
Former JAMA Editor Offers Perspective on Challenges Past and Present in American Health Care
BOOKMARK Title: Severed Trust: Why American Medicine Hasn’t Been FixedAuthor: George D. Lundberg, MD, With James StaceyPublisher: Basic BooksPublication date: March 2001Price: $28.00, hardcover, 336 pages Pathologist George D. Lundberg, MD, served as Editor-in-Chief of The Journal of the American...
Patient-Reported Outcomes With Enzalutamide in PROSPER Trial
As reported by Tombal et al in The Lancet Oncology, treatment with enzalutamide was associated with clinically meaningful delays in pain progression, symptom worsening, and deterioration in functional status vs placebo in the phase III PROSPER trial in nonmetastatic, castration-resistant prostate...
Link Discovered Between Microbiome and Cervical Cancer
Bacteria may play an important role in whether a woman develops cervical cancer, according to global health research published by scientists from the University of Nebraska–Lincoln and the Ocean Road Cancer Institute in Dar es Salaam, Tanzania, in mBio. Part of a growing body of research...
2019 GU Cancers Symposium: First-Line Pembrolizumab Plus Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma
As reported at the 2019 Genitourinary Cancers Symposium (Abstract 543) and in The New England Journal of Medicine, Rini et al found significant benefits in overall and progression-free survival with the combination of pembrolizumab plus axitinib vs sunitinib in the first-line treatment of advanced...
Adherence to Endocrine Therapy for Breast Cancer in Black Women and White Women
In a study reported in the Journal of the National Cancer Institute, Stephanie B. Wheeler, MPH, PhD, of the Department of Health Policy and Management, University of North Carolina, Chapel Hill, and colleagues found that black women reported nonadherence to endocrine therapy for breast cancer more ...
Estradiol as Potential Treatment for Subset of Triple-Negative Breast Cancers
Mayo Clinic researchers have identified estradiol as a potential new treatment for a subset of women with triple-negative breast cancer. Their findings were published by Reese et al in the Proceedings of the National Academy of Sciences of the United States of America. “Triple-negative breast...
No Survival Benefit With Avelumab vs Docetaxel in Platinum-Treated, Advanced, PD-L1–Positive NSCLC
As reported in The Lancet Oncology by Fabrice Barlesi, MD, and colleagues, the phase III JAVELIN Lung 200 trial has shown no overall survival benefit with avelumab vs docetaxel in patients with platinum pretreated programmed cell death ligand 1 (PD-L1)–positive advanced non–small cell lung cancer ...
