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Showing 5751 - 5800This Year’s FDA-ASCO Workshop Focused on Collection of Patient-Reported Tolerability Data From Clinical Trials
OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Vishal Bhatnagar, MD, Associate Director for Patient Outcomes, Bellinda King-Kallimanis, PhD, Senior Staff...
Support Builds for Anti-BCMA CAR T-Cell Therapy in Multiple Myeloma
Based on early results in clinical trials, interest in the use of chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma has been high, especially for products targeting B-cell maturation antigen (BCMA). During the ASCO20 Virtual Scientific Program, further support for CAR T-cell...
Expert Point of View: Fatima Cardoso, MD
The SOLAR-1 invited discussant, Fatima Cardoso, MD, Director of the Breast Unit at the Champalimaud Clinical Center in Lisbon and Chair of the ABC Global Alliance, commented: “The overall survival results, though numerically different by almost 8 months, unfortunately do not reach statistical...
Final Analysis of SOLAR-1: 8-Month Survival Benefit Misses Statistical Significance for Alpelisib
The statistically significant benefit of alpelisib in reducing disease progression, as reported at the European Society for Medical Oncology (ESMO) Congress 2 years ago, did not translate into a significant improvement in overall survival, although a numerical 8-month gain was observed in the final ...
AACR Announces Move to Virtual Meeting for 2021
The Annual Meeting of the American Association for Cancer Research (AACR) brings together key stakeholders in all areas of cancer research to make connections, build collaborations, and explore and expand the frontiers of integrative cancer science and medicine. After careful consideration of...
Growing Interest in Antiandrogens to Treat Male Breast Cancer
“There has been a lot of interest in the development of new antiandrogens” for clinical use in patients with breast cancer,” Anthony D. Elias, MD, reported in an update on male breast cancer at the 2020 Lynn Sage Breast Cancer Symposium, sponsored by the Robert H. Lurie Comprehensive Cancer Center...
Expert Point of View: David Cameron, MD
“This study highlights an interesting difference between breast cancers that are detected at the time a woman attends a scheduled appointment as part of a national screening program and those that are diagnosed in the interval between screenings,” commented European Breast Cancer Conference...
Expert Point of View: Keerthi Gogineni, MD, MSHP
Keerthi Gogineni, MD, MSHP, Assistant Professor of Hematology and a medical oncologist at Emory University School of Medicine, Atlanta, commented on the long-term follow-up of the MINDACT trial presented at the 12th European Breast Cancer Conference. She noted that, for patients with early-stage...
MINDACT at 8.7 Years: Primary Findings Confirmed
Long-term analysis of the phase III MINDACT trial, with a median follow-up of 8.7 years, confirmed that the 70-gene signature MammaPrint assay can identify which patients with breast cancer can safely forgo adjuvant chemotherapy, reported Emiel Rutgers, MD, PhD, FRCS, a surgical oncologist at the...
Can Antihypertensives Improve Outcomes With Immunotherapy?
Angiotensin receptor blockers, commonly used to treat hypertension, may improve outcomes in patients treated with anti–PD-1/L1 agents, according to an observational study of almost 600 patients reported at the virtual 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.1 The...
KRAS Inhibitor Adagrasib Shows Activity in Non–Small Cell Lung Cancer
Another novel oral KRAS inhibitor—adagrasib (MRTX849)—has shown promise in early clinical trials, according to investigators of the KRYSTAL-1 study who reported findings at the virtual 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.1,2 The conference is jointly provided...
Expert Point of View: Melina E. Marmarelis, MD, MSCE
Invited study discussant, Melina E. Marmarelis, MD, MSCE, of Abramson Cancer Center at the University of Pennsylvania, Philadelphia, noted that pembrolizumab has been evaluated in advanced mesothelioma in several clinical trials, with varying results. According to Dr. Marmarelis, this high...
Nagi S. El Saghir, MD, FACP, FASCO, Receives Lebanon’s National Cedar Medal Award
One of Lebanon’s highest national awards, the National Cedar Medal (Commander Rank), was recently bestowed upon Nagi S. El Saghir, MD, FACP, FASCO, in recognition of his extensive contributions to the fields of medicine, education, and science—and most particularly, for his efforts in the fight...
Stereotactic Radiosurgery May Delay Cognitive Deterioration vs Whole-Brain Radiotherapy for Multiple Brain Metastases
Stereotactic radiosurgery appears to be a new standard of care for patients with four or more nonmelanoma brain metastases, perhaps replacing whole-brain radiotherapy in this setting, according to a potentially practice-changing phase III study presented at the 2020 American Society for Radiation...
Management of Painful Spinal Metastases: SBRT vs Conventional Radiotherapy
Stereotactic body radiation therapy (SBRT) was superior to conventional radiation therapy in reducing pain from spinal metastases in a phase II/III study reported at the virtual edition of the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting.1 More than twice as many patients...
Analysis Seeks to Identify Characteristics of 'Exceptional Responders' to Cancer Therapy
In a comprehensive analysis of patients with cancer who had exceptional responses to therapy, researchers identified molecular changes in the patients’ tumors that may explain some of these outcomes. The results, published by Wheeler et al in Cancer Cell, demonstrated that genomic characterizations ...
Image-Guided IMRT Reduces GI Toxicity Without Compromising Pelvic Recurrence in Intermediate- to High-Risk Cervical Cancer
Post-hysterectomy image-guided intensity-modulated radiation therapy (IMRT) was superior to three-dimensional conformal radiation therapy (3D-CRT) in reducing the side effects of pelvic radiation while achieving similar tumor control in women with high-risk cervical cancer, according to the final...
Impact of COVID-19 on Cancer Care in India
With the announcement of a complete nationwide lockdown on March 25, 2020, to prevent the spread of COVID-19, a lot of unprecedented events came into being in India. The National Health Mission reported a 69% reduction in measles, mumps, and rubella vaccination in children; a 21% reduction in...
Phase II Study Investigates Efficacy of Anlotinib in Radioiodine-Refractory Differentiated Thyroid Cancer
Patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma demonstrated a statistically significant progression-free survival benefit when treated with anlotinib, a novel tyrosine kinase inhibitor, vs placebo, as well as higher response rates, according to...
Expert Point of View: Deborah B. Doroshow, MD, PhD
Invited study discussant, Deborah B. Doroshow, MD, PhD, Assistant Professor of Medicine at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, in New York, noted that the current first-line treatment paradigm for patients with advanced NSCLC and no driver mutation is based on...
Nivolumab Plus Ipilimumab in First-Line NSCLC: Two New Indications, Many More Questions
In May 2020, the combination of nivolumab and ipilimumab was approved by the U.S. Food and Drug Administration (FDA) for two separate indications in the first-line setting of advanced non–small cell lung cancer (NSCLC). One was in metastatic NSCLC with tumors that have PD-L1 expression ≥ 1% with...
Fluciclovine PET Imaging Benefits Radiotherapy Treatment Planning Compared With Conventional Imaging in Prostate Cancer
The addition of the radiotracer fluciclovine to positron-emission tomography (PET) imaging for radiotherapy treatment planning led to superior failure-free survival compared with conventional imaging in men with prostate cancer who had undergone radical prostatectomy and were experiencing biologic ...
ESMO Asia 2020: Early Detection and Localization of Cancer Using a Blood-Based Assay
The ELSA-seq assay was able to detect diverse cancer types at early stages with high specificity and was able to provide information regarding the tissue of origin, according to findings presented by Gao et al at the ESMO Asia Virtual Congress 2020 (Abstract LBA3). Qiang Gao, MD, PhD, of the Liver...
ESMO Asia 2020: Baseline Characteristics of Asian Patients Enrolled in the monarchE Trial
A comparison of baseline characteristics in patients with hormone receptor (HR)-positive, HER2-negative early breast cancer revealed that a higher proportion of patients enrolled from Asia had risk factors for disease recurrence than those enrolled from non-Asian countries, reported Jiang et al at...
First-Line Lorlatinib vs Crizotinib in Advanced ALK-Positive NSCLC
As reported in The New England Journal of Medicine by Alice T. Shaw, MD, PhD, and colleagues, an interim analysis of the phase III CROWN trial has shown that first-line lorlatinib significantly improved progression-free survival and intracranial response rate vs crizotinib in patients with advanced ...
Effect of Anterior Approach vs Conventional Hepatectomy in Resection of Colorectal Liver Metastases on Intraoperative Tumor Cell Dissemination
In a German single-institution study reported in JAMA Surgery, Rahbari et al found that the anterior approach to the resection of colorectal liver metastases was not associated with a reduction in the detection of intraoperative circulating tumor cells vs conventional hepatectomy. As stated by the...
Pembrolizumab Plus Bevacizumab and Oral Metronomic Cyclophosphamide for Recurrent Ovarian Cancer
In a single-institution phase II trial reported in JAMA Oncology, Zsiros et al found that the combination of pembrolizumab with bevacizumab and oral metronomic cyclophosphamide produced objective response in approximately half of women with recurrent ovarian cancer taking part in the study....
FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for December 10, 2020, to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. “The...
Final ASCEND Results Confirm Acalabrutinib as a Standard for Relapsed CLL
The Bruton’s tyrosine kinase (BTK) inhibitors have been one of the most exciting advances in the treatment of patients with chronic lymphocytic leukemia (CLL) and have led to the development of chemotherapy-free treatments for both treatment-naive as well as relapsed or refractory CLL based on...
Support Builds for Anti-BCMA CAR T-Cell Therapy in Multiple Myeloma
Based on early results in clinical trials, interest in the use of chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma has been high, especially for products targeting B-cell maturation antigen (BCMA). During the ASCO20 Virtual Scientific Program, further support for CAR T-cell...
Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies
Daratumumab and hyaluronidase-fihj: On May 1, 2020, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. Ibrutinib: On April 21, 2020, the FDA expanded the indication of ibrutinib (Imbruvica) to include...
Guideline Update Offers New Directions About Trastuzumab Emtansine for HER2-Positive Breast Cancer
About 10% to 20% of newly diagnosed breast cancers demonstrate overexpression of the HER2 protein.1 Since the introduction of trastuzumab, several new HER2-targeted therapies have been approved for use in the adjuvant and metastatic settings (eg, pertuzumab, lapatinib, and neratinib). However, for...
Study Finds Medicaid Expansion in Louisiana Increased Early-Stage Breast Cancer Diagnosis and Access to Treatment
A study by Quyen D. Chu, MD, MBA, FACS, and colleagues published in the journal Cancer investigated how expansion of the Medicaid provision in the the Patient Protection and Affordable Care Act (ACA) affected breast cancer care in Louisiana. The state is the third poorest in the country and has one ...
Does Supplementation With Vitamin D Reduce the Risk of Developing Advanced Cancer?
The Vitamin D and Omega-3 Trial (VITAL), which was completed in 2018, found that vitamin D did not reduce overall incidence of cancer, but it hinted at a decreased risk of cancer deaths. Now, in a secondary analysis of VITAL, a research team focused on the connection between taking vitamin D...
Expert Point of View: Basem M. William, MD, MRCP (UK), FACP, and Caron Jacobson, MD
Basem M. William, MD, MRCP (UK), FACP, Director of the T-Cell Lymphoma Program and a member of the Blood and Marrow Transplant Program at The Ohio State University Comprehensive Cancer Center, Columbus, said many of the new-generation bispecific antibodies are “highly promising.” He said they...
Bispecific Antibodies Poised to Impact Treatment of Lymphoma and Other Blood Cancers
Studies of second-generation bispecific antibodies were among the highlights of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition. The bispecific T-cell engager blinatumomab was the first such agent to be approved by the U.S. Food and Drug Administration (FDA) in...
Newer Therapeutic Approaches Improving Outcomes in Hodgkin Lymphoma
At the 2020 Debates and didactics in Hematology and Oncology Virtual Conference, sponsored by Emory University School of Medicine and Winship Cancer Institute, Pamela Allen, MD, Assistant Professor of Medicine at Emory, described recent trials on therapeutic approaches that are informative on this ...
Role of Rituximab in Treatment of Children and Adolescents With Mature B-Cell Non-Hodgkin Lymphoma
The European Intergroup for Childhood Non-Hodgkin Lymphoma/Children’s Oncology Group (EICNHL/COG) recently reported a significant improvement in event-free survival among children and adolescents (aged 6 months to 18 years) with high-risk mature B-cell non-Hodgkin lymphoma (B-NHL) following the...
ASH Releases New Clinical Practice Guidelines on Treatment of Older Adults With Newly Diagnosed Acute Myeloid Leukemia
The American Society of Hematology (ASH) has published new guidelines to help older adults with acute myeloid leukemia (AML) and their health-care providers make critical care decisions, including if and how to proceed with cancer treatment and the need for blood transfusions for those in hospice...
Optimizing the Treatment of Adults With Acute Lymphoblastic Leukemia
In the treatment of adults with acute lymphoblastic leukemia (ALL), use of newer antibodies and de-intensification of chemotherapy have greatly improved outcomes, according to Hagop Kantarjian, MD, FASCO, who has been very involved in much of the research in ALL treatment. Dr. Kantarjian, Professor ...
Screening Younger Women for Variants Linked to Breast and Ovarian Cancers May Be Cost-Effective
Population-wide screening for genetic variants linked to hereditary breast and ovarian cancers may be cost-effective in women between the ages of 20 and 35, according to a study published by Guzauskas et al in JAMA Network Open. However, screening for older women was not cost-effective, the...
State of Lung Cancer Report Finds People of Color Face Greater Burden, Worse Lung Cancer Outcomes in the United States
People of color diagnosed with lung cancer face worse outcomes compared to White Americans, according to the American Lung Association’s third annual State of Lung Cancer report. The 2020 State of Lung Cancer report tracks the toll of lung cancer by state, and for the first time, this year’s report ...
Study Finds the Lung Microbiome May Affect Tumor Progression and Prognosis in Patients With Lung Cancer
A new study by Tsay et al sheds light on the role the lung microbiome may play in lung cancer pathogenesis and prognosis. According to the study’s findings, enrichment of the lungs with oral commensal microbes was associated with advanced-stage disease, worse prognosis, and tumor progression....
FDA Issues Emergency Use Authorization for First COVID-19 Test for Self-Testing at Home
On November 17, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home. The Lucira COVID-19 All-In-One Test Kit, which provides rapid results, is a molecular (real-time loop mediated amplification...
FDA Pipeline: Fast Track Designations in Liver and Pancreatic Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designations to novel agents in the treatment of liver and pancreatic cancers. Fast Track Designation for SRF388 in Liver Cancer The FDA granted Fast Track designation to SRF388 for the treatment of patients with...
Paclitaxel Plus Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer: Long-Term Follow-up and Genomic Analysis
In a 7-year follow-up of the phase III CALGB 40601/Alliance neoadjuvant trial reported in the Journal of Clinical Oncology, Fernandez-Martinez et al found that paclitaxel combined with trastuzumab/lapatinib was associated with improved survival outcomes vs paclitaxel/trastuzumab in women with...
Sentinel Lymph Node Biopsy vs Lymphadenectomy for Staging of Intermediate- and High-Grade Endometrial Cancers
In a Canadian prospective cohort study (SENTOR) reported in JAMA Surgery, Cusimano et al found that sentinel lymph node biopsy showed “acceptable diagnostic accuracy” compared with lymphadenectomy in detecting nodal metastatic disease in patients with intermediate- and high-grade endometrial...
Immune-Related Adverse Events and Survival Outcomes in NSCLC
This week, we’re focusing on lung cancer—first, with a report on how therapy-related adverse events experienced by patients with lung cancer treated with immunotherapy may help to predict survival outcomes; and second, with a video about disparities in certain populations when it comes to lung...
Survey Finds Patients With Cancer May Be Less Likely to Enroll in Clinical Trials During the COVID-19 Pandemic
A portion of patients with cancer may be less likely to enroll in a clinical trial due to the ongoing coronavirus pandemic. According to a report published as a research letter by Mark E. Fleury, PhD, and colleagues in JAMA Oncology, nearly one in five patients with cancer surveyed said the...
Ivosidenib Plus Azacitidine in Newly Diagnosed IDH1-Mutant Acute Myeloid Leukemia
In a phase Ib study reported in the Journal of Clinical Oncology, Courtney D. DiNardo, MD, and colleagues found that the combination of ivosidenib and azacitidine produced a high response rate in patients with newly diagnosed isocitrate dehydrogenase 1 (IDH1)-mutant acute myeloid leukemia...
