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Showing 8551 - 8600Lorlatinib in Second- or Third-Line Treatment of ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 2, 2018, lorlatinib (Lorbrena) was granted accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK inhibitor for metastatic disease or whose disease ...
How to Build a Clinical Trial Infrastructure in the Community Oncology Setting
HISTORICALLY, CLINICAL research has been viewed as an entity belonging to academic settings alone. With the advent of the Community Clinical Oncology Program (CCOP) in the 1980s and later with the Cancer Trials Support Unit, cancer clinical trials have begun to emerge in the community setting....
New Data Reported From International Studies of Lung Cancer Treatment
At the European Society for Medical Oncology (ESMO) 2018 Congress, important studies were presented for every cancer type. Here, The ASCO Post offers some snapshots of lung cancer studies that may inform approaches to treating this common cancer, which—despite the advances in recent years—remains...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2-overexpressing, node-positive or node-negative (estrogen...
Durvalumab Improves Overall Survival After Chemoradiotherapy in Unresectable, Stage III NSCLC
AS REPORTED in The New England Journal of Medicine by Scott J. Antonia, MD, PhD, of H. Lee Moffitt Cancer Center and Research Institute, and colleagues, the phase III PACIFIC trial has shown significantly improved overall survival, a coprimary endpoint, with the programmed cell death ligand 1...
Statement From FDA Commissioner on In Vitro Companion Diagnostics
FDA Commissioner Scott Gottlieb, MD, recently issued the following statement on developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products: “With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labeling ...
Should I Have Lied?
The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
International Trials Present New Findings in Treatment of Breast Cancer
The European Society for Medical Oncology (ESMO) 2018 Congress featured an assortment of study findings, many with far-reaching clinical implications for the treatment of patients with various cancers. Many of these trials were covered in-depth in recent issues of The ASCO Post. Here, we present...
Pembrolizumab Plus Chemoradiotherapy in HPV-Positive Head and Neck Cancer
The addition of pembrolizumab (Keytruda) to a chemoradiotherapy regimen yielded complete response rates of 85% in patients with human papillomavirus (HPV)-positive advanced squamous cell carcinoma of the head and neck. These findings from a phase Ib study were presented at the 2018 Society for...
Overscreening for Prostate Cancer in Older Men Remains an Issue
Although most major cancer organizations agree on the guidelines for prostate cancer screening, there is still uneven application of the test, such as in the older patient population, resulting in overdiagnosis and waste in an already fiscally challenged health-care system. Researchers from the...
Update on Immune Checkpoint Inhibitors
Checkpoint inhibitors have moved the field of immuno-oncology to the forefront of cancer treatment and research. However, these agents come with the risk of serious adverse events. To shed light on the toxicities associated with checkpoint inhibitors and other timely issues in the field of...
The Great Opioid Debate: Treating Cancer Pain Safely
As the number of opioid-related deaths continues to rise in the United States, stakeholders are struggling to make sense of the crisis. At the 2018 Palliative and Supportive Care in Oncology Symposium, two experts in the field, Charles F. von Gunten, MD, PhD, and Leslie J. Blackhall, MD,...
Immunotherapy-Related Toxicities May Be More Common Than Originally Reported
Immunotherapy has significantly improved the overall survival of patients with non–small cell lung cancer (NSCLC) and is generally better tolerated than traditional chemotherapies, but the results of a retrospective study suggested that immunotherapy side effects may be more common than initially...
Has Scalp Cooling Reached the Level of Standard of Care?
Does evidence of the effectiveness and safety of scalp cooling to reduce hair loss among women being treated for breast cancer mean that scalp cooling is a new standard of care? “I would suggest that it is,” stated Mikel Ross, MSN, RN, AGNP-BC, of the Breast Medicine Service, Memorial Sloan...
ESMO Immuno-Oncology 2018: OAK Trial: Fast Progression in Patients With NSCLC Treated With Atezolizumab vs Chemotherapy
Overall survival (OS) was improved across all subgroups of patients with non–small cell lung cancer (NSCLC) who received atezolizumab (Tecentriq) compared with chemotherapy, including poor prognostic factors that were evaluated in an analysis of data from the OAK trial. Additionally, this...
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...
FDA 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...
Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...
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...
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...
Combining a Checkpoint Inhibitor With CAR T-Cell Therapy May Augment Immune Response
Chimeric antigen receptor (CAR) T-cell therapy is a revolutionary approach to treating hematologic malignancies. As experience with this strategy is gained, researchers are learning more about how to optimize responses, especially in patients with “immune exhaustion,” who have a suboptimal initial...
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...
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...
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...
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...
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 ...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2 overexpressing node-positive or node-negative (estrogen...
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...
RSNA 2018: Mammography Screening Beyond Age 75
Women aged 75 years and older may benefit from continued screening mammograms because of the comparatively high incidence of breast cancer found in this age group, according to a study presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSA01-04)....
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...
SELECT Trial: Adjuvant Erlotinib in Resected EGFR-Mutant NSCLC
In a phase II trial reported in the Journal of Clinical Oncology, Pennell et al found that adjuvant erlotinib (Tarceva) improved disease-free survival over historical controls in patients with resected EGFR-mutant non–small cell lung cancer (NSCLC). In the study, 100 patients with ...
Reducing Infections in Patients With AML Receiving Induction and Reinduction Chemotherapy
In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...
Vitamin D Supplementation and Cancer Risk
In a trial reported in The New England Journal of Medicine by Manson et al, vitamin D supplementation was found to have no benefit in reducing risk of invasive cancer vs placebo over 5 years of follow-up. Study Details The trial was a randomized, placebo-controlled trial, with a two-by-two...
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....
POEMS/SWOG Intergroup S0230 Study on Preventing Early Menopause
In the long-term follow-up of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230 trial reported in the Journal of the National Cancer Institute, Moore et al found that the addition of goserelin (Zoladex) to cyclophosphamide-containing chemotherapy was associated with a higher...
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...
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...
Oncology Care Team Reduces Opioid Use After Surgery by Using Quality Improvement Approach
IN A QUALITY improvement project that was featured in the Quality Care Symposium press program,1 members of an oncology care team achieved a 46% reduction in opioid use among patients who underwent a range of urologic surgeries. They did this by using a systemic approach that identified multiple...
Scientific and Career Development Retreat: Networking and Collaborating With Promising Researchers
ASCO’s Conquer Cancer Foundation is committed to supporting the research and career development of young researchers through its Grants & Awards Program. On October 10–11, 2018, Conquer Cancer hosted its 4th Scientific and Career Development Retreat at ASCO headquarters in Alexandria,...
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...
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...
