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Showing 17001 - 17050FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) in patients with advanced BRAF V600–mutant melanoma, as detected by an FDA-approved test.1 Dual targeting of the MAPK...
A Conversation With the Author: Mark Scholz, MD
To dig a bit deeper into some of the issues touched upon in the new book, The Key to Prostate Cancer: 30 Experts Explain 15 Stages of Prostate Cancer, The ASCO Post recently spoke with the author, Mark Scholz, MD. Dr. Scholz is a medical oncologist who exclusively treats men with prostate cancer....
New Guide Helps Clinicians Navigate Immunotherapy in Merkel Cell Carcinoma
Fred Hutchinson Cancer Research Center researchers have published a new guide to help clinicians navigate a recent revolution in care for advanced Merkel cell carcinoma. The guide was published in JNCCN–Journal of the National Comprehensive Cancer Network, and it accompanies NCCN’s new...
A Medical Oncologist Urges Men to Keep Their Prostates
With the development of the prostate-specific antigen (PSA) test in the early 1990s, the urology community advocated for population screening of all men of a certain age, igniting a heated argument about the test’s clinical value vs potential harms that has not abated to this day. Moreover, from...
STAG2 Genetic Test Could Reduce Overtreatment in Some Patients With Bladder Cancer
A new genetic test in bladder cancer could be key to reducing the cost of care while avoiding overtreatment in some patients, according to research published by Waldman et al in Clinical Cancer Research. Deciding whether to treat bladder cancer aggressively can be difficult—predictive...
Expensive Cancer Drugs Don’t Work if Patients Can’t Afford Them
Eight years ago, I was having a series of colds I couldn’t shake and pain that radiated throughout my back. Still, my symptoms weren’t concerning until, on Halloween morning in 2010, I stepped out of bed and fell to the floor in excruciating pain, unable to move. A visit to the emergency room and a ...
FDA Grants Priority Review for Glasdegib in Patients With Previously Untreated AML
The U.S. Food and Drug Administration (FDA) recently accepted a new drug application and granted Priority Review designation for glasdegib, an investigational oral smoothened inhibitor being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in...
Addition of Dose-Intensified Doxorubicin to Standard Chemotherapy in Rhabdomyosarcoma
As reported by Bisogno et al in The Lancet Oncology, a phase III trial (EpSSG RMS 2005) has shown no benefit of adding doxorubicin to standard IVA (ifosfamide, vincristine, dactinomycin) in 3-year event-free survival among patients with high-risk rhabdomyosarcoma. Study Details In the open-label...
Three Cancer Researchers Share Tang Prize in Biopharmaceutical Science
The 2018 Tang prize in Biopharmaceutical Science is being shared by three cancer researchers, including targeted cancer therapy researcher John Mendelsohn, MD, former President of The University of Texas MD Anderson Cancer Center; Tony Hunter, PhD, Professor of Biology at the Salk Institute; and ...
Marc E. Lippman, MD, MACP, FRCP, Returns to Georgetown’s Cancer Center
Georgetown Lombardi Comprehensive Cancer Center announces the return of physician-scientist Marc E. Lippman, MD, MACP, FRCP, as Professor of Oncology and Medicine at the Georgetown University Medical Center. From 1988 to 2001, Dr. Lippman served as Director of Georgetown Lombardi Comprehensive...
Steven T. Rosen, MD, Inducted Into AIMBE College of Fellows
City of Hope Comprehensive Cancer Center’s Provost and Chief Scientific Officer, Steven T. Rosen, MD, has been inducted into the College of Fellows of the American Institute for Medical and Biological Engineering (AIMBE). Dr. Rosen was nominated, reviewed, and elected by peers in recognition of...
Christine M. Eischen, PhD, Receives Professorship in Cancer Research at Thomas Jefferson
Christine M. Eischen, PhD, Professor and Vice Chair in the Department of Cancer Biology at Thomas Jefferson University and co-leader of the Molecular Biology & Genetics Program at the Sidney Kimmel Cancer Center, was recently invested as the inaugural Herbert A. Rosenthal, MD ’56 Professor in ...
Mindfulness in Cancer Care: Hype or Help?
GUEST EDITOR Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief, Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York. “Mindfulness” has gained significant popularity in the lay press in recent...
Endocrine Society Issues Guideline to Address the Risk of Endocrine Disorders Among Survivors of Childhood Cancers
To address a growing risk of endocrine disorders among childhood cancer survivors, the Endocrine Society has published the “Hypothalamic-Pituitary and Growth Disorders in Survivors of Childhood Cancer: An Endocrine Society Clinical Practice Guideline,” advising...
Raising Awareness of the Financial Impact of Cancer on Young Adult Survivors
GUEST EDITOR Adolescent and Young Adult Oncology explores the unique physical, psychosocial, social, emotional, sexual, and financial challenges adolescents and young adults with cancer face. The column is guest edited by Brandon Hayes-Lattin, MD, FACP, Associate Professor of Medicine and Medical...
Ensuring High-Quality Oncology Care for Patients With Intellectual Disabilities
Despite significant gains in improved access to public places, transportation, and job opportunities for people with disabilities since the enactment of the Americans With Disabilities Act in 1990, the long history of discrimination in the social and medical treatment of people with disabilities is ...
IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer
The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...
Percutaneous Ablation vs Nephrectomy in T1a Kidney Cancer
Many cases of early-stage kidney cancer can be treated with a relatively new, nonsurgical procedure used to destroy tumors, a new study by Talenfeld et al in Annals of Internal Medicine suggests. The procedure, called percutaneous ablation, involves the insertion of a needle through the skin into...
Outcomes of Tisagenlecleucel Therapy in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia
As reported in The New England Journal of Medicine by Shannon L. Maude, MD, PhD, of Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, the phase II ELIANA trial has shown that the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) ...
FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...
Addition of Concurrent Chemotherapy to EGFR Inhibitor and Radiotherapy in Locally Advanced Head and Neck Carcinoma
As reported in the Journal of Clinical Oncology by Tao et al, the phase III GORTEC (Groupe Oncologie Radiothèrapie Tête et Cou) 2007-01 trial has shown improved progression-free survival with the addition of concurrent chemotherapy to cetuximab (Erbitux) and radiotherapy (RT) in...
Addition of Veliparib to Temozolomide in Recurrent Small Cell Lung Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Pietanza et al found no benefit of adding the PARP inhibitor veliparib to temozolomide (Temodar) in recurrent platinum-sensitive or platinum-refractory small cell lung cancer. Benefit was observed with the combination in the subgroup ...
Vitamin D Levels and Colorectal Cancer Risk
In a study reported in the Journal of the National Cancer Institute, McCullough et al found reduced risk for colorectal cancer with increasing levels of circulating 25-hydroxyvitamin D (25[OH]D). Study Details The study was an international pooling project using participant-level data from 17...
FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...
IMpower133: Atezolizumab in Combination With Chemotherapy in Previously Untreated, Extensive-Stage Small Cell Lung Cancer
The phase III IMpower133 study recently met its coprimary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. The study demonstrated that first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and...
Addition of Panitumumab to Neoadjuvant Chemotherapy in Primary HER2-Negative Inflammatory Breast Cancer
In a single-center phase II study reported in JAMA Oncology, Matsuda et al found that adding the EGFR inhibitor panitumumab (Vectibix) to neoadjuvant chemotherapy produced high pathologic complete response (pCR) rates in patients with primary triple-negative inflammatory breast cancer. Study...
ASCO Practice Census Survey Identifies Challenges Facing U.S. Oncology Practices
As reported in the Journal of Oncology Practice by Kirkwood et al, the recent ASCO Oncology Practice Census survey has identified a number of factors considered to be challenging by oncology practices in the United States. Study Details ASCO used Medicare Physician Compare data to characterize...
Sodium Thiosulfate to Prevent Cisplatin-Induced Hearing Loss in Pediatric Standard-Risk Hepatoblastoma
In a phase III International Liver Tumor Strategy Group trial (SIOPEL 6) reported in The New England Journal of Medicine, Brock et al found that sodium thiosulfate reduced cisplatin-induced hearing loss in pediatric patients with standard-risk hepatoblastoma. Study Details The trial enrolled a...
Educational Interventions Decrease Sunburns Among Operators of Heavy Equipment
The implementation of educational interventions among heavy equipment operators, or operating engineers, in Michigan significantly increased the use of sunscreen and decreased the number of sunburns, reported Duffy et al in Cancer Epidemiology, Biomarkers & Prevention. “The rates of...
FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...
Colon Cancer Surgery and Resource Availability at Hospitals on Weekends and Holidays
The likelihood of severe complications after emergency colon cancer surgery is significantly higher over the weekend, according to a study published by Huijts et al in JNCCN – Journal of the National Comprehensive Cancer Network. The research was led by Perla Marang-van de Mheen, PhD, of the...
MAGE-A3 Immunotherapeutic as Adjuvant Therapy for MAGE-A3–Positive Stage III Melanoma
In the phase III DERMA trial reported in The Lancet Oncology, Dreno et al found that an adjuvant MAGE-A3 immunotherapeutic provided no benefit vs placebo in patients with resected MAGE-A3–positive stage IIIB or IIIC melanoma. Development of the agent for use in melanoma has been stopped. The ...
Trastuzumab Biosimilar vs Reference Trastuzumab in HER2-Positive Early Breast Cancer
In the phase III LILAC equivalence trial reported in The Lancet Oncology, von Minckwitz et al found similar efficacy and safety with the trastuzumab biosimilar ABP 980 vs reference trastuzumab (Herceptin) in HER2-positive early breast cancer. On local review, the risk difference and risk ratio (RR) ...
ERBB Mutations and Outcomes With Afatinib and Erlotinib in Squamous NSCLC
In an analysis of the LUX-Lung 8 trial in squamous non–small cell lung cancer (NSCLC) reported in JAMA Oncology, Goss et al found that outcomes among patients treated with afatinib (Gilotrif) were better for those with vs without ERBB mutations. The LUX-Lung 8 trial showed that afatinib was...
FDA Takes Steps to Foster Greater Efficiency in Biosimilar Development by Reconsidering Draft Guidance on Evaluating Analytical Studies
“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped. I believe that the US Food and Drug Administration (FDA) can do more to support the development of biosimilars, as well as...
IASLC Issues Statement Paper on Liquid Biopsy for Lung Cancer
The lungs can be a difficult organ to biopsy with a needle, so the promise of identifying lung cancer through a blood-based biopsy has lung cancer experts and patients optimistic. Knowing how and when to use a liquid biopsy is critically important and led global experts at the International...
Long-Term Outcomes With Dasatinib Plus Intensive Chemotherapy in Pediatric/Young Adult Ph-Positive ALL
In an analysis of the Children’s Oncology Group (COG) AALL0622 trial reported in the Journal of Clinical Oncology, Slayton et al found that adding dasatinib (Sprycel) to intensive chemotherapy produced good long-term outcomes in pediatric/young adult patients with newly diagnosed Philadelphia ...
Second-Line Pembrolizumab vs Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...
Dietary Insulin Load and Risk of Disease Recurrence in Stage III Colon Cancer
New research led by Dana-Farber Cancer Institute investigators suggests that patients treated for nonmetastatic colon cancer may sharply reduce the risk that the disease will return by following a diet low in carbohydrates and other foods that raise insulin levels. In a study published by...
FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients
As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...
Prognostic Model for Malignant Pleural Effusion
As reported in The Lancet Oncology, Psallidas et al developed a model that is predictive of 3-month survival in patients with malignant pleural effusion. Study Details The PROMISE study involved an analysis of 5 independent data sets from randomized trials to discover, validate, and prospectively ...
Genetic Risk for Subsequent Neoplasms in Long-Term Survivors of Childhood Cancer
In a study reported in the Journal of Clinical Oncology, Wang et al found that germline pathogenic/likely pathogenic mutations significantly contributed to the risk of subsequent neoplasms in long-term survivors of childhood cancers. Study Details The study involved whole-genome sequencing on...
Addition of Ribociclib to Fulvestrant Improves Progression-Free Survival in HR-Positive, HER2-Negative Advanced Breast Cancer
As reported by Slamon and colleagues in the Journal of Clinical Oncology, the phase III MONALEESA-3 trial has shown significant improvement in progression-free survival with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) to fulvestrant (Faslodex) in hormone receptor (HR)-positive,...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...
FDA Accepts Supplementary PMA for Review of BRACAnalysis CDx as a Companion Diagnostic to Talazoparib in Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted a supplementary premarket approval (PMA) application for BRACAnalysis CDx to be used as a companion diagnostic with the poly ADP ribose polymerase (PARP) inhibitor talazoparib. The new drug application (NDA) for...
JAK Inhibitor Treatment for Myelofibrosis May Be Associated With Development of Aggressive Lymphomas
Austrian researchers have discovered that a small number of patients taking targeted drugs known as Janus kinase (JAK) inhibitors to treat myelofibrosis may develop aggressive lymphomas. They also speculate that screening for a preexisting B-cell clone before starting therapy may help prevent this...
CAR T Cells Targeting B-Cell Maturation Antigen in Poor-Prognosis Relapsed Multiple Myeloma
In a first-in-human study reported in the Journal of Clinical Oncology, Brudno et al found that chimeric antigen receptor (CAR) autologous T cells targeting B-cell maturation antigen (BCMA) produced responses in patients with poor-prognosis relapsed multiple myeloma. Study Details The current...
Outcomes by Chemotherapy Backbone for Obinutuzumab vs Rituximab in Previously Untreated Follicular Lymphoma
In an analysis of the GALLIUM trial reported in the Journal of Clinical Oncology, Hiddemann and colleagues found that obinutuzumab (Gazyva) appeared to provide consistent progression-free survival benefit vs rituximab (Rituxan) in previously untreated follicular lymphoma, irrespective of which...
Addition of Atezolizumab to Bevacizumab and Chemotherapy in First-Line Treatment of Metastatic Nonsquamous NSCLC
As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by Socinski et al, the phase III IMpower150 trial has shown that the addition of atezolizumab (Tecentriq) to bevacizumab (Avastin) plus chemotherapy significantly improved progression-free and overall survival in ...
In Continued Effort to Address Physician Burnout, AMA Adopts Policy to Improve Physician Access to Mental Health Care
With growing concern among the medical community and the public regarding physician and medical student depression, burnout, and suicide, the American Medical Association (AMA) adopted policy during its Annual Meeting that continues its efforts aimed at improving physician access to mental health...
