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Showing 12501 - 12550FDA Approves CAR T-Cell Therapy to Treat Adults With Certain Types of Large B-Cell Lymphoma
On October 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment....
ASCO Guideline on Stage IV NSCLC Therapy Updated
An update of the ASCO clinical practice guideline on the systemic treatment of patients with stage IV non–small cell lung cancer (NSCLC) clarifies the role of immunotherapy in this setting. The update was published by Hanna et al in the Journal of Clinical Oncology.1 “This guideline update...
IASLC 2017: Treatment Based on BRCA1 Level Does Not Increase Survival of Stage II/III NSCLC Node-Positive Resected Patients
New research shows that treating stage II and III non–small cell lung cancer (NSCLC) node-positive resected patients with customized chemotherapy based on their specific BRCA1 expression levels, as opposed to providing the standard treatment, did not increase overall survival rates among...
Norman E. Sharpless, MD, Sworn in as Director of the National Cancer Institute
Norman E. “Ned” Sharpless, MD, took the oath of office late Tuesday, October 17, 2017, to become the 15th Director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). He succeeds Harold E. Varmus, MD, who stepped down as Director in March 2015....
Outcomes in Patients With Metastatic Lung Cancer Receiving PD-1/PD-L1 Inhibitors With Thoracic Radiotherapy
In a research letter to JAMA Oncology, Hwang et al detailed the outcomes of patients with metastatic lung cancer receiving an inhibitor of programmed cell death protein 1 (PD-1) or its ligand (PD-L1) with or without thoracic radiotherapy at Massachusetts General Hospital. Study Details The...
IASLC 2017: REVEL Trial Subgroup Analysis Further Clarifies Outcomes With Ramucirumab Plus Docetaxel in Advanced Non–Small Cell Lung Cancer
New subgroup analysis from the phase III REVEL trial of ramucirumab (Cyramza) in advanced non–small cell lung cancer (NSCLC) was presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan. Specifically, these...
PI3K Inhibition in Relapsed or Refractory Indolent Lymphoma
As reported in the Journal of Clinical Oncology by Dreyling et al, the phase II CHRONOS-1 trial has shown a high response rate and durable responses with the phosphatidylinositol 3-kinase (PI3K) inhibitor copanlisib (Aliqopa) in adults with relapsed or refractory indolent lymphoma who had received...
Immunotherapy for Previously Treated Advanced Gastric Cancer
In an Asian phase III trial (ONO-4538-12, ATTRACTION-2) reported in The Lancet, Kang et al found that nivolumab (Opdivo) produced an improvement in overall survival vs placebo in patients with advanced gastric or gastroesophageal junction cancer who had disease refractory to or who were intolerant...
FDA Grants Priority Review for Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma
On October 16, the U.S. Food and Drug Administration (FDA) determined the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted...
IASLC 2017: Race, Socioeconomic Factors Are Influential in NSCLC Survival Rates
New research found race and specific socioeconomic factors to have a significant influence on disparities in the survival rates of non–small cell lung cancer (NSCLC) patients. Yanyan Lou, MD, PhD, of the Mayo Clinic, presented these findings at the International Association for the Study of...
IASLC 2017: Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non–Small Cell Lung Cancer
At the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan, Pfizer announced full results from the phase II clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib. The agent exhibited clinically...
IASLC 2017: CheckMate-032: Nivolumab Alone or With Ipilimumab in Recurrent SCLC With High Tumor Mutation Burden
At the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan, Bristol-Myers Squibb announced data evaluating nivolumab (Opdivo) and nivolumab plus ipilimumab (Yervoy) in previously treated small cell lung cancer (SCLC) patients whose...
IASLC 2017: Brigatinib in ALK-Positive Non–Small Cell Lung Cancer
Data from the phase II ALTA clinical trial evaluating brigatinib (Alunbrig) in patients with locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have disease progression on crizotinib were presented at the International...
IASLC 2017: Early Palliative Care Provides No Quality-of-Life Benefits for Patients With Recently Diagnosed Malignant Pleural Mesothelioma
Early specialist palliative care for patients that were recently diagnosed with malignant pleural mesothelioma does not impact quality-of-life measures, according to research presented by Fraser Brims, MBcHB, MRCP, MD, FRACP, of Curtin University in Australia, at the International Association...
Maintenance Therapy After ASCT in Younger Patients With Mantle Cell Lymphoma
In a French phase III trial, maintenance rituximab (Rituxan) improved event-free survival vs observation after autologous stem cell transplantation (ASCT) in younger patints with mantle cell lymphoma. These findings were reported by Le Gouill et al in The New England Journal of Medicine. Study...
Amended Health Insurance Rule Threatens Key Component of Standard Cancer Treatment
On October 12, ASCO President Bruce E. Johnson, MD, FASCO, issued the following statement: The Trump administration's move to expand the rights of employers to opt out of the requirement for contraceptive coverage would have unexpected and deleterious consequences for patients of childbearing age...
FDA Clears 7T Magnetic Resonance Imaging Device
On October 12, the U.S. Food and Drug Administration (FDA) cleared the first 7-Tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in...
sNDA Submitted for Rucaparib as Maintenace Treatment for Patients With Platinum-Sensitive Recurrent Ovarian Cancer
On October 9, Clovis Oncology announced that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for rucaparib (Rubraca) as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer...
Results From the Phase III JUNIPER Trial Evaluating Abemaciclib in KRAS-Mutated, Advanced NSCLC
On October 10, Eli Lilly and Company announced that its phase III JUNIPER study evaluating abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non–small lung cancer (NSCLC) did not meet its primary endpoint of overall...
Role of the E7 Gene in High-Risk HPV
National Cancer Institute (NCI) researchers have found that for the most common high-risk type of human papillomavirus (HPV) to cause cervical cancer, an important viral gene may need to have a precise DNA sequence. The findings, published by Mirabello et al in Cell, contribute to a better...
Incidence of Endocrine Dysfunction With Immune Checkpoint Inhibitors
In a systematic review and meta-analysis reported in JAMA Oncology, Barroso-Sousa et al evaluated the incidence of endocrine dysfunction in patients receiving currently approved immune checkpoint inhibitors for various advanced solid tumors. Patients who received combination therapy were found to...
First-Line Immunotherapy for Cisplatin-Ineligible Patients With Advanced Urothelial Cancer
As reported in The Lancet Oncology by Balar et al, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer in the phase II KEYNOTE-052 trial. The trial supported the accelerated approval...
Osimertinib Granted Breakthrough Therapy Designation for First-Line Treatment of EGFR Mutation–Positive NSCLC
On October 9, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for osimertinib (Tagrisso) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung ...
Relationship Between Targeted HER2 Therapy and Breast Reconstruction
Trastuzumab (Herceptin) therapy for breast cancers that express the HER2 protein does not increase the risk of complications at the surgical site in women who undergo immediate breast reconstruction after mastectomy, according to findings published by Shammas et al in the Journal of the American...
Adjuvant Chemotherapy vs Observation After Preoperative Chemoradiotherapy and Resection in Gastroesophageal Cancer
In a propensity score–matched analysis reported in JAMA Oncology, Mokdad et al found that adjuvant chemotherapy had a survival benefit vs observation after preoperative chemoradiotherapy and resection in patients with locally advanced gastroesophageal cancer. Study Details The study...
Potential Biomarkers to Identify Patients at Risk for Neurotoxicity From CAR T-Cell Therapy
Although lymphodepletion chemotherapy followed by an infusion of CD19-targeted chimeric antigen receptor (CAR)-modified T cells has produced high response rates in phase I studies of patients with refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia...
Comorbidity and Prostate Cancer–Specific and Other-Cause Mortality
A Swedish population-based observational study has shown that comorbidity is a significant factor in other-cause but not prostate cancer–specific mortality after adjustment for patient, tumor, and treatment factors among men with prostate cancer. The findings were reported in the Journal of...
Immune-Related Adverse Events and Outcomes With Immunotherapy for NSCLC
In a Japanese analysis reported in JAMA Oncology, Haratani et al found that development of immune-related adverse events was associated with improved survival among patients receiving nivolumab (Opdivo) for advanced or recurrent non–small cell lung cancer (NSCLC). Study Details The study...
Treating Breast Cancer During Pregnancy Calls for Careful Timing of Therapies and Sensitive Discussions With Patients
Breast cancer during pregnancy is relatively uncommon; however, it poses a significant clinical challenge to the patient and her multidisciplinary care team. To shed light on this difficult issue, The ASCO Post spoke with Carey K. Anders, MD, a medical oncologist and researcher at the University...
For Breast Cancer Specialist Ann H. Partridge, MD, MPH, Medicine Is a Family Tradition
Breast cancer specialist Ann H. Partridge, MD, MPH, was born in Manhasset, Long Island, and grew up several miles east in Muttontown, New York. Since tiny Muttontown didn’t have its own school system, Dr. Partridge went to high school in nearby Locust Valley, a town on Long Island’s North Shore,...
Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
ON JULY 31, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of patients 12 years and older with DNA mismatch repair–deficient (dMMR) and microsatellite instability– high (MSI-H) metastatic colorectal cancer progressing following treatment with a fluoropyrimidine,...
Immunotherapy for Metastatic Mismatch Repair–Deficient Colorectal Cancer: Game-Changer for Small Group of Patients
PATIENTS WITH DNA mismatch repair–deficient (dMMR) metastatic colorectal cancer display a high level of microsatellite instability (MSI-H)1 and demonstrate poor chemosensitivity and shorter overall survival than patients with mismatch repair–proficient (pMMR) metastatic metastatic colorectal...
FDA Grants Accelerated Approval to Nivolumab for Hepatocellular Carcinoma Previously Treated With Sorafenib
ON SEPTEMBER 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 APPROVAL WAS BASED on a 154-patient subgroup of ...
Cord Blood Transplantation Proves Beneficial in High-Risk Patients With Leukemia
Studies show that only about one-third of patients with acute myeloid leukemia who have detectable amounts of cancer cells in their blood at the time of allogeneic hematopoietic cell transplantation will be alive 3 years later, compared with nearly three-quarters of those patients without minimal...
Expert Point of View: Nadia Harbeck, MD, PhD, and Sibylle Loibl, MD
NADIA HARBECK, MD, PhD, of the Breast Center at the University of Munich, Germany, said the findings of LORELEI are among a growing list of indications that “the future is bright for endocrine-based therapy.” Although the results were hypothesis-generating and not yet practice-changing, she...
Selective PI3K Inhibitor Boosts Effect of Letrozole in Neoadjuvant Setting
FOR THE first time, an inhibitor of the phosphoinositide 3-kinase (PI3K) pathway (taselisib) used in combination with endocrine therapy in the neoadjuvant setting improved response rates over endocrine therapy alone—with good tolerability—in women with early breast cancer, according to the phase...
Expert Point of View: Sandro Pignata, MD
FORMAL DISCUSSANT of ARIEL3, Sandro Pignata, MD, of the IRCCS National Cancer Institute, “Fondazione G. Pascale,” Naples, Italy, said: “This is new evidence for maintenance therapy with rucaparib [Rubraca]. These results are extraordinary, particularly in the BRCA mutation patients, but also in...
Strong Showing for Rucaparib Maintenance Therapy for Platinum-Sensitive Ovarian Cancer
EVIDENCE CONTINUES to mount for the benefits of poly (ADP-ribose) polymerase (PARP) inhibition in ovarian cancer. Rucaparib (Rubraca) maintenance therapy after response to platinum-containing therapy significantly improved progression-free survival in patients with recurrent ovarian cancer compared ...
FDA Approves Copanlisib for Relapsed Follicular Lymphoma
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib is a kinase inhibitor that works by blocking several enzymes that...
Journal of Clinical Oncology Literature Update
STAYING UP-TO-DATE in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology. Sorafenib Dosing and Outcomes in Hepatocellular Cancer IN A...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
Ontario Province–Wide Symptom Screening and Opioid Prescribing Rates in Older Patients With Cancer
In a study reported in the Journal of Oncology Practice, Barbera et al found that a province-wide effort to improve symptom screening and management has increased the frequency of screening but has not improved opioid prescription rates in elderly cancer patients with severe pain. A previous study...
Integrative Therapies in Palliative Care Project
Palliative care professionals are invited to participate in a unique project sponsored by the National Cancer Institute. Collinge and Associates, Inc, is seeking interdisciplinary professionals to help develop and evaluate a new online continuing education (CE/CME) course on the use of integrative...
FDA Accepts sNDA for Lenvatinib for the Treatment of Hepatocellular Carcinoma
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
Nivolumab Plus Ipilimumab vs Sunitinib Alone as First-Line Therapy for Metastatic Renal Cell Carcinoma
A CHANGE IN PARADIGM may be on the horizon for the treatment of metastatic renal cell carcinoma. According to the results of CheckMate 214, the combination of ipilimumab (Yervoy) plus nivolumab (Opdivo) outperformed the standard of care—sunitinib (Sutent)—for first-line treatment, with improved...
MSLT-II Completion Lymph Node Dissection Trial: Practice Changing but Not Likely Practice Abandoning
PROBABLY THE MOST IMPORTANT advance in the treatment of newly diagnosed primary melanoma has been the incorporation of sentinel lymph node biopsy as part of initial surgical management. The routine use of sentinel lymph node biopsy, often termed “sentinel lymphadenectomy,” in appropriately...
Expert Point of View: Nicholas Turner, MD
NICHOLAS TURNER, MD, of The Royal Marsden and the Institute of Cancer Research in the UK, called the findings of MONARCH 3 “practice-changing.” The cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have answered the need for agents that target the biology of estrogen receptor–positive breast cancer, ...
Can We Have a Successful Vaccine Against Cancer?
EARLY IN our careers, few of us imagined that a vaccine could one day prevent cancer. Now, there is a vaccine that keeps the risks from human papillomavirus (HPV) at bay, and yet universal adoption of the HPV vaccine has been incomplete. As a result of misinformation about the vaccine—and its...
Study Finds 'Standard Care' Treatments in Breast Cancer Clinical Trials Not Always Standard
Historically, randomized controlled trials have served as the state-of-the-art method for determining the efficacy and safety of new, innovative treatment regimens for patients with cancer and other diseases. It is imperative that such trials are carefully designed to ensure that they are...
