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Showing 5051 - 5100FDA Oncology New Drug/New Indication Approvals for 2015
The following new hematology/oncology agents and expanded indications were approved by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research in 2015: Alectinib (Alecensa), an ALK inhibitor, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive...
‘Substantial Number’ of Patients Requiring Palliative Radiotherapy for Stage IV NSCLC Are Overtreated
An analysis of data from 46,803 patients with stage IV non–small cell lung cancer (NSCLC) who received palliative chest radiation therapy found that 49% received radiotherapy for longer than 15 fractions, and 28% received more than 25 fractions. This treatment pattern “is inconsistent with the...
UnitedHealthcare Signs Agreement With Foundation Medicine for Genomic Profiling Assay for Non–Small Cell Lung Cancer
Foundation Medicine, Inc. recently announced that it has signed a national agreement for the company’s comprehensive genomic profiling assay for solid tumors, called FoundationOne, with UnitedHealthcare. The agreement, which became effective December 15, 2015, covers the assay for patients with...
SIOG Annual Conference Explores Global Perspectives on Geriatric Oncology and Supportive Care
The 15th Annual Conference of the International Society of Geriatric Oncology (SIOG) took place in Prague, Czech Republic, over 3 days (November 12–14, 2015). At the heart of the meeting were presentations on supportive care, comprehensive geriatric assessment and treatment—so that we fully...
A: Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
Question 1: Based on the rationale for the current “standard of care” for primary diffuse large B-cell lymphoma of the CNS, what is the optimal induction therapy? Correct Answer: C. A high-dose methotrexate–based regimen. Expert Perspective Untreated primary diffuse large B-cell lymphoma of the CNS ...
Necitumumab in Metastatic Squamous Non–Small Cell Lung Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 24, 2015, necitumumab (Portrazza) was approved for use ...
Ductal Carcinoma in Situ and Relevant Endpoints for Omission of Standard Treatments: Are We There Yet?
The optimal management strategy for ductal carcinoma in situ has become increasingly controversial with respect to potential overdiagnosis and overtreatment. Much of the controversy for ductal carcinoma in situ stems from its exceptional breast cancer–specific survival, which approaches close to...
Minimally Invasive Surgery for Rectal Cancer: An Evolving Issue
Over 10 years ago, we welcomed a new approach to cancer surgery when the 2004 COST trial demonstrated the benefits of laparoscopic compared with open surgery for colon cancer. This randomized trial of 872 patients showed improved perioperative recovery with laparoscopic colectomy without...
Clinical Trial System Badly in Need of Overhaul, Say Panelists at Friends-Brookings Conference
Cancer clinical trials in three distinct phases, as they have been conducted for decades, are probably no longer the best way to bring a drug or biologic agent to market. This was the consensus of three panels at the 8th Annual Conference on Clinical Cancer Research convened by Friends of Cancer...
Optimizing the Treatment of HIV-Associated Lymphoma
Non-Hodgkin lymphoma (NHL) associated with human immunodeficiency virus (HIV) infection generally can be treated the same as lymphoma in non–HIV-infected patients, with a few caveats, according to Lawrence D. Kaplan, MD, of the Helen Diller Family Comprehensive Cancer Center of the University of...
More, Earlier, and Better Goals-of-Care Conversations at the End of Life Are Feasible
An intervention called the Serious Illness Care Program helps clinicians to conduct more, earlier, and better conversations about goals of care with their seriously ill patients, according to Rachelle E. Bernacki, MD, MS, who presented the preliminary results of a study using this approach at the...
Expert Point of View: Karen Ballen, MD
This is a group of patients who have not done very well over the years. The cure rate for children with acute lymphoblastic leukemia (ALL) is over 90%, whereas this group of patients (ie, aged 18–50) typically has a 5-year survival of 40% to 50%. Use of pediatric regimens has boosted that survival, ...
Patients With Incomplete Response to Neoadjuvant Chemotherapy Benefit From Capecitabine
Treatment with capecitabine increased disease-free and overall survival in breast cancer patients with residual disease after neoadjuvant chemotherapy, according to a study reported by researchers from Japan and Korea at the 2015 San Antonio Breast Cancer Symposium.1 “It has been unclear whether...
New Study Suggests Benefits of Regular Mammography Extend to the Elderly
Breast cancer afflicts 1 in 8 women in their lifetime, and 1 in 25 die from this disease. Although a number of randomized trials have demonstrated the clear benefits of mammography screening in women up to age 74 on reducing mortality, data are sparse in women over age 74, especially among...
Tumor Tissue Specimens and Associated Analyses Appear to Be a Significant Barrier to Clinical Trial Enrollment
The requirement for tumor tissue specimens and associated analyses in order to participate in clinical trials appears to be a significant barrier to clinical trial enrollment and may delay treatment. Potential solutions to reducing or eliminating these barriers include routine tissue banking at...
More Than One-Third of Patients With Metastatic Cancer Continue to Work
A new analysis indicated that many patients continue working after being diagnosed with metastatic cancer, but a heavy burden of symptoms may prevent them from doing so. Published by Tevaarwerk et al in Cancer, the study illustrates the need to treat difficult symptoms so that patients can maintain ...
Lori Pierce, MD, on Breast Cancer Radiotherapy: Late Side Effects
Lori J. Pierce, MD, of the University of Michigan Health System, discusses findings on second cancer incidence and non-breast cancer mortality among 40,000 women in 75 clinical trials. (Abstract S5-08)
Julie Vose, MD, MBA, and John F. Gerecitano, MD, PhD, on Venetoclax for NHL
Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and John F. Gerecitano, MD, PhD, of Memorial Sloan Kettering Cancer Center, discuss a phase I study of venetoclax monotherapy in patients with relapsed/refractory non-Hodgkin lymphoma, including updated safety and efficacy data...
James Foran, MD, on Clofarabine for AML: Clinical Trial Results of ECOG-ACRIN and ALFA/Clara
James Foran, MD, of the Mayo Clinic Cancer Center, discusses two key studies on clofarabine: as a single agent for induction and postremission therapy in newly diagnosed AML, and as the basis for consolidation in nonfavorable AML (Abstracts 217 and 218).
Craig H. Moskowitz, MD, on NHL: Early Study Results on Denintuzumab Mafodotin
Craig H. Moskowitz, MD, of Memorial Sloan Kettering Cancer Center, discusses a phase I study of an anti-CD19 monoclonal antibody used in relapsed/refactory B-lineage non-Hodgkin lymphoma (Abstract 182).
John Leonard, MD, on DLBCL: Results From the Pyramid Trial
John Leonard, MD, of Weill Cornell Medical College, discusses this phase II study of R-CHOP with or without bortezomib in patients with untreated non-germinal center B-cell-like subtype diffuse large cell lymphoma (Abstract 811).
Julie Vose, MD, MBA, and David Straus, MD, on Hodgkin Lymphoma Study Results: CALGB/Alliance 50604
Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and David Straus, MD, of Memorial Sloan Kettering Cancer Center, discuss the initial results of the U.S. Intergroup Trial of response-adapted chemotherapy or chemotherapy/radiation therapy based on PET for nonbulky stage I and II...
Julie Vose, MD, MBA, and Cameron J. Turtle, MBBS, PhD, on B-Cell NHL and CLL: Clinical Trial Results on T-Cell Therapy
Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and Cameron J. Turtle, MBBS, PhD, of the Fred Hutchinson Cancer Research Center, discuss anti-CD19 chimeric antigen receptor-modified T-cell therapy and clinical outcome (Abstract 184).
ESMO Asia 2015: Results From the KEYNOTE-010 Trial Show Pembrolizumab Benefit in Patients With NSCLC
More patients with advanced non–small cell lung cancer (NSCLC) could benefit from pembrolizumab (Keytruda), said Roy Herbst, MD, PhD, Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven. Dr. Herbst presented promising results from the pivotal phase...
ESMO Asia 2015: Afatinib a Better Choice for EGFR-Mutated Lung Cancer in First-Line Treatment
Patients with epidermal growth factor receptor (EGFR)-activating mutations in advanced lung cancer seem to benefit more from afatinib (Gilotrif) than gefitinib (Iressa) as first-line treatment, Park et al reported in a study (Abstract LBA2) presented at the European Society for Medical Oncology...
Potential Overdiagnosis of Contralateral Breast Cancer With Preoperative Magnetic Resonance Imaging in Older Women With Breast Cancer
In an analysis of the Surveillance, Epidemiology, and End Results (SEER)–Medicare database reported in the Journal of Clinical Oncology, Wang et al found that use of preoperative magnetic resonance imaging (MRI) was associated with overdiagnosis of contralateral breast cancer among older...
Study Finds NSCLC to Be Genetically Different in Younger and Older Patients, Requiring Different Treatment Approaches
Unlike a number of other cancers in which young age at diagnosis is understood to represent distinct disease biology, the genomics and clinical characteristics of non–small cell lung cancer (NSCLC) in young patients are poorly understood. A study by Sacher et al investigating the relationship ...
Similar Outcomes Reported With Surgery vs Definitive Concurrent Chemoradiotherapy in Resectable Stage III NSCLC
Findings in an early-terminated German phase III trial (ESPATUE), reported in the Journal of Clinical Oncology by Eberhardt et al, indicate similar outcomes with surgery vs definitive concurrent chemoradiotherapy after induction chemotherapy and chemoradiotherapy in patients with resectable stage...
Germline ETV6 Variations as Basis of Novel Genetic Syndrome Associated With Childhood Acute Lymphoblastic Leukemia
In a systematic genetic study reported in The Lancet Oncology, Moriyama et al found that germline ETV6 variations identified in a small proportion of children with acute lymphoblastic leukemia (ALL) were associated with a novel syndrome predisposing carriers to disease. Recent data indicated that...
FDA Approves Alectinib for Advanced ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to alectinib (Alecensa) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori). ...
Alectinib Highly Active in Crizotinib-Refractory ALK-Rearranged NSCLC
In a phase II trial reported in the Journal of Clinical Oncology, Ou et al found that the investigational ALK inhibitor alectinib, which is active against acquired crizotinib (Xalkori) resistance mutations and exhibits high CNS penetration, was associated with considerable activity in patients with ...
SABCS 2015: Women With Luminal A Breast Cancer Did Not Benefit From Adjuvant Chemotherapy in Phase III Trial
Premenopausal women whose invasive breast cancers were of the luminal A subtype had comparable 10-year disease-free survival rates, regardless of whether or not they received adjuvant chemotherapy, according to data from the phase III Dutch Breast Cancer Cooperative Group (DBCG77B) clinical trial...
ASH 2015: High Response Rates, Long-Term Remissions in Relapsed/Refractory Pediatric ALL, Lymphomas After CTL019 Immunotherapy
Ninety-three percent of pediatric patients (55 of 59) with relapsed/refractory acute lymphoblastic leukemia (ALL) went into remission after receiving an investigational therapy made from their own immune cells, with continuous remissions of over 1 year in 18 patients and over 2 years in nine...
European Trial Shows Front-Line Addition of Nintedanib to Standard Chemotherapy Improves Progression-Free Survival in Advanced Ovarian Cancer
In a European phase III trial (AGO-OVAR 12) reported in The Lancet Oncology, du Bois et al found that adding the antiangiogenic multikinase inhibitor nintedanib (Ofev) to carboplatin/paclitaxel improved progression-free survival in patients with newly diagnosed ovarian cancer. Gastrointestinal...
ASH 2015: Researchers Identify Children Most at Risk of Overreporting Adherence to At-Home Chemotherapy Regimen
A study presented by Landier et al at the 57th American Society of Hematology (ASH) Annual Meeting examined the common problem of children in remission from acute lymphocytic leukemia (ALL) not adhering to their maintenance drug regimens, thus putting them at risk of relapse (Abstract 82). ...
Ronald Go, MD, on Survival in NHL and Treatment Facility Volume
Ronald Go, MD, of the Mayo Clinic, discusses a study that used the National Cancer Data Base to determine the extent to which the number of non-Hodgkin lymphoma patients treated annually in a facility affects overall survival (Abstract 266).
Study Identifies Ovarian Cancer Cell Hierarchy
Can any cancer cell form another tumor, or is it only select cancer stem cells that give rise to new cancer cells? The answer, a new study finds, is both. Researchers at the University of Michigan Comprehensive Cancer Center looked at human ovarian cancer cells, and found that, for the most part,...
Benefit of Maintenance Bevacizumab-Erlotinib vs Bevacizumab After Bevacizumab-Based Induction Therapy in Metastatic Colorectal Cancer
As reported by Tournigand et al in The Lancet Oncology, final analysis of the phase III GERCOR DREAM (OPTIMOX3) trial suggested a benefit of maintenance bevacizumab (Avastin)-erlotinib vs bevacizumab after bevacizumab-based induction therapy in patients with previously untreated metastatic...
FDA Approves Necitumumab Combination for Metastatic Squamous NSCLC
The U.S. Food and Drug Administration today approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of nonsquamous NSCLC....
Molecular Prognostic Index Improves Risk Stratification of Early-Stage NSCLC
In a study reported in the Journal of the National Cancer Institute, Gentles et al identified a nine-gene molecular prognostic index that improved the overall survival prognostic power of clinical factors in patients with stage I non–small cell lung cancer (NSCLC). Study Details In the...
FDA Approves Nivolumab to Treat Advanced Kidney Cancer
The U.S. Food and Drug Administration today approved nivolumab (Opdivo) to treat patients with metastatic renal cell carcinoma who have received a prior antiangiogenic therapy. Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2,...
Prognostic Factors Identified in Patients With ALK‑Rearranged NSCLC and Brain Metastasis
In a study reported in the Journal of Clinical Oncology, Johung and colleagues identified factors that distinguished survival rates among patients with ALK-rearranged non–small cell lung cancer (NSCLC) and brain metastasis. The study included 90 patients from six institutions. Of them, 84...
Kidney Failure and Its Treatment May Impact Cancer Risk
For patients with kidney failure, poor kidney function and immunosuppressant medications may increase their risk of developing different types of cancer. The findings, which are published by Yanik et al in the Journal of the American Society of Nephrology, suggest the need for persistent cancer...
Rates of Curative Lung Cancer Surgery Vary by State
The likelihood of receiving curative-intent surgery for patients with early-stage non–small cell lung cancer (NSCLC) varies substantially from state to state, according to data presented at the Eighth American Association for Cancer Research (AACR) Conference on the Science of Cancer Health...
FDA Approves Osimertinib for EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer After Progression on Prior EGFR-Blocking Therapy
The U.S. Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non–small cell lung cancer (NSCLC). Osimertinib (Tagrisso) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation ...
‘Substantial Number’ of Patients Requiring Palliative Radiotherapy for Stage IV NSCLC Are Overtreated
An analysis of data from 46,803 patients with stage IV non–small cell lung cancer (NSCLC) who received palliative chest radiation therapy found that 49% received radiotherapy for longer than 15 fractions and 28% received more than 25 fractions. This treatment pattern “is inconsistent...
New Prediction Model May Provide More Accurate Assessment of Breast Cancer Risk in Hispanic Women
A prediction model created for projecting absolute invasive breast cancer risk in Hispanic women provides a more accurate assessment of their risk of developing breast cancer compared with existing models that are based on data from non-Hispanic women, according to a new study by Banegas et al....
Investigational NAE Inhibitor Pevonedistat Shows Potential Activity in Patients With Relapsed/Refractory Lymphoma
A phase I study evaluating the safety, pharmacokinetic profile, pharmacodynamic effects, and antitumor activity of the first-in-class investigational NEDD8-activating enzyme (NAE) inhibitor pevonedistat (TAK-924/MLN4924) in patients with relapsed/refractory lymphoma or multiple myeloma has found...
Reported Hospitalization Rate in Patients Receiving Systemic Therapy for Metastatic NSCLC Much Higher in Real-World vs Clinical Trial Setting
In a study reported in JAMA Oncology, Prince et al found that the hospitalization rate among patients receiving systemic therapy for metastatic non–small cell lung cancer (NSCLC) was much higher in observational studies vs clinical trials among studies reporting hospitalization rates. Study...
Most Women Undergoing BRCA Genetic Testing Do Not Receive Pretest Genetic Counseling
In the ABOUT study reported in JAMA Oncology, Armstrong et al found that the majority of BRCA-tested women in a commercially insured population responding to a questionnaire about their experience had not received genetic counseling from a genetics clinician prior to testing. The study was...
