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Showing 19251 - 19300FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
California Trends in Cancer Survival by Health Insurance Status
A study using California Cancer Registry data showed that survival improvements in patients with cancer between 1997 and 2014 have largely been limited to those with private or Medicare insurance. These findings were reported in JAMA Oncology by Libby et al. Study Details The study involved...
Combination Agent in Asian Patients With Previously Treated Metastatic Colorectal Cancer
In the Asian phase III TERRA trial, trifluridine/tipiracil (Lonsurf) produced a significant improvement in overall survival vs placebo among patients with metastatic colorectal cancer refractory or intolerant of standard chemotherapies with or without exposure to biologic therapies. These findings...
FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...
Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term
Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five...
FCC, NCI Working to Improve Rural Cancer Care via Broadband Access
The Federal Communications Commission’s Connect2Health Task Force (C2HFCC) has announced that the FCC and the National Cancer Institute (NCI) have joined forces, signing a memorandum of understanding that will focus on how increasing broadband access and adoption in rural areas can improve...
Study Finds Racial Disparities in Treatment of Clinically Significant Prostate Cancer
In a study reported in the Journal of Oncology Practice, Bickell et al found underuse of treatment for clinically significant prostate cancer was infrequent among white and black patients at two New York City hospitals, but black men accounted for nearly all such underuse of treatment. As noted by...
CAR T-Cell Therapy in Refractory B-Cell Lymphomas
As reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine, Schuster et al found that chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with B-cell lymphomas refractory to or...
Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma
The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...
AMA Urges Physicians to Take Steps to Avoid Medicare Payment Penalty
The American Medical Association (AMA) is reminding physicians that the Medicare reimbursement system has changed, and, if they have not done so already, they have until December 31, 2017, to take a few simple steps to avoid a Medicare payment penalty in 2019. The changes are part of the...
Nearly 100 Leading Cancer Researchers and Physician-Scientists Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Medical Research
On December 6, the American Association for Cancer Research (AACR) delivered a letter from the current AACR President and Past Presidents—as well as Fellows of the AACR Academy that include 18 Nobel Laureates—to urge leaders in the House and Senate to “move quickly to finalize a...
FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...
Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers
At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib,...
Does Warfarin Have Anticancer Potential in Persons Older Than Age 50?
A Norwegian population–based cohort study indicated that the use of warfarin was associated with a reduced risk of cancer overall and site-specific cancers among patients aged > 50 years. The findings were reported in JAMA Internal Medicine by Haaland et al. As noted by the investigators,...
Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors
Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...
FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Intermediate- and Poor-Risk Patients With Advanced Renal Cell Carcinoma
On December 13, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously...
ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...
ASH 2017: Dasatinib Plus Standard Chemotherapy Demonstrates 3-Year Survival Benefit in Pediatric Patients With Philadelphia Chromosome–Positive ALL
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...
ASH 2017: ALCANZA Trial: Brentuximab Vedotin in CD30-Expressing Cutaneous T-Cell Lymphoma
Updated results from the phase III ALCANZA clinical trial evaluating brentuximab vedotin (Adcetris) in CD30-expressing cutaneous T-cell lymphoma (CTCL) were presented by Horwitz et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1509). The presentation...
Primary Tumor Location and Outcomes in Stage III Colon Cancer According to RAS- and BRAF-Mutation Status
In a study in the PETACC-8 trial population reported in JAMA Oncology, Taieb et al found that the risk of recurrence in patients with stage III colon cancer differed for the primary tumor location according to RAS- and BRAF-mutation status. Study Details A total of 2,559 patients were...
Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure
As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...
ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer
People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...
ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura
In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...
ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant
Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...
Number of Metastatic Lymph Nodes and Survival in Hypopharyngeal/Laryngeal Cancer
A study using National Cancer Database data has shown that the number of metastatic nodes is a primary independent factor associated with an increased mortality risk in patients with hypopharyngeal and laryngeal cancers. The study was reported in JAMA Oncology by Ho et al. Study Details The study ...
Prognostic Factors in Stage III Favorable-Histology Wilms Tumor
An analysis from the Children’s Oncology Group Study AREN0532 reported in the Journal of Clinical Oncology by Fernandez et al showed that positive lymph nodes and loss of heterozygosity (LOH) at chromosome 1p or 16q are associated with poorer event-free survival in patients with stage III...
Hormonal Contraception and Breast Cancer Risk
As reported in The New England Journal of Medicine by Mørch et al, a Danish study has shown that the risk of breast cancer is increased in hormonal contraception users vs nonusers, with the absolute increase in risk being small. Study Details The study assessed the association between the...
ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma
The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
Novel Clinical-Genomic Risk Group Classification for Localized Prostate Cancer
As reported in the Journal of Clinical Oncology, Spratt et al have developed an integrated clinical-genomic risk classifier for predicting distant metastasis in patients with localized prostate cancer. The classifier uses National Comprehensive Cancer Network® (NCCN) risk categories and risk...
Prevalence of Prior Cancer in Patients With Newly Diagnosed Cancer
In a study using Surveillance, Epidemiology, and End Results (SEER) data reported in JAMA Oncology, Murphy et al found that among persons newly diagnosed with cancer, 25% of those aged ≥ 65 years and 11% of those aged < 65 years had a history of a prior primary cancer. Prevalence of Prior...
BELLE-3 Trial: Combination Therapy in Resistant Advanced Breast Cancer
The phase III BELLE-3 trial has shown prolonged progression-free survival but a worse safety profile with the addition of the pan-phosphoinositide 3-kinase inhibitor buparlisib to fulvestrant (Faslodex) in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast...
Maria-Victoria Mateos, MD, PhD, on Multiple Myeloma: Results From the ALCYONE Trial
Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, discusses phase III study findings on daratumumab plus bortezomib, melphalan, and prednisone vs bortezomib, melphalan, and prednisone in patients ineligible for transplant who have been newly diagnosed with multiple myeloma...
John F. Seymour, MBBS, PhD, on CLL: Results From the MURANO Study
John F. Seymour, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses an interim analysis of venetoclax plus rituximab vs bendamustine plus rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (Abstract LBA-2).
Identification of Cystic Precursors to Pancreatic Cancer Using Targeted Mass Spectrometry
In a study reported in the Journal of Clinical Oncology, Jabbar et al found that mass spectroscopy proteomic analysis of the pancreatic cyst fluid biomarkers mucin-5AC (MUC5AC), mucin-2 (MUC2), and prostate stem cell antigen (PSCA) identified cystic pancreatic cancers and precursor lesions with...
Joseph M. Connors, MD, on Untreated Hodgkin Lymphoma: Results From the ECHELON-1 Trial
Joseph M. Connors, MD, of the British Columbia Cancer Agency, discusses study findings on a new front-line option: brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine in patients with previously untreated stage III or IV Hodgkin lymphoma (Abstract 6).
Brian T. Hill, MD, PhD, on Mantle Cell Lymphoma in Younger Patients: Improvement in Overall Survival
Brian T. Hill, MD, PhD, of the Cleveland Clinic, discusses study findings that showed consolidation with autologous hematopoietic cell transplant in the first remission improves overall survival in patients younger than age 65 (Abstract 341).
Gilles A. Salles, MD, PhD, on Follicular Lymphoma: Long-Term Results From the PRIMA Trial
Gilles A. Salles, MD, PhD, of the Université de Lyon, discusses study findings on rituximab maintenance after induction immunochemotherapy and the significant long-term progression-free survival benefit over observation (Abstract 486).
Mark J. Roschewski, MD, on Burkitt Lymphoma: Clinical Trial Results on DA-EPOCH-R
Mark J. Roschewski, MD, of the National Cancer Institute, discusses phase II study findings that showed DA-EPOCH-R cures most adult patients with Burkitt lymphoma, irrespective of HIV status (Abstract 188).
Jakub Svoboda, MD, on Primary Mediastinal Large B-Cell, Diffuse Large B-Cell, and Gray Zone Lymphomas: Early-Phase Treatment Findings
Jakub Svoboda, MD, of the Abramson Cancer Center, University of Pennsylvania, discusses some encouraging phase I/II results on brentuximab vedotin with R-CHP chemotherapy as front-line treatment of CD30-positive primary mediastinal large B-cell, diffuse large B-cell, and gray zone lymphomas...
Andrew M. Evens, DO, on Gray Zone Lymphoma: Results From a Multicenter Study
Andrew M. Evens, DO, of Tufts University, discusses findings on the effectiveness of DLBCL-based therapy for patients whose disease fell between diffuse large B-cell and classical Hodgkin lymphoma (Abstract 375).
Study Suggests Racial Differences in Lung Tumor Biology
According to research by the American Cancer Society, lung cancer is the second most common cancer in men and women in the United States and is the leading cause of cancer-related death. In addition, among all populations, African Americans tend to have the highest lung cancer incidence and...
Tycel J. Phillips, MD, on Intravascular DLBCL: Study of Patient Features and Outcomes
Tycel J. Phillips, MD, of the University of Michigan Medical School, discusses the findings of the largest retrospective study to date of patients with intravascular diffuse large B-cell lymphoma, a disease with a poor outcome, partly due to the difficulty in diagnosing it early (Abstract 377).
Laurie H. Sehn, MD, MPH, on DLBCL: Radiation Therapy Findings
Laurie H. Sehn, MD, MPH, of the British Columbia Cancer Agency and University of British Columbia, discusses long-term results of PET-guided radiation therapy in patients with advanced-stage diffuse large B-cell lymphoma treated with R-CHOP (Abstract 823).
Andrew D. Zelenetz, MD, PhD, and Sattva S. Neelapu, MD, on NHL: Results From the ZUMA-1 Trial
Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center, and Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, discuss long-term study findings on axicabtagene ciloleucel in patients with refractory aggressive non-Hodgkin lymphoma (Abstract 578).
Andrew D. Zelenetz, MD, PhD, and Stephen J. Schuster, MD, on DLBCL: Results of the JULIET Trial
Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center, and Stephen J. Schuster, MD, of the Abramson Cancer Center, University of Pennsylvania, discuss phase II findings on tisagenlecleucel in adult patients with relapsed or refractory diffuse large B-cell lymphoma (Abstract 577).
Michael Unterhalt, MD, on Mantle Cell Lymphoma: Long-Term Follow-up Results
Michael Unterhalt, MD, of the University Hospital Grosshadern, discusses study findings on rituximab maintenance after first-line immunochemotherapy among older patients who are not candidates for autologous stem cell transplantation (Abstract 153).
Alok A. Khorana, MD, on The Costs of VTE in Cancer Patients: Expert Perspective
Alok A. Khorana, MD, of the Cleveland Clinic, discusses the prevalence of venous thromboembolism in cancer patients treated at U. S. emergency departments and associated costs, mortality, and hospital admissions in the United States (Abstract 219).
ASH 2017: Clinical Activity Seen With Anti-BCMA CAR T-Cell Therapy in Heavily Pretreated Multiple Myeloma
A one-time infusion of an investigational chimeric antigen receptor (CAR) T-cell therapy that targets a protein found on most multiple myeloma cells elicited an 86% overall response rate in 21 patients whose disease had come back or had not responded after a median of seven prior treatments,...
