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Showing 6851 - 6900FDA Announces Approval, CMS Proposes Coverage of First Breakthrough-Designated Test to Detect Extensive Number of Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The ...
Update on Phase III JAVELIN Gastric 300 Trial of Avelumab in Pretreated Advanced Gastric Cancer
On November 28, Merck KGaA and Pfizer announced that the phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival with single-agent avelumab (Bavencio) compared with physician's choice of chemotherapy. The trial investigated avelumab as a third-line...
Patients With CLL May Be Willing to Trade Treatment Efficacy for Reduced Side Effects
When choosing their preferred treatment, patients with chronic lymphocytic leukemia (CLL) place the highest value on treatments that deliver the longest progression-free survival, but they are willing to swap some drug efficacy for a reduced risk of serious adverse events, according to a study...
Immunotherapy in Advanced Esophageal Carcinoma
As reported in the Journal of Clinical Oncology by Doi et al, pembrolizumab (Keytruda) showed activity in patients with previously treated advanced esophageal carcinoma in the phase Ib multicohort KEYNOTE-028 study. Study Details In the study, eligible patients with squamous cell carcinoma or...
Link Between Cancer and Diabetes, High Body Mass Index
According to the International Agency for Research on Cancer and the World Cancer Research Fund, there is a causal association between a high body mass index (BMI) and 14 cancers, including colorectal, gallbladder, pancreatic, kidney, liver, endometrial, postmenopausal breast, ovarian, gastric...
Vertical Roentgenography: Patient of James T. Case, MD
This image of fluoroscopy documents modern cancer diagnostic possibilities. It is in startling contrast to the photograph of fluoroscopy taken a decade earlier. Published by James T. Case, MD, in 1914 to illustrate his book Stereoroentgenography of the Alimentary Tract, it presents the advances in ...
Olaparib Tablets as Maintenance in BRCA1/2-Mutant Relapsed Ovarian Cancer
A phase III trial (SOLO2/ENGOT-Ov21) has shown improved progression-free survival with an olaparib tablet formulation vs placebo as maintenance therapy in patients with BRCA1/2-mutant platinum-sensitive relapsed ovarian cancer. These study results were reported by Eric Pujade-Lauraine, MD, of the...
Health-Related Quality of Life With Immediate vs Delayed ADT in Prostate Cancer
In a health-related quality-of-life study among patients in the phase III TOAD trial, immediate vs delayed androgen-deprivation therapy (ADT) was associated with early worsening of androgen-deprivation therapy–related symptoms but few other comparative adverse effects on functioning or quality of...
Bone-Targeted Therapies for Men With Prostate Cancer Receiving Androgen-Deprivation Therapy
Among men diagnosed with prostate cancer, about one in two will receive androgen-deprivation therapy, which is associated with many potential adverse side effects, including significant bone loss and increased risk for low trauma or fragility fractures similar to those found in people with primary ...
Donald Coffey, PhD, Cancer Pioneer, Dies at 85
Donald Coffey, PhD, a distinguished Johns Hopkins Professor and prostate cancer expert, who was the former Director of the Brady Urological Research Laboratory and Deputy Director of the Johns Hopkins Kimmel Cancer Center, died on November 9, 2017, at the age of 85. In his more than 50 years at...
The Runner
The following essay by Robert J. Green, MD, is adapted, with permission, from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories, which was coedited by Stan Winokur, MD, and Vincent Coppola and published in May 2014. The book is available on Amazon.com and...
A Vivid Look Back, a Cogent Look Forward
Cancer memoirs come in a variety of literary styles and voices. Not surprisingly, the most poignant cancer memoirs are by those who are writing, in essence, their final words before departing this earth. The most widely read of that variety has been the beautifully written best seller When Breath...
Nivolumab in Hepatocellular Carcinoma Previously Treated With Sorafenib
ON SEPTEMBER 22, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of hepatocellular carcinoma in patients previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS based on findings in a 154-patient subgroup of the CheckMate 040 trial consisting...
Luigi Naldini, MD, PhD, and Marina Cavazzana, MD, PhD, to Present 2017 ASH Ernest Beutler Lecture
THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) will honor Luigi Naldini, MD, PhD, of the San Raffaele Telethon Institute for Gene Therapy in Milan, and Marina Cavazzana, MD, PhD, of Paris Descartes University, Necker-Enfants Malades Hospital, and Imagine Institute of Genetic Diseases, AP-HP, Inserm in...
Recent Study Findings in Hematologic Malignancies
HERE IS A BRIEF LOOK at the study findings and clinical implications of several recent and important clinical trials in neoplastic hematology. Attention is focused on clonal myeloid disorders, acute lymphoblastic leukemia, lymphoma, and plasma cell dyscrasias. Clonal Myeloid Disorders STUDY:...
Gene-Expression Assays in Early-Stage Breast Cancer: Who Should Order Them and When?
A deeper understanding of biology has allowed significant advances in the treatment of breast cancer. In the early-stage setting, standard pathology measures can help identify which subset of patients with hormone receptor–positive breast cancers are more likely to experience benefit from...
ASH Honors Josef T. Prchal, MD, and Sherrill J. Slichter, MD, With 2017 Henry M. Stratton Medal
THE AMERICAN SOCIETY of Hematology (ASH) will recognize Josef T. Prchal, MD, of the University of Utah, and Sherrill J. Slichter, MD, of Bloodworks Northwest and the University of Washington, with the 2017 Henry M. Stratton Medal for their seminal contributions in the areas of basic and clinical/ ...
Tackling the High Cost of Cancer Care
AT THE 2017 ASCO ANNUAL MEETING, the leaders of the newly formed Value in Cancer Care Consortium (vi3c; vi3c.org) met to discuss the group’s plan to study how to improve the affordability of cancer drugs and make them more accessible to patients. The goal of the Value in Cancer Care Consortium is...
Digital Palliative Care Curriculum Improves Knowledge, Skills, and Opioid Prescribing Behavior
A new electronic curriculum delivered via e-mail with push technology may provide an efficient, cost-effective solution to the shortage of palliative care faculty serving the nation’s oncology fellowship programs. According to data presented at the 2017 Palliative and Supportive Care in Oncology...
Informed Consent and the Oncologist: Legal Duties to Discuss Costs of Treatment
For 50 years, clinicians in the United States have had a legal duty to disclose to patients with cancer the risks, benefits, and alternatives to a proposed cancer treatment. Until recently, however, it has been unclear whether clinicians have a similar duty to discuss the costs of that treatment....
Stephanie Lee, MD, MPH, Elected ASH Vice President; Two Councillors Appointed to 4-Year Terms
THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) has elected Stephanie Lee, MD, MPH, a member of the Clinical Research Division at Fred Hutchinson Cancer Research Center (Fred Hutch), as its Vice President. Dr. Lee will begin her 1-year term after the 2017 ASH Annual Meeting & Exposition in December...
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,1 contribute to a better...
Advancing Care Across the Cancer Continuum
Addressing the need to integrate palliative and supportive care practices into medical specialties to ensure optimal patient-centered care across the cancer continuum and the evidence-based remedies to accomplish that goal were the focus of the nearly 300 study abstracts presented at the 2017...
Pembrolizumab in Advanced Gastric Cancer
On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug...
Seattle Children’s Opens Trial for Children and Young Adults With Leukemia That Targets CD22 and CD19 Proteins Simultaneously
Seattle Children’s has opened the first chimeric antigen receptor (CAR) T-cell immunotherapy trial in the U.S. for children and young adults with relapsed or refractory CD19- and CD22-positive acute lymphoblastic leukemia (ALL) that will simultaneously attack two targets on cancer cells. With ...
Expert Point of View: Eric Van Cutsem, MD, PhD
Invited discussant Eric Van Cutsem, MD, PhD, of the University Hospitals Leuven in Belgium, put the JACOB trial findings in context of what is known for HER2-positive metastatic gastric/gastroesophageal junction cancer, where two targeted agents are approved: trastuzumab (Herceptin) in the first...
FDA Approves CAR T-Cell Therapy for 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....
IDEA Trial: ‘Going Beyond Statistics’ in Stage III Colon Cancer
According to Alberto Sobrero, MD, Head of Medical Oncology at Ospedale San Martino in Genova, Italy, the results of the pivotal IDEA trial, which evaluated the optimal duration of adjuvant chemotherapy for stage III colon cancer, were not clear to clinicians.1 The combined analysis of six...
Melanoma Mutations: What You Need to Know
CLINICIANS ARE now well acquainted with BRAF mutations in advanced melanoma, but there is more to genomics in this disease than identifying BRAF and prescribing a BRAF inhibitor. At the 2017 Debates and Didactics Conference, held at Sea Island, Georgia, Melinda L. Yushak, MD, MPH, of Emory...
ASCO Election Candidates
SIXTEEN DISTINGUISHED ASCO members have been selected by the ASCO Nominating Committee as candidates for open leadership positions within the Society, including: The offices of President-Elect and Treasurer Four seats on the Society’s Board of Directors Two seats on the Nominating Committee...
Antidepressant for Aromatase Inhibitor–Associated Arthralgia in Early-Stage Breast Cancer
The phase III SWOG S1202 trial has shown benefit of the antidepressant agent duloxetine in reducing aromatase inhibitor–associated joint pain in women with early-stage breast cancer. These results were reported in the Journal of Clinical Oncology by Henry et al. Study Details In the...
ESMO Asia 2017: FLAURA Trial: Osimertinib Improves Progression-Free Survival in Asian Patients With EGFR-Mutated NSCLC
Osimertinib (Tagrisso) improves progression-free survival compared to standard first-line therapy in Asian patients with EGFR-mutated non–small cell lung cancer (NSCLC), according to the Asian subset analysis of the FLAURA trial presented at the European Society for Medical Oncology (ESMO)...
ESMO Asia 2017: AXEPT Trial: New Second-Line Therapy for Metastatic Colorectal Cancer Is Effective and Safe
A randomized trial in 650 patients has confirmed the safety and efficacy of a new second-line treatment for metastatic colorectal cancer, researchers reported at the European Society for Medical Oncology (ESMO) Asia 2017 Congress (Abstract LBA3_PR). Oral fluorinated pyrimidines have been...
Brigatinib in Crizotinib-Pretreated Metastatic ALK-Positive Non–Small Cell Lung Cancer
On April 28, 2017, brigatinib (Alunbrig) was granted accelerated approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori).1,2 Supporting Efficacy...
Dabrafenib and Trametinib in BRAF V600E–Mutant Metastatic NSCLC
On June 22, 2017, regular approvals were granted to dabrafenib (Tafinlar) and trametinib (Mekinist) given in combination for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...
Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
On July 17, 2017, neratinib (Nerlynx) a dual inhibitor of HER2 and epidermal growth factor receptor (EGFR), was approved for extended adjuvant treatment of adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab (Herceptin)-based therapy.1,2 Supporting...
Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
On September 28, 2017, the cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib (Verzenio) was approved for use in combination with fulvestrant (Faslodex) for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following...
What Can We Do Differently for Premenopausal Patients With Breast Cancer?
While age remains a major risk factor for breast cancer, with nearly 80% of new cases occurring in women aged 50 years and older, women diagnosed at a younger age generally have poorer outcomes. This is partly because premenopausal women are more likely to have triple-negative breast cancer, which ...
Gauging the Impact of Weight Loss Intervention on Breast Cancer Outcomes
“Growing research suggests that body weight is not only related to the risk of developing malignancy, but also prognosis after diagnosis, especially in breast cancer,” said Jennifer A. Ligibel, MD, of Dana-Farber Cancer Institute and Harvard Medical School, at the 19th Annual Lynn Sage Breast...
Copanlisib in Relapsed Follicular Lymphoma
On September 14, 2017, copanlisib (Aliqopa) was granted accelerated approval for treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on durable responses observed in a multicenter phase ...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 18, 2017, the chimeric antigen receptor (CAR)...
New Options for the Management of Hodgkin Lymphoma
With the vast majority of patients cured with primary therapy, classical Hodgkin lymphoma is largely a success story. For the 10% to 20% of patients who either relapse or are refractory to front-line therapy, the disease can still be fatal. At the National Comprehensive Cancer Network® (NCCN®) 12th ...
Sequencing Therapy in Chronic Lymphocytic Leukemia
Although the indications to initiate treatment for chronic lymphocytic leukemia (CLL) have not changed, determining the optimal first-line treatment and sequence of therapies once treatment has begun remain challenges for providers. At the National Comprehensive Cancer Network® (NCCN®) 12th Annual...
PARP Inhibitors in BRCA-Related Ovarian Cancer—and Beyond!
Poly (ADP ribose) polymerase (PARP) inhibitors are among the most exciting new classes of oncology drugs, and their development has coincided with the increasing recognition of the therapeutic vulnerability in targeting DNA damage response and DNA repair. The initial clinical testing of PARP...
ESMO Asia 2017: Alectinib More Effective Than Crizotinib in Asian Patients With ALK-Positive NSCLC
A subanalysis of the phase III ALEX study has shown that alectinib (Alecensa) is more effective than the standard of care, crizotinib, in Asian patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC), researchers reported at the European Society for Medical...
FDA Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma
On November 16, Genentech announced that the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III, or...
FDA Announces Comprehensive Regenerative Medicine Policy Framework
On November 16, the U.S. Food and Drug Administration (FDA) announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework—outlined in a suite of four guidance documents—builds upon the...
FDA Approves Fulvestrant in Combination With Abemaciclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for fulvestrant (Faslodex), expanding the drug's approved use to include combined therapy with abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor, for the treatment of hormone receptor–positive,...
Immunotherapy in PD-L1–Positive Advanced Cervical Cancer
Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Frenel et al in the Journal of Clinical Oncology. Study Details In the advanced...
Donald Coffey, PhD, Prostate Cancer Expert, Dies at 85
Donald Coffey, PhD, a distinguished Johns Hopkins professor and prostate cancer expert, who was the former Director of the Brady Urological Research Laboratory and Deputy Director of the Johns Hopkins Kimmel Cancer Center, died on November 9 at the age of 85. Long Career at Johns Hopkins In his...
