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Showing 16851 - 16900FDA Grants Alectinib Priority Review for Initial Treatment of ALK-Positive Lung Cancer
Today, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental New Drug Application (sNDA) and granted Priority Review for alectinib (Alecensa) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced, or metastatic...
Sylvia
The following essay by Howard A. (Skip) Burris III, MD, is adapted 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 thebigcasino.org....
Osimertinib Improves Progression-Free Survival for EGFR-Positive NSCLC in the Phase III FLAURA Trial
On July 27, it was announced that the phase III FLAURA trial showed a statistically significant and clinically meaningful progression-free survival benefit with osimertinib (Tagrisso) compared to current first-line standard-of-care treatment (erlotinib [Tarceva] or gefitinib [Iressa]) in previously ...
Roswell Park Graduate Student Honored by National Cancer Institute
Roswell Park Cancer Institute graduate student Danielle Twum has received the prestigious Emerging Scholars Award from the National Cancer Institute (NCI), who recognized her among the distinguished alumni of its Continuing Umbrella for Research Excellence (CURE) programs. The CURE programs are...
An Expert on End-of-Life Care Shares Her Stories
“In the sufferer let me see only the human being.” So said Maimonides, the medieval Jewish philosopher and physician who espoused treating the patient rather than the illness, a philosophy that modern oncology had to relearn. This brief quote greets readers of a new book called Extreme Measures:...
A Deep and Incisive Look Into the Health-Care System
The seemingly impossible-to-cure maladies of our $3 trillion per year health-care system have been hyperanalyzed, fiercely debated, and voluminously written about by the country’s leading public health experts, opinionated doctors, and policymakers on Capitol Hill. The Affordable Care Act extended ...
A Textbook That Fills a Special Need in Oncology: Uncommon Cancers
A cancer diagnosis provokes a sea of emotions, fear and anxiety over the future foremost. However, being diagnosed with a common cancer such as breast or prostate cancer has a hard-won comfort zone, in that both patients and physicians are armed with a plethora of data and resources on how to treat ...
I Live My Life in 3- to 6-Month Increments
I first noticed a lump in my left breast in 2001 while taking a shower and shrugged it off. After all, men don’t get breast cancer. To assuage my wife’s concern that I at least have the lump examined, I consented to see our family physician, who agreed that men don’t get breast cancer because, he...
The X-Ray Era 1901–1915
The text and photograph on this page are excerpted from a four-volume series of books titled Oncology Tumors & Treatment: A Photographic History, by Stanley B. Burns, MD, FACS, and Elizabeth A. Burns. The photo below is from the volume titled “The X-Ray Era: 1901–1915.” The photograph appears...
Adverse Pathologic Findings in Low-Volume Intermediate-Risk Prostate Cancer
In a single-center analysis reported in JAMA Oncology, Patel et al found that among men undergoing elective radical prostatectomy, those with low-volume intermediate-risk disease had significantly higher rates of adverse pathologic findings compared than did those with very low-risk and low-risk...
Trastuzumab-Based Regimens in Older Women With Early Breast Cancer
A comparative analysis of outcomes with two different trastuzumab (Herceptin)-based adjuvant regimens in older women with early HER2-positive breast cancer found little difference in safety and efficacy between treatments. The study was reported by Reeder-Hayes et al in the Journal of Clinical...
Olaparib Tablets as Maintenance in BRCA1/2-Mutant Platinum-Sensitive 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 Pujade-Lauraine et al in The...
Searching for Happiness
This is the story, told through their own photographs, of a group of adolescent patients with cancer in their search for happiness. Their images relay their hopes and fears, their desire to be normal, and their urge to escape. These photographs are the outcome of a creative arts–based support...
One Size May Not Fit All: Thoughts on the New Adjuvant Bisphosphonate Guideline for Early-Stage Breast Cancer
The oncology community has now conducted several prospectively designed, hypothesis-driven randomized clinical trials among women with breast cancer to address this question: Do adjuvant bisphosphonates decrease the risk of breast cancer bone metastases and other recurrence? A meta-analysis1 by...
Cancer Care Ontario and ASCO Clinical Practice Guideline: Use of Adjuvant Bisphosphonates and Other Bone-Modifying Agents in Breast Cancer
As reported in the Journal of Clinical Oncology by Sukhbinder Dhesy-Thind, MD, MSc, FRCPC, of Juravinski Cancer Centre, Hamilton Health Sciences, and colleagues, Cancer Care Ontario and ASCO have issued a clinical practice guideline on the use of adjuvant bisphosphonates and other bone-modifying...
Advances in the Treatment of Triple-Negative Breast Cancer
WITHIN THE SPECTRUM of breast cancer subtypes, triple-negative disease is “particularly troubling,” but better scientific understanding of this malignancy is leading to advances in its treatment, according to breast cancer expert Nancy Davidson, MD. Triple-negative breast cancer does not express...
Financial Toxicity: Cancer Supportive Care Professionals Consider the Side Effects of Soaring Costs
IS IT POSSIBLE to identify patients with cancer who are at risk for financial stress and intervene to reduce that risk? And could reducing financial stress—or financial toxicity, as it is often called in the context of cancer care—improve both health-related quality of life and physical health?...
Selected Abstracts on Novel Therapies for Hematologic Malignancies
THE 22ND CONGRESS of the European Hematology Association (EHA) was held in June in Madrid, drawing hematologists and allied professionals from every subspecialty of hematology from around the world. Among the extensive educational and scientific program, the EHA Congress provides a forum for...
Convergence of Precision Medicine and Immuno-oncology
“THE CONVERGENCE of two very hot and interesting topics—precision medicine and immuno-oncology”—is being advanced by next-generation sequencing, Douglas B. Johnson, MD, MSCI, made clear at the inaugural OncoSET Symposium: Emerging Approaches to Precision Medicine,” sponsored by the Robert H. Lurie ...
New Data Reported on Vemurafenib, Vitamin D, Selective Internal Radiotherapy, and Circulating Tumor DNA in Colorectal Cancer
RESULTS OF the IDEA trial, which showed that some patients with stage III low-risk colon cancer may require less oxaliplatin therapy (see the June 25 issue of The ASCO Post), were among the findings highlighted at the 2017 ASCO Annual Meeting Plenary Session. Other studies of interest in colorectal ...
Expert Point of View: Frank Sinicrope, MD
FRANK SINICROPE, MD, Professor of Oncology and Co-Leader of the GI Cancer Program at the Mayo Clinic, Rochester, said CHARTA addressed whether patient outcomes can be improved with a triplet regimen plus bevacizumab (Avastin) vs a standard doublet plus bevacizumab. This was based upon the finding...
More Support for FOLFOXIRI/Bevacizumab in Advanced Colorectal Cancer
A RANDOMIZED head-to-head comparison in patients with advanced colorectal cancer found that a regimen of FOLFOXIRI (fluorouracil/leucovorin, oxaliplatin, irinotecan) plus bevacizumab (Avastin) was more effective than a regimen of FOLFOX (fluorouracil/leucovorin, oxaliplatin) plus bevacizumab as...
FDA Actions Yield Extended Approvals of Novel Agents, Advisory Committee Votes Favorably on Two Biosimilars and Pediatric Indication for CAR T-Cell Therapy
DURING JULY, the U.S. Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) made a number of approvals and recommendations on a variety of oncology products. Neratinib ON JULY 1 7, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of adult...
FDA Expands Ibrutinib Indications to Chronic Graft-vs-Host Disease
On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for the treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of chronic...
In Case You Missed It: Short Takes on Current Cancer Research
MOST ONCOLOGISTS are familiar with the findings of the plenary sessions featured at the 2017 ASCO Annual Meeting, with topics ranging from the duration of adjuvant oxaliplatin-based therapy in stage III colon cancer to patient-reported outcomes for symptom monitoring during routine cancer...
FDA’s First Site-Agnostic Drug Approval Marks a Paradigm Shift in Regulatory Criteria
IN MAY, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with solid tumors that have the microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) biomarker, which disrupts the ability of cells to repair DNA. The...
Tissue Specimens in Clinical Trials: A Double-Edged Sword
AN INCREASING number of clinical trials require the submission of tissue specimens, either from archived specimens or increasingly from fresh biopsies taken after enrollment into the trial. These specimens can be either mandatory, required to determine whether a given patient has the required...
A New Triumvirate in Estrogen Receptor–Positive Metastatic Breast Cancer
THE BODY OF EVIDENCE supporting the use of cell-cycle inhibitors in combination with endocrine therapy for estrogen receptor–positive metastatic breast cancer now has another agent in the spotlight. The phase III MONARCH 2 trial—reported at the 2017 ASCO Annual Meeting and by Sledge et al in the...
Cancer on the Global Stage: Incidence and Cancer-Related Mortality in Angola
The ASCO Post is pleased to continue this special feature on the worldwide cancer burden. Each installment focuses on a country from one of the six regions of the world, as defined by the World Health Organization (ie, Africa, the Americas, South-East Asia, Europe, Eastern Mediterranean, and...
An Educational Program for Safe Handling of Opioids
Improper storage, use, and disposal of prescribed opioids can lead to diversion or accidental overdose. Given that opioids are the mainstay of cancer pain treatment, this issue is particularly germane in the oncology community. The ASCO Post recently spoke with Akhila Reddy, MD, and Maxine de la...
MammaPrint Test Addressed in ASCO Breast Cancer Guideline Update
New recommendations on the use of the MammaPrint genomic test issued on July 10 will help guide decisions on adjuvant systemic therapy for women with early breast cancer. The recommendations update the ASCO 2016 clinical practice guideline on the use of biomarkers in these patients. The guideline ...
First Oncologist Elected AMA President, Barbara L. McAneny, MD, Advocates for Access to Health Care for Everyone
Since the founding of the American Medical Association (AMA) in 1847, Barbara L. McAneny, MD, is the fourth woman and first oncologist to be elected President of the venerable medical association. “I’m a generic Midwesterner. I was born in Missouri and raised in Madison County, Illinois, and went...
Two San Diego Nonprofits to Receive 2017 ASTRO Survivor Circle Grants
The American Society for Radiation Oncology (ASTRO) will award its annual Survivor Circle grants to two San Diego–based cancer support charities: Cancer Angels of San Diego and The Seany Foundation. Each organization will receive an $8,500 grant to support its programs for those who have been...
NETRF Commits $4 Million for Neuroendocrine Tumor Research
The Neuroendocrine Tumor Research Foundation (NETRF) has announced its largest research commitment ever—$4 million in collaborative grants—most from its new Accelerator Grants program to study neuroendocrine tumors, a widely misunderstood, commonly misdiagnosed cancer type without adequately...
Effect of BRAF V600E Mutation on Outcome in Pediatric Low-Grade Gliomas
An analysis reported by Lassaletta et al in the Journal of Clinical Oncology showed that BRAF V600E mutation is associated with a poor outcome in pediatric low-grade gliomas treated with standard adjuvant therapy. Study Details The study involved patients with low-grade gliomas with long-term...
Comparison of Circulating Tumor DNA and Metastatic Tissue Biopsy in Identifying Mutations in Prostate Cancer
In a study reported in the Journal of the National Cancer Institute, Wyatt et al found high agreement between driver mutations in plasma circulating tumor DNA (ctDNA) and metastatic tissue biopsy in castration-resistant prostate cancer. Mutations Identified in ctDNA In the study, targeted...
10-Year Follow-up on Adjuvant Tamoxifen and Exemestane in Postmenopausal Early Breast Cancer
The 10-year follow-up of the phase III TEAM trial has shown that exemestane alone and sequential tamoxifen/exemestane provide similar outcomes as adjuvant endocrine therapy in postmenopausal women with hormone receptor–positive early breast cancer. The findings were reported in The Lancet...
Brenda Fitzgerald, MD, Appointed CDC Director and ATSDR Administrator
On July 7, Health and Human Services Secretary Tom Price, MD, named Brenda Fitzgerald, MD, as the 17th Director of the Centers for Disease Control and Prevention (CDC) and Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR). “I am extremely proud and excited to announce...
FDA Approves Enasidenib in Relapsed or Refractory Acute Myeloid Leukemia
Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...
FDA Approves Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer...
Asparaginase-Associated Pancreatitis in Childhood Acute Lymphoblastic Leukemia
An observational study reported in The Lancet Oncology by Wolthers et al in the Ponte di Legno Toxicity Working Group identified characteristics and the course of asparaginase-associated pancreatitis in childhood acute lymphoblastic leukemia. Study Details The study involved merged data from...
Effect of BRCA1/2 Status on Response to Neoadjuvant Carboplatin in Triple-Negative Breast Cancer
An analysis of the GeparSixto trial in triple-negative breast cancer showed that adding carboplatin to neoadjuvant therapy improved pathologic complete response rate in patients without BRCA1/2 mutation and that response rates were higher overall in those with mutations, without additive effects...
Tremelimumab in Previously Treated Advanced Malignant Mesothelioma
In the randomized phase IIB DETERMINE trial, the cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) inhibitor tremelimumab did not improve overall survival vs placebo as second- or third-line treatment of relapsed malignant mesothelioma. These findings were reported in The Lancet Oncology...
FDA Grants Venetoclax Breakthrough Therapy Designation for Geriatric Patients With Acute Myeloid Leukemia
On July 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for venetoclax (Venclexta) in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. FDA...
Fulvestrant Receives EC Approval as First-Line Therapy for Advanced Breast Cancer
On July 26, the European Commission (EC) approved fulvestrant (Falsodex) for the treatment of estrogen receptor–positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The EC approval is based on pivotal data from the...
FDA Grants Durvalumab Breakthrough Therapy Designation for Patients With Locally Advanced Unresectable NSCLC
On July 31, AstraZeneca and MedImmune (AstraZeneca’s global biologics research and development arm) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for durvalumab (Imfinzi) for the treatment of patients with locally advanced,...
Association of Bisphosphonate Use and Breast Cancer Risk in Postmenopausal Women
A study in postmenopausal women in the French E3N prospective cohort indicated bisphosphonate use was not associated with a reduced risk of breast cancer. These findings were reported by Fournier et al in the Journal of Clinical Oncology. Study Details The study included 64,438 postmenopausal...
Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Advanced Melanoma
In the phase IB KEYNOTE-029 study, standard-dose pembrolizumab (Keytruda) plus reduced-dose ipilimumab (Yervoy) produced high response rates in patients with advanced melanoma. These results were reported by Long et al in The Lancet Oncology. Study Details In the study, 153 patients with...
Initial Progression-Free Survival Results From the MYSTIC Trial in Stage IV NSCLC
On July 27, researchers announced the progression-free survival (PFS) results for the phase III MYSTIC trial, a randomized, open-label, multicenter, global trial of durvalumab (Imfinzi) monotherapy or durvalumab in combination with tremelimumab vs platinum-based standard-of-care chemotherapy in...
Breast Cancer Survivor Preferences for Providers of Aspects of Primary Care After Cancer Treatment
In a study reported in the Journal of Clinical Oncology, Wallner et al found that minority women vs white women and women with a lower vs higher attained education level were more likely to prefer oncology-directed care vs primary care provider–directed care for aspects of care normally...
