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hepatobiliary cancer

Sodium Thiosulfate to Prevent Cisplatin-Induced Hearing Loss in Pediatric Standard-Risk Hepatoblastoma

In a phase III International Liver Tumor Strategy Group trial (SIOPEL 6) reported in The New England Journal of Medicine, Brock et al found that sodium thiosulfate reduced cisplatin-induced hearing loss in pediatric patients with standard-risk hepatoblastoma. Study Details The trial enrolled a...

skin cancer

Educational Interventions Decrease Sunburns Among Operators of Heavy Equipment

The implementation of educational interventions among heavy equipment operators, or operating engineers, in Michigan significantly increased the use of sunscreen and decreased the number of sunburns, reported Duffy et al in Cancer Epidemiology, Biomarkers & Prevention. “The rates of...

lung cancer
immunotherapy

FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...

colorectal cancer

Colon Cancer Surgery and Resource Availability at Hospitals on Weekends and Holidays

The likelihood of severe complications after emergency colon cancer surgery is significantly higher over the weekend, according to a study published by Huijts et al in JNCCN – Journal of the National Comprehensive Cancer Network. The research was led by Perla Marang-van de Mheen, PhD, of the...

skin cancer
immunotherapy

MAGE-A3 Immunotherapeutic as Adjuvant Therapy for MAGE-A3–Positive Stage III Melanoma

In the phase III DERMA trial reported in The Lancet Oncology, Dreno et al found that an adjuvant MAGE-A3 immunotherapeutic provided no benefit vs placebo in patients with resected MAGE-A3–positive stage IIIB or IIIC melanoma. Development of the agent for use in melanoma has been stopped. The ...

breast cancer
immunotherapy

Trastuzumab Biosimilar vs Reference Trastuzumab in HER2-Positive Early Breast Cancer

In the phase III LILAC equivalence trial reported in The Lancet Oncology, von Minckwitz et al found similar efficacy and safety with the trastuzumab biosimilar ABP 980 vs reference trastuzumab (Herceptin) in HER2-positive early breast cancer. On local review, the risk difference and risk ratio (RR) ...

lung cancer

ERBB Mutations and Outcomes With Afatinib and Erlotinib in Squamous NSCLC

In an analysis of the LUX-Lung 8 trial in squamous non–small cell lung cancer (NSCLC) reported in JAMA Oncology, Goss et al found that outcomes among patients treated with afatinib (Gilotrif) were better for those with vs without ERBB mutations. The LUX-Lung 8 trial showed that afatinib was...

FDA Takes Steps to Foster Greater Efficiency in Biosimilar Development by Reconsidering Draft Guidance on Evaluating Analytical Studies

“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped. I believe that the US Food and Drug Administration (FDA) can do more to support the development of biosimilars, as well as...

lung cancer

IASLC Issues Statement Paper on Liquid Biopsy for Lung Cancer

The lungs can be a difficult organ to biopsy with a needle, so the promise of identifying lung cancer through a blood-based biopsy has lung cancer experts and patients optimistic. Knowing how and when to use a liquid biopsy is critically important and led global experts at the International...

leukemia

Long-Term Outcomes With Dasatinib Plus Intensive Chemotherapy in Pediatric/Young Adult Ph-Positive ALL

In an analysis of the Children’s Oncology Group (COG) AALL0622 trial reported in the Journal of Clinical Oncology, Slayton et al found that adding dasatinib (Sprycel) to intensive chemotherapy produced good long-term outcomes in pediatric/young adult patients with newly diagnosed Philadelphia ...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Second-Line Pembrolizumab vs Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...

colorectal cancer
survivorship

Dietary Insulin Load and Risk of Disease Recurrence in Stage III Colon Cancer

New research led by Dana-Farber Cancer Institute investigators suggests that patients treated for nonmetastatic colon cancer may sharply reduce the risk that the disease will return by following a diet low in carbohydrates and other foods that raise insulin levels. In a study published by...

bladder cancer
immunotherapy

FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients

As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...

solid tumors
supportive care

Prognostic Model for Malignant Pleural Effusion

As reported in The Lancet Oncology, Psallidas et al developed a model that is predictive of 3-month survival in patients with malignant pleural effusion. Study Details The PROMISE study involved an analysis of 5 independent data sets from randomized trials to discover, validate, and prospectively ...

issues in oncology
survivorship

Genetic Risk for Subsequent Neoplasms in Long-Term Survivors of Childhood Cancer

In a study reported in the Journal of Clinical Oncology, Wang et al found that germline pathogenic/likely pathogenic mutations significantly contributed to the risk of subsequent neoplasms in long-term survivors of childhood cancers. Study Details The study involved whole-genome sequencing on...

breast cancer

Addition of Ribociclib to Fulvestrant Improves Progression-Free Survival in HR-Positive, HER2-Negative Advanced Breast Cancer

As reported by Slamon and colleagues in the Journal of Clinical Oncology, the phase III MONALEESA-3 trial has shown significant improvement in progression-free survival with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) to fulvestrant (Faslodex) in hormone receptor (HR)-positive,...

skin cancer

FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations

Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...

breast cancer

FDA Accepts Supplementary PMA for Review of BRACAnalysis CDx as a Companion Diagnostic to Talazoparib in Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) recently accepted a supplementary premarket approval (PMA) application for BRACAnalysis CDx to be used as a companion diagnostic with the poly ADP ribose polymerase (PARP) inhibitor talazoparib. The new drug application (NDA) for...

lymphoma

JAK Inhibitor Treatment for Myelofibrosis May Be Associated With Development of Aggressive Lymphomas

Austrian researchers have discovered that a small number of patients taking targeted drugs known as Janus kinase (JAK) inhibitors to treat myelofibrosis may develop aggressive lymphomas. They also speculate that screening for a preexisting B-cell clone before starting therapy may help prevent this...

multiple myeloma

CAR T Cells Targeting B-Cell Maturation Antigen in Poor-Prognosis Relapsed Multiple Myeloma

In a first-in-human study reported in the Journal of Clinical Oncology, Brudno et al found that chimeric antigen receptor (CAR) autologous T cells targeting B-cell maturation antigen (BCMA) produced responses in patients with poor-prognosis relapsed multiple myeloma. Study Details The current...

lymphoma
immunotherapy

Outcomes by Chemotherapy Backbone for Obinutuzumab vs Rituximab in Previously Untreated Follicular Lymphoma

In an analysis of the GALLIUM trial reported in the Journal of Clinical Oncology, Hiddemann and colleagues found that obinutuzumab (Gazyva) appeared to provide consistent progression-free survival benefit vs rituximab (Rituxan) in previously untreated follicular lymphoma, irrespective of which...

lung cancer
immunotherapy

Addition of Atezolizumab to Bevacizumab and Chemotherapy in First-Line Treatment of Metastatic Nonsquamous NSCLC

As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by Socinski et al, the phase III IMpower150 trial has shown that the addition of atezolizumab (Tecentriq) to bevacizumab (Avastin) plus chemotherapy significantly improved progression-free and overall survival in ...

In Continued Effort to Address Physician Burnout, AMA Adopts Policy to Improve Physician Access to Mental Health Care

With growing concern among the medical community and the public regarding physician and medical student depression, burnout, and suicide, the American Medical Association (AMA) adopted policy during its Annual Meeting that continues its efforts aimed at improving physician access to mental health...

lung cancer
immunotherapy

FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...

leukemia

Quizartinib in Relapsed or Refractory AML

In a phase II trial reported in The Lancet Oncology, Cortes et al found that the next-generation FLT3 inhibitor quizartinib had good activity in patients with relapsed or refractory acute myeloid leukemia (AML), with greater activity in patients with FLT3-ITD mutations. Study Details The study...

breast cancer

Long-Term Results of Adjuvant Endocrine Therapy in Premenopausal Breast Cancer

In an analysis of long-term outcomes in the SOFT and TEXT trials reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine, Francis et al found that the addition of ovarian suppression to adjuvant tamoxifen significantly improved 8-year rates of disease-free and overall...

Inside Story on the Genesis of Teen Cancer America

THANK YOU for publishing the excellent article “We Need to Fill the Gap Between Pediatric and Adult Oncology Care” by Sarah Stream (as told to Jo Cavallo) in the March 25, 2018, issue of The ASCO Post. Sarah’s story and her connection to Teen Cancer America actually go much deeper than she reported ...

gynecologic cancers

FDA Approves Bevacizumab in Combination With Chemotherapy for Ovarian Cancer

ON JUNE 13, 2018, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) for the treatment of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV...

gynecologic cancers
lymphoma

Pembrolizumab Receives FDA Approval for Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma, Advanced Cervical Cancer

THE U.S. FOOD and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or who have relapsed after two or more prior lines of therapy on June 13, 2018. The newest ...

prostate cancer

Bipolar Androgen Therapy After Disease Progression in Metastatic Castration-Resistant Prostate Cancer

In a single-center phase II study reported in The Lancet Oncology, Teply et al found that bipolar androgen therapy can induce prostate-specific antigen (PSA) response and resensitization to enzalutamide (Xtandi) in men with metastatic castration-resistant prostate cancer whose disease progressed on ...

issues in oncology

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 Ellis, PhD, of the Cancer Prevention Institute...

cns cancers

Addition of Tumor-Treating Fields to Maintenance Temozolomide in Glioblastoma

The final results of a phase III trial reported by Roger Stupp, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and colleagues in JAMA indicate that adding antimitotic treatment with tumor-treating fields to maintenance temozolomide is associated with improved...

Endangered Art of Medicine

I hold a cold, lifeless mouse instead of my patient’s heated hand, checking off the tiny box marked “Anxiety,” while she squirms under twisted blankets.  I don’t remember when or how or why it happened, that the static screen wedged itself between my patients and me and compliance with the digital...

lymphoma

I’m Proud to Have Contributed to the FDA Approval of CAR T-Cell Therapy

When I was diagnosed with diffuse large B-cell lymphoma (DLBCL) in 2013, I used to joke that if I had to get cancer, this wasn’t a bad one to have. At just 32, I was otherwise healthy, and my prognosis for a cure was good, according to my oncologist. So I felt confident that once I underwent...

Colorectal Cancer Alliance Announces Available Research Funding

THE COLORECTAL CANCER Alliance has announced up to $775,000 in available funding for up to five grants supporting research in young-onset colorectal cancer, rectal cancer, and colorectal cancer prevention. The Colorectal Cancer Alliance is committed to investing $10 million in research by 2021,...

Jens Hillengass, MD, Named Chief of Myeloma at Roswell Park

JENS HILLENGASS, MD, has been announced as the new Chief of Myeloma of the Roswell Park Comprehensive Cancer Center. As part of his new role, Dr. Hillengass will continue his research on hematologic diseases, including multiple myeloma and its precursor diseases.  A scientist with more than 15...

Researchers at Baylor Awarded Multiple Grants to Study Treatment Resistance in Breast Cancer

TO BETTER UNDERSTAND the causes of resistance to treatment in estrogen receptor–positive breast cancer, the Department of Defense has awarded researchers at Baylor College of Medicine multiple grants to study gene anomalies in estrogen receptor–positive breast cancer that are associated with...

lung cancer

Disparities Found in Lung Cancer Care, Survival in United States vs England

DESPITE STEADY declines in death rates in recent years, lung cancer remains the leading cause of cancer deaths in wealthy countries. In a study published by Anita Andreano, MD, of the University of Milan-Ciocco, and colleagues in the Journal of Thoracic Oncology,1 Yale researchers collaborated with ...

pancreatic cancer

Actively Recruiting Clinical Trials Focused on Pancreatic Cancer

THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on pancreatic cancer. These studies are investigating radiotherapy; cancer vaccines; combination treatments; novel cell therapies; response prediction; and more. All of the studies ...

issues in oncology
survivorship

Handheld Device for Detecting Heart Dysfunction in Anthracycline-Exposed Survivors of Childhood Cancer

Cardiovascular complications, such as anthracycline-related heart failure, are a leading cause of morbidity and mortality in survivors of childhood cancer, often developing at a time when these survivors are least engaged in long-term survivorship care, prompting the need for new paradigms in...

gynecologic cancers

FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases

On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil  9). The application is seeking approval for an expanded age...

issues in oncology

Statement From FDA Commissioner on Agency Efforts to Advance the Patient Voice in Medical Product Development and Regulatory Decision-Making

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement: Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for ...

colorectal cancer
cost of care

AMA Plans Advocacy Outreach to Expand Colorectal Screening

Building on the efficacy of colorectal cancer screening, the American Medical Association (AMA) endorsed a plan at its Annual Meeting to work with physicians and payers to make the screening more available and affordable. Challenges with insurance coverage remain a barrier to colorectal cancer...

lymphoma

Ibrutinib in Relapsed or Refractory Follicular Lymphoma

In the phase II DAWN study reported in the Journal of Clinical Oncology, Gopal et al found that ibrutinib (Imbruvica) produced a response in a minority of patients with relapsed or refractory follicular lymphoma. Study Details In the study, 110 patients with ≥ 2 prior lines of treatment...

leukemia

Suboptimal Use of Initial Chemotherapy in Newly Diagnosed AML

In a study of National Cancer Database data reported in Blood Advances, Bhatt et al found that 25% of patients with newly diagnosed acute myeloid leukemia (AML) did not receive initial chemotherapy, despite evidence that chemotherapy is associated with a survival benefit and improvement in symptoms ...

integrative oncology

Green Tea

The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on the potential health benefits ...

Harvard Business School Launches Initiative to Accelerate Precision Medicine in Oncology

THE HARVARD BUSINESS School Kraft Precision Medicine Accelerator, a multidisciplinary initiative with aims to advance precision medicine, focuses on four workstreams: Direct to Patient, Data & Analytics, Clinical Trials, as well as Venture and Investment. It was recently announced that under...

hematologic malignancies

From Italy to Boston, A Love of Molecular Diagnostics Shapes a Career for Valentina Nardi, MD

Valentina Nardi, MD, is a staff pathologist at Massachusetts General Hospital, and her current clinical work includes implementing molecular assays for hematologic malignancies at the Center for Integrated Diagnostics. “I was born in Rome, but I did my high school and college education in Genoa. I ...

Richard D. Schulick, MD, MBA, Named Director of University of Colorado Cancer Center

RICHARD D. SCHULICK, MD, MBA, a cancer surgeon and administrative leader, has been named Director of the University of Colorado Cancer Center, a consortium of three universities and three academic teaching hospitals. The University of Colorado Cancer Center is the hub of cancer research in the...

Steven A. Rosenberg, MD, PhD, Receives American College of Surgeons Jacobson Innovation Award

THE 2018 JACOBSON INNOVATION AWARD of the American College of Surgeons was recently presented to Steven A. Rosenberg, MD, PhD, Chief of the Surgery Branch at the National Cancer Institute (NCI) as well as Professor of Surgery at the Uniformed Services University of Health Sciences and at the...

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