issues in oncology

Social Interaction May Affect Patients’ Response to Chemotherapy

How well patients with cancer fared after chemotherapy was affected by their social interaction with other patients during treatment, according to a new study by researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, and the University of...

lung cancer

Regionalization and Lung Cancer Operative Mortality in Ontario, Canada

In a study reported in the Journal of Clinical Oncology, Bendzsak et al found that centralization of surgery services to high-volume hospitals in Ontario was not independently associated with improved operative mortality rates in lung cancer. In April 2007, a policy was implemented to regionalize...

hematologic malignancies

Italian Study of Serotherapy to Prevent GVHD in Pediatric Hematologic Malignancy

In an Italian phase III trial reported by Locatelli et al in The Lancet Oncology, a lower vs higher dose of rabbit anti–T-lymphocyte globulin (ATLG) was associated with a nonsignificantly greater incidence of acute graft-vs-host disease but better event-free and overall survival in children...

health-care policy

Insurance Approval Rates for Enrollment in Oncology Clinical Trials Increased Under Affordable Care Act

The Patient Protection and Affordable Care Act (ACA) of 2010 was the first federal law to mandate that group health insurance plans and state-licensed insurance issuers provide coverage of standard-of-care costs for patients enrolled in approved clinical trials, effective on January 1, 2014. Under...

symptom management

Understanding and Managing Radiation-Induced Bystander Effect

More than half of patients with cancer undergo radiotherapy. Due to a phenomenon known as radiation-induced bystander effect, in which irradiated cells leak chemical signals that can travel some distance to damage unexposed healthy cells, many suffer side effects such as hair loss, fatigue, and...

cns cancers

Analysis Reveals Genomic Alterations, Oncogenes Driving Medulloblastoma Subtypes

The most comprehensive analysis yet of medulloblastoma has identified genomic changes responsible for more than 75% of the brain tumors, including two new suspected cancer genes that were found exclusively in the least understood disease subgroups. The study from an international research...

multiple myeloma

Comparison of MRI vs PET-CT in Multiple Myeloma

A study reported by Moreau et al in the Journal of Clinical Oncology indicated no difference between magnetic resonance imaging (MRI) and positron-emission tomography–computed tomography (PET-CT) in detecting bone lesions at diagnosis in patients with multiple myeloma. PET-CT normalization...

cns cancers

Single-Center Trial of Stereotactic Radiosurgery for Completely Resected Brain Metastases

In a U.S. single-institution study reported in The Lancet Oncology, Mahajan et al found that stereotactic radiosurgery to the surgical cavity reduced local recurrence vs observation in patients with completely resected brain metastases. Study Details In the trial, 128 evaluable patients at MD...

gastroesophageal cancer

Addition of Cetuximab to Concurrent Chemoradiation in Esophageal Cancer

The phase III NRG Oncology RTOG 0436 trial has shown no survival benefit of adding cetuximab (Erbitux) to paclitaxel/cisplatin and radiation therapy in patients with esophageal cancer treated without surgery. These results were reported by Suntharalingam et al in JAMA Oncology. Study Details In...

cost of care

ASCO Offers Path to Addressing Affordability of Cancer Drugs in New Position Statement

Today, ASCO issued a position statement aimed at contributing to the national dialogue on rising cancer drug prices. The statement, which asserts that any solutions must also preserve patients' access to care and foster innovation, analyzes a wide array of options and recommends that a panel of...

hepatobiliary cancer

FDA Approves Three-Drug Combination Tablet for Hepatitis C

On July 18, the U.S. Food and Drug Administration (FDA) approved a combination tablet (Vosevi) to treat adults with chronic hepatitis C virus genotypes 1–6 without cirrhosis or with mild cirrhosis. This fixed-dose, combination tablet contains two previously approved drugs—sofosbuvir and ...

issues in oncology

Understanding of Stage and Cancer Status Among Patients in a Community-Based Cancer Institute

As reported by Sivendran et al in the Journal of Oncology Practice, half of patients in a large community-based cancer institute did not know their stage of cancer, and one-third did not know of their cancer-free/in-remission status. Study Details The study involved 208 adult patients treated at...

kidney cancer

Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma

The phase I CheckMate 016 trial has shown activity of the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) in metastatic renal cell carcinoma. These findings were reported in the Journal of Clinical Oncology by Hammers et al. Study Details In the dose-escalation study, patients were...

cns cancers

Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for Resected Metastatic Brain Disease

In the phase III NCCTG N107C/CEC.3 trial, stereotactic radiosurgery to the surgical cavity reduced cognitive deterioration and was associated with similar overall survival vs whole-brain radiotherapy in patients with resected brain metastasis. These results were reported by Brown et al in The...

breast cancer
solid tumors

CDK4/6 Inhibitors Have a Manageable Toxicity Profile, Are Generally Well Tolerated in Patients With Breast Cancer

A class of oral drugs for treating breast cancer known as cyclin-dependent kinase (CDK) 4/6 inhibitors are generally well-tolerated, with a manageable toxicity profile for most patients. This is the conclusion of a comprehensive review of toxicities and drug interactions related to this class of...

breast cancer

Neoadjuvant Radiation Reduces Risk of Secondary Tumors in Early-Stage Breast Cancer

Moffitt Cancer Center researchers conducted a first-of-its-kind study comparing the long-term benefits of radiation therapy in women with breast cancer in the neoadjuvant and adjuvant settings. Their study, published by Poleszczuk et al in Breast Cancer Research, found that patients who have...

solid tumors

Insertion and Deletion Mutations and Immunogenicity in Solid Tumors

In a study reported in The Lancet Oncology, Turajlic et al found that renal cell carcinomas were characterized by the highest proportion and number of frameshift insertion and deletion (indel) mutations among solid cancers and that these alterations were associated with augmented immunogenicity...

leukemia

Effect of Methotrexate and Corticosteroid Strategies on Neurocognitive Function in Patients With B-Lineage ALL

In a Children’s Oncology Group (COG) study (AALL06N1) reported in the Journal of Clinical Oncology, Hardy et al found that age < 10 years at diagnosis was associated with poorer neurocognitive function in patients with high-risk B-lineage acute lymphoblastic leukemia regardless of...

breast cancer

MammaPrint Scoring and Indolent Node-Negative Breast Cancer

In an analysis reported in JAMA Oncology, Esserman et al found that an ultralow-risk designation using the 70-gene MammaPrint assay is capable of identifying patients with node-negative disease who have a very low long-term risk of death from breast cancer after surgery without systemic therapy....

breast cancer

FDA Approves Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

Today, the U.S. Food and Drug Administration approved neratinib (Nerlynx) for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab (Herceptin)-based therapy. ExteNET Trial Approval was based on the ExteNET...

supportive care

Appropriate Distress Screening and Follow-up Leads to Fewer ER Visits and Hospitalizations in Patients With Cancer

Following a cancer diagnosis, all patients experience some level of distress—regardless of disease stage. When severe and left untreated, distress can have a significant impact on health outcomes, lead to greater mortality and morbidity, affect immune function, and result in higher...

solid tumors
issues in oncology

ASTRO Updates Insurance Coverage Recommendations for Proton Therapy

The American Society for Radiation Oncology (ASTRO) has issued an update to its recommendations for medical insurance coverage regarding the use of proton beam therapy to treat cancer. The updated Proton Beam Therapy Model Policy provides guidance to payers on clinical indications that are...

skin cancer

Nivolumab Treatment Beyond Disease Progression in Advanced Melanoma

In a retrospective analysis reported in JAMA Oncology, Long et al found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1–defined disease...

leukemia

CD33 Splicing Polymorphism and Response to Gemtuzumab Ozogamicin in AML

In an analysis of the phase III Children’s Oncology Group AAML0531 trial, published by Lambda et al in the Journal of Clinical Oncology, the CD33-targeted immunoconjugate gemtuzumab ozogamicin was shown to have benefit among patients with de novo acute myeloid leukemia (AML) who carry the CC...

FDA’s ODAC Unanimously Recommends Biosimilar Versions of Bevacizumab and Trastuzumab

On July 13, the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilar versions of bevacizumab (Avastin) and trastuzumab (Herceptin). In the morning session, ODAC members voted 17-0 in favor of approving Amgen's...

issues in oncology

Cancer Risk May Be Higher Among Holocaust Survivors

A new study indicates that survivors of the Holocaust have experienced a small but consistent increase in the risk of developing cancer. Published by Sadetzki et al in Cancer, the findings offer an example of how extreme population-level tragedies can have an impact on health. Holocaust survivors...

breast cancer

Anthracycline-Free Adjuvant Treatment in Early TOP2A-Normal Breast Cancer

The Danish phase III DBCG 07-READ trial has shown no difference in disease-free survival with adjuvant docetaxel/cyclophosphamide vs epirubicin, cyclophosphamide, and docetaxel in patients with early TOP2A-normal breast cancer. These trial results were reported in the Journal of Clinical Oncology...

cns cancers
issues in oncology

Study Demonstrates Potential for Artificial Intelligence and Whole-Genome Sequencing to Scale Access to Precision Medicine

In a study published by Wrzeszczynski et al in Neurology: Genetics, researchers at the New York Genome Center (NYGC), The Rockefeller University, and IBM illustrated the potential of IBM Watson for Genomics to analyze complex genomic data from state-of-the-art sequencing of whole genomes. The study ...

issues in oncology

New CDC Report Shows Cancer Death Rates Are Higher in Rural America

Despite decreases in cancer death rates nationwide, a new report from the Centers for Disease Control and Prevention (CDC) shows slower reduction in cancer death rates in rural America (a decrease of 1.0% per year) compared with urban America (a decrease of 1.6% per year), according to data...

leukemia

FDA’s Advisory Committee Supports CTL019 in Pediatric, Young Adult Patients With B-Cell ALL

Today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the biologics license application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory pediatric and young adult...

Impact of Health Insurance and Sociodemographic Status on Survival for AYAs With Cancer

According to the National Cancer Institute, cancer is the leading cause of disease-related death among adolescents and young adults (AYAs) between the ages of 15 and 39. And although cancer survival among this age group is more than 80%, AYAs have not experienced the same improvements in relative...

leukemia

Blinatumomab Granted Full Approval to Treat Relapsed or Refractory B-cell Precursor ALL in Adults and Children

On July 11, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include overall survival data from the phase III TOWER study. The approval converts blinatumomab's accelerated approval to a full approval. The sBLA...

lung cancer

FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies

On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell...

breast cancer

Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer

On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: ...

leukemia

FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML

On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...

issues in oncology

Factors Associated With Near-Miss/Safety Incidents in Cancer Radiotherapy

In a single-institution case-control analysis reported in the Journal of Oncology Practice, Judy et al found that complexity of procedure or schedule was a significant factor in near-miss or safety incidents involving cancer patients undergoing radiotherapy. Study Details The study involved a...

skin cancer

Overall Survival With Nivolumab vs Chemotherapy in Ipilimumab-Refractory Advanced Melanoma

As reported in the Journal of Clinical Oncology by Larkin et al, the phase III CheckMate 037 trial has shown no difference in overall survival with nivolumab (Opdivo) vs investigator’s choice of chemotherapy in ipilimumab (Yervoy)-refractory advanced melanoma. More chemotherapy patients never ...

breast cancer

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...

health-care policy
issues in oncology

Narrow Network Insurance Plans More Likely to Exclude Doctors at NCI-Designated and NCCN Member Cancer Centers

Patients with cancer in the United States may be unable to access care at the nation’s top hospitals due to narrow insurance plan coverage—leaving patients to choose between lower premiums or access to higher-quality cancer care. A new study from the Perelman School of Medicine at the...

skin cancer
issues in oncology

Delaying Lymph Node Biopsy After Melanoma Diagnosis May Not Adversely Affect Survival Rates

Postponing lymph node biopsy more than 30 days after melanoma diagnosis does not adversely impact long-term clinical outcomes, according to findings published by Nelson et al in the Journal of the American College of Surgeons. Today, management of high-risk melanomas starts with surgical removal...

breast cancer

Effect of Patient-Reported Symptoms on Adherence to Preventive Treatment for Breast Cancer

In an analysis of the UK cohort of the International Breast Cancer Intervention Study (IBIS-I) reported in the Journal of Clinical Oncology, Smith et al found similar effects of predefined symptoms on nonadherence in both tamoxifen and placebo recipients. IBIS-I randomized women at high risk of...

gynecologic cancer

Current Performance Measures for Cervical Cancer Screening

Health-care systems use performance measures for cervical cancer screening based on guidelines from such organizations as the American College of Obstetricians and Gynecologists to monitor the appropriateness of cervical cancer screening. According to the performance measure in the Healthcare...

solid tumors

FDA Grants 510(k) Clearance to Halcyon IMRT Treatment System

Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Halcyon system, a new device for cancer treatment. Halcyon simplifies and enhances image-guided volumetric-intensity modulated radiotherapy (IMRT). “We are proud that Halcyon has now...

multiple myeloma

FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma

On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...

leukemia

Idarubicin vs High-Dose Daunorubicin Induction in Newly Diagnosed Acute Myeloid Leukemia

A Korean phase III trial has shown no difference in outcomes with high-dose daunorubicin vs idarubicin induction in newly diagnosed acute myeloid leukemia, although high-dose daunorubicin was associated with better outcomes in patients with FLT3–internal tandem duplication (ITD) mutation....

sarcoma

Adding Evofosfamide to Doxorubicin in Advanced Soft-Tissue Sarcoma

A phase III trial (TH CR-406/SARC021) has shown no survival benefit of adding evofosfamide to doxorubicin in the first-line treatment of locally advanced unresectable or metastatic soft-tissue sarcoma. Trial results were reported in The Lancet Oncology by Tap et al. Evofosfamide is a...

breast cancer

Fat Grafting and Patient-Reported Outcomes in Postmastectomy Breast Reconstruction

The use of fat grafting as a tool for breast reconstruction following a mastectomy may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients, according to a study published by Bennett et al in JAMA Surgery. Fat grafting as an adjunct to breast reconstruction...

colorectal cancer

FDA Grants Marketing Approval to the Praxis Extended RAS Panel

On June 29, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel, a next-generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in the...

colorectal cancer

Effect of Salvage Surgery on Survival in Recurrence After Treatment of Rectal Cancer

In a large single-center analysis reported in the Journal of Clinical Oncology, Ikoma et al found that salvage surgery was associated with prolonged survival in patients with lung-only and liver-only recurrence but not in those with locoregional-only recurrence after preoperative chemotherapy and...

kidney cancer

MET Inhibitor Savolitinib in Advanced Papillary Renal Cell Cancer

In a biomarker-based phase II trial reported in the Journal of Clinical Oncology, Choueiri et al found that the MET tyrosine kinase inhibitor savolitinib was active in MET-driven advanced papillary renal cell cancer. Study Details In the trial, 109 patients with locally advanced or metastatic...

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