Addition of Concurrent Chemotherapy to EGFR Inhibitor and Radiotherapy in Locally Advanced Head and Neck Carcinoma

As reported in the Journal of Clinical Oncology by Tao et al, the phase III GORTEC (Groupe Oncologie Radiothèrapie Tête et Cou) 2007-01 trial has shown improved progression-free survival with the addition of concurrent chemotherapy to cetuximab (Erbitux) and radiotherapy (RT) in...

Addition of Veliparib to Temozolomide in Recurrent Small Cell Lung Cancer

In a phase II trial reported in the Journal of Clinical Oncology, Pietanza et al found no benefit of adding the PARP inhibitor veliparib to temozolomide (Temodar) in recurrent platinum-sensitive or platinum-refractory small cell lung cancer. Benefit was observed with the combination in the subgroup ...

Vitamin D Levels and Colorectal Cancer Risk

In a study reported in the Journal of the National Cancer Institute, McCullough et al found reduced risk for colorectal cancer with increasing levels of circulating 25-hydroxyvitamin D (25[OH]D). Study Details The study was an international pooling project using participant-level data from 17...

FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...

IMpower133: Atezolizumab in Combination With Chemotherapy in Previously Untreated, Extensive-Stage Small Cell Lung Cancer

The phase III IMpower133 study recently met its coprimary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. The study demonstrated that first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and...

Addition of Panitumumab to Neoadjuvant Chemotherapy in Primary HER2-Negative Inflammatory Breast Cancer

In a single-center phase II study reported in JAMA Oncology, Matsuda et al found that adding the EGFR inhibitor panitumumab (Vectibix) to neoadjuvant chemotherapy produced high pathologic complete response (pCR) rates in patients with primary triple-negative inflammatory breast cancer. Study...

ASCO Practice Census Survey Identifies Challenges Facing U.S. Oncology Practices

As reported in the Journal of Oncology Practice by Kirkwood et al, the recent ASCO Oncology Practice Census survey has identified a number of factors considered to be challenging by oncology practices in the United States. Study Details ASCO used Medicare Physician Compare data to characterize...

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...

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...

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...

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...

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 ...

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) ...

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...

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...

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

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...

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...

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,...

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,...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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 ...

DNA Test Identifies Men With Sixfold Increased Risk of Prostate Cancer

A major new study of more than 140,000 men has identified 63 new genetic variations in the DNA code that increase the risk of prostate cancer. These findings were published by Schumacher et al in Nature Genetics. Researchers devised a new test combining these single-letter genetic variants with...

Parents See Cancer Prevention Potential as Best Reason for HPV Vaccination

Parents of adolescents believed that the potential to prevent certain types of cancer is the best reason for their children to receive the human papillomavirus (HPV) vaccine, whereas other reasons health-care providers often give were far less persuasive. Findings from this study were published by...

Journal of Oncology Practice Launches New Blog to Facilitate Discussions on Care Delivery Topics

The Journal of Oncology Practice (JOP) has launched a new care delivery blog, JOP DAiS (Discussion & Analysis in Short), to serve as a forum for commentary and analysis on issues affecting the mechanisms of oncology care delivery. This new platform will be a way to collaborate, debate, and...

ASCO/CAP Clinical Practice Guideline Focused Update on HER2 Testing in Breast Cancer

As reported in the Journal of Clinical Oncology by Antonio C. Wolff, MD, of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and colleagues, ASCO and the College of American Pathologists (CAP) have issued a clinical practice guideline focused update on HER2 testing in breast cancer....

Activity of Ivosidenib in IDH1-Mutated Relapsed or Refractory Acute Myeloid Leukemia

As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by DiNardo et al, early-phase testing has shown activity of ivosidenib, an oral small-molecule inhibitor of mutant IDH1, in patients with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML). IDH1...

EHA 2018: Tazemetostat in Relapsed or Refractory Follicular Lymphoma

Positive interim data were recently presented from an ongoing phase II study of tazemetostat—a potent, selective, orally available EZH2 inhibitor—as a monotherapy for patients with relapsed or refractory follicular lymphoma. The data, presented by Salles et al at the 23rd Annual...

EHA 2018: Ruxolitinib Reduces Risk of Thrombosis, Death in Patients With Polycythemia Vera

A new comparison study showed that among polycythemia vera patients who were resistant or intolerant to hydroxyurea, those treated with ruxolitinib (Jakavi) had a significantly reduced risk of thrombosis and death compared to those who received best available therapy. The study findings are based...

EHA 2018: Single-Agent Quizartinib vs Chemotherapy in Relapsed or Refractory AML

Results from the phase III QuANTUM-R study of single-agent quizartinib in relapsed or refractory acute myeloid leukemia (AML) were presented by Cortes et al at the 23rd Annual Congress of the European Hematology Association (EHA) (Abstract LB2600). Study Findings QuANTUM-R study results showed...

EHA 2018: Undetectable MRD Rates With Venetoclax Plus Rituximab in Relapsed or Refractory CLL

Investigational data from a new analysis of undetectable minimal residual disease (MRD) rates from the phase III MURANO trial of venetoclax (Venclexta, a first-in-class oral B-cell lymphoma 2 [BCL2] inhibitor) in combination with rituximab (Rituxan) in patients with relapsed or refractory chronic...

Once- vs Twice-Weekly Carfilzomib in Relapsed or Refractory Multiple Myeloma

An interim analysis of the phase III ARROW trial reported in The Lancet Oncology by Moreau et al indicated that a higher-dose once-weekly schedule of carfilzomib was associated with prolonged progression-free survival vs a twice-weekly schedule in patients with relapsed or refractory multiple...

Activity of the PD-1 Inhibitor Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma

As reported at the 2018 ASCO Annual Meeting (Abstract 9519) and in The New England Journal of Medicine by Migden et al, results of early-phase testing show activity of the programmed cell death protein 1 (PD-1) inhibitor cemiplimab in advanced cutaneous squamous cell carcinoma. Currently, no...

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