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Showing 16601 - 16650IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer
The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...
Percutaneous Ablation vs Nephrectomy in T1a Kidney Cancer
Many cases of early-stage kidney cancer can be treated with a relatively new, nonsurgical procedure used to destroy tumors, a new study by Talenfeld et al in Annals of Internal Medicine suggests. The procedure, called percutaneous ablation, involves the insertion of a needle through the skin into...
Outcomes of Tisagenlecleucel Therapy in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia
As reported in The New England Journal of Medicine by Shannon L. Maude, MD, PhD, of Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, the phase II ELIANA trial has shown that the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) ...
FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...
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 ...
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...
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...
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 ...
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...
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 ...
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...
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 ...
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 ...
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...
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...
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,...
WHO Names St. Jude Its First Collaborating Center for Childhood Cancer
THE WORLD HEALTH ORGANIZATION (WHO) has designated St. Jude Children’s Research Hospital as the first WHO Collaborating Center for Childhood Cancer. With this collaboration, both organizations aim to expand efforts to develop strategies to strengthen the global resources, organization, and planning ...
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 ...
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 ...
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...
