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FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer

Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been...

breast cancer
gynecologic cancers
issues in oncology

BRCA Testing in Medically Underserved Women in Southeastern United States

Medically underserved women in the Southeast region of the United States diagnosed with breast cancer or ovarian cancer may have not received genetic testing that could have helped them and their relatives make important decisions about their health, according to new research from Vanderbilt-Ingram ...

FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy

The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...

cns cancers
survivorship

Functional and Social Independence in Survivors of Pediatric CNS Tumors

In a report from the St. Jude Lifetime Cohort Study published in the Journal of Clinical Oncology, Brinkman et al found that 60% of adult survivors of pediatric central nervous system (CNS) tumors do not achieve full functional or social independence in adult life. In the study, functional and...

Bendamustine Followed by Obinutuzumab Plus Venetoclax in Treatment-Naive and Relapsed/Refractory CLL

In a German phase II trial reported in The Lancet Oncology, Cramer et al found promising response rates with bendamustine followed by obinutuzumab (Gazyva) plus venetoclax (Venclexta) in both treatment-naive and relapsed/refractory chronic lymphocytic leukemia (CLL). In the trial, patients with an ...

FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). REFLECT Trial Approval was based on the international, multicenter, randomized, open-label, noninferiority REFLECT trial ...

lung cancer
issues in oncology

Small Study Looks at Physician-Patient Discussions About Lung Cancer Screening

National guidelines advise doctors to discuss the benefits and harms of lung cancer screening with high-risk patients. A small study (n = 14) by researchers from the University of North Carolina Lineberger Comprehensive Cancer Center reported there is a gap between what guidelines...

VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...

Basal Cell Carcinoma and Risk for Development of Other Cancers

Patients who develop frequent cases of basal cell carcinoma appear to be at significantly increased risk for the development of other cancers, according to a study published by Cho et al in JCI Insight. Methods Researchers studied 61 people treated at Stanford Health Care for frequent...

Broad-Based Genomic Sequencing in Advanced NSCLC in the Community Oncology Setting

In a study reported in JAMA, Presley et al found that use of broad-based genomic sequencing vs routine testing for EGFR mutations or ALK rearrangements alone directed treatment in a minority of patients with advanced non–small cell lung cancer (NSCLC) in the community oncology setting and was ...

Drug Combination Design for Multiple Myeloma Using an AI Platform

A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...

FDA Grants Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis

iCAD has announced U.S. Food and Drug Administration (FDA) clearance of its artificial intelligence software program, PowerLook Density Assessment Version 3.4, which provides an automated method of determining breast density. The software is compatible with iCAD’s digital breast...

Definitive Pelvic Radiation Therapy Plus Chemotherapy and Survival in Newly Diagnosed Metastatic Cervical Cancer

In a study using National Cancer Database data reported in JAMA Oncology, Wang et al found that definitive pelvic radiation therapy plus chemotherapy was associated with improved survival vs chemotherapy alone in newly diagnosed metastatic cervical cancer. The study included data from 3,169...

Impact of Peer-Review Intervention on Radiotherapy Schedules for Palliative Treatment of Bone Metastases

In a single-center study reported in the Journal of Oncology Practice, Walker et al found that institution of a peer-review process resulted in shorter fractionation schedules for palliation of bone metastases, consistent with current guidelines. As stated by the authors, “Shorter...

gynecologic cancers
pancreatic cancer

FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy

PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA...

breast cancer
issues in oncology

Cardiac Monitoring in Patients With Breast Cancer

Although heart failure is an uncommon complication of breast cancer treatment, the risk may be higher in patients treated with certain types of chemotherapy and lower in younger patients, according to a study published by Henry et al in JACC: Cardiovascular Imaging. Researchers studied 16,456...

FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by...

Prognostic Model for Treatment Outcomes in BRAF V600–Mutated Metastatic Melanoma

In a study reported in JAMA Oncology, Hauschild et al identified baseline lactate dehydrogenase (LDH), performance status, disease burden, and gene signature as potential determinants of treatment outcomes in BRAF V600–mutant metastatic melanoma treated with BRAF and/or MEK inhibitors. Study ...

Apatinib and Oral Etoposide in Platinum-Resistant/Refractory Ovarian Cancer

In a Chinese single-center phase II study reported in The Lancet Oncology, Lan et al found a high response rate with oral apatinib plus oral etoposide in patients with platinum-resistant or refractory ovarian cancer. Study Details The study included 35 patients with progression within 6 months...

Cory Wiegert Named New CEO of CancerLinQ LLC

Cory Wiegert has been named Chief Executive Officer (CEO) of CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO. Mr. Wiegert, a proven expert in building and successfully launching innovative technology solutions, began his new role today (August 13, 2018), overseeing the continued...

ESR1 Fusions and Metastasis in Estrogen Receptor–Positive Breast Cancer

Estrogen receptor–positive breast cancer is the most common type of breast cancer, but resistance to therapy is common, and eventual development of metastatic disease is a leading cause of death. In research published by Lei et al in Cell Reports, researchers from Baylor College of...

Assay Uses Big Data to Predict Responses to Immunotherapy

In the age of big data, cancer researchers are discovering new ways to monitor the effectiveness of immunotherapy treatments. Researchers at the Johns Hopkins Bloomberg~Kimmel Institute for Cancer Immunotherapy developed a new way to use bioinformatics as a gathering tool to determine how ...

FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids

Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...

CNS Activity of EGFR Tyrosine Kinase Inhibitor in T790M-Positive Advanced NSCLC

In a planned subgroup analysis of the phase III AURA3 trial reported in the Journal of Clinical Oncology, Wu et al found that the third-generation EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) produced higher central nervous system (CNS) response rates vs platinum plus pemetrexed (Alimta)...

Circulating Tumor Cells and Late Recurrence in Hormone Receptor–Positive Breast Cancer

In a study reported in JAMA Oncology, Sparano et al found that a single circulating tumor cell (CTC) assessment was predictive of late recurrence in patients with hormone receptor–positive, HER2-negative breast cancer. The study involved patients from a phase III trial of doxorubicin and...

Why Do You Live to Conquer Cancer? Join New ASCO Campaign to Share Your Story!

ASCO RECENTLY launched its new “I Live to Conquer Cancer” national outreach and awareness campaign to draw attention to the critical importance of federally funded cancer research. Through a series of compelling videos and written stories, “I Live to Conquer Cancer” puts a human face on cancer...

Leading International Cancer Organizations Call on United Nations Members to Reduce Disease Burden

ASCO AND the European Society for Medical Oncology (ESMO) are calling on leaders and health ministers of the 193 United Nations (UN) member countries to reduce the burden of all noncommunicable diseases (NCDs), including cancer. The two organizations issued a joint statement in advance of the third ...

Newly Updated! ASCO Answers Guide to Prostate Cancer for Your Patients

FULLY UPDATED and now with 8th Edition American Joint Committee on Cancer staging information, this updated guide from ASCO is designed for people newly diagnosed with prostate cancer. It aims to help patients get organized and learn more about their diagnosis, treatment options, side effects,...

AMA House of Delegates Adopt ASCO Resolutions

ASCO DELEGATES participated in the American Medical Association’s (AMA) June Annual Meeting of the House of Delegates (HOD). The AMA HOD is the principal policy-making body of AMA and meets twice a year to discuss pressing issues and establish association policies.  This year, delegates approved...

ASCO Annual Meeting Merit Awards: This Year’s Winners

The Conquer Cancer Merit Awards support oncology trainees who are first authors on abstracts selected for presentation at an ASCO scientific meeting, including the ASCO Annual Meeting and thematic symposia. Conquer Cancer recognized 127 recipients with Merit Awards at the 2018 ASCO Annual Meeting,...

health-care policy

CMS Proposes Extended 340B Cuts for 2019

ON JULY 25, the Centers for Medicare & Medicaid Services (CMS) released its 2019 Hospital Outpatient Prospective Payment System proposed rule. Among other provisions, the proposal would extend 2018 reimbursement cuts to the 340B Drug Pricing Program to include currently excepted, off-site...

breast cancer

TAILORx: How to Apply This Landmark Study

TAILORx changes the configuration of the ball field and the shape of the ball in deciding which women will be recommended chemotherapy after resection of node-negative, hormone receptor–positive breast cancer. TAILORx was presented by Joseph Sparano, MD, at the 2018 ASCO Plenary Session and...

gynecologic cancers

FDA Approves HPV Test for First-Line Cervical Cancer Screening

ON JULY 30, 2018, Roche announced approval by the U.S. Food and Drug Administration (FDA) of its cobas HPV Test in first-line screening for cervical cancer in women 25 years and older using cervical specimens collected in SurePath preservative fluid. The FDA first approved the cobas HPV test...

colorectal cancer
survivorship

ACS Nutrition and Physical Activity Guidelines for Cancer Survivors and Outcomes After Colon Cancer Diagnosis

IN A STUDY reported in JAMA Oncology, Erin L. Van Blarigan, ScD, of the University of California, San Francisco, and colleagues found that adherence to American Cancer Society (ACS) nutrition and physical activity guidelines for cancer survivors was associated with improved survival among patients ...

palliative care

Meeting the Challenges of Immunotherapy-Related Toxicities

In 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (Yervoy), an anticytotoxic T-lymphocyte– associated antigen 4 (CTLA-4), the first checkpoint inhibitor for the treatment of advanced melanoma.1 Since then, several more checkpoint inhibitors directed at both the programmed...

lung cancer

My Incidentally Discovered Cancer

In February 2015, there was no indication that my life was about to radically change. I was a practicing attorney and happily raising two young children with my husband. At 40 years old, I was healthy—or so I thought—and had no physical symptoms to alert me to the devastating news that was about to ...

symptom management

Actively Recruiting Clinical Trials Focused on Neurotoxicities of Treatment

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on neurotoxicities of cancer treatment. These studies focus on the effects of chemotherapy on cognitive function, changes in resting state brain networks after stem cell...

skin cancer

Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. This past June, encorafenib (Braftovi) and binimetinib...

colorectal cancer

BRAF Mutations, Survival, and Recurrence in Patients With Colorectal Cancer Liver Metastases

In a study reported in JAMA Surgery by Margonis and colleagues, the presence of a BRAF V600E mutation was associated with a higher risk of recurrence and poorer overall survival among patients undergoing surgical resection of liver metastases from colorectal cancer. Matthew J. Weiss, MD, of the...

breast cancer

CXCR4 Antagonist Plus Eribulin in HER2-Negative Metastatic Breast Cancer

Findings in a phase I trial reported in The Lancet Oncology by Pernas and colleagues indicate activity of the combination of the CXCR4 chemokine receptor antagonist balixafortide plus eribulin (Halaven) in previously treated HER2-negative metastatic breast cancer. The CXCR4–stromal cell-derived...

issues in oncology

Ensuring Quality With Patient-Reported Outcomes and Electronic Health Records

Accurately assessing the quality of cancer care over the continuum of treatment requires a special set of metrics and data-gathering methods. Moreover, with a growing number of cancer survivors, the post-treatment care involves primary care providers who are adept at managing the comorbidities...

breast cancer

Risk of Breast Cancer After Negative Screening Mammography

A study reported in JAMA Oncology by Anne Marie McCarthy, PhD, of the Division of General Internal Medicine, Massachusetts General Hospital, and colleagues identified the risk of interval breast cancer after negative screening mammography, including the risk of poor-prognosis breast cancer. The...

health-care policy
issues in oncology

ASCO Statement: Step Therapy Creates Barriers to Care for Medicare Advantage Beneficiaries With Cancer

Monica M. Bertagnolli, MD, FACS, FASCO, ASCO President, released the following statement today: “ASCO strongly opposes the Centers for Medicare & Medicaid Services (CMS) decision to allow Medicare Advantage plans to employ step therapy across physician-administered and self-administered...

genomics/genetics

Is Some DNA Worthless?

BOOKMARK Title: Junk DNA: A Journey Through the Dark Matter of the GenomeAuthor: Nessa CareyPublisher: Columbia University PressOriginal publication date: April 2015Price: $22.95, paperback, 360 pages When biologists first delved into the human wonder of genes in the 1970s, they eventually...

A Celebrity Gadfly’s Reflections on His Death and Other Things Meant to Irritate

BOOKMARK Title: MortalityAuthor: Christopher HitchensPublisher: Twelve: Hachette Book GroupOriginal Publication Date: May 13, 2014Price: $19.95, paperback, 128 pages “There are no atheists in foxholes” is an aphorism used to contend that in times of extreme fear, such as during war or facing a...

issues in oncology

The Story of a Notorious Cluster of Childhood Cancers

BOOKMARK Title: Toms River: A Story of Science and SalvationAuthor: Dan FaginPublisher: Random HouseOriginal publication date: March 2013Price: $28.00, hardcover, 560 pages The Toms River emerges in the Pine Barrens of northern Ocean County, New Jersey, and zigzags through wetlands, emptying into...

prostate cancer

NIH and Prostate Cancer Foundation Launch Large Study on Aggressive Prostate Cancer in African American Men

The largest coordinated research effort to study biologic and nonbiologic factors associated with aggressive prostate cancer in African American men has begun. The $26.5 million study is called RESPOND, or Research on Prostate Cancer in Men of African Ancestry: Defining the Roles of Genetics, Tumor ...

solid tumors

FDA Approves First Treatment for Rare Adrenal Tumors

On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection (Azedra) for intravenous use in the treatment of adults and adolescents aged 12 and older with unresectable pheochromocytoma or paraganglioma that have spread beyond the original tumor site and require ...

health-care policy

Is Universal Health Care a Human Right?

The Affordable Care Act (ACA) provided oncology services to people with cancer who had previously been denied coverage. And for that reason alone, many oncologists supported its passage. However, even though the U.S. health-care system remains in the crosshairs of partisan politics, parties on both ...

ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation

ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO...

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