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bladder cancer
immunotherapy

FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma

On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...

issues in oncology
survivorship

Impact of Doctor-Patient Communication on Outcomes in Cancer Survivors

A new study from the American Cancer Society has found that patients with cancer who reported greater satisfaction in the way their provider communicated with them received more efficient care, with fewer office visits and better health outcomes. These findings were published by Rai et al in...

head and neck cancer
immunotherapy

Cetuximab With Radiotherapy Found to Be Inferior to Standard Treatment in HPV-Positive Oropharyngeal Cancer

An interim analysis of data from a randomized clinical trial of patients with human papillomavirus (HPV)-positive oropharyngeal cancer found that treatment with radiation therapy and cetuximab (Erbitux) is associated with worse overall and progression-free survival compared to the current standard...

lung cancer
immunotherapy

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 ...

AACR Appoints New Editors-in-Chief of Cancer Prevention Research

The American Association for Cancer Research (AACR) has announced the appointments of Raymond N. DuBois, MD, PhD, and Michael N. Pollak, MD, as Editors-in-Chief of Cancer Prevention Research, one of eight journals published by the AACR. Cancer Prevention Research publishes original preclinical,...

issues in oncology

Obesity and Cancer: Complex Interplay of Multiple Factors

The evolving concept that dietary fat plays an important role in the etiology of human cancer emerged more than 50 years ago. Ernst Wynder, MD, whose seminal epidemiologic work led to identifying smoking as a contributory cause of lung cancer, presented a paper in 1967 showing a decided correlation ...

University of Pittsburgh Medical Center to Assist Cancer Center in Beijing

To meet the growing demand for high-quality cancer care in China, Tahoe Hospital Management Co Ltd has reached a 5-year agreement with the University of Pittsburgh Medical Center (UPMC) where health-care professionals from the Pennsylvania-based medical center will assist in the planning and...

Be Prepared to Assist Patients to Make Informed Decisions About Breast Reconstruction Options

Two studies about postmastectomy breast reconstruction were recently published in JAMA Surgery. One study found overall complication rates of 32.9% at 2 years after reconstruction, with women having autologous reconstruction more likely to have complications than those having implant...

breast cancer

Breast Reconstruction: ‘A Process Not a Procedure’ With Potential Short- and Long-Term Complications

The complication rate among women who underwent postmastectomy breast reconstruction was 32.9% at 2 years postoperatively, and women undergoing autologous reconstruction “had significantly higher odds of developing any complication compared with those undergoing expander-implant reconstruction,”...

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 ...

issues in oncology

Navigating the ‘New Normal’: NCCN Summit Examines Access to High-Quality Cancer Care

It’s not just the leaps in development of precision medicines, the soaring costs, the new payment models, clinical trial designs, sources of data, and federal policies. It’s all of them plus the rapidity with which change is happening that makes this era of oncology exceptional. “I would say...

issues in oncology

Stakeholders Agree: ‘Value’ in Cancer Care Depends on Perspective

In a roundtable discussion moderated by Clifford Goodman, PhD, of The Lewin Group, Falls Church, Virginia, representatives of the patient advocacy community, public and private payers, large and small clinics, and the pharmaceutical industry did not always see eye to eye on what “value” means nor ...

hematologic malignancies
lymphoma

FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma

On August 8, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...

First James O. Armitage Clinical Investigator Award Presented in Maui

Matthew S. Davids, MD, MMSc, is the recipient of the first James O. Armitage Clinical Investigator Award, presented at the 2018 Pan Pacific Lymphoma Conference in July in Maui. Dr. Davids is Director of the Lymphoma BioBank and Assistant Professor of Medicine at Dana-Farber Cancer Institute and...

issues in oncology

Medical Marijuana: Research Not Anecdotes

For patients with cancer, marijuana may be valuable in controlling pain and chemotherapy-induced nausea and vomiting. Furthermore, it may have efficacy as an appetite stimulant. No randomized clinical trial has investigated the utility of whole-plant medical marijuana to alleviate these symptoms in ...

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...

issues in oncology

Unraveling the Mystery of What Gives Exceptional Responders Their Superpower

Once dismissed as rare medical miracles that overcame overwhelming odds to thwart cancer, exceptional responders to cancer treatment are now the subject of intense study. In 2015, the National Cancer Institute (NCI) announced the launch of its Exceptional Responders Initiative, with the goal of...

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...

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...

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...

colorectal cancer
immunotherapy

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...

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...

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...

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...

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...

palliative care
immunotherapy

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 ...

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...

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...

leukemia
issues in oncology
immunotherapy

Guidelines for Pediatric CAR T-Cell Therapy Developed

Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...

Utilization of Hypofractionated Radiation Therapy in Breast Cancer

Researchers at the Feinstein Institute for Medical Research and Northwell Health’s Department of Radiation Medicine have identified methods to increase use of the radiation therapy hypofractionation in patients with breast cancer. These findings, published by Gilbo et al...

lung cancer
issues in oncology

Lung Cancer Screening Guidelines May Be Inadequate for High-Risk Minorities

Data from a lung cancer screening program at the University of Illinois at Chicago (UIC) provides evidence that national lung cancer screening guidelines, which were developed based on the National Lung Screening Trial (NLST) in 2011 and recommend screening based on age and smoking history, may be...

Cedars-Sinai Affiliate Announces New Cancer Center to Open in 2019

The Torrance Memorial Medical Center, a Cedars-Sinai Medical Center affiliate, recently announced the opening of a new cancer center. The new Hunt Cancer Center will provide patients with access to subspecialists who treat more than 60 types of common, rare, and complex cancers. As part of the...

breast cancer

FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali), in combination with an aromatase inhibitor for pre/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based...

solid tumors

NCCN Announces New Patient Guideline in Liver, Gallbladder, and Bile Duct Cancers

The National Comprehensive Cancer Network® (NCCN®) has released a new resource to help patients with liver, gallbladder, and bile duct cancers better understand their diagnosis and treatment options. This new edition of the NCCN Guidelines for Patients® takes the evidence-based, expert consensus...

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