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issues in oncology

Suboptimal Insurance Linked to Worse Survival Outcomes in Positive Clinical Trials

Findings from a recent SWOG study could cast doubt on the generalizability of treatment effects observed in positive clinical trials, especially among underinsured patients. According to data presented at the 2019 ASCO Quality Care Symposium,1 patients with Medicaid or no insurance had no observed...

yervoy
keytruda
opdivo
alimta

Tumor Mutational Burden Disappoints as Biomarker for Treatment Response in Exploratory Analyses of Nonsquamous NSCLC

Tumor mutational burden failed to prove effective as a biomarker for response to chemotherapy plus checkpoint inhibitor or chemotherapy alone as first-line treatment for nonsquamous non–small cell lung cancer (NSCLC) in two different exploratory analyses of KEYNOTE trials.1,2 In both analyses,...

colorectal cancer

Addition of Selective Internal Radiotherapy to Chemotherapy May Improve Resectability of Colorectal Cancer Liver Metastases

In a report published by Garlipp et al in the British Journal of Surgery, the addition of selective internal radiotherapy (SIRT) to modified FOLFOX6-based chemotherapy (mFOLFOX6; oxaliplatin/leucovorin/fluorouracil) improved the resectability of initially unresectable colorectal cancer liver...

lung cancer
immunotherapy

ASTRO 2019: Patterns of Disease Progression in Patients With Unresectable Stage III NSCLC: Analysis of the PACIFIC Trial

Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, presented an update of the landmark PACIFIC trial at the 61st Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Abstract LBA-6). In earlier reports from the randomized phase III trial, Antonia et al had evaluated...

gynecologic cancers
immunotherapy

FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis

The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...

onivyde
lynparza

Targeting an Important Tumor Vulnerability With Maintenance Olaparib in Germline BRCA-Mutated Pancreatic Cancer

In the POLO trial, which is discussed in this issue of The ASCO Post, Golan and colleagues evaluated the potential benefit of maintenance olaparib after disease stability or response to a minimum of 4 months of platinum-based chemotherapy in patients with metastatic pancreatic cancer and a...

prostate cancer

ASTRO 2019: Long-Term Hormone Therapy May Increase Other-Cause Mortality in Men With Prostate Cancer Receiving Early Salvage Radiotherapy

Findings from the randomized phase III NRG Oncology/RTOG 9601 trial were initially reported in 2017, and showed that the addition of 2 years of antiandrogen therapy to postsurgical radiation treatment for men with recurrent prostate cancer increased their long-term overall survival rate. That study ...

head and neck cancer
symptom management

ASTRO 2019: Machine-Learning Model May Accurately Predict Radiation Side Effects in Patients With Head and Neck Cancers

A study by Reddy et al investigating the use of a machine-learning model to predict which patients with head and neck cancer being treated with radiation may experience significant weight loss, feeding tube placement, and unplanned hospitalization has found that the model accurately identified the...

gynecologic cancers
immunotherapy

Bevacizumab/Niraparib vs Niraparib Alone for Platinum-Sensitive Recurrent Ovarian Cancer

In the phase II NSGO-AVANOVA2/ENGOT-ov24 trial reported in The Lancet Oncology, Mansoor Raza Mirza, MD, and colleagues found that the combination of bevacizumab plus niraparib prolonged progression-free survival vs niraparib alone in women with platinum-sensitive recurrent ovarian cancer. Study...

breast cancer
issues in oncology

FDA Issues Drug Safety Communication on Lung Inflammation Due to Treatment With CDK4/6 Inhibitors

On September 13, the U.S. Food and Drug Administration (FDA) issued a drug safety communication warning that palbociclib, ribociclib, and abemaciclib—used to treat some patients with advanced breast cancer—may cause rare but severe inflammation of the lungs. The agency approved new warnings about...

velcade
fragmin
lipodox
savaysa
lixiana
etopophos
xarelto
nolvadex
soltamox
venclexta
velban

Conundrums in Managing Cancer-Associated Thrombosis

Although there may be a clear role for prophylactic anticoagulation in hospitalized patients and those undergoing surgery, indication for prophylactic anticoagulation for patients with cancer seen in the ambulatory setting has yet to emerge. Until clinical trial data on prophylactic...

lung cancer
immunotherapy

ASTRO 2019: SBRT After Disease Progression on Immunotherapy Increases PFS in Patients With Metastatic NSCLC

Non–small cell lung cancer (NSCLC) accounts for the vast majority of all lung cancers—between 80% and 85% of those diagnosed in the United States—and is among the most deadly cancers for both men and women, exceeding the mortality rate of colon, breast, and pancreatic cancers combined. The results...

prostate cancer

ASTRO 2019: ORIOLE Trial: Observation vs SABR for Oligometastatic Prostate Cancer

The randomized, phase II ORIOLE trial studying the efficacy of targeted high-dose radiation for men with oligometastatic prostate cancer has shown that stereotactic ablative radiation (SABR) is an effective and safe option for patients who wish to delay hormone-suppression therapy. Data from the...

breast cancer
survivorship
symptom management

Home-Based Exercise and Weight Loss Programs for Lymphedema Management in Overweight Breast Cancer Survivors

As reported in JAMA Oncology by Schmitz et al, the WISER Survivor trial showed no benefit of home-based exercise and weight loss programs on lymphedema outcomes vs facility-based lymphedema care among overweight breast cancer survivors. Study Details In the trial, 351 overweight breast cancer...

supportive care

Chef Uses Flavor to Fuel Her Mother’s Appetite During Cancer Treatment

The battle against cancer is typically waged by the surgeon and oncologist, but a Lexington, Kentucky–based, award-winning restaurateur and chef discovered her role as a foot soldier when she applied her culinary skills to deal with the debilitating side effects of her mother’s lung cancer...

lung cancer
multiple myeloma
sarcoma

FDA Pipeline: Breakthrough Therapy Designation in Lung Cancer, Orphan Drug Designations in Myeloma and Soft-Tissue Sarcoma

Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to tepotinib for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations, and Orphan Drug designations to novel chimeric antigen receptor T-cell therapies in both multiple myeloma ...

solid tumors
immunotherapy

Liquid Biopsy to Determine Patient Response to Immune Checkpoint Blockade

Although studies have demonstrated that microsatellite instability (MSI) and high tumor mutational burden (TMB) are promising pan-tumor biomarkers for identifying patients for treatment with immune checkpoint blockade, obtaining tissue from unresectable or metastatic solid tumors for genetic...

lung cancer

WCLC 2019: Autoantibody Diagnostic Test Followed by CT Imaging May Improve Diagnosis, Reduce Mortality in Lung Cancer

A combination of the EarlyCDT-Lung Test followed by computed tomography (CT) imaging in Scottish patients at risk for lung cancer resulted in a significant decrease in late-stage diagnosis of lung cancer and may decrease lung cancer–specific mortality, according to research presented at...

issues in oncology

Mallika Sharma, MPH, on Eliminating Prior Authorizations, Anxiety, Delay in Care, Higher Costs

Mallika Sharma, MPH, of Seattle Cancer Care Alliance, discusses her findings that, by doing away with the many prior authorization denials based on administrative errors, providers may offer higher-value care by eliminating unnecessary anxiety among patients, administrative burdens, and increased...

cost of care
lung cancer

Bernardo H.L. Goulart, MD, on Stage IV NSCLC: High Drug Costs May Affect Survival

Bernardo H. L. Goulart, MD, of Seattle Cancer Care Alliance, discusses his findings that high out-of-pocket costs for oral tyrosine kinase inhibitors may lower survival rates, shorten the duration of therapy, and reduce the number of prescriptions for patients with metastatic EGFR- or ALK-positive...

solid tumors
immunotherapy

Pamiparib Plus Tislelizumab in Advanced Solid Tumors

In an Australian phase Ia/b trial reported in The Lancet Oncology, Friedlander et al found evidence of activity of the combination of the poly (ADP-ribose) polymerase inhibitor pamiparib and the programmed cell death protein 1 inhibitor tislelizumab in patients with previously treated advanced...

breast cancer
immunotherapy

T-DM1 Plus Neratinib in Metastatic HER2-Positive Breast Cancer

In the phase Ib NSABP Foundation Trial FB-10 reported in the Journal of Clinical Oncology, Jame Abraham, MD, and colleagues found evidence of activity of the combination of ado-trastuzumab emtansine (T-DM1) plus neratinib in metastatic HER2-positive breast cancer and identified the dose of the...

lipodox
gemzar
lynparza
hycamtin

Olaparib Monotherapy Improves Outcomes in BRCA-Mutated, Platinum-Sensitive Relapsed Ovarian Cancer

Compared with treatment with nonplatinum-based chemotherapy, monotherapy with the PARP (poly [ADP ribose] polymerase) inhibitor olaparib led to statistically significant and clinically relevant improvements in overall response rate and progression-free survival in women with germline...

issues in oncology

FDA Proposes New Required Health Warnings With Images for Cigarette Packages and Advertisements

On August 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule to require new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings, which feature photo-realistic...

breast cancer

Combined Use of Identification Methods for Dense Breasts and Discussion of Supplemental Imaging

In a study reported in JAMA Internal Medicine, Karla ­Kerlikowske, MD, and colleagues found that the combined use of Breast Imaging Reporting and Data System (BI-RADS) breast density and Breast Cancer Surveillance Consortium (BCSC)-defined risk for breast cancer may be an effective way of...

John Hansen, MD, Transplant Expert Who Founded Volunteer Donor Registries, Dies at 76

Over the past few decades, our understanding of transplant immunology has moved from basic allograft rejection to the current molecular level that offers life-saving treatments for patients with cancer. The scientific elegance of this remarkable therapy’s arc from experimental to standard of care...

breast cancer

Alpelisib for PIK3CA-Mutated Advanced Breast Cancer

On May 24, 2019, alpelisib was approved for use in combination with fulvestrant for postmenopausal women, and men, with hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, as detected by a U.S. Food and Drug Administration (FDA)-approved test following...

Doctor, Where Art Thou?

The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...

Nakul Singhal, MD, and Nicole Carreau, MD, Join New York Cancer & Blood Specialists

Oncologist Nakul Singhal, MD, has joined New York Cancer & Blood Specialists (NYCBS) and will be accepting new patients at the Bayside and New Hyde Park locations. NYCBS also welcomes oncologist Nicole Carreau, MD. Prior to joining NYCBS, Dr. Singhal practiced at Hackensack Meridian Health...

immunotherapy
multiple myeloma

Daratumumab-Based Therapy for Patients With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplantation

On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...

breast cancer

Insightful Advice From a College Advisor Leads to an Unexpected Career in Oncology

For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, FACP, spoke with Tatiana M. Prowell, MD, who currently serves as Associate Professor of Oncology in the Breast Cancer Program at the Johns Hopkins Kimmel Comprehensive Cancer Center and as a Medical Officer and...

lymphoma

Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas

On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...

issues in oncology

Confronting the Criticisms Facing Watson for Oncology

Over the past 2 years, IBM’s Watson for Oncology cognitive computing system, which uses artificial intelligence (AI) algorithms to generate treatment recommendations, has come under fire for allegedly not delivering on expectations to provide state-of-the-art personalized treatment for patients...

FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence

Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multiyear research collaboration agreement focused on the use of real-world evidence to support regulatory decision-making. Syapse and the OCE will work with stakeholders across the FDA to...

issues in oncology

Firing Your Patient: How to Terminate a Treatment Relationship

Many clinicians are confused by the evolving opioid prescribing guideline issued by the Centers for Disease Control and Prevention (CDC) meant to stem the rising epidemic of opioid addiction and overdose in the United States.1 Many are also worried about regulatory oversight by the U.S. Drug...

New ASCO Ethical Framework for Including Research Biopsies in Clinical Trials

ASCO has released an ethical framework for researchers on incorporating research biopsies in cancer clinical trials. The framework, published in a statement in the Journal of Clinical Oncology on July 25, provides guidance on when to include optional and mandatory biopsies based on both participant ...

pancreatic cancer

Sita Kugel, PhD, Receives Grant to Study Aggressive Type of Pancreatic Cancer

The deadly nature of most pancreatic tumors is well known, with less than 10% of patients with pancreatic ductal adenocarcinoma estimated to survive 5 years after diagnosis. Recent molecular analyses of pancreatic ductal adenocarcinoma have shown that a patient’s prognosis changes depending on the...

cns cancers
lymphoma

Primary Central Nervous System Lymphoma: Striving for a Curative Therapy

Primary central nervous system (CNS) lymphoma is a rare type of non-Hodgkin lymphoma in which standards of care have not been well established. In light of recent insights into its pathophysiology and the emergence of novel approaches, The ASCO Post asked Tracy T. Batchelor, MD, a specialist in...

NCI Community Oncology Research Program Expands to More Sites

The National Cancer Institute (NCI) has awarded 53 grants to researchers in the NCI Community Oncology Research Program (NCORP) to conduct multisite cancer clinical trials and cancer care delivery studies in their communities. In addition to 7 research hubs, these NCI grants went to 32 community...

lymphoma

Update on FDA-Approved CAR T-Cell Gene Therapy for B-Cell Lymphomas

On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Specifically, this treatment can be used after two or more lines of systemic therapy for diffuse...

lung cancer

The Mark Foundation Awards $6 Million Grant for Lung Cancer Research

The Mark Foundation for Cancer Research has awarded a 3-year $6 million grant to support a new phase of discovery for a team of investigators developing, optimizing, and integrating targeted therapies and immunotherapies to improve outcomes for patients with the most common—and most difficult to...

issues in oncology

Hey Siri, Should I Get a Medical Degree?

I received a coffee mug from a physician colleague some years ago with the tag line: “Please do not confuse your Google search with my Medical Degree.” Physicians of all stripes and colors can relate to the agony of debunking a “Dr. Google” diagnosis. However, in a fast-evolving health-care...

issues in oncology

How Patient Advocacy Is Integral to High-Quality Oncology Care

Karen M. Winkfield, MD, PhD, has made patient advocacy—with a specific emphasis on health equity and access to high-quality care—front and center of her oncology practice since she completed her residency at the Harvard Radiation Oncology Program in Boston, where she noticed that most of the...

integrative oncology

Light Intervention for Cancer-Related Fatigue, Depression, and Sleep Disturbance

GUEST EDITOR  Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief of Integrative Medicine Service at Memorial Sloan Kettering Cancer Center, New York. Cancer and its treatments are associated with severe fatigue, depression, ...

skin cancer

Stage IV Melanoma: What Current Role Should Surgery Play?

Advanced melanoma has become a different entity in the era of immunotherapy and targeted agents. Considering the potential for good outcomes from systemic therapy in advanced disease, has the role of surgery changed? Should it be offered up front or limited to patients with oligometastatic ...

First-Line Nivolumab and Ipilimumab vs Sunitinib in Advanced Renal Cell Carcinoma

This week, we’ll be talking about an extended follow-up of a phase III trial that investigated first-line nivolumab and ipilimumab vs sunitinib in advanced renal cell carcinoma. Then we’ll go over a research letter that identified strong predictors of response to immune checkpoint inhibitor...

gynecologic cancers

Does PTSD Increase the Risk of Developing Ovarian Cancer?

Women who experienced six or more symptoms of posttraumatic stress disorder (PTSD) at some point in life had a twofold greater risk of developing ovarian cancer compared with women who never experienced any PTSD symptoms. These findings were published by Roberts et al in Cancer Research. The...

pancreatic cancer

ASTRO Guideline on Use of Radiation Therapy for Patients With Pancreatic Cancer

A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides recommendations on the use of radiation therapy to treat patients diagnosed with pancreatic cancer, including when radiation treatments are appropriate, as well as the optimal dosing, timing, and...

breast cancer
survivorship

Pregnancy Appears Safe After Treatment for Breast Cancer in Patients With BRCA Mutations

Pregnancy after breast cancer appears to be safe in patients with germline BRCA mutations—and particularly among those with BRCA1 mutations—according to new research. Limited data are available on the safety of pregnancy and reproductive outcomes in patients with breast cancer and BRCA mutations,...

symptom management

ASCO and MASCC/ISOO Release a Clinical Practice Guideline on Medication-Related Osteonecrosis of the Jaw

ASCO and the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) have published a clinical practice guideline on medication-related osteonecrosis of the jaw in the Journal of Clinical Oncology.1 The guideline outlines the latest recommendations ...

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