Use of Patient-Reported Outcomes Version of CTCAE in Rectal Cancer Trial
As reported in the Journal of Clinical Oncology, Basch et al established the feasibility of using the National Cancer Institute patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in the setting of a multicenter clinical trial in locally advanced...
Addition of Hydroxycarbamide to Aspirin in Essential Thrombocythemia Without High-Risk Features
In a long-term follow-up of a study reported in the Journal of Clinical Oncology, Godfrey et al found that the addition of cytoreductive therapy with hydroxycarbamide to aspirin did not improve outcomes in patients with essential thrombocythemia aged 40 to 59 years without high-risk features or...
Study Finds Hispanic Pediatric Patients at Increased Risk of Methotrexate Neurotoxicity During Treatment for ALL
Case studies have reported a high prevalence of methotrexate subacute neurotoxicity among Hispanic adolescents with acute lymphoblastic leukemia (ALL), suggesting sensitivity to methotrexate therapy may differ by race and ethnicity. Now, a prospective study in pediatric patients with ALL has found...
ASCO/IDSA Clinical Practice Guideline Update: Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression
As reported in the Journal of Clinical Oncology by Randy A. Taplitz, MD, of UC San Diego Health, and colleagues, ASCO and the Infectious Diseases Society of America (IDSA) have updated their joint guideline on antimicrobial prophylaxis for adult patients with immunosuppression associated with...
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...
Lack of Congruence Among Tools Used to Assess Cancer-Related Cognitive Dysfunction
THE ASSESSMENT of cognitive dysfunction in patients who have undergone chemotherapy is complex, and although a number of strategies are available, each has its limitations, according to Karin Olson, RN, PhD, Professor in the Faculty of Nursing at the University of Alberta, Edmonton, Canada. At...
Expert Point of View: Rajesh Lalla, DDS, PhD
COMMENTING ON the results of this trial of GC4419, Rajesh V. Lalla, DDS, PhD, President of the Multinational Association of Supportive Care in Cancer, said, “This study demonstrated this agent’s strong potential for the management of oral mucositis in patients receiving head and neck radiation...
Novel Therapy Reduces Duration of Chemoradiotherapy-Induced Mucositis in Patients With Head and Neck Cancer
GC4419, A SMALL molecule superoxide dismutase mimetic, reduced the duration, incidence, and severity of chemoradiotherapy-induced mucositis in patients with locally advanced head and neck cancer, with a safety profile comparable to that of placebo. This finding comes from a randomized phase IIb...
FDA Approves Lusutrombopag for Thrombocytopenia in Adults With Chronic Liver Disease
Today, the U.S. Food and Drug Administration (FDA) approved lusutrombopag (Mulpleta) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. L-PLUS 1 and L-PLUS 2 Approval was based on two randomized, double-blind, placebo-controlled...
Susan Blumel, RN, BSN, and Laura J. Zitella, MS, RN, ACNP-BC, AOCN, on Managing Toxicities of Immunotherapy
Susan Blumel, RN, BSN, of the University of Nebraska Medical Center, and Laura J. Zitella, MS, RN, ACNP-BC, AOCN, of Stanford Health Center, discuss immunotherapy, CAR T-cell toxicities, and the principles of team management.
C-Reactive Protein and Radiotherapy Skin Toxicity in Patients With Breast Cancer
In a study reported in the Journal of Clinical Oncology, Hu et al found that higher postradiotherapy levels of the inflammatory marker high-sensitivity C-reactive protein (hsCRP) were associated with an increased risk of early grade 4+ skin toxicity in patients with breast cancer. Study Details...
Delayed Skin Effects of Anti–PD-1 Therapy
Patients with cancer receiving anti–programmed cell death protein 1 (anti–PD-1) therapies who develop lesions, eczema, psoriasis, or other forms of autoimmune diseases affecting the skin may experience those adverse reactions on a delay—sometimes even after treatment has...
FDA Approves Filgrastim Biosimilar Filgrastim-aafi
On July 20, the U.S. Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym), a biosimilar to filgrastim (Neupogen), for all eligible indications of the reference product. “The FDA approval of filgrastim-aafi marks an important step in helping expand access to critical...
Rivaroxaban vs Dalteparin in Patients With Venous Thromboembolism
In a UK pilot trial (SELECT-D) reported in the Journal of Clinical Oncology, Young et al found that the oral factor Xa inhibitor rivaroxaban was associated with a lower rate of recurrent venous thromboembolism (VTE) but a higher rate of clinically relevant nonmajor bleeding compared with the...
Quick Takes From Original Research Presented at the 2018 NCCN Annual Conference
THE QUANTITY of original research presented at the National Comprehensive Cancer Network® (NCCN®) Annual Conference has been growing, and at the 2018 meeting, 121 researchers presented their work. The ASCO Post captured some of the findings for this report. Blood Markers Correlate With Anti–PD-1...
Early Detection and Intervention Reduce Breast Cancer–Related Lymphedema
A NEW STUDY has found that early detection along with a simple intervention can be highly effective in preventing breast cancer–related lymphedema for at-risk women. According to data presented at the 2018 Annual Meeting of the American Society of Breast Surgeons,1 82% of women identified at an...
FDA Approves First Biosimilar to Pegfilgrastim to Help Reduce the Risk of Infection During Myelosuppressive Chemotherapy
On June 4, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as the first biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with nonmyeloid cancer who are receiving myelosuppressive...
Jun J. Mao, MD, MSCE, on Insomnia in Cancer Survivors: Trial Results
Jun J. Mao, MD, MSCE, of Memorial Sloan Kettering Cancer Center, discusses study findings on the effect of acupuncture vs cognitive behavior therapy in cancer survivors experiencing insomnia (Abstract 10001).
Ryan D. Nipp, MD, on Electronic Symptom Monitoring: Trial Results
Ryan D. Nipp, MD, of Massachusetts General Hospital, discusses study findings on electronic symptom monitoring vs usual care to assess whether the intervention, tested in hospitalized patients with advanced cancer, can improve symptom burden and reduce the risk of readmission (Abstract 10005).
Safety of PD-1/PD-L1 Inhibitors in Patients With NSCLC and Preexisting Autoimmune Disorders
In a study reported in the Journal of Clinical Oncology, Leonardi et al found that programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitor monotherapy in patients with non–small cell lung cancer (NSCLC) and autoimmune disorders worsened such disorders in a...
Treating Insomnia in Cancer Survivors
A Patient-Centered Outcomes Research Institute–supported randomized clinical trial of cancer survivors showed that 8 weeks of either acupuncture or cognitive behavioral therapy for insomnia (CBT-I) decreased the severity of insomnia among cancer survivors, though improvements were greatest among...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, 2018, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/-Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The biosimilar is...
Both Patients and Clinicians Face Challenges in Recognizing and Reporting Immune-Related Adverse Events
The publication of ASCO’s toxicity management guidelines for immune checkpoint antibodies by Brahmer and colleagues,1 reviewed in this issue of The ASCO Post, has been long awaited, considering more than 15 distinct indications have been granted by the U.S. Food and Drug Administration (FDA). The ...
ASCO Clinical Practice Guideline on Managing Immune-Related Adverse Events: Next Big Step for Immune Checkpoint Inhibitors
The publication of the ASCO clinical practice guideline for the management of immune therapy–related adverse events—reviewed in this issue of The ASCO Post—represents an important next step in the incorporation of checkpoint blocking antibodies as standard cancer treatment modalities.1 The U.S....
ASCO Clinical Practice Guideline: Management of Immune-Related Adverse Events From Immune Checkpoint Inhibitor Therapy
As reported in the Journal of Clinical Oncology by Julie R. Brahmer, MD, of Johns Hopkins Kimmel Cancer Center, and colleagues, ASCO has released a clinical practice guideline on management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy.1 Immune...
The Pharmacist’s Role in Educating the Health-Care Team About Adverse Effects of Immune Checkpoint Inhibitors
Named by ASCO as Advance of the Year for both 2016 and 2017,1 and with more than 10 U.S. Food and Drug Administration–approved indications—and more on the way—it’s safe to say the era of cancer immunotherapy is upon us. To prepare, physicians must understand not only which patients will benefit,...
Rivaroxaban May Reduce Risk of Venous Thromboembolism in Patients With Cancer
Patients with cancer have an increased risk of developing blood clots, with roughly one in five experiencing venous thromboembolism (VTE)—either deep-vein thrombosis (DVT) or pulmonary embolism (PE). Although there are many causes and risk factors for VTE, patients with cancer are...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Epoetin alfa-epbx is also...
2018 ASCO: More Choices for Treating Insomnia in Cancer Survivors: Acupuncture and Cognitive Behavioral Therapy
A Patient-Centered Outcomes Research Institute (PCORI)-supported randomized clinical trial of cancer survivors showed that 8 weeks of either acupuncture or cognitive behavioral therapy for insomnia (CBT-I) decreased the severity of insomnia among cancer survivors, though improvements were greatest...
National Survey Examines Oncologists' Practices, Beliefs on Medical Marijuana Use
Data from a new survey show that as many as 80% of oncologists have discussed medical marijuana use with their patients. According to the authors, this is the first nationally representative survey to examine oncologists’ practices and beliefs on the subject since the implementation of state...
Planning for Potential Adverse Effects of Oral Chemotherapy
THE USE OF oral chemotherapy drugs is becoming more and more prevalent—for many types and stages of cancer, during different treatment phases, and for varying lengths of time. So it’s vital that physicians, nurses, and advanced practitioners understand all the potential adverse events of these...
NCCN Debuts Three New Sets of Guidelines
THE NATIONAL Comprehensive Cancer Network® (NCCN®) debuted three sets of completely new guidelines for treating patients with uveal melanoma, for treating patients who have cancer and the human immunodeficiency virus (HIV), and for managing immune-related toxicities. Cancer in People Living With...
Use of Indwelling Pleural Catheter for Outpatient Talc Administration in Treatment of Malignant Pleural Effusion
In a UK study reported in The New England Journal of Medicine, Bhatnagar et al found that outpatient talc vs placebo administration via indwelling pleural catheter was associated with a higher rate of pleurodesis in patients with malignant pleural effusion. Study Details In the study, a target of ...
Acupuncture for Joint Pain Associated With Aromatase Inhibition
Although aromatase inhibitors are highly effective as adjuvant therapy in metastatic breast cancer and for prevention of breast cancer, the side effects can be difficult to tolerate and often lead to discontinuation of therapy. A phase III randomized trial has found that acupuncture may relieve...
Study of Patient-Reported Symptom Burden in First Year After Cancer Diagnosis
In a Canadian retrospective population-based study reported in the Journal of Clinical Oncology, Bubis et al found that patients with cancer reported higher symptom scores at 1 month after diagnosis and identified several factors associated with higher symptom scores. Study Details The study...
Analysis of Carfilzomib-Related Cardiotoxicity
In a systematic review and meta-analysis reported in Leukemia & Lymphoma, Shah et al identified the risk of cardiotoxicity among patients, most with multiple myeloma, receiving carfilzomib (Kyprolis) in clinical trials. Study Details The study included data from 4,164 patients who received...
Dexamethasone-Sparing Antiemetic Regimen in Patients Receiving Highly Emetogenic Chemotherapy
In a Japanese phase III noninferiority trial reported in the Journal of Clinical Oncology, Ito et al found that dexamethasone could be spared on days 2 and 3 in an antiemetic regimen including the neurokinin-1 (NK1) receptor antagonist aprepitant and palonosetron in patients receiving highly...
Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors
In a Danish study reported in the Journal of the National Cancer Institute, Zachariae et al found that an Internet-delivered cognitive-behavioral therapy intervention improved insomnia among breast cancer survivors. Study Details In the study, 255 patients from a national sample of Danish breast...
Cognitive Decline Prevalent Among Elderly Patients With Hematologic Cancers
A sizable percentage of elderly patients with blood-related cancers such as leukemia and multiple myeloma are apt to show signs of diminished cognitive functioning—a decline that may impact their survival—a new study by investigators at Dana-Farber Cancer Institute and Brigham and...
GC4419 Receives FDA Breakthrough Therapy Designation for the Reduction of Severe Oral Mucositis
On February 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419, a highly selective and potent small molecule dismutase mimetic, for the reduction of the duration, incidence, and severity of severe oral mucositis induced by radiation therapy with...
Edoxaban vs Dalteparin in Cancer-Associated Venous Thromboembolism
In the phase III Hokusai VTE Cancer trial reported by Raskob et al in The New England Journal of Medicine, the direct-acting oral factor Xa inhibitor edoxaban proved noninferior to the low–molecular-weight heparin dalteparin in the composite outcome of recurrent venous thromboembolism or...
ASCO Clinical Practice Guideline: Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy
As reported in the Journal of Clinical Oncology by Julie R. Brahmer, MD, of the Johns Hopkins Kimmel Cancer Center, and colleagues, ASCO has released a clinical practice guideline on management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy. To develop...
EXPERT POINT OF VIEW: Robert Brodsky, MD
“THE RESULTS of these two trials are more similar than different. I think the best conclusion would be that we now have two trials with consistent results and can probably, in most cases, replace low–molecular-weight heparin with direct oral anticoagulants,” said Dr. Raskob, lead investigator of...
Use of Direct Oral Anticoagulants in Preventing VTE in Patients With Cancer
THE FIRST TWO randomized trials to directly compare direct oral anticoagulants vs low–molecular-weight heparin for management of venous thromboembolism (VTE) in patients with cancer suggest that direct oral anticoagulants may become the new standard of care.1,2 Direct oral anticoagulants appear to...
David Baraghoshi, on Colorectal Cancer and Cardiovascular Disease Risk
David Baraghoshi, of the Huntsman Cancer Institute at the University of Utah, discusses an assessment of cardiovascular risk more than 10 years after diagnosis for colorectal cancer survivors compared with a cancer-free general population cohort (Abstract 113).
ASCO and NCCN Provide Guidelines for Managing Immunotherapy Side Effects
Immunotherapy with immune checkpoint inhibitors is the first of a new generation of immunotherapy treatments, revolutionizing treatment for many different types of cancer. By unleashing the body's immune system to attack cancer, these treatments can send even the most hard-to-treat cancers into...
Safety Information on Rolapitant Injectable Emulsion
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing health-care providers about new safety information for rolapitant (Varubi) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and...
ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer
People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...
ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant
Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...
Cognitive Behavior Therapy for Insomnia: Sleeping Well With Cancer and Beyond
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Sheila N. Garland, PhD, R Psych, and Jun J. Mao, MD, MSCE, present...
