FDA Approves Pegfilgrastim Biosimilar
On November 5, the U.S. Food and Drug Administration (FDA) approved a biosimilar to pegfilgrastim, pegfilgrastim-bmez (Ziextenzo). Pegfilgrastim-bmez is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving...
First Survivor Views Survey Highlights Barriers to Addressing Side Effects of Cancer Treatment
Barriers to accessing appropriate therapies to address the physical and psychological side effects of cancer treatment continue to persist for patients and survivors, according to results of the Survivor Views survey conducted by the American Cancer Society Cancer Action Network (ACS CAN)....
Superoxide Dismutase Mimetic for Reducing Severe Oral Mucositis From Concurrent Radiotherapy and Cisplatin in Head and Neck Cancer
In a phase IIb trial reported in the Journal of Clinical Oncology, Anderson et al found that the superoxide dismutase mimetic GC4419 was effective in reducing the duration, incidence, and severity of severe oral mucositis in patients with head and neck cancer receiving concurrent radiotherapy and...
Superoxide Dismutase Mimetic for Reducing Severe Oral Mucositis From Concurrent Radiotherapy and Cisplatin in Head and Neck Cancer
In a phase IIb trial reported in the Journal of Clinical Oncology, Anderson et al found that the superoxide dismutase mimetic GC4419 was effective in reducing duration, incidence, and severity of severe oral mucositis in patients with head and neck cancer receiving concurrent radiotherapy and...
FDA Approves Label Expansion for Single-Dose Regimen of Intravenous Aprepitant for Patients Receiving Moderately Emetogenic Chemotherapy
On October 22, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for aprepitant (Cinvanti) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130-mg single-dose regimen for...
Update to FDA Prescribing Information for Romiplostim for Adults With Immune Thrombocytopenia
On October 18, the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for romiplostim (Nplate) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia. The updated...
FDA Pipeline: Designations for Acute Graft-vs-Host Disease, Peripheral T-Cell Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a therapy for steroid-refractory acute graft-vs-host disease and granted Orphan Drug designation to a therapy for peripheral T-cell lymphoma. Fast Track Designation for T-Guard in Steroid-Refractory Acute...
Romiplostim for Patients With Chemotherapy-Induced Thrombocytopenia
In a single-center phase II study reported in the Journal of Clinical Oncology, Soff et al found that treatment with romiplostim was effective in rapidly correcting chemotherapy-induced thrombocytopenia, with maintenance treatment being effective in reducing risk of recurrent chemotherapy-induced...
International Guidelines for Treatment and Prophylaxis of VTE in Patients With Cancer
The 2019 International Initiative on Thrombosis and Cancer (ITAC) has issued updated clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism (VTE) in patients with cancer. They were published by Farge et al in The Lancet Oncology. The guidelines consist of...
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...
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...
Angela M. Stover, PhD, on Patient-Reported Outcome Performance Measures for Oncology Practice
Angela M. Stover, PhD, of the University of North Carolina at Chapel Hill, discusses ASCO’s initiative to develop patient-based performance measures for assessing and managing symptoms. The measures have made substantial differences in reducing nausea, constipation, and insomnia (Abstract 173).
2019 Quality Care: Improving Documentation of Pain and Constipation Assessment and Management
In a study reported at the ASCO Quality Care Symposium and simultaneously published in the Journal of Oncology Practice, Chineke et al found that a Quality Oncology Practice Initiative (QOPI) initiated in collaboration with ASCO at the Georgia Cancer Center for Excellence (GCCE) at Grady Health...
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 ...
Study Explores Efficacy of Lower-Dose Olanzapine in Combination With Standard Antiemetic Regimen
Olanzapine at a 5-mg dose, when combined with aprepitant, palonosetron, and dexamethasone, significantly reduced the risk of delayed nausea and vomiting in patients receiving cisplatin-based chemotherapy, according to new research. The study investigators believe this approach may be considered a...
Virtual Reality May Improve Pain, Vision, Functioning in Patients With Cancer
Virtual reality can be used to improve functioning in patients with cancer, according to David Rhew, MD, Chief Medical Officer, Vice President and General Manager of Enterprise Healthcare, Samsung Electronics America. Research has shown that this technology can decrease pain and improve vision, as...
Risk of Cardiovascular Adverse Events in Patients With Melanoma Treated With Combined BRAF and MEK Inhibition vs BRAF Inhibition Alone
In a meta-analysis reported in JAMA Network Open, Mincu et al found that the risk of some types of cardiovascular adverse events was higher with combined BRAF and MEK inhibitor treatment vs BRAF inhibitor monotherapy in patients with melanoma. The meta-analysis included 2,317 patients in five...
Anti–PD-1/PD-L1 Rechallenge After Immune-Related Adverse Events
In a study reported in JAMA Oncology, Olivier Lambotte, MD, PhD, found that rechallenge with an immune checkpoint inhibitor after occurrence of immune-related adverse events was associated with occurrence of an immune-related adverse event in approximately half of patients, with no increase in...
Novel Therapeutics on the Horizon for Treating Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy-induced peripheral neuropathy is a major clinical problem, and better therapies are needed for both its treatment and prevention. According to Charles Loprinzi, MD, a medical oncologist at the Mayo Clinic in Rochester, Minnesota, to devise better preventive and treatment approaches,...
What Causes Liver Injury During Treatment With Pembrolizumab?
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a...
Neoadjuvant Chemotherapy Duration and Obesity May Be Associated With Increased Risk of Lymphedema in Some Women With Breast Cancer
In a cohort study reported in JAMA Surgery, Armer et al found that longer duration of neoadjuvant chemotherapy and increasing body mass index (BMI) were associated with increased risk of lymphedema in women with node-positive breast cancer who received neoadjuvant chemotherapy and axillary...
Metabolic Changes May Signal Development of Chemotherapy-Associated Cardiotoxicity
To learn more about the processes that lead to chemotherapy-associated cardiotoxicity, a team of researchers at Beth Israel Deaconess Medical Center (BIDMC) conducted a study to investigate whether early changes in energy-related metabolites in the blood—measured shortly after...
Immune Checkpoint Inhibitor Rechallenge After Immune-Related Adverse Events
In a study reported in JAMA Oncology, Simonaggio et al found that rechallenge with an immune checkpoint inhibitor after occurrence of immune-related adverse events was associated with occurrence of an immune-related adverse event in approximately half of patients, with no increase in severity....
ESMO World GI 2019: REARRANGE Trial Examines Flexible Regorafenib Dosing in Refractory Metastatic Colorectal Cancer
Regorafenib is often administered to patients with refractory metastatic colorectal cancer. However, some of the adverse events related to the use of this drug often limit its use in clinical practice. A study reported by Argilés et al at the European Society for Medical Oncology (ESMO)...
Treatment of Immune Checkpoint Inhibitor Immune-Related Cutaneous Adverse Events
In a study reported in the Journal of Clinical Oncology, Phillips et al found that immune-related cutaneous adverse events in patients receiving immune checkpoint inhibitors generally responded to symptom- and phenotype-directed dermatologic therapies, and that biologic therapies were effective in...
Multidisciplinary Approach for Addressing Immunotherapy-Related Toxicities
New research published in JNCCN—Journal of the National Comprehensive Cancer Network and presented by Jarushka Naidoo, MBBCh, at the NCCN 2019 Annual Conference suggests that institutions and networks that utilize immunotherapy should consider establishing multidisciplinary teams for...
Resuming Immune Checkpoint Inhibitor Therapy After Immune-Mediated Diarrhea and Colitis
In a retrospective multicenter study reported in the Journal of Clinical Oncology, Abu-Sbeih et al found that approximately one-third of patients resuming immune checkpoint inhibitor therapy after improvement in immune-mediated diarrhea and colitis experienced a recurrence of the adverse effect....
Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer
In an international prospective cohort study reported in the Journal of Clinical Oncology, Kraaijpoel et al found that incidental pulmonary embolism in patients with cancer is associated with substantial risk of recurrent venous thromboembolism, despite anticoagulant treatment. Study Details The...
FDA Approves Ruxolitinib for Acute Graft-vs-Host Disease
On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. REACH1/Study INCB 18424-271 Approval was based on the REACH1 trial/Study INCB 18424-271, an...
Treatment-Related Ototoxicity and Reading Impairment in Pediatric Patients With Embryonal Brain Tumors
In a study reported in the Journal of Clinical Oncology, Olivier et al found that pediatric patients with severe sensorineural hearing loss associated with the treatment of embryonal brain tumors experienced greater reading difficulties over time. The study involved data from 260 children and...
FDA Approves Dalteparin Sodium for VTE in Pediatric Patients
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium (Fragmin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients....
Treatment-Related Adverse Events With PD-1/PD-L1 Inhibitors in Clinical Trials
In a systematic review and meta-analysis reported in JAMA Oncology, Wang et al characterized treatment-related adverse event profiles associated with monotherapy use of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors in clinical trials. Study Details...
ASBrS 2019: Bioimpedance Spectroscopy for Surveillance of Breast Cancer–Related Lymphedema
Surveillance of women at risk for breast cancer–related lymphedema using bioimpedance spectroscopy was more effective in preventing lymphedema progression than traditional arm circumference measurement when each was combined with immediate compression therapy. These were the results of an...
ESTRO 38: REQUITE Project Finds Predictive Biomarkers for Late Radiotherapy Toxicity
The latest results from the REQUITE project, which aimed to discover what makes patients more likely to experience adverse effects after radiotherapy, have shown that a combination of biologic markers and certain genetic changes can predict radiation sensitivity. In addition, the international team ...
Emergency Department Visits for Treatment-Related Complications of Systemic Therapy and Radiotherapy
In a study reported in JAMA Oncology, Jairam et al found that emergency department visits for complications of systemic therapy or radiotherapy in patients with cancer increased at a 5.5-fold higher rate over 10 years compared with overall emergency department visits. Study Details The study...
New Biomarkers Associated With Cancer-Related Cognitive Impairment Identified
Cognitive impairment associated with cancer—also known as “chemobrain”—has gained recognition as a complication of the disease and its treatment. With this in mind, a research team started to investigate levels of biomarkers in relation to chemobrain to better understand its ...
ASCO and ASH Release Update to Clinical Practice Guidelines for Use of Erythropoiesis-Stimulating Agents
ASCO and the American Society of Hematology (ASH) have released an update to existing guidelines for the use of erythropoiesis-stimulating agents to manage anemia in patients with cancer. The update was simultaneously published in the Journal of Clinical Oncology and Blood Advances. “The...
'Oral Cryotherapy' for Patients Undergoing Oxaliplatin-Based Chemotherapy
A study by Bauman et al in JNCCN—Journal of the National Comprehensive Cancer Network found that patients who kept ice chips in their mouths—what the study authors called “oral cryotherapy”—during oxaliplatin infusions reported less trouble with eating and...
FDA Pipeline: Designation in Uveal Melanoma, Application for MDS Side-Effect Management
Over the past week, the U.S. Food and Drug Administration (FDA) granted a Fast Track designation to a treatment for metastatic uveal melanoma and received a biologics application for an agent to control anemia. Fast Track Designation for Tebentafusp in Metastatic Uveal Melanoma The FDA granted...
Differences in Medical Cannabis Use in Patients With and Without Cancer
People with and without cancer are more likely, over time, to use a more potent form of medical marijuana with increasingly higher amounts of tetrahydrocannabinol (THC), a new study published by Kim et al in the Journal of Palliative Medicine has shown. “Although there is growing...
AACR 2019: Effect of Timing of Radiotherapy on Mucositis in Patients With Head and Neck Cancer
New research presented by Gu et al at the American Association for Cancer Research (AACR) Annual Meeting 2019 found that administering radiation treatments in the morning as opposed to later in the day may significantly reduce the severity of mucositis and its related impacts (Abstract 4860). ...
Effect of Medical Cannabis on Symptom Control in Patients With Cancer
As reported in the Journal of Oncology Practice by Anderson et al, a study of patients enrolled in Minnesota’s Medical Cannabis Program showed that the use of medical cannabis was associated with improvement in reported symptoms in patients with cancer. The study involved data on 1,120...
Mark K. Ferguson, MD, on Mitigating Frailty and Sarcopenia to Improve Treatment Outcomes
Mark K. Ferguson, MD, of the University of Chicago Hospital, discusses frailty and loss of muscle tissue, which are common among patients with lung cancer. These conditions are linked with decreased survival as well as increased surgical complications, chemotherapy toxicity, and cost of care.
FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
Can Cognitive Behavioral Therapy Improve Treatment-Induced Menopausal Symptoms in Survivors of Breast Cancer?
In a Dutch study reported in the Journal of Clinical Oncology, Atema et al found that an Internet-based cognitive behavioral therapy (iCBT) intervention improved treatment-induced menopausal symptoms in breast cancer survivors compared with a waiting list control group. In the study, 254 women...
Immunotherapy for Head and Neck Cancer Expands, but Concerns Persist About Patient Selection and Toxicities
SOME PATIENTS with advanced head and neck cancer may achieve durable responses with immunotherapy, and recent trial results suggest first-line immunotherapy may increase survival among patients with recurrent or metastatic disease. However, concerns remain about selecting patients most likely to...
Patient-Reported Outcomes With Enzalutamide in PROSPER Trial
As reported by Tombal et al in The Lancet Oncology, treatment with enzalutamide was associated with clinically meaningful delays in pain progression, symptom worsening, and deterioration in functional status vs placebo in the phase III PROSPER trial in nonmetastatic, castration-resistant prostate...
Silke Gillessen, MD, on Prostate Cancer: Results From the REDUSE Trial on Denosumab
Silke Gillessen, MD, of Cantonal Hospital St. Gallen, discusses data from a phase III study on the incidence of hypocalcemia in patients with castration-resistant prostate cancer treated with denosumab. The trial was designed to assess prevention of symptomatic skeletal events with denosumab administered every 4 weeks vs every 12 weeks (Abstract 139).
Gastric Acid Suppressants May Reduce Survival Outcomes in Patients With Sarcoma Treated With Pazopanib
It is estimated that 20% to 33% of patients undergoing cancer treatment are concomitantly using a gastric acid suppressant, most commonly a proton pump inhibitor (including omeprazole and esomeprazole magnesium) or a histamine H2-receptor blocker (such as ranitidine). A study by Mir et al...
Late-Onset Cardiotoxicity in Pediatric Cancer Survivors: Comparison of Regimens
In a study reported in JAMA Oncology, Feijen et al found that daunorubicin was associated with decreased cardiomyopathy risk vs doxorubicin among pediatric cancer survivors, with epirubicin being approximately isoequivalent to doxorubicin. Risk associated with the anthraquinone mitoxantrone was...
