Rolapitant Effective for Chemotherapy-Induced Nausea and Vomiting

TOP - August 2015, Vol 8, No 3 - Conference Correspondent
Meg Barbor, MPH

Copenhagen, Denmark—Rolapitant 180 mg significantly reduced symptoms of chemotherapy-induced nausea and vomiting (CINV) in patients treated with multiple cycles of highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC), according to research presented by Bernardo L. Rapoport, MD, at the 2015 Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology Annual Meeting on Supportive Care in Cancer.

Rolapitant is a highly selective, long-acting neurokinin-1 receptor antagonist that has already demonstrated safety and efficacy in treating patients with CINV in cycle 1 of HEC or MEC.

“Its long half-life suggests that a single 180 mg dose will prevent CINV for the entirety of a patient’s 5-day at-risk period,” stated Dr Rapoport, Specialist Physician and Medical Oncologist, The Medical Oncology Centre of Rosebank, Johannesburg, South Africa.

Previously Demonstrated Efficacy

The safety and efficacy of a single oral dose of rolapitant has been previously demonstrated in a large, global, randomized, controlled, double-blind phase 2 study of patients receiving HEC. Its efficacy and safety were also confirmed in 3 large, global, randomized, controlled, double-blind, phase 3 studies of patients receiving HEC or MEC.

Dr Rapoport and colleagues conducted a pooled analysis of 4 similar studies to evaluate the efficacy and safety of rolapitant 180 mg in the prevention of CINV during cycles 2 through 6 of chemotherapy, because patients who experience emesis during initial chemotherapy have an increased risk for CINV during subsequent treatments. “The previous papers looked only at the first cycle of chemotherapy,” the presenter noted.

Study Methods and the Primary End Point

Dr Rapoport reported data from 4 double-blind, active-controlled studies: 1 phase 3 study of patients receiving MEC (N = 1332); 1 phase 2 study of patients receiving HEC (N = 181); and 2 phase 3 studies of patients receiving HEC (N = 1070). Patients were randomized to receive oral rolapitant 180 mg or placebo 1 to 2 hours before chemotherapy. All patients received an active control dose of a 5-hydroxytryptamine receptor antagonist and oral dexamethasone, in addition to rolapitant or placebo.

“As expected, breast cancer was the most common diagnosis for patients receiving MEC chemotherapy,” he explained. “Lung cancer was more common in patients receiving HEC.”

In a daily diary, patients recorded their use of rescue medications and events of emesis that interfered with normal daily life; nausea was self-­assessed daily for 5 days. Randomized treatment could be continued in a blinded fashion for up to 5 additional cycles, and was the basis of this analysis, Dr Rapoport said.

The primary end point of the study was the incidence of CINV that interfered with normal daily life following chemotherapy, measured by asking patients 2 questions: “Have you had any episode of vomiting or retching since your chemotherapy started in this cycle?” and “Have you had any nausea since your chemotherapy started in this cycle that interfered with normal daily life?” Incidence was measured on days 6 to 8 of each subsequent cycle of treatment.

Rolapitant Effective Over Multiple Cycles

“Data could be pooled because the studies were similarly designed,” Dr Rapoport explained. “This increased the size of the data set and enabled a robust analysis.”

Effectiveness was maintained over multiple cycles; in each subsequent cycle, a greater proportion of patients on rolapitant versus placebo reported no emesis or nausea disruptive to daily life. “Adverse event rates were high,” he noted. “But there were no differences between the treatment arms, statistically, that could be attributed to this antiemetic regimen.” Treatment-related adverse events were similar in the rolapitant and control groups, with the most common adverse events being constipation and fatigue.

Over multiple cycles of emetogenic chemotherapy, patients taking rolapitant showed significant reductions in symptoms of CINV compared with patients receiving placebo, with no increase in toxicity, the investigators concluded.

Related Items
Targeted Intervention Reduces Opioid Use by Nearly 50% After Urologic Oncology Surgery
Meg Barbor, MPH
TOP - February 2019, Vol 12, No 1 published on January 29, 2019 in Symptom Management Overview
Managing Bone Metastases Through a Multidisciplinary Approach
Meg Barbor, MPH
JHOP Web Exclusives published on December 11, 2018 in Supportive Care
Oral Toxicities Associated with Cancer Therapies: What's Old Is New Again
Meg Barbor, MPH
JHOP Web Exclusives published on November 26, 2018 in Drug Therapies
The Pharmacist’s Role in Improving Quality in Oncology
Meg Barbor, MPH
TOP - November 2018, Vol 11, No 3 published on November 21, 2018 in HOPA 2018 Highlights
CAR T-Cell Therapy: Can We Afford the Cure?
Meg Barbor, MPH
TOP - November 2018, Vol 11, No 3 published on November 21, 2018 in HOPA 2018 Highlights
Harnessing the Power of Business Intelligence to Influence Oncology Practice
Meg Barbor, MPH
TOP - November 2018, Vol 11, No 3 published on November 21, 2018 in HOPA 2018 Highlights
Cannabis for Symptom Management in Cancer: Do You Know What Your Patients Are Using?
Meg Barbor, MPH
TOP - November 2018, Vol 11, No 3 published on November 21, 2018 in Symptom Management Overview
Know Your Target: Precision Medicine 101
Meg Barbor, MPH
TON - September 2018, Vol 11, No 4 published on September 19, 2018 in ONS 2018
The Samfund Provides Financial Support for Young Adult Cancer Survivors
Meg Barbor, MPH
TON - September 2018, Vol 11, No 4 published on September 19, 2018 in Survivorship
Adherence to Exercise and Nutrition Guidelines Can Prolong Life in Cancer Survivors
Meg Barbor, MPH
TON - September 2018, Vol 11, No 4 published on September 19, 2018 in Survivorship
Last modified: September 22, 2015