Hesketh, P.J., Schnadig, I.D., Schwartzberg, L.S., Modiano, M.R., Jordan, K., Arora, S., . . . Aapro, M. (2016). Efficacy of the neurokinin-1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin-based chemotherapy. Cancer, 122, 2418–2425.

To evaluate the efficacy of the addition of rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV) in patients receiving carboplatin

Patients were randomly assigned to receive a single oral dose of 180 mg rolapitant or a matching placebo 1–2 hours before chemotherapy administration on day 1. All patients received granisetron on days 2 and 3. Patients receiving taxanes also were given dexamethasone. For five days, patients recorded vomiting, use of rescue medication, and nausea daily in a diary. Additional study assessment was obtained on day 6 of cycle 1 of chemotherapy. This report is a subset of a larger phase-III trial focusing on individuals receiving the first course of chemotherapy with a carboplatin-based regimen.

• N = 401   
• MEDIAN AGE = 63 years
• AGE RANGE = 23–88 years
• MALES: 54.9%, FEMALES: 45.1%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Multiple tumor types—lung was most prevalent
• OTHER KEY SAMPLE CHARACTERISTICS: All were receiving a moderately emetogenic chemotherapy (MEC) regimen.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Multiple countries

• PHASE OF CARE: Active antitumor treatment

• Double-blind, randomized, placebo-controlled trial

• Visual analog scale (VAS) for nausea
• Functional Living Index-Emesis (FLIE)

Those receiving rolapitant had a higher prevalence of complete response (CR) for antiemetics in the overall phase (p < 0.001) and delayed phase (p < 0.001). No differences existed between groups for the response in the acute phase; 88%–91% across study groups had CR in the acute phase. No difference existed between groups in FLIE results. Nausea was also better controlled in the rolapitant group in the overall (p = 0.023) and delayed phases (p = 0.034) (patients reporting no nausea). No differences existed between groups in adverse events, and no serious adverse events occurred.

Rolapitant was shown to be effective for the prevention of emesis in patients receiving MEC. The proportion of patients reporting no nausea was also higher with rolapitant; however, only 62.5% had no nausea in the overall phase.

The findings support the use of rolapitant as part of a triple-drug regimen with a 5-HT₃ and dexamethasone for patients receiving carboplatin. NK1s are not routinely recommended for patients receiving MEC; however, this study showed significantly better control with the addition of an NK₁. A substantial proportion of patients continued to experience nausea, though this was also improved with use of rolapitant.