Fosaprepitant for the prevention of multiple-day cisplatin chemotherapy-induced nausea and vomiting: a prospective randomized controlled study.

PURPOSE: We aimed to compare the efficacy and safety of fosaprepitant plus triple therapy versus triple therapy alone, in terms of both routine and delayed regimen, in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving three-day cisplatin-based treatment.

METHODS

In a prospective randomized controlled trial, patients undergoing three-day cisplatin-based chemotherapy (25mg/m2/day) received fosaprepitant plus triple therapy or triple therapy alone on day 1 (routine regimen). For the evaluation of the delayed regimen, the administration of fosaprepitant and/or olanzapine was delayed for 1 day. Efficacy and safety in overall phase (OP) were evaluated within 5 days after initiation of chemotherapy.

RESULTS

Fosaprepitant plus triple therapy achieved a higher total protection (TP) rate during OP than triple therapy alone (56.9% vs. 40.4%; P = 0.018). Fosaprepitant plus triple therapy also produced a higher TP rate than triple therapy alone during delay phase (DP) (57.8% vs. 40.4%; P = 0.012) but not during acute phase (AP) (88.2% vs. 86.5%; P = 0.714). In addition, fosaprepitant plus triple therapy achieved higher complete response (CR) rates than triple therapy alone during DP, but not during AP. The delayed regimen appeared to have produced higher TP and CR rates than the routine regimen, but the differences were not statistically significant. The Kaplan-Meier curves showed that fosaprepitant plus triple therapy delayed the first vomiting.

CONCLUSIONS

Fosaprepitant plus triple therapy demonstrated superiority over triple therapy alone for CINV control in patients receiving three-day cisplatin-based treatment.

CLINICAL TRIALS REGISTRATION: This trial was registered in the China Clinical Trials Registry on December 8, 2020 (chiCTR2000040675).