# Granisetron transdermal delivery system versus palonosetron in the prevention of long-delayed nausea and vomiting: a phase III randomized trial

## TL;DR

A new transdermal system for granisetron was found to be more effective than palonosetron in preventing long-delayed nausea and vomiting after chemotherapy.

## Contribution

This study is the first to show that granisetron transdermal delivery outperforms palonosetron in preventing long-delayed chemotherapy-induced nausea and vomiting.

## Key findings

- GTDS showed a significantly higher complete response rate (97.3%) compared to palonosetron (92%) in the long-delayed phase.
- The benefit of GTDS was most pronounced in patients receiving highly emetogenic chemotherapy.
- GTDS provides a convenient 7-day delivery method with superior efficacy for long-delayed CINV.

## Abstract

Chemotherapy-induced nausea and vomiting (CINV) significantly impact the patients’ quality of life. Whether the granisetron transdermal delivery system (GTDS) offers better protection than palonosetron against long-delayed (120-168 hours) CINV after highly or moderately emetogenic chemotherapy (HEC/MEC) had not been prospectively tested.

A multicenter, randomized clinical study was conducted in China. Patients scheduled to receive either HEC or MEC were randomly assigned (1:1) to GTDS or palonosetron, each in combination with a neurokinin-1 receptor antagonist (NK1-RA) and dexamethasone. The primary endpoint was the complete response (CR; no vomiting and no rescue medication) rate during the long-delayed phase (120-168 hours), stratified by HEC and MEC categories, to demonstrate the superiority of GTDS over palonosetron.

Overall, 150 patients received either GTDS or palonosetron respectively. We found that the GTDS group demonstrated a significantly higher long-delayed CR rate (97.3%) than the palonosetron group (92%) (P = .04). This advantage was driven predominantly by the HEC subgroup (GTDS 97.5% vs palonosetron 90.8%, P = .028). No significant differences were observed between the groups for the acute (0-24 hours, 92.7% vs 90.0%; P = .412), delayed (24-120 hours, 80.0% vs 76.0%; P = .403), extended-delayed (24-168 hours, 80.7% vs 75.3%; P = .265), or overall (0-168 hours, 78.0% vs 74.0%; P = .417) phases.

A GTDS-based triple antiemetic regimen can effectively control CINV associated with HEC or MEC. It provides a convenient alternative route for delivering granisetron for up to 7 days, with superior efficacy in controlling long-delayed CINV.

Clinicaltrials.gov Identifier: NCT04912271 (in-house ethic number: YBCSG-21-04)