Purpose
A novel transdermal formulation of granisetron (the granisetron transdermal delivery system (GTDS)) has been developed to deliver granisetron continuously over 7ย days. This double-blind, phase III, non-inferiority study compared the efficacy and tolerability of the GTDS to daily oral granisetron for the control of chemotherapy-induced nausea and vomiting (CINV).
Patients and methods
Six hundred forty-one patients were randomized to oral (2ย mg/day, 3โ5ย days) or transdermal granisetron (one GTDS patch, 7ย days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24ย h after final administration. The prespecified non-inferiority margin was 15%.
Results
Five hundred eighty-two patients were included in the per protocol analysis. The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, โ5%; 95% confidence interval, โ13โ3). Both treatments were well tolerated, the most common adverse event being constipation.
Conclusions
The GTDS provides effective, well-tolerated control of CINV associated with moderately or highly emetogenic multi-day chemotherapy. It offers a convenient alternative route for delivering granisetron for up to 7ย days that is as effective as oral granisetron.
Electronic supplementary material
The online version of this article (doi:10.1007/s00520-010-0990-y) contains supplementary material, which is available to authorized users.