Prolonged Administration of the Granisetron Transdermal Delivery System Reduces Capecitabine plus Oxaliplatin Regimen–Induced Nausea and Vomiting

Abstract

Abstract Purpose The completion rate and intensity of Capecitabine plus oxaliplatin (CapeOX) combination therapy are low in clinical practice because of chemotherapy-induced nausea and vomiting. This open-label, prospective, multi-center phase II trial was designed to initially assess the safety and efficacy of granisetron transdermal delivery system (GTDS) and Dexamethasone for patients who were scheduled to receive CapeOX chemotherapy. Methods Patients received the GTDS (3.1 mg attached to the upper arm 48 h before chemotherapy, replaced on day 5 and discarded on day 12), and Dexamethasone. The primary end point was complete control rate. Secondary efficacy endpoints included dates of delayed complete control during the overall phase, complete control rate in the acute phase, safety and quality of life. Results Among three institutions, 29 participants were enrolled in the study. The complete control rate in delayed nausea and vomiting for the whole periods (25–480 hours) was 70.4% (95% CI 0.50–0.86). The dates of delayed complete control were 17.1 ± 4.9 days. 59.3% of patients did not experience any grade of nausea during the delayed phase. The complete control rate in the acute phase was 85.2% (95% CI 0.65–0.95). In terms of safety, there were no serious adverse events attributed to the antiemetic regimen. Conclusion Prolonged administration of the GTDS is safe and effective for preventing chemotherapy-induced nausea and vomiting in patients with gastrointestinal malignancies treated with CapeOX. This study is registered at the ClinicalTrials.gov registry (NCT05325190). The date of registration was October 10, 2021.