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Purpose: A novel transdermal formulation of granisetron (the granisetron transdermal delivery system (GTDS)) has been developed to deliver granisetron continuously over 7 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 (2 mg/day, 3-5 days) or transdermal granisetron (one GTDS patch, 7 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 24 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, -5%; 95% confidence interval, -13-3). 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 7 days that is as effective as oral granisetron.

Purpose: Hesketh scores define emetogenicity of single-agent and multiagent single-day chemotherapy. This analysis determined the emetogenicity of multiagent, multiday chemotherapy and the Granisetron Transdermal System (GTDS; Sancuso®). Methods: This was a retrospective analysis of a multicenter, randomized, double-blind, phase III noninferiority trial of GTDS versus oral granisetron in patients receiving 3 days of multiagent moderately or highly emetogenic chemotherapy, regardless of granisetron formulation. Emesis was defined as vomiting/retching or the use of rescue medication. Logistic regression and classification trees were used to determine the optimal combination of Hesketh scores over the multiagent, multiday regimens for the prediction of emesis. Results: Of 393 patients, 272 (69.2%) were chemotherapy naïve. The most common types of cancer were lung (30.5%) and gynecologic (21.9%). The most common chemotherapeutic regimen (in 14.2% of patients) was cisplatin plus etoposide on days 1-3. The best binary emesis predictor was day 1 Hesketh score. Patients with a day 1 Hesketh score of 5 had the highest rate of emesis (62.5%) versus patients with a score < 5 (31.7%). For patients with day 1 Hesketh score < 5, only 14.3% of those receiving only one drug on day 1 experienced emesis. Conclusion: Hesketh emetogenicity scores of individual agents are applicable to multiday, multiagent chemotherapeutic regimens in patients receiving antiemetics. [ABSTRACT FROM AUTHOR]