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Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study.

Author(s): Boccia RV, Gordan LN, Clark G, Howell JD, Grunberg SM; Sancuso Study Group.

Collaborators: Chilingirov P, Koynova TV, Markova H, Racheva M, Taskova V, Tomova A, Tsekov H, Tzekova VI, Yanakieva VN, Petuzelka L, Vanasek J, Chacko RT, Desai C, Dhabhar B, Digumarti R, Kumar R, Maru A, Mohamed SB, Mohapatra KR, Nag S, Walia M, Cabrera P, Figueroa J, Franco-Gonzalez E, Rodriguez AL, Sanchez E, Krzakowski M, Mruk A, Rolski J, Aldea C, Badulescu F, Ciuleanu TE, Dediu M, Motan Ganea DE, Miron L, Muresan DR, Patran M, Abdulkadirov KM, Alexeeva YA, Gershanovich ML, Iiyin NV, Karyagina EV, Lisyanskaya AS, Nizamutdinova AS, Orlov SV, Roman L, Shneider TV, Vinokurov VL, Zaritskiy AU, Bosnjak S, Donat D, Arevalo-Araujo R, Charu V, Dincer A, Ferguson S, Gabrail NY, Justice GR, Tebbi CK.

Affiliation(s): Center for Cancer and Blood Disorders, 6420 Rockledge Dr., No. 4100, Bethesda, MD 20817, USA. rboccia@ccbdmd.com

Publication date & source: 2011, Support Care Cancer. , 19(10):1609-17

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.

Page last updated: 2013-02-10

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