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.
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