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Clinical Trial
. 2011 Oct;19(10):1609-17.
doi: 10.1007/s00520-010-0990-y. Epub 2010 Sep 12.

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

Ralph V Boccia  1 , Lucio N Gordan, Gemma Clark, Julian D Howell, Steven M Grunberg; Sancuso Study Group
Collaborators, Affiliations
Clinical Trial

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

Ralph V Boccia et al. Support Care Cancer. 2011 Oct.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00273468.

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Figures

Fig. 1
Fig. 1
Flow of participants through the study SS, all patients who received ≥1 dose of study treatment. FAS, all SS patients who had ≥1 efficacy assessment after the start of chemotherapy. PPS, all FAS patients without protocol violations that directly impinged on or affected the primary endpoint. Protocol violations leading to exclusion from the PPS included changes in the planned chemotherapy regimen, receipt of banned concomitant medications, >50% patch detachment and incorrect study drug administration
Fig. 2
Fig. 2
Complete control of CINV in predefined subgroups of the PPS. CS corticosteroids
See this image and copyright information in PMC

References

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