Transdermal granisetron versus palonosetron for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: a multicenter, randomized, open-label, cross-over, active-controlled, and phase IV study.

Abstract

BACKGROUND:

Palonosetron is the second-generation 5-hydroxytryptamine 3 receptor antagonist (5-HT3RA) that has shown better efficacy than the first-generation 5-HT3RA for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC). Granisetron transdermal delivery system (GTDS), a novel transdermal formulation, was developed to deliver granisetron continuously over 7 days. This study compared the efficacy and tolerability of the GTDS to palonosetron for the control of CINV following MEC.

MATERIAL AND METHOD:

A total of 196 patients were randomized to GP or PG group. In this multicenter, randomized, open-label, cross-over, active-controlled, Phase IV study, GP group was assigned to receive transdermal granisetron (one GTDS patch, 7 days) in the first chemotherapy cycle, palonosetron (iv 0.25 mg/day, 1 days) in the second chemotherapy cycle before receiving MEC, and PG group was assigned to receive palonosetron in the first cycle and GTDS in the second cycle. Primary endpoint was the percentage of chemotherapy cycles achieving complete response (CR; defined as no emetic episodes and no rescue medication use) during the acute phase (0-24 h in post-chemotherapy; non-inferiority comparison with palonosetron).

RESULTS:

Total 333 cycles (165 in GTDS and 168 in palonosetron) were included in the per protocol analysis. The GTDS cycles showed non-inferiority to palonosetron cycles during the acute phase: CR was achieved by 124 (75.2 %) patients in the GTDS cycles and 134 (79.8 %) patients in the palonosetron cycles (treatment difference, -4.6 %; 95 % confidence interval, -13.6-4.4). There was no significant difference in CR rate during acute phase after the end of the first and second chemotherapy cycle between GP and PG group (p = 0.405, p = 0.074). Patients' satisfaction, assessed using Functional Living Index-Emesis (FLI-E), GTDS cycle were higher than those of palonosetron cycle in GP group (FLI-E score; median 1549.5 in GTDS cycle, median 1670.0 in palonosetron cycle). Both treatments were well tolerated and safe.

CONCLUSION:

Transdermal granisetron is a good alternative therapeutic option to palonosetron for preventing CINV after MEC.

• Authors: Young Mi Seol, Hyo Jeong Kim, Young Jin Choi, Eun Mi Lee, Yang Soo Kim, Sung Yong Oh, Su Jin Koh, Jin Ho Baek, Won Sik Lee, Young Don Joo, Hyun Gi Lee, Eun Young Yun, Joo Seop Chung
• Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 24 Issue 2 Pg. 945-952 (Feb 2016) ISSN: 1433-7339 [Electronic] Germany
• PMID: 26265119 (Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antiemetics
• Antineoplastic Agents
• Isoquinolines
• Quinuclidines
• Serotonin Antagonists
• Palonosetron
• Granisetron

Topics

• Administration, Cutaneous
• Adult
• Aged
• Antiemetics (therapeutic use)
• Antineoplastic Agents (adverse effects)
• Cross-Over Studies
• Double-Blind Method
• Female
• Granisetron (therapeutic use)
• Humans
• Isoquinolines (therapeutic use)
• Male
• Middle Aged
• Nausea (chemically induced, drug therapy, prevention & control)
• Palonosetron
• Patient Satisfaction
• Quinuclidines (therapeutic use)
• Remission Induction
• Serotonin Antagonists (therapeutic use)
• Vomiting (chemically induced, drug therapy, prevention & control)