1489P - Transdermal granisetron versus palonosetron for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Supportive Care
Presenter Young Mi Seol
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors Y.M. Seol
  • Hemato- Oncology, Pusan National University Hospital, 602-739 - Busan/KR

Abstract

Aim

Palonosetron is the second-generation 5-hydroxytryptamine 3 (5-HT3)-receptor antagonist that has shown better efficacy than the first generation 5-HT3 in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy. A novel transdermal formulation [granisetron transdermal delivery system (GTDS)] has been developed to deliver granisetron continuously over 7 days. This study compared the efficacy and tolerability of the GTDS to palonosetron for the control of chemotherapy-induced nausea and vomiting (CINV) following MEC.

Methods

In this multicenter, randomized, open-label, cross-over, active-controlled, Phase IV study, 196 patients were randomized to GP group or PG group. GP group is assigned to receive transdermal granisetron (one GTDS patch, 7 days) in the first cycle, palonosetron (iv 0.25 mg/day, 1 days) in the second cycle before receiving MEC in two consecutive cycles, and PG group is assigned to receive palonosetron in the first cycle and GTDS in the second cycle. Primary endpoint is the proportion of chemotherapy cycles with a complete response (CR, defined as no emetic episodes and no rescue medication) during the acute phase (0–24 h post-chemotherapy; non-inferiority comparison with palonosetron) and secondary endpoints were the proportion of chemotherapy cycles with a CR during the delayed phase (24-72 h post-chemotherapy; non-inferiority comparison with palonosetron), CR rate during acute phase after the end of first cycle and second cycle in each GP group and PG group and patients' satisfaction using functional living index-emesis (FLI-E). The non-inferiority margin was predefined in the study protocol as a 15% difference between GTDS and palonosetron cycles in the proportion of chemotherapy cycles with complete response.

Results

Three hundred thirty three cycles were included in the per protocol analysis. 165 cycles for the GTDS and 168 cycles for the palonosetron were analyzed. The GTDS cycles displayed non-inferiority to palonosetron cycles during the acute phase : complete response was achieved by 75.8% of patients in the GTDS cycles, and 80.4% in the palonosetron cycles (treatment difference,-4.6%; 95% confidence interval, -13.5–4.3) and during the delayed phase: complete response was achieved by 63.6% of patients in the GTDS cycles, and 68.5% in the palonosetron cycles. There was no significant difference in complete response rate during acute phase after the end of the first cycle and the second cycle between GP group and PG group (p = 0.405, p = 0.074). Both treatments were well tolerated. Conclusion Three hundred thirty three cycles were included in the per protocol analysis. 165 cycles for the GTDS and 168 cycles for the palonosetron were analyzed. The GTDS cycles displayed non-inferiority to palonosetron cycles during the acute phase : complete response was achieved by 75.8% of patients in the GTDS cycles, and 80.4% in the palonosetron cycles (treatment difference,-4.6%; 95% confidence interval, -13.5–4.3) and during the delayed phase: complete response was achieved by 63.6% of patients in the GTDS cycles, and 68.5% in the palonosetron cycles. There was no significant difference in complete response rate during acute phase after the end of the first cycle and the second cycle between GP group and PG group (p = 0.405, p = 0.074). Both treatments were well tolerated.

Conclusions

The transdermal granisetron is well-tolerated and shows the efficacy for the control of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy is non-inferior to that of palonosetron in the acute and delayed phase.

Disclosure

All authors have declared no conflicts of interest.