342P - Comparison of 0.25 mg versus 0.75 mg of palonosetron in combination with aprepitant and dexamethasone for prevention of chemotherapy-induced nausea and vomiting following cisplatin-containing chemotherapy in patients with esophageal cancer

Background

Palonosetron (PALO) is a second generation 5HT-3 receptor antagonist recommended as a preferred drug for high-emetogenic chemotherapies. PALO 0.25 mg has been reported to be as effective as 0.75 mg with less adverse events, such as constipation, when used alone or in combination with dexamethasone (DEX). The efficacy and safety of PALO 0.25 mg compared to 0.75 mg in combination with aprepitant (APR) plus DEX in patients (pts) with esophageal cancer remain unclear.

Methods

We retrospectively evaluated the efficacy and safety of PALO 0.25 mg versus 0.75 mg in combination with APR plus DEX in pts with localized or metastatic esophageal cancer who received cisplatin (CDDP)-containing chemotherapy between Nov. 2015 and Mar. 2017 at our institution. Complete response was defined as no emetic episodes and no rescue medication use.

Results

This study enrolled 58 and 55 pts who received PALO 0.25 mg and 0.75 mg. The baseline characteristics were similar between both groups. Sixteen (28%) and 24 (44%) pts received triplet regimen (docetaxel, CDDP and 5-fluorouracil), respectively. The complete response rates were 72% for 0.25 mg and 62% for 0.75 mg, with no significant difference (odds ratio [OR] = 0.62, p = 0.23). Percentages of no nausea was also similar with 40% and 33%, respectively (OR = 0.74, p = 0.44). Grade 2-3 constipation and any grade of aspartate aminotransferase increase were more frequently observed in 0.75 mg group (38% vs. 58%, p < 0.05; 7% vs. 22%, p < 0.05). In univariate and multivariate analyses, no association between baseline characteristics, including dose of PALO, and complete response rate was observed. Meanwhile, PALO 0.75 mg, older age, localized disease, and tobacco consumption were significantly associated with grade 2 or more constipation (OR = 0.28, p < 0.01; OR = 0.28, p < 0.01; OR = 3.09, p < 0.05; OR = 0.27, p < 0.05).

Conclusions

PALO 0.25 mg in combination with APR plus DEX may contributed to the decrease in constipation in pts with esophageal cancer who received CDDP-containing chemotherapy without compromising the anti-emetic effect compared to 0.75 mg.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

National Cancer Center.

Funding

Has not received any funding.

Disclosure

Y. Nakamura: Research grant/Funding (institution): Taiho Pharmaceutical. H. Taniguchi: Honoraria (self): Bayer; Honoraria (self): Sanofi; Honoraria (self), Research grant/Funding (institution): Takeda; Honoraria (self): Chugai; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Lilly Japan; Honoraria (self): Merck Serono; Honoraria (self): Yakult Honsha; Honoraria (self): MBL; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): MSD; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Daiichi-Sankyo; Honoraria (self): Mitsubishi Tanabe Pharma; Honoraria (self): Nippon Kayaku; Research grant/Funding (institution): Sumitomo-Dainippon Pharma; Research grant/Funding (institution): Array BioPharma; Research grant/Funding (institution): MSD Oncology; Research grant/Funding (institution): Ono Pharmaceutical; Research grant/Funding (institution): Sysmex. T. Kojima: Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Advisory/Consultancy, Research grant/Funding (institution): MSD; Research grant/Funding (institution): Astellas Amgen BioPharma; Research grant/Funding (institution): Chugaiseiyaku; Research grant/Funding (institution): Parexel; Research grant/Funding (institution): Shionogi; Advisory/Consultancy: Bristol-Myers Squibb Company; Advisory/Consultancy: Merck Biopharma; Honoraria (self): Oncolys BioPharma. T. Yoshino: Research grant/Funding (institution): Novartis Pharma; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Sumitomo Dainippon Pharma; Research grant/Funding (institution): Chugai; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Daiichi-Sankyo; Research grant/Funding (institution): Parexel International; Research grant/Funding (institution): Ono Pharmaceutical; Research grant/Funding (institution): GlaxoSmithKline. All other authors have declared no conflicts of interest.