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Efficacy of single dose NEPA, a fixed combination of netupitant and palonosetron, versus a 3-day regimen of aprepitant/granisetron (APR/GRAN) for prevention of nausea in patients receiving high dose cisplatin

Date

24 Nov 2018

Session

Poster display - Cocktail

Presenters

Arunee Dechaphunkul

Citation

Annals of Oncology (2018) 29 (suppl_9): ix129-ix138. 10.1093/annonc/mdy444

Authors

A. Dechaphunkul1, S. Lu2, S. Olivari3, L. Zhang4

Author affiliations

  • 1 Division Of Medical Oncology, Prince of Songkla University, 90110 - Songkhla/TH
  • 2 Shanghai Chest Hospital, Shanghai Jiao Tong University, 200030 - Shanghai/CN
  • 3 Medical Affairs, Helsinn Healthcare, Lugano/CH
  • 4 State Key Laboratory Of Oncology In South China, Collaborative Innovation Center For Cancer Medicine, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
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Background

Antiemetic guidelines recommend an NK1 receptor antagonist (NK1RA), a 5-HT3RA, and dexamethasone (DEX) for patients receiving cisplatin-based highly emetogenic chemotherapy (HEC), regardless of dose. In a head-to-head trial in Asia a single dose of NEPA was non-inferior to a 3-day regimen of APR/GRAN for overall (0-120 h) complete response (no emesis/no rescue). While prevention of vomiting has improved with multimodal combination regimens, attention has shifted to evaluating control of nausea, widely regarded as the greater unmet need. This post-hoc analysis evaluated nausea control for NEPA vs APR/GRAN in the subset of patients receiving the highest doses (≥70 mg/m2) of cisplatin.

Methods

In this randomized double-blind, parallel group study chemotherapy-naïve patients with solid tumors received either a single oral dose of NEPA prior to cisplatin-based (>50 mg/m2) HEC or a 3-day regimen of APR/GRAN, both with oral DEX on days 1-4. This post-hoc analysis evaluated no significant nausea rates (NSN: defined as < 25mm on 100mm VAS) for pts receiving cisplatin at doses ≥70 mg/m2. The risk difference for NEPA – APR/GRAN and 95% confidence intervals were analyzed using the Cochran-Mantel-Haenszel (CMH) test for NSN during each of the 5 days post-cisplatin.

Results

The high dose cisplatin subset (n = 490) constituted 59% of the total population (n = 828). Patient characteristics were similar between groups; most patients were male (72%), mean age 54, lung cancer (65%) was most common. NSN rates were similar for the groups on Days 1-2 and significantly higher for NEPA on Days 3-5 (Table).Table: 428P

%PatientsNEPA (N = 251)APR/GRAN (N = 239)Difference NEPA - APR/GRAN (95% CI)p-value
Day 188.484.14.5 (-1.5, 10.6)0.140
Day 283.376.66.9 (-0.1,13.9)0.054
Day 386.177.09.2 (2.4, 16.0)0.008
Day 485.778.27.5 (0.7, 14.3)0.031
Day 586.977.49.6 (2.8, 16.3)0.005

Conclusions

As a fixed NK1RA/5HT3RA combination in a single capsule given once/cycle, NEPA offers patients an effective convenient antiemetic that may offer an advantage over a standard 3-day APR/GRAN regimen in preventing nausea in pts receiving high doses of cisplatin-based HEC.

Editorial acknowledgement

Jennifer Vanden Burgt.

Clinical trial identification

Legal entity responsible for the study

Helsinn Healthcare.

Funding

Helsinn Healthcare.

Disclosure

S. Lu: Consultant: Boehringer Ingelheim, Roche; Speaker\'s bureau: Lilly; Travel reimbursed: Hutchison, Medipharm Limited. S. Olivari: Employee: Helsinn Healthcare. L. Zhang: Consultant: MSD; Research Funding Helsinn, Lilly, MSD. All other authors have declared no conflicts of interest.

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