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Efficacy and Safety of Oral NEPA (Netupitant/Palonosetron), the First Fixed-Combination Antiemetic, in Patients With Gynecological Cancers Receiving Platinum-Based Chemotherapy
  1. Snežana M. Bošnjak, MD, PhD*,
  2. Ljiljana Stamatovic, MD*,
  3. Maria Elisa Borroni, BS,
  4. Giada Rizzi, BS and
  5. Karin Jordan, MD
  1. *Department of Supportive Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia;
  2. Helsinn Healthcare SA, Lugano/Pazzallo, Switzerland; and
  3. Department of Medicine V, University of Heidelberg, Heidelberg, Germany.
  1. Address correspondence and reprint requests to Snežana M. Bošnjak, MD, PhD, Department of Supportive Oncology, Institute for Oncology and Radiology of Serbia, Pasterova 14, Belgrade, Serbia. E-mail: nena.bosnjak@gmail.com.

Abstract

Objective Patients with gynecological cancers are at high risk for chemotherapy-induced nausea and vomiting (CINV) after platinum-based chemotherapy (CT). NEPA (300-mg netupitant, 0.50-mg palonosetron) is the first oral fixed-combination antiemetic. Pivotal trials demonstrated the superiority of oral NEPA over intravenous palonosetron in preventing CINV after highly emetogenic (anthracycline-cyclophosphamide–based [AC] and cisplatin-based [non-AC]) CT. This post hoc subset analysis considered patients with gynecological cancer receiving cisplatin- or carboplatin-based CT from 1 pivotal trial and from 1 multicycle safety trial to evaluate the efficacy of oral NEPA in preventing CINV.

Methods Single-dose NEPA was given before CT in combination with dexamethasone. The efficacy end points for the acute (0–24 hours), delayed (25–120 hours), and overall (0–120 hours) CINV phases after CT included complete response (CR; no emesis, no rescue medication) and no significant nausea (<25 mm on a 0- to 100-mm visual analog scale). Safety was also assessed.

Results For cisplatin-induced CINV, NEPA achieved high CR rates (acute phase: >90%; delayed, overall phases: ≥85%). For carboplatin-induced CINV, NEPA was also highly effective, with high acute, delayed, and overall CR rates (cycle 1: >75%; cycles 2–4: >95%). No significant nausea rates were more than 90% and more than 80% in the acute and delayed phases, respectively, for patients receiving cisplatin or carboplatin. NEPA was well tolerated.

Conclusions Results suggest that oral NEPA is effective and safe in preventing CINV in patients with gynecological cancers treated with cisplatin- or carboplatin-based CT. Single fixed-combination NEPA is a convenient option for CINV prevention in high-risk CINV patients.

  • CINV
  • NEPA
  • Gynecological cancer
  • Antiemetic
  • Netupitant

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Footnotes

  • The trials described within this article were sponsored by Helsinn Healthcare SA, Lugano, Switzerland. Editorial and medical writing assistance was provided by Joanne Franklin, PhD, CMPP, TRM Oncology, The Hague, the Netherlands, and funded by Helsinn Healthcare SA, Lugano, Switzerland.

  • S.M.B. received consultancy and/or honoraria from Helsinn. M.E.B. is an employee at Helsinn Healthcare SA. G.R. is an employee at Helsinn Healthcare SA. K.J. received consultancy and/or honoraria from MSD, Merck, Tesaro, Helsinn. L.S. declares no conflicts of interest.

  • Helsinn Healthcare SA also participated in the writing, review, and approval of the article.

  • This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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