Retrospective Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Aug 24, 2020; 11(8): 606-613
Published online Aug 24, 2020. doi: 10.5306/wjco.v11.i8.606
Effectiveness of a novel, fixed dose combination of netupitant and palonosetron in prevention of chemotherapy induced nausea and vomiting: A real-life study from India
Bharat Vaswani, Sagar Bhagat, Saiprasad Patil, Hanmant Barkate
Bharat Vaswani, Medical Oncology, Yashoda Cancer Institute, Secunderabad 500003, India
Sagar Bhagat, Saiprasad Patil, Hanmant Barkate, Medical Services, Glenmark Pharmaceutical limited, Mumbai 400099, India
Author contributions: Vaswani B and Bhagat S designed the research; Vaswani B performed the research; Bhagat S, Patil S and Barkate H analysed the data; Bhagat S, Patil S and Barkate H wrote the paper.
Institutional review board statement: The study was reviewed and approved by the ethics committee at the St.Theresa's hospital Library.
Informed consent statement: Institutional review board has granted waiver of informed consent based on ethical considerations
Conflict-of-interest statement: We have no financial relationships to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Sagar Bhagat, MD, Doctor, Medical Services, Glenmark Pharmaceutical limited, B D Sawant Road, Andheri East, Mumbai, Maharashtra 400099, India. sagar.bhagat@glenmarkpharma.com
Received: February 17, 2020
Peer-review started: February 17, 2020
First decision: March 28, 2020
Revised: April 9, 2020
Accepted: July 26, 2020
Article in press: July 26, 2020
Published online: August 24, 2020
Processing time: 185 Days and 18.3 Hours
Abstract
BACKGROUND

A new, oral fixed dose combination of highly selective neurokinin-1 receptor antagonist, netupitant with 5HT3 receptor antagonist, netupitant and palonosetron (NEPA) was approved in India for prevention of chemotherapy induced nausea and vomiting (CINV).

AIM

To assess effectiveness of NEPA in real-world scenario.

METHODS

We retrospectively assessed the medical records and patient dairies of adult patients who received highly emetogenic or moderately emetogenic chemotherapy (HEC/MEC) and treated with NEPA (Netupitant 300 mg + Palanosetron 0.50 mg) for prevention of CINV. Complete response (CR) was defined as no emesis or no requirement of rescue medication in overall phase (0 to 5 d), acute phase (0-24 h) and delayed phase (2 to 5 d).

RESULTS

In 403 patients included in the analysis, mean age was 56.24 ± 11.11 years and 55.09% were females. Breast cancer (25.06%) was most common malignancy encountered. HEC and MEC were administered in 54.6% and 45.4% patients respectively. CR in overall phase was 93.79% whereas it was 98.01% in acute CINV and 93.79% in delayed CINV. Overall CR in HEC and MEC groups was 93.63% and 93.98% respectively. CR was more than 90% in different chemotherapy cycles except in group of patients of cycle 4 where CR was 88.88%.

CONCLUSION

NEPA is a novel combination that is effective in preventing CINV in up to 93% cases treated with highly emetogenic or moderately emetogenic chemotherapy. This study brings the first real-life evidence of its effectiveness in India population.

Keywords: Chemotherapy induced nausea vomiting; Netupitant; Palonosetron; Cancer; Chemotherapy

Core tip: A fixed-dose combination of Netupitant (300 mg) and Palonosetron (0.50 mg) indicated for the prevention of acute and delayed phase of nausea-vomiting in patients on highly and moderately emetogenic chemotherapeutic regimen was recently approved in India. There was no data on the effectiveness of this fixed dose combination in Indian patients in real world setting,the pervious data available was part of regulatory trial conducted in controlled environment, which may not give the real picture of the usage of the molecule in clinical setting. So to look for the effectiveness of the molecule in real world setting this study was conducted among.