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:
Corresponding author: Sagar Bhagat, MD, Doctor, Medical Services, Glenmark Pharmaceutical limited, B D Sawant Road, Andheri East, Mumbai, Maharashtra 400099, India.
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
Research background

Chemotherapy induced nausea and vomiting (CINV) is one of the most feared adverse events with patient receving chemotherapy regimens. Pathomechanistically, serotonin and substance P are major neurotransmitters involved in acute and delayed CINV, targeting both optimizes CINV control. NEPA, an oral fixed dose combination Netupitant (300 mg) and Palonosetron (0.50 mg), was recently approved in India for the management of CINV. Hence there was a need to evaluate the effectiveness of NEPA in Indian setting in real world scenario.

Research motivation

To analyse the effectiveness of NEPA in prevention of CINV among Indian patients who have received highly and moderately emetogenic chemotherapy regimen.

Research objectives

To elucidate the clinical effectiveness of NEPA, in terms of the complete response in acute-delayed and overall phase of nausea-vomiting irrespective of the chemotherapy cycle. Thereby, we hope to generate the real world evidnce on the usefulness of NEPA in the management of CINV patients in India.

Research methods

Medical records and patient diaries of adults cancer patients who were treated with highly emetogenic or moderately emetogenic chemotherapy and received NEPA irrespective of the number of chemotherapy cycles from June 2019 to December 2019 were retrieved. Relevant clinical variables such as presence or absence of nausea-vomiting and if present, the severity of nausea on visual analog scale and cycle wise distribution of the data were captured.

Research results

The study demonstrated that complete response in overall phase was 93.79% whereas it was 98.01% in acute CINV and 93.79% in delayed CINV. Overall complete response in highly emetogenic chemotherapy group of patients was 93.63% and in moderately emetogenic group of patients was 93.98%.

Research conclusions

We found that the oral fixed dose combination of netupitant 300 mg and palonosetron hydrochloride 0.5 mg is effective in preventing CINV in patients receiving highly or moderately emetogenic chemotherapy regimen in the real world setting. Also, the response was consistent across number of chemotherapy cycles.

Research perspectives

This study demonstrated the clinical effectiveness of NEPA among Indian patients in managing CINV, and serves as an impetus for future research.