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Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: Analysis of Number Needed To Treat and Number Needed To Harm.

Authors
  • Sugarman, Ryan1
  • Betts, Keith A2
  • Nie, Xiaoyu2
  • Hartman, John3
  • Nguyen, Hiep3
  • 1 Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: [email protected].
  • 2 Analysis Group Inc, Los Angeles, California.
  • 3 Bristol-Myers Squibb, Lawrenceville, New Jersey. , (Jersey)
Type
Published Article
Journal
Clinical therapeutics
Publication Date
Nov 01, 2023
Volume
45
Issue
11
Pages
1155–1158
Identifiers
DOI: 10.1016/j.clinthera.2023.08.014
PMID: 37748935
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Nivolumab, a programmed cell death protein (PD)-1 inhibitor, was approved by the US Food and Drug Administration in 2021 advanced/metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, in combination with fluoropyrimidine and platinum-based chemotherapy. In the present study, the number needed to treat (NNT) for overall survival (OS), progression-free survival (PFS), and objective response rate (ORR)-and the number needed to harm (NNH) for tolerability outcomes-with nivolumab + chemotherapy versus chemotherapy alone were determined. NNT and NNH were calculated as the reciprocal of the risk difference between the two treatment arms, with the 95% CIs calculated as the reciprocals of the upper and lower bounds of the 95% CI of the risk difference, using data from the CheckMate 649 study. Among all treated patients, the NNTs for OS over 1 and 2 years were 15.15 and 12.05; for PFS, 10.87 and 19.61; and for ORR over the entire trial period, 8.95. The corresponding NNTs in the subgroup with PD-L1 CPS ≥5 were less. The NNH for grade ≥3 treatment-related adverse events (TEAEs) over 1 year among all treated patients was 7.02. The small estimated NNT values in this study suggest that patients would benefit from nivolumab + chemotherapy, and while the NNH for grade ≥3 TRAEs was small, the NNH for any individual TRAE were large or negative. Copyright © 2023 Elsevier Inc. All rights reserved.

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