Nivolumab plus chemotherapy for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: Analysis of number needed to treat and number needed to harm Journal Article
| Authors: | Sugarman, R.; Betts, K. A.; Nie, X.; Hartman, J.; Nguyen, H. |
| Article Title: | Nivolumab plus chemotherapy for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: Analysis of number needed to treat and number needed to harm |
| Abstract: | Purpose: 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. Methods: 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. Findings: 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. Implications: 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. © 2023 Elsevier Inc. |
| Keywords: | immunohistochemistry; adult; cancer chemotherapy; controlled study; treatment outcome; major clinical study; overall survival; fluorouracil; side effect; capecitabine; antineoplastic agent; adenocarcinoma; progression free survival; antineoplastic metal complex; anemia; nausea; vomiting; antineoplastic combined chemotherapy protocols; pathology; folinic acid; oxaliplatin; esophageal adenocarcinoma; stomach adenocarcinoma; stomach neoplasms; fluoropyrimidine; esophagus tumor; esophageal neoplasms; stomach tumor; attributable risk; triacylglycerol lipase; esophagogastric junction; programmed death 1 receptor; post hoc analysis; gastroesophageal junction adenocarcinoma; gastroesophageal junction; nivolumab; humans; human; male; female; article; treatment response time; adenocarcinoma of esophagus; numbers needed to treat |
| Journal Title: | Clinical Therapeutics |
| Volume: | 45 |
| Issue: | 11 |
| ISSN: | 0149-2918 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2023-11-01 |
| Start Page: | 1155 |
| End Page: | 1158 |
| Language: | English |
| DOI: | 10.1016/j.clinthera.2023.08.014 |
| PUBMED: | 37748935 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- MSK corresponding author is Ryan Sugarman -- Source: Scopus |
