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Patrick M. Forde, Jonathan Spicer, Shun Lu, Mariano Provencio, Tetsuya Mitsudomi, Mark M. Awad, Enriqueta Felip, Stephen R. Broderick, Julie R. Brahmer, Scott J. Swanson and 19 more
BACKGROUND: Neoadjuvant or adjuvant chemotherapy confers a modest benefit over surgery alone for resectable non-small-cell lung cancer (NSCLC). In early-phase trials, nivolumab-based neoadjuvant regimens have shown promising clinical activity; however, data from phase 3 trials are needed to confirm these findings. METHODS: In this open-label, phase 3 trial, we randomly assigned patients with stage IB to IIIA resectable NSCLC to receive nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection. The primary end points were event-free survival and pathological complete response (0% viable tumor in resected lung and lymph nodes), both evaluated by blinded independent review. Overall survival was a key secondary end point. Safety was assessed in all treated patients. RESULTS: The median event-free survival was 31.6 months (95% confidence interval [CI], 30.2 to not reached) with nivolumab plus chemotherapy and 20.8 months (95% CI, 14.0 to 26.7) with chemotherapy alone (hazard ratio for disease progression, disease recurrence, or death, 0.63; 97.38% CI, 0.43 to 0.91; P = 0.005). The percentage of patients with a pathological complete response was 24.0% (95% CI, 18.0 to 31.0) and 2.2% (95% CI, 0.6 to 5.6), respectively (odds ratio, 13.94; 99% CI, 3.49 to 55.75; P<0.001). Results for event-free survival and pathological complete response across most subgroups favored nivolumab plus chemotherapy over chemotherapy alone. At the first prespecified interim analysis, the hazard ratio for death was 0.57 (99.67% CI, 0.30 to 1.07) and did not meet the criterion for significance. Of the patients who underwent randomization, 83.2% of those in the nivolumab-plus-chemotherapy group and 75.4% of those in the chemotherapy-alone group underwent surgery. Grade 3 or 4 treatment-related adverse events occurred in 33.5% of the patients in the nivolumab-plus-chemotherapy group and in 36.9% of those in the chemotherapy-alone group. CONCLUSIONS: In patients with resectable NSCLC, neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival and a higher percentage of patients with a pathological complete response than chemotherapy alone. The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence of adverse events or impede the feasibility of surgery. (Funded by Bristol Myers Squibb; CheckMate 816 ClinicalTrials.gov number, NCT02998528.).
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Forde, P. M., Spicer, J., Lu, S., Provencio, M., Mitsudomi, T., Awad, M. M., Felip, E., Broderick, S. R., Brahmer, J. R., Swanson, S. J., Kerr, K., Wang, C., Ciuleanu, T.-E., Saylors, G. B., Tanaka, F., Ito, H., Chen, K.-N., Liberman, M., Vokes, E. E., … Girard, N. (2022). Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. New England Journal of Medicine, 386(21), 1973–1985. https://doi.org/10.1056/nejmoa2202170
Forde, Patrick M., et al. "Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer." New England Journal of Medicine, vol. 386, no. 21, 2022, pp. 1973–1985, https://doi.org/10.1056/nejmoa2202170.
Forde, Patrick M., Jonathan Spicer, Shun Lu, Mariano Provencio, Tetsuya Mitsudomi, Mark M. Awad, Enriqueta Felip, et al. "Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer." New England Journal of Medicine 386, no. 21 (2022): 1973–1985. https://doi.org/10.1056/nejmoa2202170.
Forde P. M., Spicer J., Lu S. [и др.] Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer // New England Journal of Medicine. — 2022. — Vol. 386, № 21. — P. 1973–1985. — URL: https://doi.org/10.1056/nejmoa2202170
@article{forde2022neoadjuvant,
title = {{Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer}},
author = {Patrick M. Forde and Jonathan Spicer and Shun Lu and Mariano Provencio and Tetsuya Mitsudomi and Mark M. Awad and Enriqueta Felip and Stephen R. Broderick and Julie R. Brahmer and Scott J. Swanson and Keith Kerr and Changli Wang and Tudor-Eliade Ciuleanu and Gene B. Saylors and Fumihiro Tanaka and Hiroyuki Ito and Ke-Neng Chen and Moïshe Liberman and Everett E. Vokes and Janis M. Taube and Cecile Dorange and Junliang Cai and Joseph Fiore and Anthony Jarkowski and David Balli and Mark Sausen and Dimple Pandya and Christophe Yannick Calvet and Nicolas Girard},
journal = {New England Journal of Medicine},
year = {2022},
volume = {386},
number = {21},
pages = {1973--1985},
doi = {10.1056/nejmoa2202170},
url = {https://doi.org/10.1056/nejmoa2202170}
}TY - JOUR AU - Forde, Patrick M. AU - Spicer, Jonathan AU - Lu, Shun AU - Provencio, Mariano AU - Mitsudomi, Tetsuya AU - Awad, Mark M. AU - Felip, Enriqueta AU - Broderick, Stephen R. AU - Brahmer, Julie R. AU - Swanson, Scott J. AU - Kerr, Keith AU - Wang, Changli AU - Ciuleanu, Tudor-Eliade AU - Saylors, Gene B. AU - Tanaka, Fumihiro AU - Ito, Hiroyuki AU - Chen, Ke-Neng AU - Liberman, Moïshe AU - Vokes, Everett E. AU - Taube, Janis M. AU - Dorange, Cecile AU - Cai, Junliang AU - Fiore, Joseph AU - Jarkowski, Anthony AU - Balli, David AU - Sausen, Mark AU - Pandya, Dimple AU - Calvet, Christophe Yannick AU - Girard, Nicolas TI - Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer JO - New England Journal of Medicine VL - 386 IS - 21 SP - 1973 EP - 1985 PY - 2022 DA - 2022/04/11 DO - 10.1056/nejmoa2202170 UR - https://doi.org/10.1056/nejmoa2202170 ER -
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