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http://hdl.handle.net/10553/128212
Título: | Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer | Autores/as: | Wakelee, H Liberman, M Kato, T Tsuboi, M Lee, SH Gao, SG Chen, KN Dooms, C Majem, M Eigendorff, E Martinengo, GL Bylicki, O Rodríguez Abreu, Delvys Chaft, JE Novello, S Yang, J Keller, SM Samkari, A Spicer, JD |
Clasificación UNESCO: | 32 Ciencias médicas 320713 Oncología 3209 Farmacología |
Palabras clave: | Hematology/Oncology Lung Cancer Pulmonary/Critical Care Pulmonary/Critical Care General Treatments in Oncology |
Fecha de publicación: | 2023 | Publicación seriada: | New England Journal of Medicine | Resumen: | Background: Among patients with resectable early-stage non-small-cell lung cancer (NSCLC), a perioperative approach that includes both neoadjuvant and adjuvant immune checkpoint inhibition may provide benefit beyond either approach alone. Methods: We conducted a randomized, double-blind, phase 3 trial to evaluate perioperative pembrolizumab in patients with early-stage NSCLC. Participants with resectable stage II, IIIA, or IIIB (N2 stage) NSCLC were assigned in a 1:1 ratio to receive neoadjuvant pembrolizumab (200 mg) or placebo once every 3 weeks, each of which was given with cisplatin-based chemotherapy for 4 cycles, followed by surgery and adjuvant pembrolizumab (200 mg) or placebo once every 3 weeks for up to 13 cycles. The dual primary end points were event-free survival (the time from randomization to the first occurrence of local progression that precluded the planned surgery, unresectable tumor, progression or recurrence, or death) and overall survival. Secondary end points included major pathological response, pathological complete response, and safety. Results: A total of 397 participants were assigned to the pembrolizumab group, and 400 to the placebo group. At the prespecified first interim analysis, the median follow-up was 25.2 months. Event-free survival at 24 months was 62.4% in the pembrolizumab group and 40.6% in the placebo group (hazard ratio for progression, recurrence, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.72; P<0.001). The estimated 24-month overall survival was 80.9% in the pembrolizumab group and 77.6% in the placebo group (P=0.02, which did not meet the significance criterion). A major pathological response occurred in 30.2% of the participants in the pembrolizumab group and in 11.0% of those in the placebo group (difference, 19.2 percentage points; 95% CI, 13.9 to 24.7; P<0.0001; threshold, P=0.0001), and a pathological complete response occurred in 18.1% and 4.0%, respectively (difference, 14.2 percentage points; 95% CI, 10.1 to 18.7; P<0.0001; threshold, P=0.0001). Across all treatment phases, 44.9% of the participants in the pembrolizumab group and 37.3% of those in the placebo group had treatment-related adverse events of grade 3 or higher, including 1.0% and 0.8%, respectively, who had grade 5 events. Conclusions: Among patients with resectable, early-stage NSCLC, neoadjuvant pembrolizumab plus chemotherapy followed by resection and adjuvant pembrolizumab significantly improved event-free survival, major pathological response, and pathological complete response as compared with neoadjuvant chemotherapy alone followed by surgery. Overall survival did not differ significantly between the groups in this analysis. | URI: | http://hdl.handle.net/10553/128212 | ISSN: | 0028-4793 | DOI: | 10.1056/NEJMoa2302983 | Fuente: | New England Journal of Medicine [0028-4793], v. 389, pp. 491-503 (agosto 2023) |
Colección: | Artículos |
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