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LBA-1 Phase 3 APACT trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P + Gem) vs gemcitabine (Gem) alone in patients with resected pancreatic cancer (PC): Updated 5-year overall survival

2021; Elsevier BV; Volume: 32; Linguagem: Inglês

10.1016/j.annonc.2021.06.009

1569-8041

Margaret A. Tempero, Eileen M. O’Reilly, Eric Van Cutsem, Jordan Berlin, P. A. Philip, David Goldstein, Josep Tabernero, Mitesh J. Borad, J-B. Bachet, Vibeke Parner, Niall C. Tebbutt, Yu Chua, Pippa Corrie, Marion Harris, Julien Taı̈eb, Matthew Burge, Volker Kunzmann, G. Zhang, D. McGovern, Helen Margaret Marks, Andrew V. Biankin, Michele Reni,

Renal cell carcinoma treatment

The APACT trial evaluated the safety and efficacy of adjuvant nab -P + Gem vs Gem alone in patients with resected PC. Between April 2014 and April 2016, 866 patients were randomized. As previously reported, APACT did not meet the primary endpoint of independently assessed disease-free survival (DFS); however, the prespecified sensitivity analysis for median investigator-assessed DFS was 16.6 months with nab -P + Gem and 13.7 months with Gem (HR, 0.82; 95% CI, 0.694–0.965; nominal P=0.0168). The overall survival (OS; secondary endpoint) at the time of the primary analysis trended in favor of nab -P + Gem: median 40.5 vs 36.2 months (427 events; 68% mature; HR, 0.82; 95% CI, 0.680–0.996; nominal P=0.045).