Pancreas

J Clin Oncol. 2023;41(11):2007–19

Tempero MA, Pelzer U, O’Reilly EM, Winter J, Oh DY, Li CP, Tortora G, Chang HM, Lopez CD, Bekaii-Saab T, Ko AH, Santoro A, Park JO, Noel MS, Frassineti GL, Shan YS, Dean A, Riess H, Van Cutsem E, Berlin J, Philip P, Moore M, Goldstein D, Tabernero J, Li M, Ferrara S, Le Bruchec Y, Zhang G, Lu B, Biankin AV, Reni M; APACT Investigators

Adjuvant nab-paclitaxel + gemcitabine in resected pancreatic ductal adenocarcinoma: Results from a randomized, open-label, phase 3 trial

Purpose: This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma.
Methods: The authors assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcita-bine (1000 mg/m2) or gemcitabine alone to one 30−40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was inde-pendently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety.
Results: 287 of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cut-off (December 31, 2018; median follow-up, 38.5 [interquartile range {IQR}, 33.8−43] months), the median independently assessed DFS was 19.4 (nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR] = 0.88; 95% confidence interval [CI]: 0.729−1.063; p = 0.18). The median investigator-assessed DFS was 16.6 (IQR, 8.4−47.0) and 13.7 (IQR, 8.3−44.1) months, respectively (HR = 0.82; 95% CI: 0.694−0.965; p = 0.02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7−53.3) months, re-spectively (HR = 0.82; 95% CI: 0.680−0.996; p = 0.045). At a 16-month follow-up (cut-off, April 3, 2020; median follow-up, 51.4 [IQR, 47.0−57.0] months), the median OS (511 events; 81% mature) was 41.8 (nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR = 0.82; 95% CI: 0.687−0.973; p = 0.0232). At the 5-year follow-up (cut-off, April 9, 2021; median follow-up, 63.2 [IQR, 60.1−68.7] months), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR = 0.80; 95% CI: 0.678−0.947; p = 0.0091). 86% (nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events.

Conclusion: The primary end point (independently assessed disease-free survival) was not met despite favorable overall survival seen with nab-paclitaxel + gemcitabine.

M.A. Tempero, M.D., Professor of Medicine, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA,
E-Mail: mtempero@medicine.ucsf.edu

DOI: 10.1200/jco.22.01134

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