The following is a summary of “Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial,” published in the April 2023 issue of Oncology by Tempero, et al.
For a study, researchers sought to compare the efficacy and safety of adjuvant nab-paclitaxel plus gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma.
In a randomized, open-label trial, 866 treatment-naive patients with pancreatic ductal adenocarcinoma were assigned to receive nab-paclitaxel (125 mg/m2) plus gemcitabine (1,000 mg/m2) or gemcitabine alone, administered intravenously on days 1, 8, and 15 of six 28-day cycles. The primary endpoint was independently assessed disease-free survival (DFS), with additional endpoints including investigator-assessed DFS, overall survival (OS), and safety.
A total of 287 of 432 patients received nab-paclitaxel + gemcitabine, whereas 310 of 434 patients received gemcitabine. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 months with nab-paclitaxel plus gemcitabine versus 18.8 months with gemcitabine alone (hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P = .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 to 0.965; P = .02). The median OS was 40.5 (IQR, 20.7 to not reached) months with nab-paclitaxel plus gemcitabine and 36.2 (IQR, 17.7-53.3) months with gemcitabine alone (HR, 0.82; 95% CI, 0.680 to 0.996; P = .045) at primary data cutoff, with similar results at the 16-month (median follow-up, 51.4 months [IQR, 47.0-57.0]) and 5-year (median follow-up, 63.2 months [IQR, 60.1-68.7]) follow-ups (median OS of 41.8 vs. 37.7 months, HR 0.82 and median OS of 41.8 vs. 37.7 months, HR 0.80, respectively). The incidence of grade ≥ 3 treatment-emergent adverse events was 86% with nab-paclitaxel plus gemcitabine and 68% with gemcitabine alone, with two deaths from treatment-emergent adverse events in each study arm.
The primary endpoint of independently assessed DFS was not met, despite favorable OS seen with nab-paclitaxel plus gemcitabine.