Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial.

ABSTRACT:

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 (ClinicalTrials.gov identifier: NCT01964430).

Methods

We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m²) + gemcitabine (1,000 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 independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety.

Results

Two hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel +

SUBMITTER: Tempero MA 

PROVIDER: S-EPMC10082313 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature