Gemcitabine/Nab-Paclitaxel Fails to Best Adjuvant Gemcitabine in Pancreatic Cancer

Adjuvant chemotherapy after resection of pancreatic cancer includes either 6 months of modified FOLFIRINOX, the preferred option, or the combination of gemcitabine and capecitabine. Investigators now report the results of an industry-sponsored, randomized, phase 3 trial comparing 6 months of adjuvant gemcitabine to the combination of gemcitabine and nab-paclitaxel after resection of pancreatic cancer.

Of 866 patients, median age was 64 and 56% were male. Most patients had primaries of the head of the pancreas (81%), were node positive (72%), and had a normal carbohydrate antigen 19-9 level (80%); a minority had surgical margins <1 mm from the tumor (26%).

At a median follow-up of 38.5 months, the combination of gemcitabine/nab-paclitaxel did not lead to improvement in the primary outcome — centrally assessed disease-free survival (DFS) — compared with gemcitabine alone (median, 18.8 vs. 19.4 months; hazard ratio, 0.88; P=0.1824). The secondary endpoint of investigator-assessed DFS favored combination therapy over single-agent gemcitabine (median, 16.6 vs. 13.7 months; HR, 0.82; P=0.02) as did overall survival (OS; median, 40.5 vs. 36.2 months; HR, 0.82; P=0.045) and 5-year OS (38% vs. 34%; HR, 0.80; P=0.0091). Rates of one or more grade 3 or higher treatment-related adverse events, including neutropenia, anemia, fatigue, and peripheral neuropathy, were higher with gemcitabine/nab-paclitaxel than single-agent gemcitabine (86% vs. 68%).