Dr. Bekaii-Saab on the APACT Trial in Pancreatic Cancer

Tanios S. Bekaii-Saab, MD, FACP, medical oncologist, medical director, Cancer Clinical Research Office, vice chair and section chief, Medical Oncology, Department of Internal Medicine, Mayo Clinic, discusses the implications of the randomized phase III APACT trial (NCT01964430) evaluating gemcitabine alone versus gemcitabine plus nab-paclitaxel (Abraxane) as adjuvant therapy in patients with pancreatic cancer.

The primary endpoint of disease-free survival (DFS) was not met in APACT. At a median follow up of 38.5 months, DFS per independent review was 19.4 months with the combination compared with 18.8 months with gemcitabine alone (HR, 0.88; 95% CI, 0.729-1.063; stratified log-rank P = 0.1824).

Notably, investigator assessed DFS was 16.6 months with the combination and 13.7 months with gemcitabine alone (HR, 0.82; 95% CI, 0.694-0.965; P = 0.0168). These results were closer to the expected outcome, says Bekaii-Saab.

Additional analysis showed that overall survival was improved with nab-paclitaxel and gemcitabine versus gemcitabine alone at 40.5 months and 36.2 months respectively.

Although the trial was negative, the combination may be an option for patients who cannot tolerate standard FOLFIRINOX, says Bekaii-Saab.