Nab-paclitaxel (nab-P) in combination with gemcitabine (G) significantly improved overall survival in patients with pancreatic cancer and is considered as standard first line therapy. However, the efficacy and safety data in Korean patients are lacking as the phase III study was done only in Western countries.
This open-label, multicenter, phase II, single-arm study was conducted at seven hospitals in South Korea (NCT02426281). Patients with pathologically confirmed metastatic pancreatic cancer were enrolled. Patients received nab-P (125mg/m2) followed by G (1000mg/m2) on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Through a randomized phase III trial, Von Hoff et al. observed a median PFS of 3.7 months from the G alone arm and 5.5 months from the nab-P + G arm. This study is to confirm this outcome from the Korean population. We will not be interested in the combination therapy of nab-P + G if its median PFS is 3.7 months or shorter and will be highly interested in it if its median PFS is 5.5 months or longer. (90% of power and by the one-sample log-rank test with a one-sided alpha=5%).
A total of 65 patients were enrolled between May 2015 and November 2016. The median age of patients was 60 years (range 43-83), 75% of patients were male, and all had an ECOG performance status of 0 or 1. The median PFS was 7.0 months (95% CI; 5.6-8.3), which met primary endpoints. Median overall survival was 12.9 months (95% CI; 10.1-15.6) and the objective response rate was 41.5 % (95% CI; 29.5-53.5) according to RECIST v1.1. The median relative dose intensity was 84% for nab-paclitaxel and 88% for gemcitabine. Grade 3-4 adverse events included neutropenia (62%), anemia (14%), neuropathy (12%) and febrile neutropenia (9%). There was one treatment-related deaths of septic shock.
In Korean patients with metastatic pancreatic cancer, nab-paclitaxel plus gemcitabine regimen showed comparable efficacy and safety profile to previous phase III study of Western countries. Based on this result, we are conducting a phase II trial with the nab-P + G in an expansion cohort of locally advanced pancreatic cancer.
Clinical trial identification
Legal entity responsible for the study
Joon Oh Park (PI).
Nab-paclitaxel was provided by Celgene.
All authors have declared no conflicts of interest.