Neoadjuvant Chemotherapy (
FOLFIRINOX
or Gemcitabine With Nab‐Paclitaxel) for Borderline‐Resectable Pancreatic Cancer: Long‐Term Results of a Randomized Controlled Trial (
NU
Junpei Yamaguchi, Hideki Takami, Yukihiro Yokoyama, Tsutomu Fujii, Suguru Yamada, Hiroki Kawashima, Takuya Ishikawa, Osamu Maeda, Hiroshi Ogawa, Tomoki Ebata ABSTRACT
Background
Initial results of NUPAT‐01 suggest the feasibility of multidrug neoadjuvant chemotherapy for borderline‐resectable pancreatic cancer and favorable survival of patients, and we report on the long‐term results of this study.
Methods
In this multicenter, phase II trial (NUPAT‐01), patients with borderline‐resectable pancreatic cancer were randomly assigned to receive neoadjuvant chemotherapy with either FOLFIRINOX (original regimen) or gemcitabine with nab‐paclitaxel (GEM/nab‐PTX) and underwent subsequent surgery if feasible. The primary endpoint was the R0 resection rate.
Results
Fifty‐one eligible patients were randomly assigned to FOLFIRINOX ( n = 26) or GEM/nab‐PTX ( n = 25). Forty‐three patients underwent surgery, and R0 resection was achieved in 33 patients. An Intention‐to‐treat (ITT) analysis revealed a 3‐year overall survival of 51.0% and a 5‐year overall survival of 35.3% with a median survival time of 36.5 months. No significant difference between the FOLFIRINOX group and the GEM/nab‐PTX group was found in the ITT analysis or in patient survival after surgery. However, patients with a favorable response to chemotherapy had significantly better disease‐free survival.
Conclusion
These results suggest no significant difference between the benefit of FOLFIRINOX and GEM/nab‐PTX as neoadjuvant chemotherapy for borderline‐resectable pancreatic cancer, and the survival of patients depends not on the regimen but on the response to chemotherapy.