Neoadjuvant treatment strategy has been investigated for patients (pts) with borderline resectable pancreatic cancer (BRPC). Although FOLFIRINOX has been more widely used based on its success in patients with metastatic disease, there is lack of data based on the prospective randomized trial in this setting. Therefore, we performed retrospective analysis comparing the efficacy of FOLFIRINOX and gemcitabine-based regimen.
Between February 2013 and December 2014, a total of 18 patients with histologically confirmed BRPC according to the NCCN resectability criteria were treated with FOLFIRINOX. For the comparative analysis, data of all patients with BRPC (n = 18) in our previous phase 2 study of neoadjuvant gemcitabine plus capecitabine (GEM-CAP) were extracted and included in the current analysis (Lee et al., Surgery 2012;152:851-62).
In pts treated with FOLFIRINOX, median age was 54 year old (range, 29-73), and 9 patients (50%) were male. There were no significant differences in baseline characteristics between FOLFIRINOX and GEM-CAP groups, except the number of chemotherapy cycles (median 6 vs 3, respectively, p = 0.02). Surgical resection was performed in 12 pts (67%) with FOLFIRINOX and 11 pts (61%) with GEM-CAP (p = 1.00). R0 resection rates were 50% (n = 9) in each group. Progression-free survival (PFS) was significantly higher in the FOLFIRINOX group compared to GEM-CAP group (median 16.8 months [95% CI, 9.4-24.2] vs 6.5 months [1.6-11.3]; p = 0.044) and there was a trend toward improved overall survival (OS) in the FOLFIRINOX group (median 21.2 months [95% CI, 15.0-27.3] vs 13.6 months [11.8-15.4]; p = 0.17). In the FOLFIRINOX and GEM-CAP groups, 1-year PFS rates were 62% (95% CI, 35%-88%) and 22% (95% CI, 3%-41%), respectively, and 2-year OS rates were 45% (95% CI, 20%-70%) and 28% (95% CI, 7%-49%), respectively. The trends for the improved OS in the FOLFIRINOX group were observed regardless of surgical resection.
FOLFIRINOX might be associated with improved efficacy outcomes compared with GEM-CAP regimen in patients with BRPC. Further validations are necessary in the randomized trials.
Clinical trial identification
Legal entity responsible for the study
Asan Medical Center
Asan Medical Center
All authors have declared no conflicts of interest.