Published online Dec 15, 2018. doi: 10.4251/wjgo.v10.i12.505
Peer-review started: September 19, 2018
First decision: October 15, 2018
Revised: October 24, 2018
Accepted: November 25, 2018
Article in press: November 26, 2018
Published online: December 15, 2018
To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC).
This study was a prospective, multicenter, one-arm, open-label, phase II trial. Patients with unresectable PC, who showed disease progression during GEM-based chemotherapy were enrolled. All patients were administered FOLFIRINOX with reduced irinotecan and oxaliplatin (RIO; irinotecan 120 mg/m2 and oxaliplatin 60 mg/m2), which was set according to the phase I study of FOLFIRINOX. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), adverse events were evaluated. Additionally, changes in quality of life (QoL) were assessed using a questionnaire on QoL.
Between August 2015 and May 2016, a total of 48 patients were enrolled. The median follow-up time was 259 d with a median of 8.5 cycles. The ORR and DCR were 18.8% and 62.5%, respectively, including one patient who showed complete remission. The median PFS was 5.8 mo [95% confidence interval (CI): 3.7-7.9] and median OS was 9.0 mo (95%CI: 6.4-11.6). Neutropenia (64.6%) was the most common grade 3-4 adverse event, followed by febrile neutropenia (16.7%). Although 14.6% of patients experienced grade 3 fatigue, most non-hematologic AEs were under grade 2. In the QoL analysis, the global health status score before treatment was not different from the score at the last visit after treatment (45.43 ± 22.88 vs 48.66 ± 24.14, P = 0.548).
FOLFIRINOX with RIO showed acceptable toxicity and promising efficacy for GEM-refractory unresectable PC. However, this treatment requires careful observation of treatment-related hematologic toxicities.
Core tip: For gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC), there are limited options of second-line chemotherapy regimen. To find new treatment option for GEM-refractory unresectable PC, we conducted a multicenter phase II trial, which evaluated the efficacy and safety of uniquely modified FOLFIRINOX with reduced irinotecan and oxaliplatin. In our results, FOLFIRINOX with reduced irinotecan and oxaliplatin showed acceptable toxicity and promising efficacy. With careful observation of treatment-related hematologic toxicities, this chemotherapy regimen is a promising option for patients with GEM-refractory PC after first-line treatment failure.