Final survival results from a multicenter, randomized phase II trial of intravenous paclitaxel plus FOLFOX (ivPOF) and/or intraperitoneal paclitaxel plus FOLFOX (ipPOF) versus mFOLFOX6 as first-line treatment of advanced gastric cancer (AGC): SYLT/FNF 004.

Abstract

4041 Background: Progression-free (PFS) and overall (OS) survival for SYLT/FNF 004 were previously reported in ASCO and ASCO-GI 2019. At that time, PFS was statistically significantly improved with ivPOF or ipPOF compared to mFOLFOX6 as first-line treatment of AGC; however, there were no significant between-treatment differences in OS. Herein, we report final survival results for this trial. Methods: Subjects were randomly assigned to one of three treatments: intravenous paclitaxel 135 mg/m2 + mFOLFOX6 omitting the 5-FU bolus (ivPOF); intraperitoneal paclitaxel 80 mg/m2 + mFOLFOX6 omitting the 5-FU bolus (ipPOF); or mFOLFOX6 (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 followed by 5-FU 400 mg/m2 bolus and 5-FU 2400 mg/m2 as a 46-hour continuous infusion). Treatment cycles were repeated every 14 days for up to 9 cycles. Thereafter, maintenance treatment with S-1 80 mg/m2/day for 14 days every 3 weeks until disease progression, unacceptable toxicity, patient refusal, or physician decision. The original study objective was to compare ivPOF or ipPOF vs. mFOLFOX6 for PFS. Due to slow accrual, the protocol was later amended to compare POF (ivPOF and ipPOF) with mFOLFOX6 for PFS. Results: Between Nov 2015 and May 2018, 89 subjects (30 ivPOF, 29 ipPOF, 30 mFOLFOX6) were enrolled. As of the data cutoff on Dec 31, 2020, median follow-up was 41 (IQR: 37-43) months. The median number of cycles administered was 7 (IQR: 4-9) for POF; 6 (IQR: 4-9) for ivPOF; 9 (IQR: 4-9) for ipPOF; and 4 (IQR: 3-9) for mFOLFOX6. Median PFS and OS, respectively, were 6.23 (95% CI: 4.90 to 9.07) and 10.17 (95% CI: 8.97 to 16.4) months for POF and 4.55 (95% CI: 2.73 to 6.87) and 6.87 (95% CI: 5.83 to 13.6) months for mFOLFOX6. Both PFS and OS were statistically significantly better with POF, ivPOF or ipPOF versus mFOLFOX6 (Table). Safety was consistent with previous reports. Conclusions: POF, ivPOF or ipPOF improved both PFS and OS compared with mFOLFOX6, with similarly manageable adverse effects. Clinical trial information: NCT02845908. [Table: see text]