Neoadjuvant FOLFIRINOX, chemoradiotherapy improve pancreatic cancer surgery outcomes
Treatment with a neoadjuvant regimen containing fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) followed by individualized chemoradiotherapy for borderline resectable pancreatic cancer leads to high margin-negative (R0) resection rate, which translates to longer survival, according to the results of a single-arm phase II trial.
The trial enrolled 48 treatment-naïve patients (median age 62 years; 56.3 percent male) who had ECOG performance status of 1–0 and adequate haematologic, renal and hepatic function. Forty-three received eight cycles of FOLFIRINOX. Those who showed resolution of vascular involvement underwent short-course chemoradiotherapy (5 Gy) with capecitabine, while those with persistent vascular involvement underwent long-course treatment with fluorouracil or capecitabine.
Of the patients who planned to receive eight preoperative cycles of chemotherapy, 34 (79 percent) completed treatment. Twenty-seven (56 percent) had short-course chemoradiotherapy, while 17 (35 percent) received long course. Nearly all the 32 patients who underwent resection achieved R0 (97 percent).
In the entire cohort, median progression-free survival (PFS) was 14.7 months (95 percent CI, 10.5–not reached) while median overall survival was 37.7 months (19.4–not reached). The respective 2-year PFS and OS were 43 percent and 56 percent.
In the group of patients who underwent resection, median PFS was 48.6 months while median OS had not been reached. The corresponding 2-year PFS and OS were 55 percent and 72 percent.
Neoadjuvant FOLFIRINOX followed by chemoradiotherapy had a favourable toxicity profile, with no single grade 3 toxicity exceeding 10 percent and no toxic effect resulting in death.
The median follow-up for the analysis was 18.0 months for the 30 patients still alive at study completion.