Phase 3 trials have identified FOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil and Leucovorin) as the most active chemotherapy regimen in metastatic pancreatic ductal adenocarcinoma (PDAC); however, this regimen is not always selected for use by clinicians due to toxicity. It is unknown whether results from FOLFIRINOX in clinical practice in the Australasian population reflect that of the international trials.
An international multi-centre retrospective study of consecutive patients with PDAC was performed using the Australasian Pancreatic cancer registry (PURPLE: Pancreatic cancer: Understanding Routine Practice and Lifting End Results). The database was queried to identify patients receiving FOLFIRINOX. Baseline characteristics including resectability of disease as assessed by the centre, treatment details, toxicity and outcome data were analysed. Efficacy measures included objective response (OR), overall survival (OS) and progression-free (progression/recurrence) survival (PFS).
From a total of 774 patients, 55 (7%) received FOLFIRINOX. Median age of FOLFIRINOX-treated patients was 57 yrs (range: 41–80). The ECOG performance score was 0-1 for 96%. FOLFIRINOX was administered for borderline resectable disease (BRD) in 28 cases and for metastatic disease (MD) in 16; the median number of cycles were 6 (range 3-16) and 8 (range 3-12) in patients with BRD and MD respectively. 63% (15/24) of patients had OR, defined by CT following neoadjuvant FOLFIRINOX and 13 of 26 (50%) proceeded to curative intent surgery. Median OS and PFS were 34 and 15 months respectively in patients who had resection compared to 17 and 8 months in patients with unresectable or MD. The most common grade 3/4 toxicities were diarrhoea (25%) and myelosuppression (21%). 35% of patients received GCSF and 46% experienced at least one admission related to FOLFIRINOX toxicity.
Our study shows a modest overall uptake of FOLFIRINOX in routine practice. Where FOLFIRINOX is used in patients with BRD the conversion rate to resectable is promising. Survival outcomes in patients with MD approach that seen in clinical trials; however, adverse events are frequent, most notably diarrhoea and haematological toxicities.
Clinical trial identification
Legal entity responsible for the study
Systems Biology and Personalised Medicine Division, Walter and Eliza Hall Institute of Medical Research, VIC, Australia.
Has not received any funding.
All authors have declared no conflicts of interest.