Abstract 2244
Background
Advanced pancreatic ductal adenocarcinoma (aPDAC) remains a challenging, non-curable disease. FOLFIRINOX regimen is the standard in first-line chemotherapy (L1) in this setting. FOLFOXIRI, a similar schedule with a lower dose of irinotecan and no bolus 5-fluorouracil, has demonstrated efficacy and good tolerance in metastatic colorectal cancer. We aimed to compare clinical outcomes of this two regimens in patients with aPDAC in routine clinical practice.
Methods
Analyses were derived from all consecutive aPDAC patients treated in L1, between 2011 and 2017 in two French institutions, with FOLFOXIRI (n = 165) or standard (n = 124) regimens. FOLFOXIRI consisted of irinotecan (165 mg/m2), oxaliplatin (85 mg/m2), leucovorin (200 mg/m2) and 5-fluorouracil (3200 mg/m2 as a 48-hour continuous infusion) every two weeks. One hundred pairs of patients were selected through propensity score matching (PSM) analysis and clinical outcomes of the two treatments were compared.
Results
After a median follow up of 44.1 months, median overall survival (OS) was 11.1 months (95% confidence interval [CI], 9.8 to 13.1) in the FOLFOXIRI group and 11.6 months (95% CI, 10.8 to 15.5) in the FOLFIRINOX group. Median progression free survival (PFS) was 5.8 months (95% CI, 3.9 to 6.9) in the FOLFOXIRI group and 6.7 months (95% CI, 6.0 to 7.7) in the FOLFIRINOX group. After PSM, the survival of patients remained similar between the two regimens in OS (hazard ratio [HR], 0.79; 95% CI, 0.58 to 1.08; P = 0.137) and PFS (HR, 0.80; 95% CI, 0.60 to 1.08; P = 0.139). The objective response rate was 33.3% in the FOLFOXIRI group versus 47.2% in the FOLFIRINOX group, while disease-control rates were 62.8% and 75.3%, respectively (P = 0.129). The grade 3 or 4 toxicities were occurring in 29.0% of patients in FOLFOXIRI group versus 21.3% in FOLFIRINOX group (P = 0.216). FOLFOXIRI was associated with a higher incidence of grade 3 or 4 digestive adverse events compared to FOLFIRINOX group (11.0% versus 5.0%, respectively) but was similar to the safety profile of FOLFIRINOX previously reported in the PRODIGE 4/ACCORD 11 trial.
Conclusions
FOLFOXIRI is feasible in L1 in patients with aPDAC but does not confer any therapeutic benefit as compared with FOLFIRINOX regimen.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Besançon University Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2670 - Molecular subtypes of metastatic(met) gastric cancer(GC) (MoTriGastric): new biomarkers closer to the clinics
Presenter: Maria Alsina Maqueda
Session: Poster Display session 2
Resources:
Abstract
3797 - Exploring candidate signal transduction pathways for targeted therapy in esophageal cancer
Presenter: Aafke Creemers
Session: Poster Display session 2
Resources:
Abstract
5485 - Clinical implication of CLDN18, RhoGAP, and E-cadherin in gastric signet ring cell carcinoma
Presenter: Hyunho Kim
Session: Poster Display session 2
Resources:
Abstract
1970 - Identification of a spectrum of germline mutations for hereditary diffuse gastric cancer in the Russian population by next-generation sequencing.
Presenter: IRINA EFIMOVA
Session: Poster Display session 2
Resources:
Abstract
4989 - The molecular profiling and prognostic value of Chinese gastric signet ring cell carcinoma patients
Presenter: Jia Wei
Session: Poster Display session 2
Resources:
Abstract
7145 - A phase 2 basket study of MCLA-128, a bispecific antibody targeting the HER3 pathway, in NRG1 fusion-positive advanced solid tumors
Presenter: Alison Schram
Session: Poster Display session 2
Resources:
Abstract
1406 - Simultaneous Resection of Pancreatic Cancer and Liver Oligometastases After Induction Chemotherapy in Stage IV Patients:an Open-Label Prospective Randomized Multicenter phase 3 trial(CSPAC-1)
Presenter: Miaoyan Wei
Session: Poster Display session 2
Resources:
Abstract
1530 - Multicenter randomized phase II trial of 5-Fluorouracil/leucovorin (5-FU/LV) with or without liposomal irinotecan (nal-IRI) in metastatic biliary tract cancer (BTC) as second-line therapy after progression on gemcitabine plus cisplatin (GemCis): NIFTY trial
Presenter: Changhoon Yoo
Session: Poster Display session 2
Resources:
Abstract
1563 - A randomized phase II study of Maintenance therapy with multiepitope vaccine Tedopi (OSE2101) ± nivolumab or FOLFIRI after induction chemotherapy (CT) with FOLFIRINOX in patients (Pts) with advanced Pancreatic ductal adenocarcinoma (aPDAC) (TEDOPaM – PRODIGE 63 GERCOR study)
Presenter: Cindy Neuzillet
Session: Poster Display session 2
Resources:
Abstract
2780 - A phase 3, randomized, double-blind, placebo-controlled, international study of durvalumab in combination with gemcitabine plus cisplatin for patients with advanced biliary tract cancers: TOPAZ-1
Presenter: Do-Youn Oh
Session: Poster Display session 2
Resources:
Abstract