Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer

Abstract

AIMTo directly compare the efficacy and toxicity of standard-dose FOLFIRINOX (sFOLFIRINOX) and modified-dose FOLFIRINOX (mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer.METHODSOne hundred and thirty pancreatic cancer patients who received sFOLFIRINOX (n = 88) or mFOLFIRINOX (n = 42) as their first-line chemotherapy from January 2013 to July 2017 were retrospectively reviewed. For efficacy analysis, the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated and compared using Pearson’s chi-square test, Kaplan-Meier plot and log-rank test. The adverse events (AEs) were evaluated, and severe (≥ grade 3) AEs rates of the two groups were compared for toxicity analysis.RESULTSThe mFOLFIRINOX group included more female patients (30.7% vs 57.1%; P = 0.004) and older patients [age (median), 57 vs 63.5; P = 0.018] than the sFOLFIRINOX group. In the efficacy analysis, the ORR and DCR were not significantly different between the two groups (ORR: 39.8% vs 35.7%; P = 0.656; DCR: 80.7% vs 83.3%; P = 0.716). The median PFS and OS were also not different between the groups (PFS: 8.7 mo vs 8.1 mo, P = 0.272; OS: 13.9 mo vs 13.7 mo, P = 0.476). In the safety analysis with severe AEs, the rates of neutropenia (83.0% vs 66.7%; P = 0.044), anorexia (48.9% vs 28.6%; P = 0.029) and diarrhea (13.6% vs 0.0%; P = 0.009) were markedly lower in the mFOLFIRINOX group.CONCLUSIONmFOLFIRINOX showed comparable efficacy but better safety compared to sFOLFIRINOX. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.

A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer

“…Instead, the patient-tailored FOLFIRI-NOX regimen used here confirmed its satisfactory tolerance we previously reported in advanced pancreatic adenocarcinoma [13], with no new safety issues observed in comparison with existing literature [17,18,30]. We speculate that the patient-tailored approach we adopted here, which recapitulates similar ones with FOLFIRINOX in pancreatic adenocarcinoma [13,31,32] displayed favorable tolerance profile thanks to the deal made between the decreased dose intensity of the three cytotoxics and the global duration of treatment, somewhat allegedly avoiding over-or under-exposure to the drugs [33]. Thus, median actual delivered dose intensities were of the order of~70% (Fig.…”

FOLFIRINOX De-Escalation in Advanced Pancreatic Cancer: A Multicenter Real-Life Study

“…Thus, in patients who achieve longer survival, the challenge of cytotoxic treatments is to reach a compromise between quality of life and disease control. Modified doses of FOLFIRINOX (bolus removal and reduced dose of irinotecan) did not decrease survival but resulted in fewer toxicities [6]. This protocol is the preferred first‐line regimen in France, where access to gemcitabine‐nab‐paclitaxel, the alternative active first‐line regimen, is limited because of reimbursement issues [7, 8].…”

Immunomodulatory Effect after Irreversible Electroporation in Patients with Locally Advanced Pancreatic Cancer

“…Limited responses and little impact on survival or life were achieved after the standard treatments, which was mainly systemic chemotherapy [5, 6]. Moreover, the high rates of adverse events due to the toxicity of chemotherapy limited the use and promotion of treatment, such as the combination chemotherapy of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX), even though it was shown to display some progression in improving the survival of patients with LAPC [7–9]. Therefore, it is necessary to evaluate new treatment to optimize common therapeutic approaches.…”