Vienot Angélique, Chevalier Hortense, Bolognini Clément, Gherga Elisabeta, Klajer Elodie, Meurisse Aurélia, Jary Marine, Kim Stefano, d'Engremont Christelle, Nguyen Thierry, Calcagno Fabien, Almotlak Hamadi, Fein Francine, Nasri Meher, Abdeljaoued Syrine, Turpin Anthony, Borg Christophe, Vernerey Dewi
Department of Medical Oncology, Besançon University Hospital, Besançon F-25030, France.
Department of Medical Oncology, Lille University Hospital, Lille F-59000, France.
World J Gastrointest Oncol. 2020 Mar 15;12(3):332-346. doi: 10.4251/wjgo.v12.i3.332.
FOLFIRINOX regimen is the first-line reference chemotherapy (L1) in advanced pancreatic ductal adenocarcinoma (aPDAC). FOLFOXIRI, a schedule with a lower dose of irinotecan and no bolus 5-fluorouracil, has demonstrated efficacy and feasibility in colorectal cancer.
To investigate the potential clinical value of FOLFOXIRI in patients with aPDAC in routine clinical practice.
Analyses were derived from all consecutive aPDAC patients treated in L1 between January 2011 and December 2017 in two French institutions, with either FOLFOXIRI ( = 165) or FOLFIRINOX ( = 124) regimens. FOLFOXIRI consisted of irinotecan (165 mg/m), oxaliplatin (85 mg/m), leucovorin (200 mg/m) and 5-fluorouracil (3200 mg/m as a 48-h continuous infusion) every 2 wk. Ninety-six pairs of patients were selected through propensity score matching, and clinical outcomes of the two treatment regimens were compared.
Median overall survival was 11.1 mo in the FOLFOXIRI and 11.6 mo in the FOLFIRINOX cohorts, respectively. After propensity score matching, survival rates remained similar between the two regimens in terms of overall survival (hazard ratio = 1.22; = 0.219) and progression-free survival (hazard ratio = 1.27; = 0.120). The objective response rate was 37.1% in the FOLFOXIRI group 47.8% in the FOLFIRINOX group ( = 0.187). Grade 3/4 toxicities occurred in 28.7% of patients in the FOLFOXIRI cohort 19.5% in the FOLFIRINOX cohort ( = 0.079). FOLFOXIRI was associated with a higher incidence of grade 3/4 digestive adverse events. Hematopoietic growth factors were used after each chemotherapy cycle and the low hematological toxicity rates were below 5% with both regimens.
FOLFOXIRI is feasible in L1 in patients with aPDAC but does not confer any therapeutic benefit as compared with FOLFIRINOX. The low hematological toxicity rates strengthened the relevance of primary prophylaxis with hematopoietic growth factors.
FOLFIRINOX方案是晚期胰腺导管腺癌（aPDAC）的一线参考化疗方案（L1）。FOLFOXIRI方案中伊立替康剂量较低且无推注5-氟尿嘧啶，已在结直肠癌中证明了其疗效和可行性。
探讨FOLFOXIRI方案在aPDAC患者常规临床实践中的潜在临床价值。
分析来自2011年1月至2017年12月在法国两家机构接受L1治疗的所有连续aPDAC患者，采用FOLFOXIRI方案（n = 165）或FOLFIRINOX方案（n = 124）。FOLFOXIRI方案包括每2周给予伊立替康（165 mg/m²）、奥沙利铂（85 mg/m²）、亚叶酸钙（200 mg/m²）和5-氟尿嘧啶（3200 mg/m²持续输注48小时）。通过倾向评分匹配选择96对患者，比较两种治疗方案的临床结局。
FOLFOXIRI组和FOLFIRINOX组的中位总生存期分别为11.1个月和11.6个月。倾向评分匹配后，两种方案在总生存期（风险比 = 1.22；P = 0.219）和无进展生存期（风险比 = 1.27；P = 0.120）方面的生存率仍相似。FOLFOXIRI组的客观缓解率为37.1%，FOLFIRINOX组为47.8%（P = 0.187）。FOLFOXIRI组3/4级毒性反应发生率为28.7%，FOLFIRINOX组为19.5%（P = 0.079）。FOLFOXIRI方案与3/4级消化系统不良事件发生率较高相关。每个化疗周期后均使用造血生长因子，两种方案的低血液学毒性发生率均低于5%。
FOLFOXIRI方案在aPDAC患者的L1治疗中是可行的，但与FOLFIRINOX方案相比未显示出任何治疗优势。低血液学毒性发生率强化了使用造血生长因子进行一级预防的相关性。
