From the *Department of Hematology and Medical Oncology, †Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute, ‡Department of Biostatistics, §Division of Surgical Oncology, Department of Surgery, and ∥Department of Radiation Oncology, Emory University, Atlanta, GA.
Pancreas. 2013 Nov;42(8):1311-5. doi: 10.1097/MPA.0b013e31829e2006.
FOLFIRINOX (5-fluorouracil [5-FU], oxaliplatin, and irinotecan) as compared with gemcitabine in pancreatic cancer (PC) has superior activity and increased toxicity. The bolus 5-FU contributes to the toxicity. We hypothesized that the elimination of bolus 5-FU and use of hematopoietic growth factor will improve the safety profile without compromising the activity of FOLFIRINOX.
Sixty patients with PC treated with modified FOLFIRINOX (no bolus 5-FU) were reviewed. Patients were divided into metastatic or nonmetastatic (locally advanced or borderline resectable) disease. Toxicity, response rate, progression-free survival, and overall survival were evaluated.
Nonmetastatic and metastatic disease were present in 24 (40%) and 36 (60%) patients, respectively. The incidence of grade 4 neutropenia, grade 3/4 diarrhea, and fatigue were 3%, 13%, and 13%, respectively. Response rate was 30%. The median progression-free survival for nonmetastatic disease was 13.7 months (95% confidence interval [CI], 9.6-24.6 months), and that for metastatic disease was 8.5 months (95% CI, 3.7-11.0 months), respectively. The median overall survival for nonmetastatic disease was 17.8 months (95% CI, 9.9 months to not estimable), and that for metastatic disease was and 9.0 months (95% CI, 7.1 months to not estimable), respectively.
Modified FOLFIRINOX has an improved safety profile with maintained efficacy in metastatic PC. Modified FOLFIRINOX has promising activity in nonmetastatic disease.
与胰腺癌(PC)中的吉西他滨相比,FOLFIRINOX(5-氟尿嘧啶[5-FU]、奥沙利铂和伊立替康)具有更高的活性和增加的毒性。推注 5-FU 导致毒性。我们假设消除推注 5-FU 并使用造血生长因子将改善安全性而不影响 FOLFIRINOX 的活性。
回顾了 60 例接受改良 FOLFIRINOX(无推注 5-FU)治疗的 PC 患者。患者分为转移性或非转移性(局部晚期或边界可切除)疾病。评估了毒性、反应率、无进展生存期和总生存期。
非转移性和转移性疾病分别存在于 24 例(40%)和 36 例(60%)患者中。4 级中性粒细胞减少症、3/4 级腹泻和疲劳的发生率分别为 3%、13%和 13%。反应率为 30%。非转移性疾病的无进展生存期中位数为 13.7 个月(95%置信区间[CI],9.6-24.6 个月),转移性疾病的无进展生存期中位数为 8.5 个月(95% CI,3.7-11.0 个月)。非转移性疾病的总生存期中位数为 17.8 个月(95% CI,9.9 个月至不可估计),转移性疾病的总生存期中位数为 9.0 个月(95% CI,7.1 个月至不可估计)。
改良 FOLFIRINOX 在转移性 PC 中具有改善的安全性和维持疗效。改良 FOLFIRINOX 在非转移性疾病中具有有前途的活性。