Bai Xueli, Su Riga, Ma Tao, Shen Shichao, Li Guogang, Lou Jianying, Gao Shunliang, Que Risheng, Yuan Ying, Yu Risheng, Wei Qichun, Liang Tingbo
Department of Hepatopancreatobiliary Surgery, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310009, China.
Zhonghua Wai Ke Za Zhi. 2016 Apr 1;54(4):270-5. doi: 10.3760/cma.j.issn.0529-5815.2016.04.006.
To explore efficacy and safety of modified FOLFIRINOX (mFOLFIRINOX) regimen by dose attenuation in locally advanced pancreatic cancer (LAPC) and metastatic pancreatic cancer(MPC).
Between April 2014 and October 2015, 35 patients with LAPC (n=18) or MPC (n=17) were treated with mFOLFIRINOX regimen (irinotecan 135 mg/m(2), oxaliplatin 68 mg/m(2), 5-FU 2 400 mg/m(2), no bolus of 5-FU, leucovorin 400 mg/m(2)) in the Second Affiliated Hospital of Zhejiang University School of Medicine. The primary end point was progression free survival. The second end points were overall survival, objective response rate, adverse effects, surgical resection rate for LAPC.
Among 35 patients, 6 patients (17.1%) who dropped out and received less than 2 cycles were excluded for response analysis. Among the other 29 patients, 9 patients had grade 3 or 4 adverse effects. No patients ceased treatment due to adverse effects. The 29 patients received 5 (2-13) cycles were evaluated by efficacy and found partial remission in 16 cases, stable disease in 10 cases, progression disease in 3 cases. Response rate was 55.2%. Nine patients with LAPC accomplished surgery after neoadjuvant treatment without perioperative complication and death, and 6 patients accepted R0 resection.
The mFOLFIRINOX regimen used in the study is well-tolerated in Chinese population with high treatment efficacy on patients with LAPC and MPC. Further investigation of efficacy and adverse effects on more advanced pancreatic cancer patients is necessary.
探讨剂量递减的改良FOLFIRINOX(mFOLFIRINOX)方案治疗局部晚期胰腺癌(LAPC)和转移性胰腺癌(MPC)的疗效及安全性。
2014年4月至2015年10月,浙江大学医学院附属第二医院对35例LAPC患者(n = 18)或MPC患者(n = 17)采用mFOLFIRINOX方案(伊立替康135 mg/m²、奥沙利铂68 mg/m²、5-氟尿嘧啶2400 mg/m²,不推注5-氟尿嘧啶,亚叶酸钙400 mg/m²)进行治疗。主要终点为无进展生存期。次要终点为总生存期、客观缓解率、不良反应、LAPC的手术切除率。
35例患者中,6例(17.1%)退出且接受周期数少于2个周期,被排除在疗效分析之外。其余29例患者中,9例出现3或4级不良反应。无患者因不良反应停止治疗。对接受5(2 - 13)个周期治疗的29例患者进行疗效评估,发现部分缓解16例,病情稳定10例,病情进展3例。缓解率为55.2%。9例LAPC患者新辅助治疗后完成手术,无围手术期并发症及死亡,6例接受R0切除。
本研究中使用的mFOLFIRINOX方案在中国人群中耐受性良好,对LAPC和MPC患者具有较高的治疗疗效。有必要对更多晚期胰腺癌患者的疗效和不良反应进行进一步研究。