FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer: A subset analysis of data from a nationwide multicenter observational study in Japan
FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer: A subset analysis of data from a nationwide multicenter observational study in Japan
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DOI：
10.1016/j.pan.2020.07.006
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发表时间：
2020-10-01
期刊：
影响因子：
3.6
通讯作者：
Fukutomi, Akira
中科院分区：
文献类型：
--
作者：
Kobayashi, Noritoshi;Omae, Katsuhiro;Fukutomi, Akira
背景：关于FOLFIRINOX作为晚期胰腺癌二线化疗的数据有限。在JASPAC06研究--一项全国性、多中心、观察性研究--FOLFIRINOX治疗不能切除或复发的胰腺癌患者的临床实践中，显示出良好的疗效和安全性。方法：我们对日本临床环境下接受FOLFIRINOX作为二线化疗的不能切除或复发的胰腺癌患者进行探索性分析。结果：在399名可评价的患者中，44人符合纳入分析的条件。患者的特征如下：中位年龄62岁；男性26例(59%)；东部合作肿瘤组-表现状态0/1，30(68%)/14(32%)；疾病状态，复发/局部/转移：4(9%)/8(18%)/32(73%)。28例(%)患者的初始剂量减少。中位治疗失败时间为4.5个月(0.2~19.1个月)，周期数为6个周期(1~13个或以上)。主要的3/4级不良反应为白细胞减少29例(66%)，白细胞减少17例(39%)，厌食7例(16%)，发热中性粒细胞减少5例(11%)，贫血5例(11%)。中位总生存率、无进展生存率和1年生存率分别为10.3(95%可信区间，7.2~13.3)个月、4.1(95%可信区间，2.6~5.5)个月和30%。结论：FOLFIRINOX作为二线化疗方案治疗晚期胰腺癌疗效显著。它显示出与作为一线治疗观察到的毒性相似的毒性。(C)2020年由Elsevier B.V.代表IAP和EPC出版。
Background: Data on FOLFIRINOX as a second-line chemotherapy for advanced pancreatic cancer are limited. In the JASPAC06 study-a nationwide, multicenter, observational study-FOLFIRINOX for patients with unresectable or recurrent pancreatic cancer as any line of treatment showed favorable efficacy and safety in Japanese clinical practice.Methods: We performed exploratory analyses of patients with unresectable or recurrent pancreatic cancer who received FOLFIRINOX as the second-line chemotherapy in Japanese clinical settings.Results: Of the 399 evaluable patients, 44 were eligible for inclusion in the analysis. The patients' characteristics were as follows: median age, 62 years; men, 26 (59%); Eastern Cooperative Oncology Group-Performance status 0/1, 30 (68%)/14 (32%); disease status, recurrent/local/metastatic: 4 (9%)/8 (18%)/32 (73%). The initial dose was reduced in 28 (64%) patients. The median time to treatment failure and number of cycles were 4.5 (range, 0.2-19.1) months and 6 cycles (range, 1-13 or more), respectively. The major grade 3/4 adverse events were neutropenia in 29 (66%), leucopenia in 17 (39%), anorexia in 7 (16%), febrile neutropenia in 5 (11%), and anemia in 5 (11%) patients. The median overall survival, progression-free survival, and 1-year survival rates were 10.3 (95% confidence interval [CI], 7.2-13.3), 4.1 (95% CI, 2.6-5.5) months, and 30%, respectively.Conclusion: Our findings suggest that FOLFIRINOX as a second-line chemotherapy for advanced pancreatic cancer was effective in patients with a good performance status . It displayed toxicity similar to that observed with its use as a first-line treatment. (C) 2020 Published by Elsevier B.V. on behalf of IAP and EPC.