FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study
FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study
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DOI：
10.1007/s00280-012-1875-1
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发表时间：
2012-06-01
影响因子：
3
通讯作者：
Labianca, Roberto
中科院分区：
文献类型：
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作者：
Zaniboni, Alberto;Aitini, Enrico;Labianca, Roberto
本研究的目的是评价FOLFIRI方案作为二线化疗方案对局部晚期或转移性胰腺癌患者的疗效和耐受性。局部晚期或转移性疾病患者接受吉西他滨+/-A铂(顺铂、奥沙利铂)一线化疗(仅一线)，并有符合RECIST标准的疾病。FOLFIRI包括伊立替康180 mg/m(2)静脉滴注，第1天，亚叶酸钙(L形式)200 mg/m(2)静脉滴注，第1天5-FU 400 mg/m(2)静脉推注，第1、2天；5-FU 600 mg/m(2)静脉滴注，第1、2天，连用22h，每2周重复。在50例入选患者中，观察到4例部分缓解(PR)(8%)和14种稳定疾病，疾病控制率为18/50(36%)。41例患者(82%)接受了顺铂/奥沙利铂+吉西他滨的一线化疗。中位无进展生存期为3.2个月，总生存期为5个月。6个月存活率为32%。出现3-4级中性粒细胞减少和腹泻的患者分别为10例(20%)和6例(12%)。FOLFIRI方案在这些经过大量预处理的局部晚期或转移性胰腺癌患者中显示出适度的临床活性，毒性可控。
The purpose of the present study was to evaluate the activity and the tolerability of the FOLFIRI regimen, administered as second-line chemotherapy in patients with locally advanced or metastatic pancreatic cancer after the failure of a gemcitabine-based regimen.Patients with locally advanced/metastatic disease who received a first-line chemotherapy (one line only) with gemcitabine +/- A platinoid (cisplatin, oxaliplatin) and who had measurable disease conform with the RECIST criteria were eligible for the study.FOLFIRI consists of irinotecan 180 mg/m(2) iv on day 1, leucovorin (l-form) 200 mg/m(2) iv on day 1 and 2, 5-FU 400 mg/m(2) iv bolus on days 1 and 2, and 5-FU 600 mg/m(2) iv by ci for 22 h on days 1 and 2, repeated every 2 weeks. The primary end point was the response rate.Among the 50 enrolled patients, 4 partial responses (PR) (8 %) and 14 stable diseases were observed, for a disease control rate of 18/50 (36 %). Forty-one patients (82 %) have been pretreated with cisplatin/oxaliplatin+gemcitabine as first-line chemotherapy. The median progression-free and overall survivals were 3.2 and 5 months, respectively. The 6-month survival rate was 32 %. Grade 3-4 neutropenia and diarrhea occurred in 10 (20 %) and 6 (12 %) patients, respectively.The FOLFIRI regimen showed a modest clinical activity in this quite heavily pretreated patients' population with locally advanced or metastatic pancreatic cancer with a manageable toxicity profile.