一项关于奥沙利铂、亚叶酸钙、5-氟尿嘧啶和伊立替康联合化疗用于转移性胃癌的II期试点研究。

A pilot phase II study of chemotherapy with oxaliplatin, folinic acid, 5-fluorouracil and irinotecan in metastatic gastric cancer.

作者信息

Chiesa Matteo Dalla, Buti Sebastiano, Tomasello Gianluca, Negri Federica, Buononato Massimo, Brunelli Antonio, Lazzarelli Silvia, Brighenti Matteo, Donati Gianvito, Passalacqua Rodolfo

机构信息

Medical Oncology, 2Surgery Division, Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.

出版信息

Tumori. 2007 May-Jun;93(3):244-7. doi: 10.1177/030089160709300303.

DOI:10.1177/030089160709300303

PMID:17679458

Abstract

AIMS AND BACKGROUND

Previous phase II studies have reported that combinations of oxaliplatin, folinic acid and 5-fluorouracil or irinotecan, folinic acid and 5-fluorouracil are associated with good efficacy and an acceptable safety profile in metastatic gastric cancer. The aim of this study was to evaluate chemotherapy with oxaliplatin, folinic acid, 5-fluorouracil and irinotecan (COFFI regimen) in metastatic gastric cancer.

METHODS

Patients received oxaliplatin (85 mg/m2 d 1), irinotecan (140 mg/m2 d 1), and L-folinic acid (200 mg/m2 d 1) followed by 5-fluorouracil bolus (400 mg/m2 d 1) and then 5-fluorouracil (2,400 mg/m2 48-h continuous infusion), every 14 days.

RESULTS

Seventeen patients with metastatic gastric cancer were enrolled. Eight patients were pretreated for advanced disease. Of the 9 chemo-naïve patients, 8 were evaluated for response (1 patient was lost to follow-up): one complete response, 5 partial responses and 2 progressions of disease occurred, giving an overall response rate, at intention-to-treat analysis, of 67%. Of the 8 pretreated patients, 6 were evaluated for response (2 patients had nonmeasurable disease): one partial response, 2 disease stabilizations and 3 progressions of disease occurred, giving an overall response rate, at intention-to-treat analysis, of 12%. Median progression-free and overall survival in chemo-naïve patients were 8.2 and 10.2 months, respectively, and in pretreated patients 2.7 and 3 months. Grade 3-4 neutropenia occurred in 55% of chemo-naïve patients. Thrombocytopenia, and anemia were observed in 18% and 29%, respectively. Grade 3 nausea/vomiting occurred in 12% and grade 3 diarrhea in 6%.

CONCLUSIONS

The COFFI regimen is active and well tolerated, therefore phase III studies are warranted.

摘要

目的与背景

既往的II期研究报告称，奥沙利铂、亚叶酸钙和5-氟尿嘧啶联合用药，或伊立替康、亚叶酸钙和5-氟尿嘧啶联合用药，在转移性胃癌中疗效良好且安全性可接受。本研究的目的是评估奥沙利铂、亚叶酸钙、5-氟尿嘧啶和伊立替康联合化疗（COFFI方案）用于转移性胃癌的效果。

方法

患者接受奥沙利铂（85mg/m²，第1天）、伊立替康（140mg/m²，第1天）和左亚叶酸钙（200mg/m²，第1天）治疗，随后给予5-氟尿嘧啶推注（400mg/m²，第1天），然后5-氟尿嘧啶（2400mg/m²，持续输注48小时），每14天重复一次。

结果

17例转移性胃癌患者入组。8例患者曾接受晚期疾病的预处理。在9例初治患者中，8例接受了疗效评估（1例失访）：出现1例完全缓解、5例部分缓解和2例疾病进展，在意向性分析中，总缓解率为67%。在8例预处理患者中，6例接受了疗效评估（2例有不可测量的疾病）：出现1例部分缓解、2例疾病稳定和3例疾病进展，在意向性分析中，总缓解率为12%。初治患者的无进展生存期和总生存期的中位数分别为8.2个月和10.2个月，预处理患者分别为2.7个月和3个月。55%的初治患者发生3-4级中性粒细胞减少。血小板减少和贫血的发生率分别为18%和29%。3级恶心/呕吐的发生率为12%，3级腹泻的发生率为6%。