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一项关于伊立替康、持续输注氟尿嘧啶和亚叶酸(FOLFIRI)联合化疗用于既往接受氟嘧啶为基础方案治疗的复发性或转移性胃癌患者的 II 期研究。

A phase II study of irinotecan, continuous 5-fluorouracil, and leucovorin (FOLFIRI) combination chemotherapy for patients with recurrent or metastatic gastric cancer previously treated with a fluoropyrimidine-based regimen.

机构信息

Department of Internal Medicine, Gyeongsang National University, Jinju, Korea.

出版信息

Am J Clin Oncol. 2010 Dec;33(6):572-6. doi: 10.1097/COC.0b013e3181bead7b.

DOI:10.1097/COC.0b013e3181bead7b
PMID:20042971
Abstract

OBJECTIVES

A phase II study was carried out to assess the efficacy and toxicity of combination chemotherapy with irinotecan, 5-fluorouracil (5-FU), and leucovorin (FOLFIRI) for the treatment of patients with metastatic or recurring gastric cancer previously treated with fluoropyrimidine-based chemotherapy.

METHODS

Eligible patients were those who had metastatic gastric cancer previously treated with a fluoropyrimidine-based chemotherapy regimen or had disease recurrence within 6 months of completing adjuvant fluoropyrimidine-containing chemotherapy. Participants received irinotecan (150 mg/m² on day 1) and leucovorin (LV; 20 mg/m² on days 1-2) followed by continuous infusion of 5-FU (1500 mg/m² on days 1-2), every 2 weeks.

RESULTS

Between April 2006 and March 2008, 33 patients were enrolled in the study. FOLFIRI served as a second-line treatment in 27 patients, third-line treatment in 4 patients, and fourth-line treatment in 2 patients. The patients had a median age of 60 years (range, 40-75) and underwent 132 cycles of chemotherapy, with a median of 3 cycles (range, 1-15) per patient. The response rate was 18.2%, and the disease control rate was 36%. Median overall survival was 5.1 months (95% confidence interval, 3.74-6.45), and median time to progression was 2.3 months (95% confidence interval, 1.81-2.78). The major grade 3-4 toxicity was neutropenia (45.4%).

CONCLUSION

Combination chemotherapy with irinotecan, 5-FU, and LV is feasible in gastric cancer patients previously treated with fluoropyrimidine-based chemotherapy.

摘要

目的

进行了一项 II 期研究,以评估伊立替康、5-氟尿嘧啶(5-FU)和亚叶酸(FOLFIRI)联合化疗治疗先前接受氟嘧啶类化疗的转移性或复发性胃癌患者的疗效和毒性。

方法

符合条件的患者为先前接受氟嘧啶类化疗方案治疗的转移性胃癌患者,或在完成含氟嘧啶辅助化疗后 6 个月内疾病复发的患者。患者接受伊立替康(第 1 天 150mg/m²)和亚叶酸(LV;第 1-2 天 20mg/m²),随后连续输注 5-FU(第 1-2 天 1500mg/m²),每 2 周 1 次。

结果

2006 年 4 月至 2008 年 3 月,共有 33 名患者入组该研究。27 名患者接受 FOLFIRI 二线治疗,4 名患者接受三线治疗,2 名患者接受四线治疗。患者中位年龄为 60 岁(范围,40-75 岁),共接受 132 个周期的化疗,中位每个患者接受 3 个周期(范围,1-15 个周期)。客观缓解率为 18.2%,疾病控制率为 36%。中位总生存期为 5.1 个月(95%置信区间,3.74-6.45),中位无进展生存期为 2.3 个月(95%置信区间,1.81-2.78)。主要的 3-4 级毒性为中性粒细胞减少症(45.4%)。

结论

对于先前接受氟嘧啶类化疗的胃癌患者,伊立替康、5-FU 和 LV 的联合化疗是可行的。

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