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伊立替康联合顺铂三周方案用于既往未治疗的广泛期小细胞肺癌的II期研究。

Phase II study of a 3-week schedule of irinotecan combined with cisplatin in previously untreated extensive-stage small-cell lung cancer.

作者信息

Lee Jeong Eun, Park Hee Sun, Jung Sung Soo, Kim Ju Ock, Kim Sun Young

机构信息

Department of Internal Medicine, College of Medicine, Chungnam National University Hospital and Cancer Research Institute, Daejeon, South Korea.

出版信息

Oncology. 2007;73(1-2):76-80. doi: 10.1159/000120632. Epub 2008 Mar 12.

DOI:10.1159/000120632
PMID:18334853
Abstract

BACKGROUND

Irinotecan has been introduced to improve the treatment of small-cell lung cancer (SCLC). We conducted a trial involving a 3-week schedule of irinotecan combined with cisplatin (IP) to validate the efficacy and toxicity of this regimen in patients with previously untreated extensive-stage SCLC (ES-SCLC).

PATIENTS AND METHODS

Twenty-eight patients with previously untreated ES-SCLC were enrolled in the study between January 2003 and December 2005. Irinotecan 60 mg/m(2) was administered intravenously on days 1 and 8 in combination with cisplatin 60 mg/m(2) on day 1 every 21 days.

RESULTS

Twenty-eight patients were followed until July 2007. The median follow-up time was 15.6 months. The actual dose intensities (DIs) of cisplatin and irinotecan were 97.7 and 92.2%, respectively. Among the 28 ES-SCLC patients, the objective response rate was 89.3% (25 patients). The major grade 3/4 hematological toxicity was neutropenia (26.9% of cycles). Grade 3/4 non-hematological toxicities were rare. The median progression-free and overall survival times were 8.7 and 16.5 months, with a 1-year survival rate of 66.6% and 2-year survival rate of 22.2%.

CONCLUSION

The 3-week schedule of IP was feasible and showed a high DI of irinotecan and decreased toxicity.

摘要

背景

伊立替康已被用于改善小细胞肺癌(SCLC)的治疗。我们开展了一项试验,采用伊立替康联合顺铂(IP)的3周方案,以验证该方案对既往未治疗的广泛期小细胞肺癌(ES-SCLC)患者的疗效和毒性。

患者与方法

2003年1月至2005年12月期间,28例既往未治疗的ES-SCLC患者入组本研究。每21天为一周期,第1天静脉给予顺铂60mg/m²,第1天和第8天静脉给予伊立替康60mg/m²。

结果

28例患者随访至2007年7月。中位随访时间为15.6个月。顺铂和伊立替康的实际剂量强度(DI)分别为97.7%和92.2%。28例ES-SCLC患者中,客观缓解率为89.3%(25例患者)。主要的3/4级血液学毒性为中性粒细胞减少(占周期数的26.9%)。3/4级非血液学毒性罕见。中位无进展生存期和总生存期分别为8.7个月和16.5个月,1年生存率为66.6%,2年生存率为22.2%。

结论

IP的3周方案可行,伊立替康的剂量强度高且毒性降低。

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