拓扑替康用于晚期结直肠癌患者的II期评估。一项西南肿瘤协作组试验（SWOG 9241）。

Phase II evaluation of topotecan in patients with advanced colorectal cancer. A Southwest Oncology Group trial (SWOG 9241).

作者信息

Macdonald J S, Benedetti J K, Modiano M, Alberts D S

机构信息

Temple University, Philadelphia, Pennsylvania, USA.

出版信息

Invest New Drugs. 1997;15(4):357-9. doi: 10.1023/a:1005941603420.

DOI:10.1023/a:1005941603420

PMID:9547679

Abstract

The topoisomerase-1 inhibitor, topotecan, was tested in 48 eligible patients with advanced colorectal cancer. The patients had no prior chemotherapy and a Southwest Oncology Group performance status of 0-2. Topotecan was administered intravenously at 1.5 mg/m2/day for five days and repeated every 21 days. The major toxicity was hematologic with 19 out of 48 (40%) patients having grade IV granulocytopenia and 4 out of 48 (8%) patients demonstrating grade IV thrombocytopenia. Two patients (4%) demonstrated partial response. Thirty patients have died and the Kaplan-Meier estimate of median survival is 9 months (95% confidence interval; 7-16 months). Topotecan in this dose and schedule does not appear active in patients with advanced colorectal cancer.

摘要

拓扑异构酶-1抑制剂拓扑替康在48例符合条件的晚期结直肠癌患者中进行了试验。这些患者此前未接受过化疗，西南肿瘤协作组体能状态评分为0至2分。拓扑替康以1.5mg/m²/天的剂量静脉给药，持续5天，每21天重复一次。主要毒性为血液学毒性，48例患者中有19例（40%）出现IV级粒细胞减少，48例患者中有4例（8%）出现IV级血小板减少。2例患者（4%）出现部分缓解。30例患者死亡，根据Kaplan-Meier法估计的中位生存期为9个月（95%置信区间：7至16个月）。该剂量和给药方案的拓扑替康在晚期结直肠癌患者中似乎无活性。