Pitot H C
Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Oncology (Williston Park). 1998 Aug;12(8 Suppl 6):48-53.
Phase I trials of irinotecan (CPT-11 [Camptosar]), conducted at Johns Hopkins and the University of Texas, San Antonio, demonstrated some activity in patients with refractory advanced cancer. Three pivotal phase II studies of irinotecan in advanced colorectal carcinoma were conducted at The University of Texas, San Antonio, Mayo/North Central Cancer Treatment Group (NCCTG), and the CPT-11 Study Group in a total of 304 patients. All patients had received prior fluorouracil (5-FU) chemotherapy, and over 90% had progressed while on treatment within the last 6 months. The initial starting dose of irinotecan ranged from 100 to 150 mg/m2. The overall response rate was 12.8% (95% confidence interval, 9.1% to 16.6%) with a 15% response rate at a recommended starting dose of 125 mg/m2. The response durations and overall median survivals were similar in the three studies. The principal toxicities included diarrhea, nausea, vomiting, and neutropenia. Severe diarrhea was limited by use of an intensive loperamide regimen and appropriate dose modification. The three pivotal studies of irinotecan in advanced colorectal carcinoma demonstrate consistent response rates and duration, with manageable toxicity. Future studies will focus on the use of irinotecan in chemotherapeutically naive colorectal carcinoma, the adjuvant treatment of colon carcinoma, combination chemotherapeutic regimens, and treatment of other malignant diseases.
在约翰霍普金斯大学和德克萨斯大学圣安东尼奥分校开展的伊立替康（CPT-11 [开普拓]）I期试验表明，该药对难治性晚期癌症患者有一定活性。德克萨斯大学圣安东尼奥分校、梅奥/北中部癌症治疗组（NCCTG）以及CPT-11研究组针对304例晚期结直肠癌患者开展了三项关键的伊立替康II期研究。所有患者均接受过氟尿嘧啶（5-FU）化疗，且超过90%的患者在过去6个月内接受治疗时病情进展。伊立替康的初始起始剂量为100至150 mg/m²。总体缓解率为12.8%（95%置信区间，9.1%至16.6%），推荐起始剂量为125 mg/m²时缓解率为15%。三项研究中的缓解持续时间和总体中位生存期相似。主要毒性包括腹泻、恶心、呕吐和中性粒细胞减少。通过使用强化洛哌丁胺方案和适当的剂量调整，严重腹泻得到了控制。伊立替康在晚期结直肠癌中的三项关键研究表明，缓解率和持续时间一致，毒性可控。未来的研究将集中于伊立替康在未接受过化疗的结直肠癌中的应用、结肠癌的辅助治疗、联合化疗方案以及其他恶性疾病的治疗。
