Irinotecan in combination with fluorouracil in a 48-hour continuous infusion as first-line chemotherapy for elderly patients with metastatic colorectal cancer:: A Spanish cooperative group for the treatment of digestive tumors study
Irinotecan in combination with fluorouracil in a 48-hour continuous infusion as first-line chemotherapy for elderly patients with metastatic colorectal cancer:: A Spanish cooperative group for the treatment of digestive tumors study
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DOI：
10.1200/jco.2005.03.004
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发表时间：
2005-05-20
影响因子：
45.3
通讯作者：
Díaz-Rubio, E
中科院分区：
文献类型：
--
作者：
Sastre, J;Marcuello, E;Díaz-Rubio, E
目的老年患者构成了一个具有不同于非老年患者的特殊特征的亚群，并且在临床试验中代表性不足。本研究是为了确定伊立替康（CPT-11）与氟尿嘧啶（FU）联合给药作为48小时连续输注每月两次在老年患者中的疗效和安全性。患者和方法患者年龄>= 72岁，患有转移性结直肠癌，东部肿瘤协作组体能状态为0至1，无老年综合征，结果85例可评价患者中，按意向治疗分析，客观有效率为35%，其中12例（12/85）有效率为35（95% CI，25%至46%），疾病稳定为33%（95% CI，23%至44%）。中位至进展时间为8.0个月（95% CI，6.0至10.0个月），中位总生存时间为15.3个月（95% CI，13.8至16.9个月）。毒性为中度。分别在21%、17%和13%的患者中观察到3级和4级中性粒细胞减少、腹泻和虚弱。仅发生1例血小板减少性发热。有两个中毒死亡，一个是4级腹泻和急性肾衰竭的结果，另一个是第一个周期大量肠道出血的结果。对预后因素的研究未发现任何反应的预测因素。对治疗的反应和基线乳酸脱氢酶的主要因素条件下的无进展和总survivs.Conclusion每月两次连续输注CPT-11联合FU是一种有效的治疗选择，为老年患者在良好的一般条件。(c)2005年，美国临床肿瘤学会。
Purpose Elderly patients constitute a subpopulation with special characteristics that differ from those of the nonelderly and have been underrepresented in clinical trials. This study was performed to determine the efficacy and safety of irinotecan (CPT-11) in combination with fluorouracil (FU) administered as a 48-hour continuous infusion twice a month in elderly patients.Patients and Methods Patients >= 72 years old with metastatic colorectal cancer, Eastern Cooperative Oncology Group performance status of 0 to 1, no geriatric syndromes, and no prior treatment were treated every 2 weeks with CPT-11 180 mg/m(2) plus FU 3,000 mg/m(2) in a 48-hour continuous infusion.Results By intent-to-treat analysis, in 85 assessable patients, the objective response rate was 35% (95% Cl, 25% to 46%), and stable disease was 33% (95% Cl, 23% to 44%). Median time to progression was 8.0 months (95% Cl, 6.0 to 10.0 months), and median overall survival time was 15.3 months (95% Cl, 13.8 to 16.9 months). Toxicity was moderate. Grade 3 and 4 neutropenia, diarrhea, and asthenia were observed in 21%, 17%, and 13% of patients, respectively. Only one case of neutropenic fever occurred. There were two toxic deaths, one was a result of grade 4 diarrhea and acute kidney failure, and the other was a result of massive intestinal hemorrhage in the first cycle. The study of prognostic factors did not reveal any predictive factor of response. Response to treatment and baseline lactate dehydrogenase were the main factors conditioning progression-free and overall survival.Conclusion Twice a month continuous-infusion CPT-11 combined with FU is a valid therapeutic alternative for elderly patients in good general condition. (c) 2005 by American Society of Clinical Oncology.