Fírvida J L, Irigoyen A, Vázquez-Estévez S, Díz P, Constenla M, Casal-Rubio J, Valladares-Ayerbes M, Castellanos J, Rodríguez R, Balcells M
Complexo Hospitalario de Ourense, Ourense, Spain.
Cancer. 2001 Feb 15;91(4):704-11.
The objective of this multicenter, open-labeled, Phase II study performed in Spain was to assess the efficacy and safety of irinotecan (CPT-11) as first-line chemotherapy for patients suffering from advanced colorectal carcinoma (CRC).
Patients with histologically proven CRC and at least one bidimensionally measurable lesion, ages 18-70 years, with a performance status < or = 2, normal analytical values, and no prior chemotherapy or only adjuvant chemotherapy completed before study entry were selected. The treatment schedule was CPT-11 350 mg/m(2) intravenously administered once every 3 weeks. Both tumor response and toxicity were assessed using the World Health Organization and National Cancer Institute common toxicity criteria. Changes in performance status, weight, and symptoms also were measured.
Sixty-five patients (44 chemotherapy-naïve patients and 21 patients who completed prior adjuvant treatment) were enrolled. Of these, 24.7% of patients responded to the treatment, and 41.5% of patients had stable disease. Patients who had not received prior adjuvant chemotherapy had a lower rate of progression on therapy (27.3%) compared with those who had received prior adjuvant chemotherapy (42.9%). The median survival was 19.9 months (range, 0.3-29.3 months). No significant differences were found in the median survival between chemotherapy-naïve patients and patients who had received previous chemotherapy. Grade 3-4 diarrhea and neutropenia were the most frequent severe toxic events, which were observed in 23.1% and 30.8% of patients and in 5.9% and 10.9% of the cycles, respectively.
The current antitumor efficacy results show that 350 mg/m(2) of CPT-11 administered every 3 weeks is an active and feasible first-line chemotherapy regimen for patients with CRC. Finally, the overall safety data confirmed that CPT-11 is a well tolerated treatment.
在西班牙进行的这项多中心、开放标签的II期研究的目的是评估伊立替康（CPT - 11）作为晚期结直肠癌（CRC）患者一线化疗的疗效和安全性。
选择组织学确诊为CRC且至少有一个二维可测量病灶、年龄在18 - 70岁、体能状态≤2、分析值正常且未接受过化疗或仅在研究入组前完成辅助化疗的患者。治疗方案为CPT - 11 350 mg/m²静脉注射，每3周一次。使用世界卫生组织和美国国立癌症研究所的通用毒性标准评估肿瘤反应和毒性。还测量了体能状态、体重和症状的变化。
共纳入65例患者（44例未接受过化疗的患者和21例完成过辅助治疗的患者）。其中，24.7%的患者对治疗有反应，41.5%的患者病情稳定。未接受过辅助化疗的患者在治疗期间的进展率（27.3%）低于接受过辅助化疗的患者（42.9%）。中位生存期为19.9个月（范围为0.3 - 29.3个月）。未接受过化疗的患者和接受过化疗的患者在中位生存期上无显著差异。3 - 4级腹泻和中性粒细胞减少是最常见的严重毒性事件，分别在23.1%和30.8%的患者中观察到，在5.9%和10.9%的周期中出现。
目前的抗肿瘤疗效结果表明，每3周给予350 mg/m²的CPT - 11是CRC患者一种有效的一线化疗方案。最后，总体安全性数据证实CPT - 11是一种耐受性良好的治疗方法。
