Cassinello J, López-Alvarez P, Martínez-Guisado A, Valladares M, Huidobro G, López R, Bohn U, Sevilla I, Ballesteros P, Jorge M, Pérez-Carrión R, Fernández J L, Dorta J
Hospital general de Guadalajara, Spain.
Med Oncol. 2003;20(1):37-43. doi: 10.1385/MO:20:1:37.
This phase II trial studied the antitumor effect and toxicity of weekly irinotecan (CPT-11, 125 mg/m(2) 60 min iv infusion, weekly for 4 wk plus 2 wk rest) as second-line chemotherapy in patients with advanced colorectal cancer (CRC) resistant or refractory to prior 5-fluorouracil (5-FU) therapy. Sixty-nine patients with adenocarcinoma (57% in the colon and 43% in the rectum) were enrolled. The median number of treatment cycles received per patient was 4 (range, 1-6). Overall response rate was 18% (95% CI, 9-26), with 4 complete responses (6%) and 8 partial responses (12%), and a median duration of response of 8.1 mo (95% CI, 4.2-12.1). Stable disease was observed in 19 patients (28%). The median time to disease progression was 5.2 mo (95% CI, 4.3-6.1), and the median overall survival was 13.3 mo (95% CI, 9.8-16.8 months). The toxicity profile was favorable: grade 3/4 delayed diarrhea was observed in 10 patients (14.5%) in one cycle each, and grade 3/4 neutropenia in 6 patients (8.7%) and 6 cycles (3.3%). No febrile neutropenia or infection was documented. Grade 3/4 nausea and vomiting were reported in 1 (1.4%) and 7 patients (10.1%), respectively. In conclusion, this phase II trial showed a response rate and a toxicity profile of weekly CPT-11 in line with the results of prior phase II studies.
这项II期试验研究了每周一次伊立替康（CPT - 11，125 mg/m²，静脉输注60分钟，每周一次，共4周，加2周休息）作为二线化疗方案对先前接受5 - 氟尿嘧啶（5 - FU）治疗耐药或难治的晚期结直肠癌（CRC）患者的抗肿瘤作用和毒性。69例腺癌患者（57%位于结肠，43%位于直肠）入组。每位患者接受的治疗周期中位数为4个（范围1 - 6个）。总缓解率为18%（95%CI，9 - 26），其中4例完全缓解（6%），8例部分缓解（12%），缓解持续时间中位数为8.1个月（95%CI，4.2 - 12.1）。19例患者（28%）病情稳定。疾病进展的中位时间为5.2个月（95%CI，4.3 - 6.1），总生存中位数为13.3个月（95%CI，9.8 - 16.8个月）。毒性特征良好：10例患者（14.5%）在每个周期出现1次3/4级延迟性腹泻，6例患者（8.7%）和6个周期（3.3%）出现3/4级中性粒细胞减少。未记录到发热性中性粒细胞减少或感染。3/4级恶心和呕吐分别报告于1例患者（1.4%）和7例患者（10.1%）。总之，这项II期试验显示每周一次CPT - 11的缓解率和毒性特征与先前II期研究结果一致。
