Lavrenkov K, Man S, Mermershtain W, Cohen Y
Department of Oncology, Soroka University Medical Center, Beer Sheva, Israel.
J Chemother. 2002 Feb;14(1):84-7. doi: 10.1179/joc.2002.14.1.84.
This study is a retrospective analysis of response, toxicity and freedom from progression of two single-agent chemotherapy regimens in patients with previously treated metastatic colorectal cancer. Thirty-five patients with histologically confirmed measurable metastatic colorectal cancer received chemotherapy after failure of first-line 5-fluorouracil (5-FU) and leucovorin treatment. The median age was 61 years. Twenty-seven patients had liver metastases, 6 had local recurrence, 1 had retroperitoneal lymph node metastases and 1 had lung metastases. Eighteen patients received weekly 2600 mg/m2 5-FU and 17 patients received weekly 125 mg/m2 irinotecan (CPT-11). Treatment was given until disease progression. Total number of cycles was 202 for 5-FU and 248 for CPT-11. The relative dose intensity was 1.0 for 5-FU and 0.84 for CPT-11. No grade 3-4 toxicity was registered in patients who received 5-FU. Grade 3-4 toxicity rates were as follows in those who received CPT-11: vomiting 1 (5.9%) patient in 1 cycle, diarrhea 3 (17.7%) patients in 3 cycles and neutropenia in 3 (17.7%) patients in 3 cycles. No patients manifested febrile neutropenia. Two patients (11.8%) needed hospital admission because of toxicity: 1 for vomiting and 1 for diarrhea. No objective responses were observed in the 5-FU group of patients. Three patients (17.6%) who received CPT-11, achieved partial response with a median duration of 8 months. Stable disease was registered in 3 (17.6%) and 9 (52.9%) patients in 5-FU and CPT-11 groups respectively (p=0.05). Median time to progression was 3.3 months for patients who received 5-FU and 4.2 months for those treated with CPT-11 (not significant). One-year survival was 22.2% and 54.3% respectively (p=0.05).
Weekly chemotherapy with CPT-11 is tolerated with acceptable toxicity and leads to a better response rate than weekly high dose 5-FU. It also significantly improves survival but does not prolong freedom from progression.
本研究是对两种单药化疗方案用于先前接受过治疗的转移性结直肠癌患者的疗效、毒性和无进展生存期的回顾性分析。35例经组织学确诊为可测量的转移性结直肠癌患者在一线5-氟尿嘧啶（5-FU）和亚叶酸治疗失败后接受化疗。中位年龄为61岁。27例患者有肝转移，6例有局部复发，1例有腹膜后淋巴结转移，1例有肺转移。18例患者接受每周2600mg/m²的5-FU，17例患者接受每周125mg/m²的伊立替康（CPT-11）。治疗持续至疾病进展。5-FU的总疗程为202个，CPT-11为248个。5-FU的相对剂量强度为1.0，CPT-11为0.84。接受5-FU治疗的患者未出现3-4级毒性反应。接受CPT-11治疗的患者3-4级毒性反应发生率如下：1个周期中有1例（5.9%）患者出现呕吐，3个周期中有3例（17.7%）患者出现腹泻，3个周期中有3例（17.7%）患者出现中性粒细胞减少。无患者出现发热性中性粒细胞减少。2例（11.8%）患者因毒性反应需要住院治疗：1例因呕吐，1例因腹泻。5-FU组患者未观察到客观缓解。接受CPT-11治疗的3例患者（17.6%）获得部分缓解，中位缓解持续时间为8个月。5-FU组和CPT-11组分别有3例（17.6%）和9例（52.9%）患者病情稳定（p=0.05）。接受5-FU治疗的患者中位无进展生存期为3.3个月，接受CPT-11治疗的患者为4.2个月（无显著性差异）。1年生存率分别为22.2%和54.3%（p=0.05）。
每周使用CPT-11进行化疗耐受性良好，毒性可接受，且比每周高剂量5-FU的缓解率更高。它还能显著提高生存率，但不能延长无进展生存期。
