Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer
Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer
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DOI：
10.1016/s0140-6736(98)02309-5
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发表时间：
1998-10-31
期刊：
影响因子：
168.9
通讯作者：
Herait, P
中科院分区：
文献类型：
--
作者：
Cunningham, D;Pyrhönen, S;Herait, P
背景在II期研究中，伊立替康对转移性结直肠癌有效，但在随机临床试验中尚未评估其总体获益。方法经证实的转移性结直肠癌患者，在氟尿嘧啶治疗6个月内进展，随机分配300-350 mg/m2伊立替康，每3周一次，同时给予支持性治疗或仅给予支持性治疗。结果189例患者被分配伊立替康和支持性治疗和90支持性治疗。参与者的平均年龄为58.8岁; 181名（65%）为男性，98名（35%）为女性。79例（42%）患者的WHO体能状态为0，77例（41%）患者为1，32例（17%）患者为2。134例（71%）患者出现肿瘤相关症状，15例（8%）患者体重减轻超过5%。中位随访时间为13个月，伊立替康组的总生存率显著更好（p=0.0001），伊立替康组的1年生存率为36.2%，而连续治疗组为13.8%。在多变量分析中调整预后因素后，生存获益仍然显著（p=0.001），伊立替康组患者的无体力状态恶化生存期（p=0.0001）、体重减轻不超过5%（p=0.018）和无痛生存期（p=0.003）显著更好。在生活质量分析中，所有显着差异，除了腹泻评分，都有利于伊立替康group.Interpretation，我们的研究表明，尽管治疗的副作用，转移性结直肠癌患者，并为谁氟尿嘧啶失败，有更长的生存期，更少的肿瘤相关症状，和更好的生活质量时，与伊立替康治疗比单独的支持性治疗。
Background In phase II studies, irinotecan is active in metastatic colorectal cancer, but the overall benefit has not been assessed in a randomised clinical trial.Methods Patients with proven metastatic colorectal cancer, which had progressed within 6 months of treatment with fluorouracil, were randomly assigned either 300-350 mg/m(2) irinotecan every 3 weeks with supportive care or supportive care alone, in a 2:1 ratio.Findings 189 patients were allocated irinotecan and supportive care and 90 supportive care alone. The mean age of the participants was 58.8 years; 181 (65%) were men and 98 (35%) were women. WHO performance status was 0 in 79 (42%) patients, 1 in 77 (41%) patients, and 2 in 32 (17%) patients. Tumour-related symptoms were present in 134 (71%) patients and weight loss of more than 5% was seen in 15 (8%) patients. With a median follow-up of 13 months, the overall survival was significantly better in the irinotecan group (p=0.0001), with 36.2% 1-year survival in the irinotecan group versus 13.8% in the supportive-care group. The survival benefit, adjusted for prognostic factors in a multivariate analysis, remained significant (p=0.001), Survival without performance-status deterioration (p=0.0001), without weight loss of more than 5% (p=0.018), and pain-free survival (p=0.003) were significantly better in the patients given irinotecan. In a quality-of-life analysis, all significant differences, except on diarrhoea score, were in favour of the irinotecan group.Interpretation Our study shows that despite the side-effects of treatment, patients who have metastatic colorectal cancer, and for whom fluorouracil has failed, have a longer survival, fewer tumour-related symptoms, and a better quality of life when treated with irinotecan than with supportive care alone.