Mitry E, Ducreux M, Rougier P
Service d'hépato-gastro-entérologie et d'oncologie digestive, hôpital Ambroise-Paré, Boulogne.
Bull Cancer. 1998 Dec;Spec No:38-42.
Treatments of advanced colorectal cancer progressing after a 5FU based chemotherapy have not been extensively studied. However, 5FU in continuous infusion, L-OHP alone or in combination with 5FU and CPT11 have proved their efficacy in terms of tumor growth control and symptomatic effect. Irinotecan only has been evaluated prospectively in phase III studies. This paper reports the results of the two randomized European studies which have demonstrated the efficacy of irinotecan used at the dose of 350 mg/m2 administered over 90 minutes every 3 weeks in patients progressing after a 5FU-based chemotherapy. The first study compared irinotecan versus best supportive care in a group of 279 patients. It demonstrated an overall survival benefit (9.2 versus 6.5 months, p < 0.0001) with a one-year survival of 36.2% for patients treated by irinotecan versus 13.8%. There was also a quality of life benefit, especially for asthenia and pain in favor of the irinotecan arm. The second study compared irinotecan to a second-line infusional 5FU and randomized 260 patients. Irinotecan treated patients lived for significantly longer than those on 5FU: median time of survival was 10.8 months versus 8.5 months (p = 0.035). Survival at 1 year was increased from 32% in the 5FU arm to 45% in the irinotecan arm. Pain-free survival and symptom-free survival were better for patients treated by irinotecan and the global quality of life score was in favor of irinotecan when assigning null value to missing data due to death in both arms. Both treatments were equally well tolerated. These two randomized studies have proved the efficacy of irinotecan as second line chemotherapy for colorectal cancers progressing under 5FU. Combination of irinotecan to 5FU and/or L-OHP have now to be evaluated in this situation.
对于在基于5-氟尿嘧啶（5FU）的化疗后病情进展的晚期结直肠癌，其治疗方法尚未得到广泛研究。然而，持续输注5FU、单独使用奥沙利铂（L-OHP）或与5FU及伊立替康（CPT11）联合使用，在肿瘤生长控制和症状缓解方面已证明了其疗效。仅伊立替康已在III期研究中进行了前瞻性评估。本文报告了两项欧洲随机研究的结果，这些研究证明了在基于5FU的化疗后病情进展的患者中，每3周静脉输注90分钟、剂量为350mg/m²的伊立替康的疗效。第一项研究在279例患者中比较了伊立替康与最佳支持治疗。结果显示伊立替康治疗组具有总体生存获益（9.2个月对6.5个月，p<0.0001），伊立替康治疗患者的一年生存率为36.2%，而最佳支持治疗组为13.8%。在生活质量方面也有获益，尤其是在乏力和疼痛方面，伊立替康组更具优势。第二项研究将伊立替康与二线输注用5FU进行比较，并将260例患者随机分组。接受伊立替康治疗的患者生存时间明显长于接受5FU治疗的患者：中位生存时间分别为10.8个月和8.5个月（p=0.035）。一年生存率从5FU组的32%提高到伊立替康组的45%。伊立替康治疗的患者无痛生存期和无症状生存期更好，在对两组因死亡导致的缺失数据赋予无效值时，总体生活质量评分有利于伊立替康组。两种治疗的耐受性相当。这两项随机研究证明了伊立替康作为5FU治疗失败后的晚期结直肠癌二线化疗的疗效。目前需要在这种情况下评估伊立替康与5FU和/或L-OHP联合使用的效果。
