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首页> 外文期刊>Clinical drug investigation >Modified-irinotecan/fluorouracil/levoleucovorin therapy as ambulatory treatment for metastatic colorectal cancer: results of phase I and II studies.
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Modified-irinotecan/fluorouracil/levoleucovorin therapy as ambulatory treatment for metastatic colorectal cancer: results of phase I and II studies.

机译：改良的伊立替康/氟尿嘧啶/左旋卵磷脂治疗作为转移性结直肠癌的门诊治疗：I和II期研究的结果。

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BACKGROUND: Combined therapy with irinotecan/fluorouracil/levoleucovorin (calcium levofolinate) [IFL] has lost its position as the standard regimen for metastatic colorectal cancer because its toxicity and effectiveness have become controversial. OBJECTIVE: To (i) identify the optimal regimen for IFL therapy in terms of irinotecan dosage, and (ii) determine the maximum tolerated dose and efficacy of the modified-IFL regimen in patients with histologically confirmed advanced colorectal cancer. METHODS: In a phase I study, nine patients with advanced colorectal cancer received IFL treatment modified such that irinotecan was administered every 2 weeks, as opposed to the more toxic once-weekly administration. The study evaluated three escalating dose levels of irinotecan (100, 125 and 150 mg/m(2)). Each treatment cycle consisted of irinotecan on days 1 and 15; fluorouracil 600 mg/m(2) on days 1, 8, 15 and 22; and levoleucovorin 250 mg/m(2) on days 1, 8, 15 and 22. Data from the phase I study were used to determine the recommended dose of irinotecan for the phase II study. The latter study evaluated the effectiveness (overall response rate, median time to disease progression and median survival time) and tolerability of this modified-IFL therapy as ambulatory treatment in 22 patients with advanced colorectal cancer. RESULTS: The dose-limiting toxicity of irinotecan was grade 3 neutropenia, which occurred in three patients at dose level 2 (125 mg/m(2)); furthermore, a fourth patient developed grade 4 neutropenia at this dose level. Therefore, 125 mg/m(2) was considered to be the maximum tolerated dose, and the dose of irinotecan for the phase II study was set at 100 mg/m(2). Fourteen patients achieved partial response using this modified-IFL regimen, and the overall response rate was 63.6% (95% CI 43.5, 83.7). The median time to progression was 197 days (range 111-283 days) and the median survival time was 414 days (95% CI 116, 712). Toxicities were acceptable and manageable. CONCLUSIONS: Modified-IFL therapy is a practical, effective and tolerable option for ambulatory treatment of advanced colorectal cancer.
机译：背景：与伊立替康/氟尿嘧啶/左旋卵磷脂（左叶甲酸钙）[IFL]联合治疗已失去其作为转移性结直肠癌标准疗法的地位，因为其毒性和有效性已引起争议。目的：（i）根据伊立替康剂量确定最佳的IFL治疗方案，（ii）确定经组织学证实为晚期结直肠癌的患者的最大耐受剂量和改良IFL方案的疗效。方法：在一项I期研究中，对9位晚期结直肠癌患者进行了改良的IFL治疗，使得伊立替康每2周给药一次，而毒性更高的药物应每周给药一次。该研究评估了伊立替康的三种递增剂量水平（100、125和150 mg / m（2））。每个治疗周期在第1天和第15天由伊立替康组成。第1、8、15和22天的氟尿嘧啶600 mg / m（2）;在第1、8、15和22天服用左氧氟沙星和250 mg / m（2）左旋卵磷脂（I）使用I期研究的数据来确定II期研究推荐的伊立替康剂量。后者的研究评估了这种改良的IFL疗法在22例晚期大肠癌患者中作为门诊治疗的有效性（总体缓解率，疾病进展的中位时间和中位生存时间）和耐受性。结果：伊立替康的剂量限制性毒性为3级嗜中性白血球减少症，三名患者在剂量水平2（125 mg / m（2））时发生。此外，第四名患者在该剂量水平出现了4级中性粒细胞减少。因此，将125 mg / m（2）视为最大耐受剂量，用于II期研究的伊立替康剂量设定为100 mg / m（2）。使用这种改良的IFL方案，有14例患者获得了部分缓解，总缓解率为63.6％（95％CI 43.5，83.7）。中位进展时间为197天（111-283天），中位生存时间为414天（95％CI 116，712）。毒性是可以接受且可控的。结论：改良的IFL疗法是动态，有效且可耐受的门诊治疗晚期大肠癌的方法。

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