Bajetta E, Celio L, Ferrario E, Di Bartolomeo M, Denaro A, Dotti K, Mancin M, Bajetta R, Colombo A, Pusceddu S
Medical Oncology Unit 2, Fondazione IRCCS 'Istituto Nazionale Tumori', Milan, Italy.
Ann Oncol. 2007 Nov;18(11):1810-6. doi: 10.1093/annonc/mdm347. Epub 2007 Sep 6.
A phase I/II study was performed to determine the safety and activity of a capecitabine plus oxaliplatin and irinotecan (COI) regimen using capecitabine concurrently with oxaliplatin and irinotecan in previously untreated patients with metastatic colorectal cancer.
Patients received irinotecan on day 1, oxaliplatin (85 mg/m(2)) on day 2 and capecitabine (1000 mg/m(2) orally twice daily) on days 2-6 of a biweekly schedule. Three dose levels ranging from 150 to 180 mg/m(2) were explored for irinotecan in sequential cohorts of three to six patients. Once the recommended dose was determined, a total of 28 eligible patients were planned at this dose level.
Thirty-eight patients received a median of six cycles. The recommended phase II dose of irinotecan was 180 mg/m(2). Toxicity was manageable: the most common severe toxicities were diarrhoea (24%) and nausea (16%). Of 27 assessable patients treated at the recommended dose, 17 achieved a partial response (overall response rate (ORR) 63%; 95% confidece interval (CI), 44 to 78%), with eight patients undergoing liver metastasectomy. Estimated progression-free survival and overall median survival were 8.5 and 23.5 months, respectively.
Biweekly COI is feasible and active. Tolerability and ease of administration make the regimen well suited for downsizing hepatic colorectal metastases before curative surgery.
开展了一项I/II期研究，以确定在既往未接受过治疗的转移性结直肠癌患者中，使用卡培他滨与奥沙利铂及伊立替康同时给药的卡培他滨加奥沙利铂及伊立替康（COI）方案的安全性和活性。
患者在双周方案的第1天接受伊立替康治疗，第2天接受奥沙利铂（85mg/m²）治疗，第2至6天接受卡培他滨（1000mg/m²，口服，每日两次）治疗。在每组三至六名患者的连续队列中探索了三种剂量水平的伊立替康，剂量范围为150至180mg/m²。一旦确定了推荐剂量，计划在该剂量水平纳入总共28名符合条件的患者。
38名患者接受了中位数为6个周期的治疗。伊立替康的推荐II期剂量为180mg/m²。毒性可控：最常见的严重毒性为腹泻（24%）和恶心（16%）。在按推荐剂量治疗的27名可评估患者中，17名获得部分缓解（总缓解率（ORR）63%；95%置信区间（CI），44%至78%），8名患者接受了肝转移灶切除术。估计无进展生存期和总中位生存期分别为8.5个月和23.5个月。
双周COI方案可行且有效。耐受性和给药便利性使该方案非常适合在根治性手术前缩小肝结直肠癌转移灶的大小。
