Kouroussis Charalambos, Souglakos John, Mavroudis Dimitris, Papadouris Savvakis, Kakolyris Stylianos, Agelaki Sophia, Kalbakis Kostas, Panopoulos Christos, Vardakis Nikos, Sarra Evanthia, Georgoulias Vassilis
Department of Medical Oncology, University General Hospital of Heraklion, Crete, Greece.
Am J Clin Oncol. 2002 Dec;25(6):627-31. doi: 10.1097/00000421-200212000-00021.
The purpose of this study was to evaluate the efficacy and tolerance of the bimonthly administration of oxaliplatin in combination with high-dose leucovorin and infusional 5-fluorouracil (5-FU) (FOLFOX2 regimen) in patients with advanced colorectal cancer (ACC) who did not respond or whose disease progressed within 3 months after front-line treatment with CPT-11-containing regimens. Forty-one patients with ACC who did not respond or whose disease progressed after front-line treatment with CPT-11 + 5-FU/leucovorin were enrolled. Oxaliplatin was administered at the dose of 100 mg/m2 on day 1 as a 2-hour infusion simultaneously but through different lines with leucovorin (500 mg/m2 on days 1 and 2); 5-FU was given at the dose of 1,750 mg/m2/d as a 22-hour continuous intravenous infusion on days 1 and 2. The regimen was repeated every 2 weeks. In an intention-to-treat analysis, complete response was achieved in one (2.4%) and partial response in six (14.6%) patients (overall response rate: 17%; 95% CI: 5.56-28.59%); stable disease and progressive disease were observed in 15 (36.6%) and in 19 (46.31%) patients, respectively. The median duration of response and the median time to tumor progression were 6 and 8.5 months, respectively. The median overall survival was 12 months and the probability for 1-year survival was 42.9%. Grade III/IV neutropenia occurred in 17 (41%) patients and febrile neutropenia developed in one of them (2%). There was no treatment-related death. Peripheral neuropathy greater than or equal to grade II occurred in 24 (58%) patients. Other toxicities were relatively mild. The bimonthly administration of oxaliplatin in combination with high-dose leucovorin and 48-hour continuous infusion of 5-FU is a relatively active and well-tolerated regimen for patients with ACC resistant or refractory to CPT-11 + 5-FU (continuous infusion)/leucovorin.
本研究旨在评估每两个月给予奥沙利铂联合高剂量亚叶酸钙及持续静脉输注5-氟尿嘧啶（5-FU）（FOLFOX2方案），用于一线接受含伊立替康方案治疗后3个月内无反应或疾病进展的晚期结直肠癌（ACC）患者的疗效和耐受性。41例一线接受伊立替康+5-FU/亚叶酸钙治疗后无反应或疾病进展的ACC患者入组。奥沙利铂于第1天以100mg/m²剂量静脉输注2小时，同时通过不同管路与亚叶酸钙（第1天和第2天为500mg/m²）同时给药；5-FU于第1天和第2天以1750mg/m²/d剂量持续静脉输注22小时。该方案每2周重复一次。在意向性分析中，1例（2.4%）患者达到完全缓解，6例（14.6%）患者达到部分缓解（总缓解率：17%；95%CI：5.56-28.59%）；分别有15例（36.6%）和19例（46.31%）患者观察到疾病稳定和疾病进展。缓解的中位持续时间和肿瘤进展的中位时间分别为6个月和8.5个月。中位总生存期为12个月，1年生存率为42.9%。17例（41%）患者发生III/IV级中性粒细胞减少，其中1例（2%）发生发热性中性粒细胞减少。无治疗相关死亡。24例（58%）患者发生大于或等于II级的周围神经病变。其他毒性相对较轻。对于对伊立替康+5-FU（持续输注）/亚叶酸钙耐药或难治的ACC患者，每两个月给予奥沙利铂联合高剂量亚叶酸钙及48小时持续输注5-FU是一种相对有效的且耐受性良好的方案。
