Cassinello Javier, Alvarez Jose Valero, López María José García, Pujol Eduardo, Colmenarejo Antonio, Segovia Fernando, Marcos Fernando, Filipovich Elena, Arcediano Alberto, Castro Inés García
Hospital Universitario de Guadalajara, Spain.
Clin Colorectal Cancer. 2006 Mar;5(6):429-35. doi: 10.3816/ccc.2006.n.014.
The purpose of this study was to evaluate the antitumor activity and toxicity of fixed sequences of capecitabine/oxaliplatin followed by capecitabine/irinotecan in patients with previously untreated metastatic colorectal cancer.
Adult patients with histologically confirmed, previously untreated, nonresectable, locally advanced or metastatic colorectal adenocarcinoma were enrolled in the study. Patients were treated as follows: capecitabine (1000 mg/m2 orally twice daily) on days 1-14 and oxaliplatin (130 mg/m2 2-hour intravenous infusion) on day 1, followed by capecitabine (1000 mg/m2 twice daily) on days 1-14 and irinotecan (240 mg/m2 1.5-hour intravenous infusion) on day 1. Each combination was administered every 21 days during 4 consecutive cycles followed by the alternating sequence to a maximum of 16 cycles.
A total of 35 eligible patients have been included in this ongoing study. Response rate (complete responses plus partial responses) was 37.1%. With a median follow-up of 9.5 months, the median time to disease progression and overall survival were 7.4 months and 16.4 months, respectively. Treatment was well tolerated, with only 6% of the patients developing grade 3/4 neurotoxicity. However, the low number of patients treated beyond 4 cycles limits the interpretation of the data.
The preliminary results from this ongoing study suggest the feasibility of this strategy, which resulted in promising antitumor activity with less neurotoxicity.
本研究旨在评估卡培他滨/奥沙利铂固定疗程序贯卡培他滨/伊立替康对既往未经治疗的转移性结直肠癌患者的抗肿瘤活性和毒性。
组织学确诊、既往未经治疗、不可切除、局部晚期或转移性结直肠腺癌的成年患者纳入本研究。患者接受如下治疗：第1 - 14天口服卡培他滨（1000 mg/m²，每日2次），第1天静脉输注奥沙利铂（130 mg/m²，2小时），随后第1 - 14天口服卡培他滨（1000 mg/m²，每日2次），第1天静脉输注伊立替康（240 mg/m²，1.5小时）。每21天进行1次上述联合治疗，共4个连续周期，之后交替使用该方案，最多进行16个周期。
本正在进行的研究共纳入35例符合条件的患者。缓解率（完全缓解加部分缓解）为37.1%。中位随访9.5个月，疾病进展的中位时间和总生存期分别为7.4个月和16.4个月。治疗耐受性良好，仅6%的患者出现3/4级神经毒性。然而，接受超过4个周期治疗的患者数量较少，限制了数据解读。
本正在进行的研究初步结果表明该策略可行，具有良好的抗肿瘤活性且神经毒性较低。
