Zeuli M, Nardoni C, Pino M S, Gamucci T, Gabriele A, Ferraresi V, Giannarelli D, Cognetti F
Department of Medical Oncology A, Regina Elena Cancer Institute, Roma, Italy.
Ann Oncol. 2003 Sep;14(9):1378-82. doi: 10.1093/annonc/mdg360.
Capecitabine and oxaliplatin are both active anticancer agents in the treatment of patients with advanced colorectal cancer. The aim of this phase II study is to determine the efficacy and tolerability of combining oxaliplatin with capecitabine in the treatment of advanced non-pretreated colorectal cancer.
Forty-three chemotherapy-naïve patients were enrolled. Capecitabine 2500 mg/m(2)/day was administered orally twice a day continuously for 14 days and oxaliplatin 120 mg/m(2) was administered as a 2-h infusion on day 1, repeated every 3 weeks.
Forty-three patients were assessable for toxicity and 39 for clinical activity: the main toxicity was grade 3 or 4 diarrhea, which occurred in 28% of the patients. The response rates were 44% [95% confidence interval (CI), 29.3% to 59.0%] and 48.7% (95% CI 33.0% to 64.4%) (intention-to-treat and per protocol analysis, respectively). The median overall survival was 20 months (95% CI 12-28).
Combining capecitabine and oxaliplatin yields promising activity in advanced colorectal cancer; therefore, the capecitabine dose we utilized is probably too high. The main toxicity is diarrhea, which is manageable with appropriate dose reductions. This combination may be preferable compared to a standard combination with infusional fluorouracil/leucovorin as it is more convenient and practical with similar efficacy. Thus, phase III trials are needed to clarify its role in the treatment of chemotherapy-naïve advanced colorectal cancer patients.
卡培他滨和奥沙利铂都是治疗晚期结直肠癌患者的有效抗癌药物。本II期研究的目的是确定奥沙利铂联合卡培他滨治疗未经预处理的晚期结直肠癌的疗效和耐受性。
纳入43例未接受过化疗的患者。卡培他滨2500mg/m²/天，每日口服两次，持续14天，奥沙利铂120mg/m²在第1天静脉滴注2小时，每3周重复一次。
43例患者可评估毒性，39例可评估临床活性：主要毒性为3级或4级腹泻，发生率为28%。意向性分析和符合方案分析的缓解率分别为44%[95%置信区间（CI），29.3%至59.0%]和48.7%（95%CI 33.0%至64.4%）。中位总生存期为20个月（95%CI 12 - 28）。
卡培他滨联合奥沙利铂治疗晚期结直肠癌有良好活性；因此，我们使用的卡培他滨剂量可能过高。主要毒性是腹泻，通过适当降低剂量可控制。与氟尿嘧啶/亚叶酸钙标准联合方案相比，该联合方案可能更优，因为其更方便实用且疗效相似。因此，需要进行III期试验以明确其在治疗未接受过化疗的晚期结直肠癌患者中的作用。
