奥沙利铂联合氟尿嘧啶和亚叶酸钙方案治疗70岁及以上转移性结直肠癌的疗效和安全性

A comparative study on safety and efficacy of FOLFOX4 treatment in elderly versus young patients with advanced coiorectal cancer

目的对比观察奥沙利铂联合氟尿嘧啶和亚叶酸钙方案（FOLFOX4）治疗70岁及以上转移性结直肠癌患者与70岁以下患者的不良反应和疗效。方法61例转移性结直肠癌患者，其中≥70岁组28例，〈70岁组33例，两组患者均接受FOLFOX4方案化疗，14d为1个周期，治疗期间观察不良反应，3个周期后评价疗效。结果61例患者均可评价不良反应及疗效。主要不良反应为骨髓抑制、胃肠道反应及神经毒性，≥70岁组腹泻的发生率高于〈70岁组，但主要为1～2度不良反应。≥70岁组白细胞和中性粒细胞下降的发生率高于〈70岁组（92．8％比78．8％和39．3％比36．3％），但差异无统计学意义。≥70岁组神经系统毒性发生率为46．5％，〈70岁组为36．4％，均为1～2度，两组间差异无统计学意义。≥70岁组患者近期有效率为25％，疾病控制率为71．4％，中位疾病进展时间（TTP）为6个月，〈70岁组患者近期有效率24．2％，疾病控制率84．8％，中位TTP7个月，两组有效率和疾病控制率差异无统计学意义，而〈70岁组患者的中位TTP比≥70岁组略长。结论FOLFOX4方案同样适用于≥70岁转移性结直肠癌患者，其耐受性较好且疗效肯定。

Objective To observe the safety and efficacy of FOLFOX4 regiment in elderly versus young patients with advanced colorectal cancer. Methods There were 61 patients enrolled in this study, with 28 elderly patients aged 70 years and over, 33 young patients aged less than 70 years. They suffered from advanced/recurrent colorectal cancer and received FOLFOX4 regiment （Oxaliplatin ＋CF＋5-FU）. Every 14 days were as a cycle, and the therapeutic safety and efficacy were evaluated after three cycles. Adverse events and response to treatment were compared between the elderly and young patients. disturbance and Results The main adverse effects were myelosuppression, gastrointestinal neurotoxieity patients than in young patients, The incidence rate of diarrhea was significantly higher in elderly but the most of diarrhea were at grade Ⅰ -Ⅱ. The incidence rates of leucocyte decrease and neutrophil decrease were higher in elderly patients than in young patients （92.8% vs. 78.8%, 39.3% vs. 36.3%）, but there were no statistically significant differences between them. The incidence rate of neurotoxicity was 46.5% in elderly patients and 36.4% in young patients （P〉0.05）. The recent efficacy rate was 25%, disease control rate was 71.4% and median time to-progression （TTP） was 6 months in elderly patients and 24.2%, 84.8% and 7 months in young patients （all P〉0.05）. Conclusions FOLFOX4 regiment is well-tolerated and effective in both young and elderly patients.