奥沙利铂联合卡培他滨新辅助化疗治疗可切除局部晚期结肠腺癌的疗效及安全性——病例对照分析

【摘要】 目的 研究奥沙利铂联合卡培他滨新辅助化疗可切除的局部晚期结肠腺癌的疗效及安全性。方法〓前瞻性入组汕头大学医学院附属肿瘤医院2010年1月至2014年12月间100例可手术切除的局部晚期结肠腺癌患者(T3/T4或N+),随机分为新辅助化疗组(研究组)及手术组(对照组),每组各50例,对比两组患者的疗效及手术、化疗并发症情况。结果〓随访至2015年12月,研究组有2例失访,平均随访时间35.2个月;对照组3例失访,平均随访时间27.7个月。两组患者入院时临床T、N分期的差异均无统计学意义。研究组经新辅助化疗后T、N分期降期明显,PR38例(76%),SD11例(22%),PD1例(2%),新辅助化疗期间无3°以上化疗药物不良反应发生,最常见的1°~2°不良反应为胃肠道反应(21例/42%)、粒细胞降低(4例/8%)及血小板降低(2例/4%)。术后T分期、N分期、阳性淋巴结数及TNM分期均较对照组改善,差异具有统计学意义(P<0.01)。两组患者手术时间、术中出血量、吻合口瘘发生率及腹腔感染发生率的差异均无统计学意义。平均随访31.5个月后(6~68个月),两组患者的5年无瘤生存率(DFS)分别为44.9%及33.6%(P=0.041)。5年总生存率(OS)分别为51.0%及41.6%(P=0.033)。DFS及OS差异均有统计学意义。结论〓应用奥沙利铂联合卡培他滨对局部晚期可切除的结肠腺癌患者行新辅助化疗是安全有效的。

Neoadjuvant chemotherapy for resectable locally advanced colon carcinoma :a prospective case controlled trial

【Abstract】〓Objective〓To investigate the feasibility, safety, and efficacy of neo-adjuvant chemotherapy of XELOX (oxaliplatin and capecitabine) for the resectable locally advanced colon carcinoma. Methods〓From Jan. 2010 to Dec. 2014, 100 patients with resectable locally advanced colon carcinoma (T3/T4 or N+) were randomized into either perioperative chemotherapy and surgery (study group, n=50) or surgery followed by postoperative chemotherapy (control group, n=50). Perioperative chemotherapy consisted of two-four preoperative cycles of intravenous Oxaliplatin(130 mg/m2) on day 1, and oral capecitabine (1000 mg/m2) for two weeks (day 1 to day 14) every 21 days and four to six postoperative cycles of the same regimen. Results〓All the patients completed neo-adjuvant chemotherapy and no severe grade 3-4 toxicity happened. All the tumours were resected with no significant differences in postoperative morbidity between the study group and the control group. These two groups were comparable in clinical T stage and N stage, and when compared with control, neo-adjuvant chemotherapy resulted insignificant involvement in N stage (P<0.01) and TNM (P<0.01) and less positive node (P<0.01). With a median follow-up of four years, median survival was 46 months in the neo-adjuvant chemotherapy group compared with 26 months in the control group. 5-year DFS were 44.9% and 33.6% (P=0.041) and 5-year OS were 51.0% and 41.6% (P=0.33). Conclusion〓Neo-adjuvant chemotherapy with Oxaliplatin and Capecitabine improve survival without additional serious adverse events in the treatment of patients with resectable locally advanced colon carcinoma.