局部晚期直肠癌同期放化疗的多中心随机临床研究

目的 观察两种不同化疗方案同期联合三维适形放疗对局部晚期(不可手术)直肠癌患者的治疗依从性及疗效,并比较两组间差异.方法 76例经病理证实的局部晚期或局部.区域复发直肠癌患者,随机分为奥沙利铂组和卡培他滨组,两组患者均接受了全盆腔三维适形放疗D_T 46～50 Gy分23～25次,后缩野至肿瘤区继续推量至D_T 64～66 Gy分32～33次.前者同期接受奥沙利铂130 mg/m~2第1天,氟尿嘧啶350 mg/m~2第1～5天,甲酰四氢叶酸200 mg/m~2第1～5天,每4周为1个周期,共2个周期;后者接受卡培他滨1650 mg/(m~2·d),分2次口服,第1～14天,每3周为1个周期,共2个周期.结果 中位随访19个月.奥沙利铂组和卡培他滨组患者的总有效率、中位生存时间、1年生存率、2年总生存率分别为64%、22个月、68%、21%和58%、18个月、63%、19%,两组间差异无统计学意义(χ~2=0.08,P=0.772;u=17.71,P=0.077;χ~2=0.97,P=0.326).两组患者均无3级以上毒副反应发生,其中卡培他滨组在中性粒细胞减少、腹泻、恶心呕吐和周围神经系统一级及以上毒副反应发生率均明显低于奥沙利铂组,分别为39.5%:77.7%(z=-3.97,P=0.000)、47.4%:88.9%(z=-4.78,P=0.000)、68.4%:97.2%(z=-3.17,P=0.000)和5.3%:66.7%(z=-6.56,P=0.000).结论 同期放化疗是局部晚期(不可手术)直肠癌患者较理想的治疗方法,其治疗依从性高,疗效确切,值得临床进一步推广.

A randomized multicentre study of chemoradiotherapy in patients with locally advanced (inoperable) rectal cancer

Objective To evaluate the feasibility and efficacy of chemoradiotherapy for locally advanced (inoperable) rectal cancer. Methods Seventy-six patients with locally advanced (T_4) or recurrent rectal cancer were randomized into two groups of concurrent chemoradiotherapy with either oxaliplatin plus 5-FU (oxaliplatin 130 mg/m~2, day 1,5-FU 350 mg/m~2, day 1 -5 ,LV 200 mg/m~2, day 1 -5, 4 weeks per cycle) or capecitabine (1650 mg/m~2, day 1 -14, 3 weeks per cycle) alone. All patients received pelvic three-dimensional conforrnal radiotherapy (3 DCRT) of 46 -50 Gy in 23 -25 fractions, with a boost of 14 -18 Gy in 7 -9 fractions. Results The median follow-up time was 19 months. The overall response rate was 64% in the oxaliplatin/5-FU group comparing with 58% in the capecitabine group (χ~2 = 0. 08 ,P =0. 772), with the median survival time of 22 months and 18 months (u = 17.71, P = 0. 077), respectively. The overall survival in the two groups was 68% and 63% at 1 year, and 21% and 19% at 2 years, respectively (χ~2 = 0. 97, P = 0. 326). There were no treatment-related deaths or grade 4 toxicities. Neutrocytopenia (39. 5% vs 77.7%, z = -3.97,P =0. 0001), diarrhea (47.4% vs 88.9%, z = -4. 78, P = 0. 0001), nausea and vomiting (68.4% vs 97.2%, z = -3. 17, P = 0. 0001), and neurotoxicity (5.3% vs 66.7%, z= -6.56, P= 0.0001) were more common in the oxaliplatin/5-FU group. Conclusions Concurrent chemoradiotherapy is well-tolerated and effective in patients with locally advanced (inoperable) rectal cancer.