Ⅱ期和Ⅲ期直肠癌根治术后卡培他滨同期放化疗疗效及失败原因分析

Outcome of locally advanced rectal cancer patients treated with radical surgery followed by concurrent capecitabine and radiotherapy

目的分析Ⅱ、Ⅲ期直肠癌根治术后卡培他滨同期放化疗Ⅱ期临床研究结果。方法2005--2007年间共131例病理诊断明确的Ⅱ、Ⅲ期直肠癌患者纳入研究，所有患者均接受根治术后同期化放疗和辅助化疗。治疗方案为全盆腔放疗50Gy分25次，放疗期间同期应用卡培他滨1600mg／m＾2，每天分2次服用，连用2周停1周。结果同期放化疗期间3＋4级不良反应发生率为28，2％。随访率为93．9％，3年总生存率、无局部区域复发生存率和无远处转移生存率分别为85．1％、96．7％和79．5％。共31例出现复发，包括5例局部区域复发和28例远处转移。单因素分析提示病理低分化或中低分化、未接受辅助化疗、Ⅲ。期和淋巴结阳性率〉30％是影响总生存的因素（χ2=15．49、15．85、8．80和9．76，P=0．000、0．000、0．011和0．002），Ⅲc期、未接受辅助化疗和淋巴结阳性率〉30％是影响无远处转移生存的因素（χ2=6．51、11．57和9．70，P=0．034、0．001和0．002）。但未接受辅助化疗者中病理为低分化或T4期的患者更多（χ2=7．20、6．48，P=0．027、0．039）。结论Ⅱ、Ⅲ期直肠癌根治术及卡培他滨同期放化疗后局部区域控制率高，远处转移是主要失败原因。

Objective To evaluate the toxicities and long-term survival of a pilot study of radical surgery followed by concurrent capecitabine and radiotherapy for stageⅡ/Ⅲ rectal cancer patients. Methods From March 1, 2005 to December 31, 2007, 131 pathologically proved stage Ⅱ and Ⅲrectal cancer patients received radical surgery followed by chemoradiotherapy and adjuvant chemotherapy. Capecitabine was delivered daily in twice, for 2 weeks followed by a 2nd cycle after a rest of 7 days during radiotherapy, with the dosage of 1600 mg/m2/d. Three-dimensional conformal radiotherapy was encouraged to the dose of 50 Gy in 25 fractions, and Oxaliplatin/5-fluorouracil or leucovorin based adjuvant chemotherapy was recommended. Results Grade 3 ＋ 4 toxicities during concurrent chemoradiotherapy were observed in 28.2% of patients. The follow-up rate was 93.9%. The 3-year overall survival （OS）, locoregional-free survival and distant metastasis-free survival rates were 85.1%, 96. 7% and 79. 5%, respectively. Among the 31 patients with relapse, 5 had loco-regional recurrence and 28 had distant metastasis. Univariate analysis indicated that patients with low and moderate-low differentiated adenocarcinoma, no adjuvant chemotherapy, stage Ⅲc. disease or positive lymph node ratio （LNR） more than 30% had lower OS （χ2 = 15.49, 15.85,8.80 and 9. 76,P=0.000,0.000,0.011 and 0.002）. Patients with N： disease had more loco-regional recurrence. Patients with stage Ⅲc, without adjuvant chemotherapy, or LNR more than 30% were at higher risk of distant metastasis （ χ2 = 6. 51,11.57 and 9. 70 , P = 0. 034 , 0. 001 and 0. 002 ） . However , patients who didn ＇ t receive adjuvant chemotherapy were likely to have low differentiated adenocarcinoma and T4 stage disease （χ2 =7.20,6.48 ,P = 0. 027,0. 039）. Conclusions After radical surgery and concurrent capecitabine and radiotherapy for stage Ⅱ/Ⅲ rectal cancer patients, loco-regional recurrence rate is pretty low. Distant metastasis is the main treatment failure.