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目的探讨肝外胆道恶性肿瘤切除术后辅助放化疗的临床价值和安全性。方法 2003年1月—2007年12月,45例肝外胆道恶性肿瘤患者在我院实施手术,其中外科切缘病理阴性(R0切除)24例、阳性(R1/R2切除)21例,伴区域淋巴结癌细胞浸润27例。术后给予辅助放疗(36～50 Gy)及3～6个疗程化疗(第1天奥沙利铂130 mg/m2,第1～14天卡培他滨2 000 mg/m2,21 d为1个疗程)。随访5年,观察术后肿瘤局部控制、局部复发或转移情况,分析中位生存期、5年总生存率及放化疗不良反应。结果本组患者均接受了术后辅助放化疗及随访。中位化疗周期数4.5个,中位放疗剂量42 Gy;中位随访32个月,中位生存期36个月。至随访终点16例仍存活,其中14例无瘤生存;除1例术后13个月失访外,其余患者死于肿瘤局部失控或伴远处转移(腹膜、肝、肺、骨),原发肿瘤局部淋巴结远处转移(tumor lymbp node metastasis,TNM)分期≥Ⅲ期患者占92.9%(26/28)。5年内肿瘤局部控制率66.7%(30/45),外科切缘病理阴性、阳性患者的局部控制率分别为83.3%(20/24)、47.6%(10/21)(P<0.005)。患者5年的总生存率为35.6%(16/45),外科切缘病理阴性患者和阳性患者的总生存率分别为58.3%(14/24)和9.5%(2/21)(P<0.005)。TNM分期早(Ⅰ、Ⅱ)与分期晚(Ⅲ、Ⅳ)患者的中位生存期分别为50个月和21个月(P=0.035)。辅助放化疗治疗不良反应轻微,多为1～2度;无患者因不良反应而完全中断治疗。结论根治性外科手术(R0切除)是肝外胆道恶性肿瘤患者长期生存的重要因素。术后辅助放化疗有益于患者肿瘤的局部控制,提高了中位生存期和5年的总生存率;外科切缘病理阴性患者优于阳性患者;安全及耐受性好,有待于进一步深入探讨研究。
Objective To investigate the clinical value and safety of adjuvant chemoradiotherapy after resection of extrahepatic biliary malignant tumor. Methods From January 2003 to December 2007, 45 patients with extrahepatic biliary malignancies underwent surgery in our hospital. Twenty-four patients were pathologically negative (R0 excision) and 21 were positive (R1 / R2 excision) Twenty - seven cases of lymph node cancer infiltrated. Postoperative adjuvant radiotherapy (36-50 Gy) and 3-6 courses of chemotherapy (oxaliplatin 130 mg / m2 on day 1, capecitabine 2000 mg / m2 on day 1-14, and day 1 on day 21 A course of treatment). After 5 years of follow-up, the local tumor control and local recurrence or metastasis were observed. The median survival time, 5-year overall survival rate and adverse reactions of radiotherapy and chemotherapy were analyzed. Results All patients underwent adjuvant chemoradiotherapy and follow-up. The median number of chemotherapy cycles was 4.5 and the median dose was 42 Gy. The median follow-up period was 32 months and the median survival time was 36 months. 16 patients survived until the end of follow-up, of which 14 patients survived without tumor. Except for 1 patient who was lost to follow-up at 13 months after operation, other patients died of local uncontrolled or distant metastasis (peritoneum, liver, lung and bone) The incidence of tumor lymphatic node metastasis (TNM) stage Ⅲ stage was 92.9% (26/28). The local control rate of tumor was 66.7% (30/45) within 5 years. The positive rate of surgical margins was 83.3% (20/24) and 47.6% (10/21) respectively (P <0.005). The overall 5-year survival rate was 35.6% (16/45) in patients with surgical margins and 58.3% (14/24) and 9.5% (2/21), respectively (P <0.005 ). Median survival was 50 months and 21 months (P = 0.035) for TNM staging as early as (stage I, II) and late stage (stage III, IV), respectively. Adjuvant radiotherapy and chemotherapy treatment of adverse reactions was mild, mostly 1 to 2 degrees; no patient due to adverse reactions and complete interruption of treatment. Conclusions Radical surgery (R0 resection) is an important factor in the long-term survival of patients with extrahepatic biliary malignancies. Postoperative adjuvant chemoradiotherapy is beneficial to the local control of tumor in patients and improves the median survival time and 5-year overall survival rate. Surgical margins negative patients are better than positive patients; safety and tolerability need to be further explored the study.