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目的前瞻性比较3种不同化疗方案和根治性放射治疗的不同组合方式的同期放化疗疗效、不良反应及对生存的影响。方法将261例IIB、IIIA、IIIB、ⅣA期的局部晚期宫颈鳞状细胞癌前瞻性随机分入3组:放疗加每周顺铂增敏化疗组(RT+DDP)、放疗加同期5-氟脲嘧啶和顺铂(RT+FC)化疗组、放疗加同期紫杉和顺铂(RT+TC)化疗组。放疗均是全程根治性放疗。放疗方法:盆腔外照射45~50Gy,外照射30~40Gy时挡直肠区域;腔内高剂量率Ιγ192后装治疗A点剂量25~36Gy。RT+DDP组中每周顺铂30mg/m2、每周1次,共5~6次;RT+FC和RT+TC组中顺铂75mg/m2,分3d静脉注射,RT+FC组每日缓慢静脉点滴5-氟脲嘧啶650mg/m2,连用4d;RT+TC组中紫杉醇135mg/m2静脉点滴,两药联合化疗在每个患者的整个放疗中完成2周期。结果完成计划的总病例数为261例,其中RT+DDP组88例、RT+FC组89例、RT+TC组84例。3组患者的一般临床特点差异无统计学意义。3组的总生存率差异、近期疗效、直肠和膀胱的3/4级晚期并发症发生率差异亦均无统计学意义(P>0.05);TC+RT组的无病生存率与DDP+RT组比较差异有统计学意义(P<0.017)。结论 RT+DDP、RT+FC、RT+TC治疗局部晚期宫颈鳞状细胞癌疗效均可,患者均可耐受急性不良反应。RT+TC在无病生存方面可能使患者获益。
Objective To prospectively compare the efficacy of concurrent chemoradiotherapy, adverse reactions and survival on different combinations of three different chemotherapy regimens and radical radiotherapy. Methods 261 patients with locally advanced cervical squamous cell carcinoma of stage IIB, IIIA, IIIB and ⅣA were prospectively randomized into three groups: radiotherapy plus weekly cisplatin sensitization chemotherapy (RT + DDP), radiotherapy plus 5-fluorouracil And cisplatin (RT + FC) chemotherapy group, radiotherapy plus the same period of taxane and cisplatin (RT + TC) chemotherapy group. Radiotherapy is the whole radical radiotherapy. Radiotherapy methods: external pelvic irradiation 45 ~ 50Gy, 30 ~ 40Gy external irradiation block the rectum area; cavity high dose rate Ιγ192 after treatment A dose of 25 ~ 36Gy. RT + FC group and RT + TC group cisplatin 75mg / m2, intravenous injection of 3d, RT + FC group daily slow venous 5-fluorouracil 650mg / m2, once daily for 4 days. Paclitaxel 135mg / m2 was intravenously dripped in RT + TC group, and two cycles of radiotherapy combined with chemotherapy were completed in the whole radiotherapy of each patient. RESULTS: The total number of completed cases was 261, with 88 in RT + DDP group, 89 in RT + FC group and 84 in RT + TC group. There was no significant difference in the general clinical features between the three groups. There was no significant difference in the overall survival rate between the three groups (P> 0.05). There was no significant difference in the recent curative effect between the two groups (P> 0.05) The difference was statistically significant (P <0.017). Conclusion RT + DDP, RT + FC, RT + TC treatment of locally advanced cervical squamous cell carcinoma curative effect, patients can tolerate acute adverse reactions. RT + TC may benefit patients in disease-free survival.