局部进展期宫颈癌同步放化疗的临床随机对照研究

Clinical randomized study of concurrent radiotherapy and chemotherapy with local advanced cervical cancer

目的比较强调的两种放疗方式并同步化疗治疗局部进展期宫颈癌，评价其治疗反应情况和疗效。方法符合入组条件的Ⅱa-Ⅲb。期宫颈癌患者采用信封法随机分组，研究组制定IMRT放疗计划，对宫颈原发病灶予以45Gy／22次，盆壁淋巴引流区50Gy／22次；对照组靶区设定标准同研究组，采用四野盒式照射45Gy／22次，其后予以盆壁补充6Gy／3次。两组患者同期化疗方案相同，给予奈达铂30mg／m2，每周1次，共6周期化疗。后装治疗于外照射3～4周开始，每次6Gy，共6次，A点总剂量36Gy。结果自2006年9月至2009年9月，共招募72例患者，其中研究组36例，对照组36例。两组在恶心呕吐、血红蛋白下降、中性粒细胞下降等差异均无统计学意义；研究组Ⅲ级腹泻发生率为5．6％；对照组Ⅲ级腹泻发生率为30．6％，两组Ⅲ-Ⅳ级腹泻发生率比较差异有统计学意义（χ2=31．35，P〈0．05）。1、2、3年生存率分别为94．4％、86．1％、77．8％，1、2、3年无瘤生存率分别为91．7％、75．0％、72．2％，对照组1、2、3年生存率分别为91．7％、86．1％、75．0％，1、2、3年无瘤生存率分别为91．7％、72．2％、69．4％，差异无统计学意义。结论宫颈癌调强放疗并同步化疗可以明显减少急性直肠炎的发生率，总生存率与无病生存率与四野盒式照射相似。

Objective To study two different methods of radiotherapy and their side-effects in treating local advanced cervical cancer. Methods Eligible patients with stage Ⅱa-Ⅲb cervical cancer were randomly divided into the study group and the control group. The patients in the study group were irradiated to 45 Gy/22 fractions at primary lesions and 50 Gy/22 fractions at lymphatic drainage using IMRT followed by high-dose rate （HDR） brachytherapy （36 Gy/6 fractions）. The control group had the same target range sizes as the study group, and the patients were irradiated to 45 Gy/22 fractions at pelvic cavity and additional 6 Gy/3 fractions at pelvic wall using four-field cassette technique followed by high- dose rate （HDR） braehytherapy （36/6 fractions ）. Both groups were treated with concurrent chemotherapy, by nedaplatin 30 mg/m2 weekly for a total of 6 cycles. Results Between Sep 2006 and Sep 2009, 72 patients were enrolled into the study, and 36 cases were assigned in the study group and 36 cases in the control group. Nausea and vomiting, decline of hemoglobin and neutrophil were similar in two groups. Grade diarrhea in the study group and the control group was 5.6% and 30. 6% , respectively, with significant difference in diarrhea. 1-, 2-and 3-year overall survival rates of the study group were 94.4% , 86.1% , 77.8% , and 1-, 2-and 3-year disease-free survival rate were 91.7% , 75.0% , 72.2% in the study group, and 1-, 2-and 3-year overall survival rate were 91.7% , 86. 1% , 75.0% , and 1-, 2- and 3-year disease-free survival rate were 91.7% , 72.2% , 69.4% in the control group, respectively. There were no significant differences for overall survival and disease-free survival between two groups. Conclusions Intensity modulated radiation therapy with cervical cancer can reduce significantly the rate of acute proctitis. Overall survival and disease-free survival might be similar in two groups.