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目的通过随机对照研究,分析比较每次分割剂量为2.3 Gy与常规分割2.0 Gy治疗T1声门癌的疗效及其毒副反应情况。方法 1995年1月至2005年12月我院首次接受单纯放射治疗的T1声门型喉鳞癌患者165例,男158例,女7例,抽烟患者占95.8%(158/165),随机分组研究,加大分割剂量组(LF组)83例,每次分割量2.3 Gy,原发灶靶区中心参考点剂量中位值为66.7 Gy(66.7～71.3 Gy),中位放疗时间为40 d(40～42 d);常规分割剂量组(CF组)82例,每次分割量2.0Gy,原发灶靶区中心参考点剂量中位值为70.0 Gy(70.0～74.0 Gy),中位放疗时间分别为49 d(49～51 d)。Kaplan-Meier法计算肿瘤专项生存率(CSSR)及肿瘤局部控制率(LCR),Log-rank法检验生存及肿瘤局部控制率差异,Cox比例风险模型进行多变量分析。结果 (1)LF组与CF组相比,5、10年肿瘤专项生存率分别为95.18%和95.12%、91.57%和91.46%,χ2=0.071,P=0.789,差异无显著性。(2)治疗结束后观察12周,LF与CF组的客观有效率均为100%,完全缓解率(CR)分别为100.0%(83/83)、97.6%(80/82)(χ2=0.518,P=0.471)。(3)LF组及CF组放疗后5年及10年局部控制率分别为95.18%和80.49%、92.77%和78.05%,差异具显著性(χ2=7.944,P=0.005)。(4)多变量分析结果显示,分割方式及前联合是否受侵是影响T1声门癌放疗长期局部控制率的预后因子,较大的放疗分割量与常规分割相比有较高的局部控制率(HR=0.35,95%CI=0.13～0.7,P=0.002),而前联合受侵局控率较低(HR=3.54,95%CI=1.74～8.32,P=0.01)。(5)LF组及CF组急性放疗副反应及远期并发症相仿。结论 (1)放疗治疗T1声门癌的5、10年肿瘤专项生存率很高,分别达95%及91%以上。(2)加大分割剂量及缩短放疗时间能显著提高5、10年的局控率,未见增加近期及远期毒副反应。(3)分割方式及前联合是否受侵影响T1声门癌放疗的局部控制率。
Objective To compare and analyze the curative effect and toxicity of 2.3 g Gy with T1 gated carcinoma of 2.0 Gy per divisional dose and 2.0 g Gy divided by conventional randomized controlled trials. Methods A total of 165 patients with T1 glottic laryngeal squamous cell carcinoma of the glottic duct from January 1995 to December 2005 were treated with radiotherapy alone for the first time in our hospital. There were 158 males and 7 females, and 95.8% (158/165) smokers were randomized into groups In the study, 83 patients in the divided dose group (LF group) were enrolled in this study. Each divided amount was 2.3 Gy. The median reference value of the center of the primary focus was 66.7 Gy (66.7 ~ 71.3 Gy) and the median duration of radiotherapy was 40 d (40-42 days). The conventional divided dose group (CF group), 82 cases, with 2.0Gy each time, had a median of 70.0 Gy (70.0 ~ 74.0 Gy) Time was 49 d (49 ~ 51 d). The Kaplan-Meier method was used to calculate the tumor specific survival rate (CSSR) and tumor local control rate (LCR). Log-rank test was used to test the difference of survival and tumor local control rate. Cox proportional hazards model was used for multivariate analysis. Results (1) The 5-year and 10-year tumor-specific survival rates in LF group and CF group were 95.18% and 95.12%, 91.57% and 91.46% respectively, χ2 = 0.071 and P = 0.789 respectively. There was no significant difference between the two groups. (2) After 12 weeks of treatment, the objective and effective rates of LF and CF group were 100% and 100% (83/83), 97.6% (80/82) respectively (χ2 = 0.518 , P = 0.471). (3) The local control rates of LF group and CF group at 5 years and 10 years after radiotherapy were 95.18% and 80.49%, 92.77% and 78.05%, respectively. The difference was significant (χ2 = 7.944, P = 0.005). (4) The results of multivariate analysis showed that the segmentation method and the invasion of the anterior commissure were the prognostic factors influencing the long-term local control rate of T1 glottic cancer radiotherapy. The larger radiotherapy fractionation had a higher local control rate than the conventional one (HR = 0.35, 95% CI = 0.13-0.7, P = 0.002). However, the rate of invasion in the former combination was lower (HR = 3.54, 95% CI = 1.74-8.32, P = 0.01). (5) The side effects and long-term complications of acute radiotherapy in LF group and CF group were similar. Conclusions (1) The 5-year and 10-year tumor-specific survival rate of radiotherapy for T1 glottic cancer is very high, reaching 95% and 91% respectively. (2) Increasing split dose and shortening radiotherapy time can significantly increase the local control rate for 5 to 10 years, no increase in short-term and long-term toxicity. (3) the method of segmentation and whether the former joint invasion affected the local control rate of T1 glottic cancer radiotherapy.