Preliminary clinical observation of stereotactic radiotherapy in the treatment of localized prostate cancer
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摘要: 目的 探讨立体定向放疗(SBRT)治疗局限期前列腺癌的有效性与安全性。方法 选取2018年8月—2021年6月收治的局限期前列腺癌患者80例，随机分为试验组和对照组。试验组40例，平均年龄(70.34±8.38)岁，平均前列腺特异性抗原(PSA)水平(16.81±7.41) ng/mL，治疗方案7.25 Gy/次剂量分割，总剂量36.25 Gy，放疗5次，1~2周完成。对照组40例，平均年龄(71.23±6.78)岁，平均PSA水平(20.62±6.52) ng/mL，治疗方案1.8~2.0 Gy/次剂量分割，总剂量76~80 Gy，每周5次，7.5周完成。主要观察指标包括放射损伤、PSA、次要观察指标总生存期。结果 两组患者中位随访24个月，最长随访41个月，两组患者年龄、PSA、Gleason评分、T分期、去势治疗方式比较差异均无统计学意义(P＞0.05)。早、晚期放疗不良反应主要为泌尿道及胃肠道不良反应，不良反应分级为1、2级；两组早期不良反应发生率及晚期泌尿道不良反应率相近；试验组晚期胃肠道不良反应发生率明显低于对照组(60.00% vs.82.50%，P=0.031)。结论 SBRT与常规分割调强放疗比较，SBRT治疗局限期前列腺癌患者耐受良好，治疗时间短，PSA控制及早期不良反应相似，晚期胃肠道不良反应发生率更低。Abstract: Objective To investigate the efficacy and safety of stereotactic body radiotherapy(SBRT) in the treatment of localized prostate cancer.Methods From August 2018 to June 2021, 80 patients with prostate cancer in our hospital were randomly divided into radiotherapy group and control group. There were 40 patients in the experimental group, with an average age of (70.34±8.38) years, an average prostate specific antigen (PSA) level of (16.81±7.41) ng/mL, a treatment regimen of 7.25 Gy/time, a total dose of 36.25 Gy, 5 times of radiotherapy, completed in 1-2 weeks. There were 40 patients in the control group, with an average age of (71.23±6.78) years, an average PSA level of (20.62±6.52) ng/mL, a treatment regimen of 1.8-2.0 Gy/dose division, and a total dose of 76-80 Gy, 5 days of continuous radiotherapy and completed it in 7.5 weeks. The main outcome measures included radiation injury, PSA evaluation and secondary outcome measure was overall survival (OS).Results The median follow-up was 24 months and the longest was 41 months. There was no significant difference in age, PSA, Gleason score, T stage or castration treatment between the two groups (P> 0.05). The main adverse reactions of early and late radiotherapy between the two groups were urinary tract adverse reactions and gastrointestinal adverse reactions. The adverse reactions were classified as grade 1 and 2, and there were no grade 3 adverse reactions. The incidence of grade 1-2 early adverse reactions and late urinary adverse reactions were similar between the experimental group and the control group. The incidence of grade 1-2 late gastrointestinal toxicity in the experimental group was significantly lower than that in the control group (60.00% vs. 82.50%,P=0.031).Conclusion Compared with intensity-modulated radiation therapy, stereotactic radiotherapy is well tolerated, and its treatment time is short. PSA control and early adverse reactions of two groups are similar, but the rate of late gastrointestinal adverse reactions of the experimental group is lower.
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表 1 两组患者基线特征比较
X±S 指标 试验组(n=40) 对照组(n=40) P值 年龄/岁 70.34±8.38 71.23±6.78 0.648 治疗前PSA/(ng·mL-1) 16.81±7.41 20.62±6.52 0.086 T分期/例 0.746 T1~T2a 10 11 T2b 19 20 T2c~T3 11 9 Gleason评分/例(%) 0.754 6分 9(22.50) 5(12.50) 7分 12(30.00) 14(35.00) 8~10分 19(47.50) 21(52.50) 去势治疗/例(%) 30(75.00) 31(77.50) 0.625 
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表 2 放射治疗后早、晚期相关不良反应分布情况
例(%) 不良反应 试验组(n=40) 对照组(n=40) P值 早期 泌尿道不良反应 36(90.00) 38(95.00) 0.254 1级 28(70.00) 29(72.50) 0.266 2级 8(20.00) 9(22.50) 0.182 胃肠道不良反应 28(70.00) 31(77.50) 0.234 1级 24(60.00) 26(65.50) 0.189 2级 4(10.00) 5(12.50) 0.342 晚期 泌尿道不良反应 37(92.50) 40(100.00) 0.228 1级 34(85.00) 36(90.00) 0.214 2级 3(7.50) 4(10.00) 0.286 胃肠道不良反应 24(60.00) 33(82.50) 0.031 1级 23(57.50) 30(75.00) 0.035 2级 1(2.50) 3(7.50) 0.026
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表 3 两组患者随访2年PSA水平变化
指标 试验组(n=40) 对照组(n=40) P值 PSA/(ng·mL-1) 3个月 6.36(1.32，10.85) 11.25(3.46，30.85) 0.156 6个月 1.89(1.24，4.68) 2.35(1.68，12.68) 0.168 12个月 0.76(0.44，2.76) 0.89(0.52，4.76) 0.213 24个月 0.34(0.01，1.76) 0.42(0.01，1.96) 0.104 PSA最低值/(ng·mL-1) 12个月 0.65(0.26，2.16) 0.78(0.37，2.48) 0.044 24个月 0.28(0.01，1.58) 0.36(0.01，1.66) 0.032
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