高度恶性前列腺癌根治治疗加化疗非随机对照研究中期分析  

Radical therapy with or without chemotherapy in highly malignant non-metastatic prostate cancer:interim analysis of a prospective non-randomized controlled study

作　　者：马茗微 唐琦[2] 高献书[1] 虞巍[2] 李洪振[1] 孙明霞[3] 杨恺惟[2] 李晓颖[1] 亓昕[1] 陈佳琰 任雪盈 Ma Mingwei;Tang Qi;Gao Xianshu;Yu Wei;Li Hongzhen;Sun Mingxia;Yang Kaiwei;Li Xiaoying;Qi Xin;Chen Jiayan;Ren Xueying(Department of Radiation Oncology,Peking University First Hospital,Beijing 100034,China;Department of Urology,Peking University First Hospital,Beijing 100034,China;Department of Medical Oncology,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院放射治疗科,北京100034 [2]北京大学第一医院泌尿外科,北京100034 [3]北京大学第一医院肿瘤化疗科,北京100034

出　　处：《中华放射肿瘤学杂志》2023年第3期229-234,共6页Chinese Journal of Radiation Oncology

基　　金：中央高校基本科研业务费专项资金/北京大学青年科技创新培育基金(BMU2021PYB 026);中央高水平医院临床科研业务费资助(北京大学第一医院青年临床研究专项基金)(2022 CR109)。

摘　　要：目的比较高度恶性非转移性前列腺癌患者在标准治疗基础上联合或不联合辅助化疗的疗效及安全性。方法采用前瞻性、非随机对照研究的方法,在北京大学第一医院连续入组病理确诊的Gleason评分总分9~10分或Gleason评分为包含5分的非转移性前列腺癌患者。在标准根治性治疗后增加或不增加4~6个周期多西他赛±卡铂方案化疗。主要终点为5年无事件生存(EFS),次要终点为无远处转移生存(MFS)、总生存(OS)、治疗相关不良反应。采用Kaplan-Meier法绘制生存曲线,log-rank检验比较组间差异。结果2019年11月至2022年1月连续入组患者176例患者,其中138例仅接受标准根治性治疗(对照组),38例在根治性治疗后接受辅助化疗(化疗组)。中位随访13.4(2.0~34.0)个月,患者均存活。化疗组及对照组30个月EFS率为100%∶85.6%(P=0.064),化疗组未出现任何事件,对照组12例出现事件,其中6例为单纯生化复发、6例为影像学进展。两组30个月MFS率为100%∶91.9%(P=0.205)。在进行1∶2倾向评分匹配后,两组的EFS率为100%∶85.7%(P=0.056),MFS率为100%∶92.2%(P=0.209)。化疗组及对照组患者2级及以上的泌尿系统不良反应发生率分别为2.6%∶7.2%(P=0.354),2级及以上的直肠不良反应发生率为5.3%∶5.1%(P=0.711)。化疗组患者3级及以上化疗相关不良反应为白细胞减少(31.6%)、血小板减少(2.6%)以及脱发(13.2%)。结论高度恶性前列腺癌在标准根治性治疗后增加辅助化疗有改善患者总EFS的趋势,且不良反应可耐受,期待长期随访结果证实。Objective To compare the efficacy and safety of standard treatment with or without adjuvant chemotherapy in patients with highly malignant non-metastatic prostate cancer.Methods In this prospective non-randomized controlled study,consecutive non-metastatic prostate cancer patients with pathologically proven Gleason score of 9-10 or Gleason score of 5 admitted to Peking University First Hospital were enrolled.Four to six cycles of chemotherapy using docetaxel±carboplatin regimen were added or not after standard radical therapy.The primary end point was 5-year event-free survival(EFS),and the secondary end points were distant metastasis-free survival(MFS),overall survival(OS),and treatment-related adverse events.The survival curve was drawn by Kaplan-Meier method.The differences between two groups were analyzed by log-rank test.Results A total of 176 patients were consecutively enrolled from November 2019 to January 2022 of which 138 patients received only standard radical therapy(control group),and 38 patients received adjuvant chemotherapy after standard radical therapy(chemotherapy group).The median follow-up time was 13.4(2.0-34.0)months.All patients survived.The 30-month EFS rates in the chemotherapy and control groups were 100%and 85.6%,respectively(P=0.064).There were no events in the chemotherapy group,while there were 12 cases of events in the control group,including 6 cases of biochemical recurrence and 6 cases of imaging progression.The 30-month MFS rates in two groups were 100%and 91.9%,respectively(P=0.205).After the 1 vs.2 propensity score matching,the EFS and MFS rates in two groups were 100%vs.85.7%(P=0.056),and 100%vs.92.2%(P=0.209),respectively.The incidence rates of grade 2 and above urinary toxicity in the chemotherapy and control groups were 2.6%and 7.2%(P=0.354),respectively.The incidence rates of grade 2 and above rectal toxicity were 5.3%and 5.1%(P=0.711),respectively.Grade 3 and above chemotherapy-related toxicity in the chemotherapy group were leukopenia(31.6%),thrombocytopenia(2.6%)and a

关 键 词：前列腺肿瘤 高度恶性 放射疗法 前列腺癌根治术 化学疗法 GLEASON评分 

分 类 号：R737.25[医药卫生—肿瘤]