高危前列腺癌围手术期综合治疗专家共识（2023年版）

doi:10.19401/j.cnki.1007-3639.2023.12.006

摘要/Abstract

摘要：

前列腺癌的发病率呈逐年上升趋势，正逐步成为影响中老年男性健康的重要疾病，高危前列腺癌是一种具有至少一种高危因素，存在较高转移风险和较差预后的前列腺癌类型，有研究指出10年内死于前列腺癌的患者中有66%来自高危前列腺癌。关于高危前列腺癌的治疗，围手术期进行新辅助治疗和辅助治疗的价值和意义存在争议。本共识采用循证医学方法，查阅和整理评估大量相关文献，进行质量等级评价、证据综合，编写初稿后，通过专家会议讨论、德尔菲问卷调查等方法，经过2轮逾33个不同城市、71家医院共计78名专家意见的调查汇总、归纳梳理和总结，依托中国抗癌协会男性生殖系统肿瘤专业委员会，形成《高危前列腺癌围手术期综合治疗专家共识（2023年版）》。针对高危前列腺癌围手术期的新辅助治疗和辅助治疗进行探索、讨论，希望为临床医师开展高危前列腺癌患者围手术期的治疗提供指导意见和规范依据。

关键词: 高危前列腺癌, 围手术期, 新辅助治疗, 辅助治疗, 专家共识

Abstract:

The incidence rate of prostate cancer is showing an upward trend year by year, gradually becoming an important disease affecting the health of middle-aged and elderly men. The high-risk prostate cancer is a type of prostate cancer with at least one high-risk factor, which has a higher risk of metastasis and a poorer prognosis. Studies have indicated that 66% of patients who die from prostate cancer within 10 years are having high-risk prostate cancer. There is controversy regarding the value and significance of neoadjuvant and adjuvant therapy during the perioperative period for high-risk prostate cancer treatment. The consensus adopted the evidence-based medical method, extensively reviewed and organized relevant literature, conducted quality grade evaluations and evidence synthesis. After drafting the initial version, expert meetings and Delphi questionnaire surveys were conducted. After two rounds of surveys collecting opinions from 78 experts across 33 different cities and 71 hospitals, the data were summarized and refined. Relying on Society of Male Reproductive System Oncology, China Anti-Cancer Association for the “expert consensus on perioperative comprehensive treatment for high-risk prostate cancer (2023 edition)” was formulated. The aim was to explore and discuss neoadjuvant and adjuvant treatments for high-risk prostate cancer during the perioperative period, hoping to provide clinical doctors with guidance and standardized criteria for treating perioperative patients with high-risk prostate cancer.

Key words: High-risk prostate cancer, Perioperative period, Neoadjuvant therapy, Adjuvant therapy, Expert consensus

中图分类号:

R737.25

中国抗癌协会男性生殖系统肿瘤专业委员会. 高危前列腺癌围手术期综合治疗专家共识（2023年版）[J]. 中国癌症杂志, 2023, 33(12): 1204-1214.

Society of Male Reproductive System Oncology, China Anti-Cancer Association. Expert consensus on perioperative comprehensive treatment for high risk prostate cancer (2023 edition)[J]. China Oncology, 2023, 33(12): 1204-1214.

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参考文献 52

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项目	内容
证据级别
高质量	证据基于高水平前瞻性随机对照试验（randomized control trial，RCT）或RCT的meta分析，研究结果具有高度可信性和推广性
中等质量	证据基于低水平随机试验或设计良好的非对照试验或队列研究，可信度一般
低质量	证据基于病例对照研究、回顾性研究、亚组分析、专家共识或科学假设，可信度较低
推荐级别
强推荐	证据级别较高，结果与因素具有显著相关性时，专家组给予强推荐
一般推荐	证据级别较低，结果与因素相关性不显著或无明确证据显示相关性时，专家组给予一般推荐

研究类型	纳入患者	干预措施	主要结果	证据级别	推荐级别
回顾性研究^[13]	430例前列腺癌患者	前列腺根治术联合比卡鲁胺 vs 前列腺根治术	接受比卡鲁胺治疗的患者手术阴性切缘增加了3.5倍（OR = 3.5，95% CI：1.4 ~ 8.74，P = 0.011)。特别是在pT_3a期肿瘤中，比卡鲁胺治疗与阴性手术切缘增加5倍相关（OR = 5.4，95% CI：1.9 ~ 15.5，P = 0.002）。在pT₂期患者中，手术结果差异无统计学意义	中等质量	一般推荐
回顾性研究^[15]	1 170例高危前列腺癌患者	新辅助内分泌治疗联合前列腺根治术 vs 前列腺根治术	新辅助内分泌治疗联合术后辅助放疗能降低前列腺癌的死亡风险，5年特异死亡率降低到2.3%（对照组为7.5%）	中等质量	一般推荐

研究类型	纳入患者	干预措施	主要结果	证据级别	推荐级别
Ⅱ期RCT^[19]	58例高危前列腺癌患者	ADT联合阿比特龙 vs 阿比特龙	使用3个月，pCR率及最小肿瘤残留率等前列腺肿瘤负荷指标降低48%，切缘阳性率降低到19%；使用6个月肿瘤负荷降低率达62%，切缘阳性率降低至10%	中等质量	一般推荐
单中心随机试验^[20]	65例高危前列腺癌患者	ADT联合阿比特龙+泼尼松 vs ADT单药	3个月新辅助内分泌治疗显著缩小肿瘤体积，降低肿瘤细胞密度。长期随访结果显示，联合治疗后肿瘤体积越小的患者生化复发率越低，有力地证实了ADT联合阿比特龙+泼尼松联合治疗能改善无生化复发生存时间	中等质量	一般推荐

研究类型	纳入患者	干预措施	主要结果	证据级别	推荐级别
Ⅱ期RCT^[26]	20例高危前列腺癌患者	ADT联合阿比特龙+阿帕他胺	20例患者新辅助治疗接受12周的ADT联合阿帕他胺+阿比特龙的研究，结果显示。1例患者实现pCR，6例患者实现MRD，治疗耐受性良好	低质量	一般推荐
单中心随机试验^[20]	65例高危前列腺癌患者	ADT联合阿比特龙+阿帕他胺vs ADT联合阿帕他胺	与ADT联合阿帕他胺的患者相比，双重新型ARSI联合治疗组在pCR和MRD方面并未观察到明显的病理学检查结果有所改善（9.7% vs 15.6%）	中等质量	一般推荐
Ⅱ期RCT[^27]	118例高危前列腺癌患者	ADT联合阿比特龙+阿帕他胺 vs ADT联合阿比特龙	两个队列之间的pCR和MRD方面差异无统计学意义（20% vs 22%），提示通过双重新型ARSI药物治疗相比单一新型ARSI治疗并没有带来明显的病理学改善	中等质量	一般推荐

研究类型	纳入患者	干预措施	主要结果	证据级别	推荐级别
回顾性研究^[31]	177例前列腺癌患者	新辅助化疗联合内分泌治疗 vs 内分泌治疗	新辅助化疗联合内分泌治疗组有6例（6/42，14%）患者出现BCR，中位时间19个月；优于新辅助内分泌治疗组（BCR率为47%，中位时间13个月）和即刻手术组（BCR率为81%，中位时间9个月）。	低质量	一般推荐
Ⅲ期RCT^[32]	788例高危前列腺癌患者	新辅助ADT联合6个周期多西他赛静脉化疗 vs 单纯根治性前列腺切除术	新辅助联合治疗组的手术切缘阳性降低（18% vs 45%），淋巴结阳性率减少（19% vs 27%）和病理学分期为T分期降期（60% vs 77%）。长期随访结果提示，3年无BCR率这一主要研究终点差异无统计学意义（新辅助联合治疗组89%，对照组为84%），但其10年OS率存在生存获益，死亡风险下降39%。	高质量	强推荐