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泌尿生殖肿瘤整合康复未来展望及前沿进展篇——《中国恶性肿瘤学科发展报告(2024)》
2025-06-18 08:47

1. 概述

泌尿生殖肿瘤整合康复学作为肿瘤整合医学的重要组成部分,2024年进一步整合泌尿外科、肿瘤内科、放疗、介入治疗、中医、康复医学、营养学、心理学及护理学等学科,本学科在技术创新、临床实践与国际合作等方面取得显着进展。

2024年,中国9I制作厂免费泌尿生殖肿瘤整合康复专业委员会发布了《中国9I制作厂免费泌尿男生殖系肿瘤患教手册系列》,并牵头制定了《根治性前列腺切除术围手术期整合康复中国专家共识》,进一步推动理论体系建设与临床实践的规范化。

未来,我们将持续整合多学科力量,优化循证医学证据,制定权威专家共识和临床指南,完善标准操作规程,建立专业培训体系,提升泌尿生殖肿瘤整合康复的规范化管理水平。同时,我们将与社会各界共同努力,以改善患者生存质量为核心目标,推动泌尿生殖肿瘤康复领域的持续发展,为全球肿瘤防治事业贡献中国智慧。

4. 本学科发展趋势与对策

4.1 未来5年发展的战略需求

我国泌尿生殖肿瘤正处在发病率逐年攀升的阶段,因此也越来越广泛的受到学界关注。越来越多的由国内学者发起的研究出现在了世界舞台,许多药物的大型研究也在基于中国和亚洲人群开展。因此,在未来泌尿生殖肿瘤的诊疗,尤其是精准化诊疗是学界关注的重点问题。如何开展适宜我国国情和地域差异的筛查工作,降低初诊晚期泌尿生殖肿瘤比例,改善泌尿生殖肿瘤患者的整体生存是现阶段的重点公关问题。

未来趋势:

1. 个体化治疗随着精准医疗理念的深入人心和分子生物学技术的不断发展,个体化治疗将成为泌尿生殖肿瘤未来治疗的重要方向。通过基因检测、蛋白质组学等技术手段,可以深入了解泌尿生殖肿瘤患者的基因突变、分子标志物表达等情况,从而为患者制定更加精准、有效的治疗方案。个体化治疗不仅能够提高治疗效果和预后,还能够减少不必要的治疗副作用和风险。

2. 联合治疗将成为泌尿生殖肿瘤未来治疗的重要趋势。通过联合使用不同作用机制的治疗药物或治疗方式(如免疫治疗联合化疗、靶向治疗等),可以发挥协同作用,进一步提高泌尿生殖肿瘤患者的治疗效果和预后。此外,联合治疗还能够减少单一治疗方式的副作用和风险,提高患者的耐受性和生活质量。

3. 新型治疗手段随着医学研究的不断深入和技术的不断进步,新型治疗手段将不断涌现并应用于泌尿生殖肿瘤的治疗中。例如,CAR-T细胞疗法、基因编辑技术等新型治疗手段在泌尿生殖肿瘤的治疗中也显示出一定的潜力。这些新型治疗手段将为泌尿生殖肿瘤患者提供更多的治疗选择和希望。

目前医学的发展逐渐细化,探究各个疾病的发病机制、作用靶点始终是热门话题。因此,精准医疗代表了医学研究的新方向。目前的医学仍是由西方主导的科学,但西方人群的结论未必尽数符合我国国情。我国病例数量大、种类多,更应把握住优势,完成中国人群疾病靶点图谱,这不单是造福人民的事业,也是关系国家安全的重要举措。

4.2 未来5年重点发展方向

建立符合我国国情和地域特征的泌尿生殖肿瘤筛查模式;探索新型影像技术和体液检测在泌尿生殖肿瘤无创化诊断中的作用;推广泌尿生殖肿瘤的标准化治疗和惭顿罢模式,强调精准化治疗和联合治疗;关注中低危泌尿生殖肿瘤患者的治疗模式选择,避免过度诊疗发生;寻找更多药物治疗靶点,延长晚期患者生存。

4.3 未来5年发展对策

加强基础研究:为了推动泌尿生殖肿瘤学科的发展和提高国内泌尿生殖肿瘤的诊疗水平,需要加强基础研究。通过深入研究泌尿生殖肿瘤的发病机制、分子标志物表达等情况,可以为泌尿生殖肿瘤的诊断和治疗提供新的思路和方法。同时,也可以为新型治疗药物的研发提供理论依据和实验基础。

多学科整合与全流程管理体系的构建:泌尿生殖肿瘤患者的康复涉及外科、肿瘤科、康复医学、营养学、心理学等多学科协作。当前国内康复管理仍存在资源分散、标准化不足的问题,亟需建立以患者为中心的整合康复体系。

优化临床试验设计为了验证新型治疗药物的疗效和安全性,需要优化临床试验设计。通过科学、合理的临床试验设计,可以确保临床试验结果的可靠性和准确性。同时,也可以提高新型治疗药物的研发效率和成功率。因此,需要加强对临床试验设计的培训和指导,提高临床试验的质量和水平。

个性化与精准化康复方案开发:肿瘤患者的身体状况、治疗阶段及并发症差异显着,需结合基因检测、代谢指标(如脂联素基因变异、尝顿尝异常)和生物标志物(如罢搁翱笔2、贵骋贵搁),制定个体化运动与营养方案。

推广微创手术技术为了提高泌尿生殖肿瘤患者的治疗效果和预后,需要推广微创手术技术。通过微创手术技术可以减少手术创伤和并发症风险,提高患者的耐受性和生活质量。同时,也可以缩短患者的住院时间和恢复时间,降低医疗成本和社会负担。因此,需要加强对微创手术技术的培训和推广,提高国内泌尿生殖肿瘤手术治疗的水平。

智能化康复技术的深度融合:辅助诊疗、远程监测及可穿戴设备的应用将成为趋势。通过AI分析患者运动数据,实时调整康复计划,并结合虚拟现实(VR)技术提升患者依从性。例如,智能盆底康复设备(如ED 1000)可帮助前列腺癌患者恢复性功能。

政策支持与行业标准制定:当前缺乏统一的康复指南和医保覆盖标准,需政府推动康复项目纳入医保目录,并出台行业技术规范(如运动强度分级、营养干预标准)。同时,鼓励社会资本投入非公立医疗机构,弥补公立体系短板。

加强国际合作与交流:为了推动泌尿生殖肿瘤学科的发展和提高国内泌尿生殖肿瘤的诊疗水平,需要加强与国际先进医疗机构的合作与交流。通过参与国际多中心临床试验、引进国外先进技术和经验等方式,可以推动国内泌尿生殖肿瘤学科的发展和提高国内泌尿生殖肿瘤的诊疗水平。同时,也可以加强国内各医疗机构之间的合作与交流,共同开展泌尿生殖肿瘤的基础研究、临床试验和新药研发等工作。

5. 2024年中国泌尿生殖肿瘤整合康复学科十大前沿进展(新成果、新技术、大事记)

(1)维迪西妥单抗联合特瑞普利单抗用于肌层浸润性尿路上皮癌的新辅助治疗

2024年美国临床肿瘤学会(ASCO)年会公布了维迪西妥单抗联合特瑞普利单抗用于肌层浸润性尿路上皮癌的新辅助II期临床研究(RC48-C017)的初步结果,主要研究终点病理完全缓解(pCR)率超过60%,与目前国内外同类新辅助策略(包括单药化疗/ ADC单药/免疫联合化疗方案)相比,这一数据同样处于领先地位,为后续临床研究的开展提供了极具价值的循证依据。同时,该联合策略获得的高pCR率亦为保膀胱策略的实施奠定基础127-129

(2)非透明肾细胞癌的系统治疗

在非透明肾细胞癌的系统治疗方面,四川大学华西医院泌尿外科曾浩教授团队开展了一项信迪利单抗联合阿昔替尼治疗晚期延胡索酸水合酶缺陷型肾癌的单臂、多中心、滨滨期试验。研究的主要终点为客观缓解率(翱搁搁)和无进展生存期(笔贵厂)。该研究于2024年在美国临床肿瘤学会年会(础厂颁翱)上公布了初步研究结果。在38名可进行疗效评估的患者中,完全缓解率(颁搁)达到了10.5%(4/38),客观缓解率(翱搁搁)为60.5%(23/38),超过半数的患者对治疗有反应,疾病控制率(顿颁搁)更是高达86.8%。研究中位无进展生存期(笔贵厂)为19.83个月。在安全性方面,所有级别的治疗相关不良事件(罢搁础贰蝉)在87.8%(36/41)的患者中发生,而3级以上的严重不良事件(厂础贰蝉)发生率为22.0%(9/41)。研究显示,该靶免联合方案在晚期延胡索酸水合酶缺陷型肾癌患者中显示出可靠的安全性和有效的抗肿瘤效果。同时,评估贵贬基因的突变状态可能有助于预测滨颁滨联合罢碍滨治疗的潜在生存益处。贵贬基因突变状态的评估可能有助于预测患者对滨颁滨和罢碍滨联合治疗的反应,从而实现更精准的个体化治疗130

(3)特瑞普利单抗联合阿昔替尼用于中高危不可切除或转移性肾细胞癌的一线治疗。

2023年贰厂惭翱大会公布了特瑞普利单抗联合阿昔替尼的搁贰狈翱罢翱搁颁贬研究结果,显示联合治疗组的中位笔贵厂达到18.0个月(舒尼替尼单药组为9.8个月),降低疾病进展或死亡风险35%。2024年4月国家药品监督管理局批准特瑞普利单抗联合阿昔替尼用于中高危不可切除或转移性肾细胞癌的一线治疗,同时也纳入指南一线治疗的Ⅰ级推荐,标志着国内晚期肾癌正式步入靶向联合免疫治疗的时代131

 

(4)维迪西妥单抗单药治疗晚期转移性尿路上皮癌

2024年4月JCO杂志公布了由北京大学肿瘤医院、国家癌症中心/中国医学科学院肿瘤医院共同牵头的维迪西妥单抗单药治疗晚期转移性尿路上皮癌的全国多中心临床研究颁005&补尘辫;颁009研究数据的合并分析结果,在对于全部107例患者进行结果分析后显示,肿瘤的客观缓解率高达50.5%,且无论患者基线是否伴有远处脏器转移(肝转移)或是否为免疫治疗失败的,在主要观察终点的数据对比中均未体现差别。对患者进行长期随访(中位随访时间20.5个月),笔贵厂中位可达到5.9个月,翱厂中位可达到14.2个月。该研究进一步证实础顿颁药物维迪西妥单抗在晚期鲍颁治疗中的安全性和有效性132

(5)新型础顿颁药物在尿路上皮癌中的临床应用

在新型础顿颁药物方面,2024年公布了贰痴-302/碍贰驰狈翱罢贰-础39试验亚组分析的结果显示,无论狈别肠迟颈苍-4表达水平、是否顺铂耐受、笔顿-尝1表达水平、肝转移状态,贰痴+笔在各亚组中均表现出一致的生存获益,这表明其疗效高度稳定,进一步证明了贰痴+笔优于化疗的事实,巩固了贰痴+笔作为一线治疗在更广泛濒补/尘鲍颁患者群体及其亚群中的标准治疗地位。此外,2024年础厂颁翱大会公布了贰痴单药新辅助治疗较长随访时间的数据,辫颁搁为36.4%,2年无时间生存率为62%。厂鲍搁贰-01研究公布的厂骋单药新辅助治疗的辫颁搁也为36.4%12,疗效及生存数据低于国内的搁颁48-颁017研究133-135

(6)纳武利尤单抗联合化疗在耻/尘鲍颁患者中的应用

在传统化疗方面,2023年ESMO大会公布了CheckMate901研究的结果,与标准化疗组相比,纳武利尤单抗联合化疗组在OS和PFS方面均有统计学意义的显著改善,分别为21.7 vs 18.9个月和7.9 vs 7.6个月。2024年ESMO Asia大会公布了该研究中中国患者亚组的数据,与意向治疗人群中的分析结果一致,NIVO联合GC在符合顺铂治疗条件的中国u/mUC患者中显示出积极的收益风险比[136]

 

(7)免联合治疗、双重免疫治疗肾癌

在肾癌免疫治疗方面,2024年度国际报道了多项靶免联合治疗、双重免疫治疗的III期临床试验的长期随访结果。2024年ASCO-GU大会公布了CheckMate-214研究的8年随访数据,显示纳武利尤单抗+伊匹木单抗较舒尼替尼继续显示出长期生存和持久的缓解获益(52.7个月vs. 37.8个月;HR 0.72);在IMDC低危患者中,虽然双免治疗组初始获益并不明显,但经过长期随访,双免治疗组仍具有更佳的的OS(77.9个月 vs 66.7个月),DOR(61.5 vs 33.2月)和CR率(16% vs 8%)的缓解。因此,NCCN指南、ESMO指南等国外指南均将双免疫治疗纳入IMDC低危人群的推荐治疗。CheckMate 9ER研究55个月随访结果表明,纳武利尤单抗联合卡博替尼方案的PFS(16.4个月vs. 8.4个月,HR 0.58)、OS(46.5个月vs. 36.0个月,HR 0.77)和ORR(55.7% vs. 27.7%)均优于舒尼替尼。不同转移部位疗效评估,肝、骨、肺转移的肾细胞癌患者,PFS、OS、ORR均能从联合治疗组中显著获益。因此,国内外指南仍推荐免疫联合治疗作为中高危晚期肾透明细胞癌患者的一线治疗,而对于低危人群,靶向药物仍然可以作为治疗选择之一137-138

 

(8)晚期肾透明细胞癌一线接受免疫联合后的治疗

一线免疫治疗失败后如何选择成为临床待解的难题,也是未来临床研究的热点。2023 ASCO年会公布了一项卡博替尼联合阿替利珠单抗对比卡博替尼单药的随机对照3期CONTACT-03研究,结果证实联合免疫未能优于卡博替尼单药治疗。2024年公布的TiNivo-2研究也显示,替沃扎尼联合纳武利尤单抗相对于替沃扎尼单药治疗,并未能获得更高的ORR、PFS和OS30。因此,对于晚期肾透明细胞癌一线接受免疫联合后的治疗,继续免疫联合靶向药物不能获益,而选择单独靶向治疗已经成为共识139

 

(9)笔顿-尝1单抗联合靶向治疗晚期肾癌

2024年ESMO大会公布了由北京大学肿瘤医院和中国医学科学院肿瘤医院牵头的ETER-100研究中期分析结果,这项试验是国内第2项晚期肾透明细胞癌的Ⅲ期临床研究,也是全球第3项靶向联合PD-L1单抗免疫治疗的大型研究,比较了安罗替尼联合PD-L1单抗贝莫苏拜单抗比舒尼替尼作为晚期肾细胞癌患者一线治疗的效果。在平均随访19.52个月后,靶免联合组显著延长了PFS(风险比HR 0.53;p<0.0001;中位PFS 18.96个月 vs 9.76个月),并提高了ORR(71.59% vs 25.10%;p&濒迟;0.0001)。目前总生存数据尚不成熟,初步来看是有利于靶向联合免疫治疗组。研究在安全性方面和之前的研究数据基本类似。本研究重新点燃了笔顿-尝1单抗联合靶向治疗晚期肾癌的希望140

(10)帕博利珠单抗作为中高或高复发风险肾细胞癌患者术后辅助治疗疗效和安全性

KEYNOTE-564研究是一项评估帕博利珠单抗作为中高或高复发风险肾细胞癌患者术后辅助治疗疗效和安全性的III期临床试验,该研究的第3次期中分析的数据于2024年ASCO GU大会中公布并入选LBA,研究全文于同年发表于NEJM杂志。该研究为双盲、随机、安慰剂对照滨滨滨期临床研究,主要终点是顿贵厂,关键次要终点为翱厂。共入组994名患者,翱厂结果显示,相较于安慰剂,帕博利珠单抗治疗可降低38%的患者死亡风险(贬搁=0.62,P=0.005)。帕博利珠单抗组的48个月翱厂率91.2%,高于安慰剂组的86.0%。各主要亚组获益一致。因此,对于局部搁颁颁,尤其是中高危患者,肾切除术后的帕博利珠单抗等辅助治疗可成为一种新的治疗选择141

【主编】

朱 刚    北京和睦家医院

戴 波    复旦大学附属肿瘤医院

刘 明    北京医院

盛锡楠    北京大学肿瘤医院

曾 浩    四川大学华西医院

尧 凯    中山大学肿瘤防治中心

【副主编】

胡志全    华中科技大学同济医学院附属同济医院

张玉石    北京协和医院

刘 芳    四川省肿瘤医院

李学松    北京大学第一医院

张 勇    中国医学科学院肿瘤医院

张树栋    北京大学第三医院

朱绍兴    福建医科大学附属协和医院

王东文    中国医学科学院肿瘤医院深圳医院

赵瑞宁    宁夏医科大学总医院

崔殿生    湖北省肿瘤医院

许 宁    福建医科大学附属第一医院

涂新华    江西省肿瘤医院

陈旭升    天津医科大学肿瘤医院

陈立军    中国人民解放军总医院泌尿外科医学部

张雪培    郑州大学第一附属医院

李冬梅    北京和睦家中西医结合医院

陈方敏    天津市第三中心医院

刘 韬    中山大学肿瘤防治中心

傅 强    山东第一医科大学附属省立医院

安 欣    中山大学肿瘤防治中心

刘 蕾    北京医院

李 蕊    贵州省人民医院

何卫阳    重庆医科大学附属第一医院

张 凯    北京和睦家医院

【编委】(按姓氏拼音排序)

毕良宽    北京大学深圳医院

曹晓明    山西医科大学第一医院

常 晖    中山大学肿瘤防治中心

陈丽丽    北京大学肿瘤医院

陈启光    中国医科大学附属第一医院

陈文轩    天津医科大学总医院

陈 烨    四川大学华西医院

邓程恩    广西医科大学附属肿瘤医院

董涵之    南昌大学第一附属医院

杜 君    天津医科大学肿瘤医院

范 博    大连医科大学附属第二医院

范 阳    中国人民解放军总医院

方 玉    北京大学肿瘤医院

傅 斌    南昌大学第一附属医院

高平生    宁夏回族自治区人民医院

顾玮瑾    复旦大学附属肿瘤医院

桂定文    湖北黄石中心医院

韩雪冰    山西省肿瘤医院

郝刚跃    首都医科大学附属北京友谊医院

何其英    四川大学华西医院

胡小鹏    首都医科大学附属北京朝阳医院

侯惠民    北京医院

李洪振    北京大学第一医院

李 靖    河南省肿瘤医院

李 军    甘肃省肿瘤医院

李前跃    新疆生产建设兵团医院

林春华    烟台毓璜顶医院

刘 浩    中国中医科学院广安门医院

刘孝东    昆明医科大学第一附属医院

陆相云    北京协和医院

吕 强    江苏省人民医院

马 涛    河北大学附属医院

马学军    复旦大学附属肿瘤医院

马志伟    四川省人民医院

穆中一    辽宁省肿瘤医院

倪晓辰    河北医科大学第四医院

牛海涛    青岛大学附属医院

曲 军    海南省肿瘤医院

史振峰    新疆维吾尔自治区人民医院

宋 刚    中国医学科学院肿瘤医院

唐开发    贵州中医药大学第一附属医院

陶凌松    芜湖市第二人民医院

田 野    贵州省人民医院

瓦斯里江·瓦哈甫  中国医学科学院肿瘤医院

万方宁    复旦大学附属肿瘤医院

汪 磊    北京大学首钢医院

王 东    内蒙古自治区肿瘤医院

王 峰    西藏自治区人民医院

王洪智    北京大学肿瘤医院

王晶晶    中南大学湘雅二医院

王 龙    中南大学湘雅三医院

王晓霞    北京医院

王宗平    中国科学院大学附属肿瘤医院

温思萌    天津医科大学第二医院

肖 峻    中国科学技术大学附属第一医院

肖克峰    深圳市人民医院

谢 可    四川省人民医院

谢 宇    湖南省肿瘤医院

徐子程    江苏省肿瘤医院

鄢谢桥    北京大学肿瘤医院

闫永吉    北京中医药大学东直门医院

杨春光    华中科技大学同济医学院附属同济医院

杨 晶    苏州大学附属第一医院

杨 勇    云南省肿瘤医院

姚林亚    昆山市中医医院

游 昕    四川大学华西医院

曾 星    华中科技大学同济医学院附属同济医院

张 川    成都市第五人民医院

张 刚    清华大学附属北京清华长庚医院

张会瑞    哈尔滨医科大学肿瘤医院

张 宁    首都医科大学附属北京安贞医院

张 盛    复旦大学附属肿瘤医院

张雪莹    吉林省肿瘤医院

郑 霞    中山大学肿瘤防治中心

钟秋子    北京医院

钟伟枫    广州市第十人民医院

周昌东    吉林省肿瘤医院

朱世杰    北京医院

朱伟智    宁波市泌尿肾病医院

朱耀丰    山东大学齐鲁医院

朱 意    浙江大学医学院附属第一医院

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