Bicalutamide

肿瘤专业医保结算清单编码填报共识 （节选自《深圳市医保结算清单编码填报指南（2026版）》） （分享链接见文后） 一、专业概述 肿瘤专业，即肿瘤学，是医学科学中致力于研究肿瘤（尤其是恶性肿瘤）的病因、预防、诊断、治疗、康复和姑息关怀的综合性学科。它是医学领域的重要分支学科，核心目标是通过多学科协作治疗与技术创新，逐渐降低恶性肿瘤的发病率和死亡率，不断提升患者生存率及生活质量。 （一）专业特点 1. 肿瘤疾病复杂性与异质性： 病因复杂性：肿瘤的发生是多种因素（遗传、环境、生活方式、感染等）长期、多阶段作用的结果，机制极其复杂。 高度异质性：即使在同一个病人体内，肿瘤细胞也不是均一的，存在空间异质性和时间异质性（在治疗过程中会发生演变和耐药），这将导致肿瘤治疗的困难。 2. 肿瘤疾病类型多样性：肿瘤不是一种病，而是一大类疾病的总称。不同器官、不同组织来源、不同分子分型的肿瘤，其生物学行为、治疗反应和预后千差万别。肿瘤学可分为多个专业方向：主要是肿瘤内科学、肿瘤外科学、放射肿瘤学、儿童肿瘤学等。 3. 多学科协作诊疗：肿瘤诊疗需结合病理学、影像学、外科、内科、放疗科、介入科、营养科、心理科等多学科知识，形成MDT（多学科诊疗团队），为患者制定个体化方案。 4. 新技术和药物发展迅速：肿瘤诊疗各类新技术是基于基因突变、肿瘤微环境等基础研究到新药研发、临床试验，进而推动肿瘤治疗手段的不断创新。如手术微创化（达芬奇机器人、腹腔镜）、放疗精准化（质子重离子、立体定向放射治疗SBRT）、靶向与免疫治疗突破（小分子抑制剂、单克隆抗体、CAR-T细胞疗法）。肿瘤治疗己经从传统治疗进入了精准治疗时代。 （二）主要诊治疾病 二、常用术语解释 1. 肿瘤：是机体的细胞异常增殖形成的，常表现为机体局部的异常组织团块（肿块）。通常分为良性肿瘤和恶性肿瘤。 2. 良性肿瘤：通常生长缓慢、边界清楚，常有包膜;肿瘤分化好，色泽及质地接近正常相应组织，一般不复发或仅少数复发，不转移，通常预后良好。 3. 恶性肿瘤：通常生长迅速，呈浸润性生长，可破坏周围组织，无包膜或仅有假包膜，肿瘤分化差，组织形态显示异形性，常复发，容易转移。 4. 交界性肿瘤：指存在于良、恶性之间的中间型肿瘤，难以区别良性和恶性的肿瘤称之为交界性肿瘤。 5. 原位癌：是指癌细胞仍局限于上皮层内的癌。原位癌基底膜完整，未被癌细胞穿破。原位癌可发展为早期浸润癌，偶尔原位癌可以消退。 6. 癌前病变：WHO将癌前期病变称为癌的前兆变化包括癌前病变和癌前疾病。WHO将发展成恶性肿瘤可能性超过20%的病变定义为癌前病变，癌前病变在形态学上出现某些程度非典型增生但本身尚不具备恶性肿瘤特征性改变。很多常见肿瘤具有癌前病变，如：食管癌前病变包括食管鳞状上皮细胞异型增生和Barrett食管异型增生。 7. 继发恶性肿瘤（转移性恶性肿瘤）：通过转移形成的肿瘤称为转移性恶性肿瘤或继发恶性肿瘤。恶性肿瘤从原发部位侵入淋巴管、血管、体腔，迁徙到其他部位继续生长形成同样类型的肿瘤的过程即为转移。恶性肿瘤转移途径多为淋巴道转移、血道转移、种植性转移。 8. 性质未特指（性质未肯定）的肿瘤：指既不知道肿瘤的病理形态，也不明确的肿瘤动态的肿物，一般指无法取得病理，但临床诊断为肿瘤。例如：腹腔肿瘤。 9. 肿瘤功能活性：是指肿瘤具有影响内分泌功能的能力，需要采用内分泌、营养和代谢疾病的编码附加说明。 10. 恶性肿瘤交搭跨越：原发部位不明的一个恶性肿瘤生长的边缘界限交搭在两个或多个相邻的解剖部位上时，称为交搭跨越恶性肿瘤。 11. 复合恶性肿瘤：独立的多个部位的原发恶性肿瘤。 12. 肿瘤根治术（肿瘤根治性切除术）：在ICD-9-CM-3中很少使用，根治性切除术不是一个标准的手术操作名称，临床只有明确具体的手术方式才能正确编码。 13. 恶性肿瘤放射治疗：简称放疗，是指利用电离辐射（如X射线、伽马射线、电子束、质子束等）来杀灭、破坏或抑制恶性肿瘤细胞生长的一种局部治疗方法。放疗可在肿瘤治疗的各个阶段进行，可分为根治性放疗、辅助性放疗和姑息性放疗。辅助性放疗包括术前、术中、术后辅助放疗，同步放化疗，其中，术后放疗指术后首个放射治疗疗程;姑息放疗针对某些病情复杂或比较危重的患者，以达到缓解症状，改善生活质量的目的，有些姑息放疗的患者需要进行急诊放疗，如剧烈疼痛、脊髓压迫、上腔静脉压迫综合征、梗阻等。 14. 恶性肿瘤化学治疗：是使用细胞毒性药物杀死快速增殖的细胞，是传统的全身治疗手段。分为术前化疗、术后化疗、维持性化疗和姑息化疗等。 （1）术前化疗又称新辅助化疗，是指手术前进行的全身化疗，目的是控制已播散的微小转移灶使原发病灶缩小或使疾病降期从而增加病灶完全切除率，尽量保存器官及其功能。 （2）术后化疗又称术后辅助化疗，是指对已行根治性手术后有复发潜在风险者给予的全身化疗，其目的是消灭亚临床微小转移，延缓肿瘤复发转移，争取达到治愈或延长生存期。 （3）姑息化疗，是指对肿瘤晚期病人为减轻痛苦改善生活质量及延长生存期进行的化疗。 15. 恶性肿瘤靶向治疗（targetedtherapy）：针对在肿瘤发生、发展及转移过程中起关键作用的特定靶分子及其相关信号通路，进行点对点的干扰或阻断，从而达到控制肿瘤生长、转移的目的。靶向治疗药物具有高选择性、高敏感性及高效性、对正常细胞伤害更小特点，但也存在一系列毒副反应。 16. 恶性肿瘤免疫治疗：是通过外源性干预重启并维持肿瘤-免疫循环，重塑肿瘤免疫微环境，恢复机体正常的控瘤免疫反应，从而控制肿瘤生长的治疗方法，已成为继手术、放疗、化疗等传统疗法后肿瘤治疗领域的新突破。目前临床应用主要集中在免疫检查点抑制剂（ICIs）治疗和过继性细胞免疫治疗。 17. 恶性肿瘤介入治疗：是以局部血管解剖、血液供应、血液循环为基础的，以局部治疗为主的一种治疗方法，同时对全身亦有一定的治疗作用。由于治疗是将导管选择性插入靶器官的供血动脉内注射药物，因此，首次到达局部的药物浓度100%。肿瘤的介入治疗又分为动脉灌注化疗及肿瘤血管栓塞治疗。 18. 肿瘤消融治疗：临床实践中应用最多的是物理消融技术即温度消融，包括射频、微波、冷冻消融等，目前还有一种新型的消融治疗方式纳米刀消融，是利用常温物理消融技术来治疗特殊部位的肿瘤。 19. 肿瘤支持治疗：预防、治疗肿瘤本身及控瘤治疗的不良反应，包括从诊断到治疗及治疗后全程所有不良反应、生理及心理症状的处理，目的在于改善肿瘤康复、预防继发肿瘤、改善肿瘤生存及提高终末期护理质量。 20. 恶性肿瘤终末期：指无法接受肿瘤病灶根治术、减瘤术以及常规放化疗治疗，且预期生存期3-6个月为恶性肿瘤终末期。 21. 恶性肿瘤终末期化疗：是指在肿瘤终未期进行的非计划性化学治疗，通常在化疗药物选择、剂量、给药方式等方面超出常规，且没有十分确定的治疗效果预期。 三、编码规则要点及详解 1.本次住院针对肿瘤进行手术治疗或进行确诊的，选择肿瘤为主要诊断。 【举例1】：患者女性，因发现左侧乳腺外上象限肿物1周入院，住院后经穿刺活检病理诊断为浸润性导管癌，HER2阳性，给予术前TPH方案化疗1次，过程顺利，准予出院。 主要诊断：乳房上外象限恶性肿瘤C50.400（临床版为乳腺外上象限恶性肿瘤C50.400x001） 主要手术及操作：乳房穿刺活检85.1100x001 【举例2】：患者女性，因“左乳外上象限结节”人院，入院后行单侧乳房改良根治术，术后病理诊断为浸润性导管癌，患者病情好转平稳出院。 主要诊断：乳房上外象限恶性肿瘤C50.400（临床版为乳腺外上象限恶性肿瘤C50.400x001） 主要手术及操作：单侧乳房改良根治术85.4301 【举例3】：患者女性，因“肝细胞癌”入院，入院后行超声引导下射频消融术术，术后予以保肝治疗，恢复可，予以出院。 主要诊断：肝细胞癌C22.000 主要手术及操作：超声引导下肝病损射频消融术50.2401 2. 本次住院针对继发肿瘤进行手术治疗或进行确诊的，即使原发肿瘤依然存在，选择继发肿瘤为主要诊断。 【举例】：患者男性，56岁，因头痛、恶心、呕吐1周入院。既往肺癌术后5年病史。头部CT提示颅内占位性病变，临床考虑右肺上叶腺癌脑转移，入院后行开颅手术治疗，病理诊断为肺癌脑转移，手术后患者病情好转平稳出院。 主要诊断：脑继发恶性肿瘤C79.300x002 其他诊断：右肺上叶恶性肿瘤C34.100x004 3. 本次住院同时切除原发和继发恶性肿瘤，主要诊断为原发恶性肿瘤，继发恶性肿瘤写入其他诊断。 【举例】：患者，男性，40岁，因“体检发现肺部结节2年，腹胀1个月”入院。2年前体检时发现右肺上叶有一约1.5cmX2cm的磨玻璃结节，定期随访未见明显变化。1个月前，患者出现腹胀，伴食欲减退，腹部超声检查发现肝脏右叶有一约4cmX5cm的低回声占位，边界尚清。为进一步诊治，患者入院。入院后，完善相关检查，经支气管镜肺活检病理诊断为肺腺癌。肝脏穿刺活检病理诊断为转移性腺癌，免疫组化结果与肺腺癌一致。经多学科会诊（MDT），考虑患者肺部原发癌及肝脏转移瘤均局限，无远处其他转移，建议行根治性手术，同时切除肺部原发灶和肝脏转移灶。术后病理结果显示：右肺上叶腺癌，肝右叶转移瘤，病理诊断与肺腺癌一致。术后1周复查胸部CT及腹部超声，未见明显异常。患者恢复良好，顺利出院。 主要诊断：右肺上叶恶性肿瘤C34.100x004 其他诊断：肝部和肝内胆管继发性恶性肿瘤C78.700（临床版为肝继发恶性肿瘤C78.700x011） 4. 原发恶性肿瘤已行手术，本次住院对原发部位行进一步扩大切除或标准手术而住院，无论术后病理是否发现恶性肿瘤，仍以原发恶性肿瘤为主要诊断。如术后病理未见肿瘤组织，病理诊断按原肿瘤形态学填写。 【举例】：患者因“左侧乳腺外上象限恶性肿瘤”行保乳手术，术后再次入院，要求行扩大切除术，术后病理诊断未发现癌细胞。 主要诊断：乳房上外象限恶性肿瘤C50.400（临床版为乳腺外上象限恶性肿瘤C50.400x001） 5. 本次住院仅对恶性肿瘤进行放疗、化疗、靶向治疗等其他治疗方式时，选择恶性肿瘤放疗、化疗、靶向治疗等其他治疗方式为主要诊断。 * （1）住院期间同时开展放疗、化疗、靶向治疗等其他治疗方式，放疗为主要诊断，化疗、靶向治疗等其他治疗方式编入其他诊断，即主要诊断选择放疗>其他治疗方式。 【说明】从医疗资源消耗的角度分析，放疗通常是本次住院过程中占主导地位、消耗资源最集中的治疗方式，放疗需按计划每日或隔日执行，贯穿整个住院周期，持续占用直线加速器等核心设备及相应技术、护理资源，直接决定了患者的住院天数。化疗或靶向治疗虽属重要综合治疗手段，但其给药常为周期性（如每周一次），在资源消耗的连续性、对住院天数的决定性影响上，通常不及放疗，放疗更符合“消耗资源最多”的判断标准。 【举例】：患者因“胃窦恶性肿瘤术后19年余”收入院，上腹部平扫+动态增强（3.0磁共振）：“胃窦恶性肿瘤术后”复查，肝内多发转移瘤。胃窦恶行间质瘤二次手术后肝转移患者，选择甲磺酸伊马替尼（靶向口服药）联合肝转移灶局部放疗，患者按期结束治疗后办理出院手续。 主要诊断：恶性肿瘤放射治疗Z51.003 其他诊断：胃窦恶性肿瘤C16.301 肝部和肝内胆管继发性恶性肿瘤C78.700（临床版为肝继发恶性肿C78.700x011） 恶性肿瘤靶向治疗Z51.801 主要手术及操作：放射治疗 92.2 *（2）住院期间同时进行了化疗、靶向、免疫或内分泌等药物抗肿瘤治疗，主要诊断选择按照化疗>靶向治疗>免疫治疗>内分泌治疗原则确定本次住院的主要诊断。 【说明】在肿瘤联合治疗情况下，不同病例因病情与治疗组合的差异，主要诊断的选择往往不一致，导致肿瘤相关病种划分复杂。相同治疗方式下，不同诊断则可能产生不同的支付分值，存在付费公平的风险。为规范病种归类、统一肿瘤联合治疗主要诊断填报口径，姑且特设定上述主要诊断的优先级顺序。该规则有助于简化DIP病种设置，使病种分组与分值计算更具可比性，提升医保支付的规范性与公平性。 *（3）住院期间行化疗并同时进行了输液港置入或PICC、颈静脉置管时，主要诊断为恶性肿瘤化疗，主要手术操作为静脉注射化疗，其他手术操作为输液港置入或PICC置入、颈静脉置管术。 【说明】当无细则明确主要诊断选择时，应优先用清单原则1判断，主要诊断应体现患者本次住院的主要医疗需求与核心治疗目的。当患者住院的根本原因是“化疗”，静脉输液港植入术（或PICC、中心静脉置管等）是为保障化疗安全、顺利进行而实施的辅助性操作。 【举例】：患者右肺上叶腺癌T1NOMOI期术后2个月入院，再次入院后在手术室行“静脉输液港植入术”，且给予培美曲塞+奈达铂化疗，治疗结束后顺利出院。 主要诊断：恶性肿瘤术后化疗Z51.102 其他诊断：右肺上叶恶性肿瘤C34.100x004 主要手术及操作：静脉注射化疗药物99.2503 其他手术及操作：静脉输液港植入术86.0701 【评析】突出“诊疗目的优先”逻辑，阐明主要诊断与主要手术操作的选择均需围绕住院核心目的（化疗），静脉输液港植入术为辅助。 *（4）对于入院前已经确诊的恶性肿瘤患者，此次住院仅行“输液港置入”（入院后未行化疗等抗肿瘤治疗），主要诊断应选“输液港置入”，主要手术操作选“静脉输液港植入术” 【举例】：患者右肺上叶腺癌T1NOM0I期术后1个月入院，此次入院行输液港置入术，未行其他任何抗肿瘤治疗，置入输液港后观察无不适患者办理出院。 主要诊断：血管通路装置的调整和管理Z45.200（临床版为输液港置入Z45.800x012） 其他诊断：右肺上叶恶性肿瘤C34.100x004 主要手术及操作：静脉输液港植入术86.0701 【评析】本例悲者住院的唯一旦明确的目的是进行“静脉输液港植入术”，并未在此次住院期间接受任何抗肿瘤治疗（如化疗）。因此，本次住院的主要医疗事件就是该植入术本身。本案例清晰地展现了当住院的核心目的发生根本性变化时，主要诊断与主要手术操作的选择逻辑也相应改变，从而体现了“住院目的、主要诊断与主要手术操作高度统一”的核心原则，与上一案例形成鲜明对比。 需特别说明的是，静脉输液港植入术在主要诊断编码上存在“医保版”与“临床版”的差异，这正是部分医院反映的“Z45.800x012编码数量已达分组阈值，却在DIP病种库中无法对应”的原因。在实际填报与分组过程中，必须注意两个版本之间的区别。 *6.本次住院对已确诊的恶性肿瘤进行血管介入栓塞化疗治疗时，选择恶性肿瘤介入治疗为主要诊断，主要操作为动脉栓塞术。 【举例】：患者，男性，68岁，因“确诊直肠癌术后1年，腹痛伴腹部包块1个月”入院。患者1年前因直肠癌行根治性手术，术后病理诊断为中分化腺癌，术后规律化疗6个周期。1个月前，患者出现腹部疼痛，伴腹部可触及包块，经CT检查发现肝内多发转移灶，最大约3cmX4cm，考虑直肠癌肝转移。入院后，完善相关检查，包括肝功能、凝血功能等，均未见明显禁忌证。经多学科会诊（MDT）,鉴于患者肝转移灶较多，且不适合再次手术切除，决定行肝动脉化疗栓塞术（TACE）进行介入治疗。 主要诊断：恶性肿瘤介入治疗Z51.800x092 其他诊断：肝部和肝内胆管继发性恶性肿瘤C78.700（临床版为肝继发恶性肿C78.700x011） 直肠恶性肿瘤C20.x00 主要手术及操作：经导管肝动脉栓塞术39.7903 其他手术及操作：肝局部灌注50.9300 化疗药物灌注99.2505 肝动脉造影88.4701 【评析】恶性肿瘤介入治疗的主要诊断选择应遵循“肿瘤主要诊断选择原则”其核心判定逻辑聚焦于“本次住院诊疗的核心目的与完整诊疗链路”，若患者入院为“明确肿瘤性质/范围（含穿刺活检、影像学评估等诊断阶段）+介入治疗（含栓塞、灌注等治疗阶段）”的连贯诊疗流程，且诊断与治疗目标均指向该恶性肿瘤，主要诊断应选择恶性肿瘤;若患者已明确恶性肿瘤诊断，本次入院的核心目的为实施介入治疗，无额外诊断性操作，主要诊断则应选择Z51.8（恶性肿瘤的介入治疗/灌注治疗），恶性肿瘤列为其他诊断。 7.本次住院对已确诊的恶性肿瘤进行血管介入动脉内化疗灌注治疗时，选择恶性肿瘤灌注治疗为主要诊断，主要操作为肝局部灌注。 【举例】：患者，女性，66岁，因“肝细胞癌综合治疗2月余”入院。患者2月前因右上腹疼痛伴腹胀就诊，在外院经MRI及其他检查临床诊断为肝细胞癌，并行替雷利珠单抗+仑伐替尼治疗2周期，1月前行肝动脉栓塞+化疗药物灌注（FOLFOX6）治疗，现为进一步治疗入院，入院后完善相关检查给予介入治疗肝动脉化疗药物灌注（奥沙利铂+5-FU）。 主要诊断：恶性肿瘤灌注治疗Z51.800x922 其他诊断：肝细胞癌C22.000 主要手术及操作：肝局部灌注50.9300 其他手术及操作：化疗药物灌注99.2505 8.本次住院针对肿瘤并发症或肿瘤以外的疾病进行治疗的，选择并发症或该疾病为主要诊断。 （1）本次住院主要针对恶性肿瘤患者某一个合并症或并发症，选择主要治疗的合并症或并发症作为主要诊断。 【举例1】：患者因“右肺上叶恶性肿瘤1年余，全身乏力，纳差”收入院。入院后完善相关检查，血常规示：血红蛋白112g/L;血生化示：白蛋白37.9g/L，钠123mmo1/L;皮质激素两项示：皮质醇8ug/d1;感染标志物二项示：白介素-650.26pg/mL。余尿常规，凝血六项，肌钙蛋白，均未见明显异常。入院后检查提示低钠血症，给予浓氯化钠注射液（补充电解质）、托伐普坦片（补钠）、注射用甲泼尼龙（抗炎）、注射用艾司奥美拉唑钠（抑酸护胃）、维生素C注射液、维生素B6注射液（补液）对症治疗。现患者乏力、纳差症状缓解，办理出院。 主要诊断：低钠血症E87.102 其他诊断：右肺上叶恶性肿瘤C34.100x004 【举例2】：患者某某，确诊右肺下叶腺癌T4N3M1IV期3年余，伴有肺门淋巴结、纵隔淋巴结、锁骨上淋巴结转移、骨转移，本次因呼吸困难加重入院。入院后胸CT提示左肺间质性肺炎，予以糖皮质激素、抗纤维化等治疗，患者病情好转后出院。 主要诊断：间质性肺炎J84.9x002 其他诊断：右肺下叶恶性肿瘤C34.300x004 9.未确诊恶性肿瘤不可按确诊的恶性肿瘤诊断和编码（经MDT或疑难病例讨论等临床确诊恶性肿瘤除外），也不可以使用肿瘤的特殊筛选检查编码（Z12）。 （1）因诊治其他疾病而住院，通过检查怀疑恶性肿瘤，出院时仍未确诊恶性肿瘤，恶性肿瘤相关疾病不可按确诊进行编码。 【举例】：患者因“反复腹痛、腹泻2个月”入院，初步诊断为“急性胃肠炎”。入院后，医生在进行腹部CT检查时发现患者腹部有一个边界不清的占位性病变，怀疑可能是恶性肿瘤（如肠癌）。于是，医生进一步完善了肿瘤标志物检查、肠镜检查等，但因患者病情复杂，且检查结果尚未完全明确，出院时仍未确诊为恶性肿瘤。 主要诊断：急性胃肠炎K52.905 其他诊断：腹部肿物R19.001 （2）为明确是否为恶性肿瘤而住院，出院时仍未确诊，主断编码可为肿物、占位、指标异常，恶性肿瘤相关疾病不可按确诊进行编码。 【举例】：患者因“右下肺占位性病变”收入院，入院完善相关检查，胸部增强：1.两肺上叶及右肺下叶结节及肿块，恶性肿瘤可能性大，肺脓肿待排。2.纵隔及双肺门淋巴结稍大。给予吸氧、雾化吸入（布地奈德+特布他林）解痉平喘（氨茶碱）、扩张气道（氨溴索）等治疗后，症状好转。肺恶性肿瘤可能性大，建议行肺穿刺病理分型同时完善相关影像学检查，明确有无远处转移，与家属沟通，但患者家属拒绝进一步检查及治疗。 主要诊断：肺占位性病变R91.x03 其他诊断：纵隔淋巴结肿大R59.010 （3）为明确是否为恶性肿瘤而住院，出院时排除恶性肿瘤诊断，主要诊断为可疑恶性肿瘤的观察（Z03.1）。 【举例】：患者因体检前列腺特异性抗原（PSA）升高怀疑前列腺癌入院，完善相关检查及前列腺穿刺活检等已排除前列腺癌，考虑为非癌性因素导致的PSA升高。 主要诊断：可疑前列腺恶性肿瘤的观察Z03.103 其他诊断：PSA升高R77.800x002 10.造血干细胞移植治疗白血病/淋巴瘤时，主要诊断为原发肿瘤。 [举例1】：患者某某，诊断非霍奇金淋巴瘤弥漫大B细胞淋巴瘤，侵及腹腔淋巴结、颈部淋巴结、锁骨上淋巴结，侵及食管、胃、结肠。为行自体造血干细胞移植入院。入院后排除化疗禁忌，于12月6日行卡莫司汀+环磷酰胺方案预处理，于12月12日行干细胞回输，过程顺利，准予出院。 主要诊断：弥漫大B细胞淋巴瘤（C83.3）一一原发肿瘤 其他诊断：淋巴瘤结外侵及（C85.9） 主要手术及操作：自体造血干细胞移植术（41.04） 其他手术及操作：静脉注射化疗药物（99.25） 【举例2】：患者某某，诊断非霍奇金淋巴瘤弥漫大B细胞淋巴瘤，侵及腹腔淋巴结、颈部淋巴结、锁骨上淋巴结，侵及食管、胃、结肠。除外治疗禁忌，行外周血干细胞采集。过程顺利，准予出院。 主要诊断：自体外周血干细胞动员（Z51.400x001） 其他诊断：弥漫大B细胞淋巴瘤（C83.3） 淋巴瘤结外侵及（C85.9） 主要手术及操作：干细胞采集（99.79） 【评析】1.造血干细胞移植，在给予骨髓毁损性的高剂量化疗/放疗剂量后通过移植自体或异基因的造血干细胞，重新挽救和恢复患者骨髓造血功能的治疗方法。 2. 造血干细胞移植分为自体移植和异基因移植两大类。自体移植是指造血干细胞来源于患者自身。 3. 造血干细胞移植可分为干细胞采集、高剂量化/放疗和造血干细胞回输/骨髓功能重建三个主要阶段。 4. 干细胞采集是为下一步干细胞回输做准备，主诊应为“自体外周血干细胞动员”，而不能为原发肿瘤。 11.关于因某种原因导致操作未进行Z53编码的使用 （1）原计划患者为手术治疗恶性肿瘤入院，后因某种因素治疗未能进行治疗而出院，以恶性肿瘤为主要诊断，Z53为其他诊断，说明未进行操作的原因。 【举例1】：患者，女，41岁，因“同房后出血半年余，发现宫颈病变4天余”收入院。1天前来我院行宫颈活检，结果尚未回示，建议住院治疗。入院后完善相关检查，宫颈后唇处低回声，子宫肌层回声增粗。宫颈活检病理结果提示：（宫颈活检组织）鳞状细胞癌。告知患者及家属目前病情，建议限期行手术治疗，患者及家属表示知情理解拒绝手术并要求出院。 主要诊断：子宫颈恶性肿瘤C53.900x001 其他诊断：因病人原因未进行操作Z53.2 【举例2】：患者某某，一周前胃镜检查提示胃窦腺癌，今为行手术治疗入院，入院后完善术前检查，除外手术禁忌，计划行“腹腔镜下胃大部切除术”，手术过程中，腹腔探查发现腹腔广泛散在结节，取腹腔结节术中快速病理提示可见癌浸润，向患者家属交代病情，腹腔广泛转移，无法行胃切除术，遂关腹。 主要诊断：胃窦恶性肿瘤C16.3 其他诊断：未按计划诊疗Z53.8 【举例3】：患者某某，既往高血压、冠心病10年，确诊乙状结肠癌一周，为行手术治疗入院，入院后完善检查，查动态心电图提示频发室早，请麻醉科及ICU会诊认为手术风险大，建议出院先控制心律不齐及高血压，待稳定后再考虑手术，准予出院。 主要诊断：乙状结肠恶性肿瘤C18.7 其他诊断：因禁忌症未进行操作Z53.0 （2）原计划患者为放疗、化疗、靶向治疗等其他治疗方式治疗恶性肿瘤入院，后因某种因素未按诊疗计划执行、且无其他治疗而出院的，以放疗、化疗、靶向治疗等原计划的治疗方式作为主要诊断，Z53为其他诊断，说明未进行操作的原因。 【举例】：患者，女，68岁，因“肺腺癌9年余，为进一步抗肿瘤治疗”收入院。入院后行颅脑MR及PET-CT检查，结果未回报，但患者要求出院，建议患者待结果回报后行姑息性化疗，并告知延后治疗可导致病情进展等严重后果，但患者坚持要求出院。 主要诊断：姑息性化疗Z51.104 其他诊断：右肺中叶恶性肿瘤C34.200x001 由于其他或未特指原因而使病人决定不进行操作Z53.200 12. 有多个原发肿瘤存在时，如同时手术治疗多原发恶性肿瘤时，选择手术技术难度高、过程复杂程度高、风险级别高的手术为主要手术操作，选择相对应手术难度的原发恶性肿瘤为主要诊断，多个原发恶性肿瘤作为其他诊断分别编码，C97作为其他诊断;如果只对一个肿瘤进行治疗时，则用所治疗的肿瘤做主要诊断，C97作为其他诊断。 【举例】：患者，男，72岁，因“肠镜检查发现降结肠以及直肠肿物”收入院。入院后完善相关检查，未见明确手术禁忌。在全麻下行腹腔镜左半结肠癌根治术+腹腔粘连松解术+内镜下直肠粘膜下剥离术。过程顺利，术后予以止痛、抑酸、抑酶、营养支持等对症治疗，恢复良好，达到出院标准，经上级医师同意，予以办理出院。术后病理诊断为直肠中分化腺癌，降结肠中分化腺癌。 主要诊断：降结肠恶性肿瘤C18.600） 其他诊断：直肠恶性肿瘤C20.x00 多部位原发恶性肿瘤C97.x00x001 13. 患者因恶性肿瘤的预防性手术住院时，应以“与恶性肿瘤有关的危险因素的预防性手术”Z40.0为主要编码，原发恶性肿瘤为其他编码。 【举例】：患者，女，42岁，因“乳腺癌术后4月余，要求入院切除双侧附件”收入院。后于我院肿瘤科行后续化疗4疗程，现为求进行卵巢去势手术就诊于我科，根据肿瘤科及患者意愿，要求行卵巢去势手术，具备手术指征，辅助检查无明显手术禁忌症，于全麻下行“腹腔镜双侧卵巢和输卵管切除术”，手术顺利。 主要诊断：与恶性肿瘤有关的危险因素的预防性手术Z40.000 其他诊断：乳腺内下象限恶性肿瘤C50.300x001 14. 术后、治疗后随诊检查作为主要诊断仅限于常规复查无阳性发现的情况，如果发现新的疾病或异常发现，则将疾病或异常发现作为主要诊断。 15. 为随后治疗的准备医疗（Z51.4）做主诊的情况。 （1）入院已确诊恶性肿瘤，本次住院的目的为行术前准备，主要诊断为随后治疗的准备医疗（Z51.4），其他诊断为恶性肿瘤。 （2）入院已确诊恶性肿瘤，本次住院进行了放疗前的检查及定位，但未行放射治疗，主要诊断选择随后治疗的准备医疗（Z51.4），其他诊断为恶性肿瘤。 【举例】：患者，男性，62岁，因“确诊食管癌1个月，拟行术前放疗”入院。患者1个月经胃镜检查发现食管胸中段有一约5cm长的溃疡型病变，活检病理诊断为鳞状细胞癌。影像学检查（胸部CT、腹部CT）未发现远处转移，但肿瘤局部侵犯较深，且周围淋巴结有可疑转移。多学科会诊（MDT）建议患者先行术前放疗，以缩小肿瘤体积，降低手术难度和复发风险。患者入院后，完善相关检查，进行了放疗前的定位检查，包括模拟CT扫描，以确定放疗的靶区和剂量分布。住院第3天，患者完成所有放疗前的定位检查和准备工作，顺利出院，准备在门诊或放疗科开始术前放疗。 主要诊断：随后治疗的准备医疗Z51.400x002 其他诊断：食管胸中段恶性肿瘤C15.100x003 16. 恶性肿瘤个人史（Z85）仅作为附加编码使用。 （1）恶性肿瘤个人史，指患者曾经诊断某系统肿瘤但目前为非现患状态。 （2）恶性肿瘤现患状态，是指患者体内有实体肿瘤、肿瘤细胞或可疑存在肿瘤细胞的三种状态。 17. 本次住院仅对恶性肿瘤进行中医治疗时，选择恶性肿瘤中医治疗作为主要诊断。 【举例】：患者女，70岁，因“确诊直肠恶性肿瘤1年余，乏力一周”入院，患者暂拒绝放疗、化疗等抗肿瘤治疗，入院予中医治疗。经治疗后，患者症状较前好转出院。 主要诊断：恶性肿瘤中医治疗Z51.802 其他诊断：直肠恶性肿瘤C20.x00 18. 即使患者做了放疗或化疗等其他抗肿瘤治疗，但住院目的是为了明确肿瘤诊断（如恶性程度、肿瘤范围等）或者因为肿瘤进展需重新进行穿刺活检行基因检测以决定后续的治疗方案，或为了确诊肿瘤进行某些操作（如穿刺活检等），即使做了放疗或化疗，仍选择原发（或继发）部位的恶性肿瘤作为主要诊断。 【举例】：患者“因确诊右上肺周围型肺腺癌伴多发淋巴结转移（cT3N3M1IV期PS0分）9月，返院治疗”入院。既往曾行右肺肿物穿刺活检，分子检测未见具有明确意义的靶向治疗突变，PD-L1检测结果为0，曾给予贝伐珠单抗+培美曲塞+顺铂治疗3疗程，此次返院查胸部CT示肺内病灶较前增多，考虑肿瘤进展。建议患者再次活检，向患者及家属告知病情患者及家属表示知情理解，同意再次活检，遂行B超引导下经皮肺穿刺活检，病理回报：符合恶性肿瘤，并送PD-L1及外送基因检查（详细病理诊断：01.（右肺肿物）纤维胶原组织中见异型细胞呈腺样或条索状浸润，形态学初步考虑为癌（非小细胞癌），待免疫组化进一步诊断。2025/6/201A号标本免疫组化结果：癌细胞CK7（+），TTF1（部分+），NapsinA（-），CK5/6 （部分+），P40（部分+），P63（部分+），Syn （个别细胞+），CgA（-），Ki67（约50%+）。应临床要求加做免疫组化结果：PD-L1（TPS评分0%），PDL-1-Neg（-）。PD-L1（克隆号：22C3）TPS评分为肿瘤细胞阳性比例分数，计数呈完整或不完整弱-强阳性染色的肿瘤细胞占全部肿瘤细胞的比例。结合HE形态及免疫组化结果，（右肺肿物）符合恶性肿瘤，需鉴别肺腺癌、腺肌上皮癌等，需待科内会诊进一步补充报告。2025/6/25补充免疫组化结果：Desmin（-），MC（部分+）,WT1（-）,GATA3（-），INI-1（+）。结合免疫组化结果及患者病史，并经科内会诊讨论，（右肺肿物）符合恶性肿瘤，需鉴别腺癌、腺肌上皮癌等，建议加做更全面分子检测（520基因检测）协助诊断并寻找治疗靶点）。因患者骨转移，本次住院给予地舒单抗120mgq4w护骨治疗，余继续补钙、对症治疗后，准予办理带药出院，嘱出院后跟踪基因检查结果再定下步治疗方案。 主要诊断：右肺上叶恶性肿瘤C34.100x004 主要手术及操作：肺穿刺活检33.2600x001 19. 对于肿瘤患者住院死亡时应根据上述要求，根据本次住院的具体情况正确选择主要诊断。 【说明】本原则在于明确肿瘤患者死亡时，其主要诊断不应简单地依据“死亡”这一结局进行选择。死亡是疾病发展的终点，而非选择主要诊断的依据。主要诊断选择应遵循主要诊断选择基本原则，依据本次住院的“入院原因”、并结合“消耗医疗资源最多、对健康危害最大、住院时间最长”这三最原则及其他相关细则，进行综合判定。其核心逻辑在于，结算清单主要诊断的选择不是从“死亡原因统计”的角度出发，而应始终服务于医保支付与管理的目的，即真实、准确地反映本次住院服务的核心医疗行为与资源消耗方向。肿瘤病情复杂，死亡往往涉及肿瘤本身、终末期状态、急症或合并症等多种因素。因此：在填报医保结算清单时，必须紧紧围绕“医疗资源消耗重心”和“住院期间主要医疗行为”这一付费逻辑，做出最符合诊疗事实与费用补偿原则的判断。 （1）住院期间首次确诊恶性肿瘤并死亡 主诊选择：选择该首次确诊的恶性肿瘤为主要诊断。 临床特征与判定要点：本次住院的核心医疗行为在于明确肿瘤诊断和/或启动初始治疗。患者死亡直接归因于该晚期肿瘤本身（如广泛转移、恶病质、器官衰竭），期间未出现比肿瘤本身更突出、消耗资源更多的独立急性并发症。 【举例】：患者男性，68岁，因“持续腹痛、体重下降3个月”入院。检查后确诊胰腺导管腺癌（IV期，肝转移）。予姑息治疗，病情迅速恶化，于入院第10天因多器官功能衰竭死亡。 主要诊断：胰腺体尾部恶性肿瘤C25.801 其他诊断：肝继发恶性肿瘤C78.700 多器官功能衰竭R68.801 【评析】“确诊恶性肿瘤”是驱动本次住院并消耗核心医疗资源（检查、病理、多学科评估）的根本原因。死亡是该晚期肿瘤自然病程的结局。因此，恶性肿瘤本身是对消耗资源最多、健康危害最大的诊断，应作为主要诊断，此选择符合主要诊断选择的基本原理。 （2）因肿瘤相关急症入院救治无效死亡 主诊选择：选择导致本次入院的、最严重的肿瘤急症为主要诊断，恶性肿瘤作为其他诊断。 临床特征与判定要点：患者因肿瘤直接引发的、危及生命的急性并发症（如上腔静脉综合征、脊髓压迫、恶性气道梗阻、肿瘤破裂大出血、高钙危象等）急诊入院。整个住院期间的诊疗核心与资源倾斜在于紧急处理该并发症（如放疗、介入、手术、抢救），而非针对肿瘤的常规治疗。 【举例】：患者男性，62岁，食管癌病史。本次因“突发吞咽困难、喘憋1天”急诊入院。CT示肿瘤增大导致气管严重受压。拟行急诊放疗解除梗阻，但首次治疗后突发气道梗阻窒息、呼吸衰竭，抢救无效死亡。 主要诊断：气管梗阻J98.800x006 其他诊断：食管胸中段恶性肿瘤C15.100x003 急性呼吸衰竭J96.000 【评析】本次住院的直接原因和救治核心是“气管梗阻”这一肿瘤急症。尽管患者有肿瘤基础病，但本次医疗行为的指向性和资源消耗（急诊、抢救、放疗解除梗阻）均聚焦于处理急症。因此，选择急症作为主要诊断更符合事实和规范。 （3）肿瘤与非肿瘤严重疾病并存导致死亡 主诊选择：根据清单原则1（入院原因）和原则2（三最）综合判断，若两者相当或难以区分，可优先依据“消耗医疗资源最多”进行选择。 临床特征与判定要点：患者同时患有需要积极干预的活动性恶性肿瘤，以及另一个独立的、严重的非肿瘤性急重症（如急性心肌梗死、大面积肺栓塞、重症肺炎、消化道大出血等）。两者的诊疗活动在本次住院中均占据重要比重，且共同影响最终结局。 【举例】：患者女性，58岁，确诊晚期卵巢癌，正在进行周期性化疗。本次因“突发胸痛、呼吸困难2小时”急诊入院。CT肺动脉造影确诊为急性大面积肺栓塞（高危），D-二聚体显著升高。同时，肿瘤标志物CA125较前次升高，影像提示腹腔病灶进展。 情景A（肺栓塞为绝对治疗重心）：患者入院后生命体征不稳定，立即入住ICU，予急诊血管介入取栓及强化抗凝治疗为主要抢救措施，同时暂停了原计划的化疗。后续救治始终以维持循环呼吸稳定、处理抗凝并发症为核心。患者最终因肺栓塞相关并发症死亡。 主要诊断：急性大面积肺栓塞I26.009 其他诊断：卵巢恶性肿瘤C56.x00 情景B（肿瘤与肺栓塞治疗并重，但肿瘤治疗主导资源消耗）：患者肺栓塞经评估为次高危，予标准抗凝治疗，病情相对稳定。住院期间，因肿瘤进展迅速，出现肠梗阻、严重癌痛，医疗团队将主要精力与资源用于调整全身抗肿瘤方案（更换化疗方案）、处理肠梗阻（置管、营养支持）及疼痛综合治疗。患者最终死于肿瘤全身衰竭。 主要诊断：卵巢恶性肿瘤C56.x00 其他诊断：急性肺栓塞I26.009 恶性肠梗阻K56.500 【评析】此情形是编码实践中的难点与关键点，核心在于通过病历记录精准识别本次住院的“医疗资源消耗重心”。必须进行回溯性分析：1治疗强度与紧急性：何种疾病触发了最高级别的抢救（如入住ICU、急诊手术/介入）?2医疗资源的主动倾斜：医师的病程记录、会诊意见及医疗计划将何者列为优先处理目标?3诊疗活动的连续性：主要的检查、治疗、护理工作是围绕哪一个疾病系统展开的?由临床经治医师与病案编码员根据上述要点共同研判，形成一致意见。若判断困难，应在科室或院内病例讨论中确定，并将简要理由在病案中备注，确保选择过程有理有据、经得起推敲。 （4）其他情形 对于其他的复杂情况，应始终回归《医疗保障基金结算清单填写规范》主要诊断选择原则，组织多学科（临床、编码、医保）讨论，基于病历记录达成共识。 四、专业常见病种 五、肿瘤药物分类 分类 药物名称 化疗药物 氮芥、环磷酰胺、异环磷酰胺、美法仑、硝卡芥、苯丁酸氮芥、苯达莫司汀、卡莫司汀、洛莫司汀、司莫司汀、尼莫汀、福莫司汀、雌莫汀、六甲蜜胺、塞替派、白消安、达卡巴嗪、丙卡巴肼、替莫唑胺、阿糖胞苷、地西他滨、氟达拉滨、氟尿嘧啶、吉西他滨、甲氨蝶呤、卡莫氟、卡培他滨、克拉屈滨、雷替曲塞、硫鸟嘌呤、尿嘧啶替加氟、羟基脲、巯嘌呤、去氧氟尿苷、替吉奥、替加氟、阿扎胞苷、培美曲塞、曲氟尿苷替匹嘧啶、氯法拉滨、放线菌素D、多柔比星、阿柔比星、吡柔比星、表柔比星、伊达比星、米托葱醌、博安霉素、博来霉素、平阳霉素、柔红霉素、丝裂霉素、紫杉醇、、紫杉醇聚物胶束、多西他赛、长春地辛、长春瑞滨、长春新碱、三尖杉酯碱、高三尖杉酯碱、托泊替康、伊立替康、依托、替尼泊、羟喜树碱、顺铂、卡铂、洛铂、奈达铂、奥沙利铂、氯氧喹、优替德隆、艾立布林 靶向药物 克唑替尼、阿来替尼、恩沙替尼、塞瑞替尼、布格替尼、劳拉替尼、伊鲁阿克、埃克替尼、厄洛替尼、吉非替尼、阿法替尼、达可替尼、阿美替尼、奥希替尼、伏美替尼、莫博赛替尼、贝福替尼、赛沃替尼、谷美替尼、特泊替尼、普拉替尼、塞普替尼、恩曲替尼、拉罗替尼、维莫非尼、达拉非尼、曲美替尼、拉帕替尼、吡咯替尼、奈拉替尼、图卡替尼、阿贝西利、哌柏西利、达尔西利、瑞波西利、帕米帕利、氟唑帕利、尼拉帕利、奥拉帕利、多纳非尼、安罗替尼、瑞戈非尼、索凡替尼、索拉非尼、阿昔替尼、呋喹替尼、阿帕替尼、培唑帕尼、舒尼替尼、伏罗尼布、尼达尼布、依维莫司、西达本胺、伊马替尼、达沙替尼、尼洛替尼、奥雷巴替尼、氟马替尼、瑞派替尼、仑伐替尼、阿伐替尼、伊布替尼、奥布替尼、泽布替尼、阿可替尼、吡妥布替尼、卡非佐米、伊沙佐米、硼替佐米、芦可替尼、度维利塞、林普利塞、可泮利塞、艾伏尼布、维奈克拉、佩米替尼、吉瑞尼、普拉曲沙、伊基奥仑赛、阿基仑赛、瑞基奥仑赛、帕妥珠单抗、曲妥珠单抗、伊尼妥单抗、尼妥珠单抗、西妥昔单抗、贝伐珠单抗、雷莫西尤单抗、奥妥珠单抗、利妥昔单抗、瑞帕妥单抗、泽贝妥单抗、达雷妥尤单抗、地舒单抗、莫格利珠单抗、恩美曲妥珠单抗、维迪西妥单抗、德曲妥珠单抗、维布妥昔单抗、维泊妥珠单抗、戈沙妥珠单抗、重组人血管内皮抑制素、泊马度胺、沙利度胺、来那度胺、Amivantamab（埃万妥） 免疫药物 派安普利单抗、赛帕利单抗、卡瑞利珠单抗、纳武利尤单抗、帕博利珠单抗、特免疫瑞普利单抗、替雷利珠单抗、信迪利单抗、普特利单抗、斯鲁利单抗、阿得贝利单抗、恩沃利单抗、阿替利珠单抗、度伐利尤单抗、舒格利单抗、伊匹木单抗、达妥昔单抗β、卡度尼利单抗、贝林妥欧单抗、 内分泌药物 阿那曲唑、来曲唑、福美坦、依西美坦、他莫昔芬、氯米芬、托瑞米芬、氟维司群、艾拉司群、阿帕他胺、达罗他胺、比卡鲁胺、瑞维鲁胺、恩扎卢胺、氟他胺、阿比特龙、地加瑞克、丙氨瑞林、戈那瑞林、戈舍瑞林、亮丙瑞林、曲普瑞林 放射性药物 碘[131I]、美妥昔单抗、氯化镭[223Ra]、铱[90Y]（微球）、氯化锶[89Sr] 通过网盘分享的文件：CHS-DRG分科病例入组解析 (2020) 等3个文件 公众号发送红色关键词：主诊编码 获取链接，提取码: kgmn

10 abstracts, including two oral presentations, reinforce Astellas' long-term commitment to advancing oncology care TOKYO , May 18, 2026 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced it will present new data across its oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29 - June 2 in Chicago, reinforcing Astellas' sustained commitment to improving outcomes for people living with cancer. The data will provide further insight into the durable efficacy of established treatment approaches, their use in clinical practice, and ongoing areas of research and development. Urothelial carcinoma In urothelial cancer, a key highlight will be a 3.5-year follow-up oral presentation from the Phase 3 EV-302 study (also known as KEYNOTE-A39), evaluating enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic disease. These data provide additional insight into the durability of outcomes with this treatment approach in advanced disease, an important consideration in clinical management. Additional data from multiple studies exploring the use of this combination in earlier settings will be presented during the congress. Together, these findings contribute to a broader understanding of how this treatment approach may be applied across advanced disease settings, as well as across patient subgroups. Prostate cancer In advanced prostate cancer, additional analyses from established clinical programs in non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR) and hormone- (or castration-) sensitive prostate cancer (mHSPC or mCSPC), including EMBARK and ARCHES, will provide further insight into treatment outcomes in patients with varying clinical characteristics, supporting clinical decision-making in practice. Women's health For the first time at ASCO, Astellas will present an update on HIGHLIGHT 1, a trial-in-progress investigating the safety and efficacy of fezolinetant for the treatment of moderate to severe vasomotor symptoms in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not been established in this patient population. Fezolinetant is currently approved by the U.S. Food and Drug Administration for the treatment of moderate to severe vasomotor symptoms due to menopause. Astellas Presentations at the 2026 ASCO Annual Meeting Enfortumab vedotin Presentation Title Lead Author Presentation Details Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study T. Powles Type: Oral Presentation Abstract Number: 4507 Date: May 29, 2026, 2:45 PM-5:45 PM CDT Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin ineligible: Phase 3 KEYNOTE-905 study P. O'Donnell Type: Oral Presentation Abstract Number: 4510 Date: May 30, 2026, 8:00 AM-9:30 AM CDT Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants with cisplatin-ineligible muscle-invasive bladder cancer: An analysis of clinically relevant subgroups in KEYNOTE-905 N. Adra Type: Poster Presentation Abstract Number: 4613 Date: May 31, 2026, 9:00 AM-12:00 PM CDT Exploratory subgroup outcomes in the phase 3 KEYNOTE-B15 study of neoadjuvant-adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer eligible for cisplatin C. Hoimes Type: Poster Presentation Abstract Number: 4614 Date: May 31, 2026, 9:00 AM-12:00 PM CDT Enzalutamide Presentation Title Lead Author Presentation Details Predictors of treatment duration in patients with metastatic hormone-sensitive prostate cancer treated with enzalutamide: a post hoc analysis of ARCHES A. Armstrong Type: Poster Presentation Abstract Number: 5093 Date: May 31, 2026, 9:00 AM-12:00 PM CDT Efficacy and safety of enzalutamide in patients with metastatic hormone-sensitive prostate cancer and cardiometabolic comorbidities and/or related concomitant medications: ARCHES post hoc A. Stenzl Type: Poster Presentation Abstract Number: 5092 Date: May 31, 2026, 9:00 AM-12:00 PM CDT EMBARK: Testosterone recovery to >250 ng/dL following treatment suspension S. Freedland Type: Poster Presentation Abstract Number: 5088 Date: May 31, 2026, 9:00 AM-12:00 PM CDT Outcomes with androgen-deprivation therapy (ADT) plus androgen receptor pathway inhibitors (ARPIs) in veterans with de novo metastatic castration-sensitive prostate cancer (mCSPC) who were elderly, frail, or had high comorbidity: a subgroup analysis of enzalutamide and high-volume disease M. Schoen Type: Poster Presentation Abstract Number: 5094 Date: May 31, 2026, 9:00 AM-12:00 PM CDT Fezolinetant Presentation Title Lead Author Presentation Details HIGHLIGHT 1: A randomized, placebo-controlled, double-blind, phase 3 clinical study to investigate the efficacy and safety of fezolinetant for treatment of moderate to severe vasomotor symptoms (hot flashes) in women with stage 0 to 3 hormone receptor–positive breast cancer who are receiving adjuvant endocrine therapy C. Bouchard Type: Poster Presentation Abstract Number: TPS642 Date: June 1, 2026, 1:30 PM-4:30 PM CDT Pipeline Presentation Title Lead Author Presentation Details Trial in progress: ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory antibody-drug conjugate with dual payloads, in patients with locally advanced unresectable or metastatic solid tumors: A phase 1b/2 study. G. Sonpavde Type: Poster Presentation Abstract Number: TPS2665 Date: May 30, 2026, 1:30 PM-4:30 PM CDT About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . About the Pfizer, Astellas and Merck Collaboration Seagen and Astellas previously entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV ® (enfortumab vedotin-ejfv) and Merck's KEYTRUDA ® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer and in patients with muscle-invasive bladder cancer (MIBC). Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). About XTANDI and the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI ® (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S. Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. PADCEV Important Safety Information BOXED WARNING: SERIOUS SKIN REACTIONS PADCEV (enfortumab vedotin-ejfv) can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. Closely monitor patients for skin reactions. Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. INDICATIONS PADCEV, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. PADCEV, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC). PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or mUC who: have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 61% (all grades) of the 167 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC in clinical trials. The majority of skin reactions that occurred included rash and maculo-papular rash. Grade 3-4 skin reactions occurred in 10% of patients (Grade 3: 9%, Grade 4: 1.2%), including rash, maculo-papular rash, toxic skin eruption, dermatitis exfoliative generalized, erythema, exfoliative rash, skin toxicity, toxic epidermal necrolysis, and toxic erythema of chemotherapy. A fatal reaction of toxic epidermal necrolysis occurred in one patient (0.6%). The median time to onset of severe skin reactions was 0.6 months (range: 0.2 to 8.8 months). Skin reactions led to discontinuation of PADCEV in 10% of patients. Of the patients who experienced a skin reaction and had data regarding resolution (n=102), 83% had complete resolution and 17% had residual skin reactions at their last evaluation. Of the patients with residual skin reactions at last evaluation, 29% (5/17) had Grade ≥2 skin reactions. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC in clinical trials. The majority of skin reactions that occurred included maculo-papular rash, macular rash, and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients. Of the patients who experienced a skin reaction and had data regarding resolution (n= 391), 59% had complete resolution and 41% had residual skin reactions at their last evaluation. Of the patients with residual skin reactions at last evaluation, 27% (43/159) had Grade ≥2 skin reactions. Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 3.1% of patients. Of the patients who experienced a skin reaction and had data regarding resolution (n=328), 58% had complete resolution and 42% had residual skin reactions at their last evaluation. Of the patients with residual skin reactions at last evaluation, 39% (53/137) had Grade ≥2 skin reactions. Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre‑existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%). Fatal events of hyperglycemia and diabetic ketoacidosis occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months). Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin by the time of last evaluation. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV. Pneumonitis/Interstitial lung disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given in combination with intravenous pembrolizumab for the treatment of MIBC, 4.2% of the 167 patients had pneumonitis/ILD of any grade. All events were Grade 1-2. The median time to onset of any grade pneumonitis/ILD was 2.5 months (range: 1.9 to 9.7 months). When PADCEV was given in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC, 10% of the 564 patients had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%). The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months). In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months). Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD. Peripheral neuropathy (PN) When PADCEV was given in combination with intravenous pembrolizumab for the treatment of MIBC, 39% of the 167 patients had PN of any grade, 12% had Grade 2 neuropathy, and 3% had Grade 3 neuropathy. The median time to onset of Grade ≥2 PN was 4.7 months (range: 0.2 to 11 months). Of the patients who experienced neuropathy and had data regarding resolution (n=65), 32% had complete resolution, and 68% of patients had residual neuropathy at last evaluation. Of the patients with residual neuropathy at last evaluation, 27% (12/44) had Grade ≥2 neuropathy. When PADCEV was given in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC, 67% of the 564 patients had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months). Of the patients who experienced neuropathy and had data regarding resolution (n= 373), 13% had complete resolution, and 87% of patients had residual neuropathy at last evaluation. Of the patients with residual neuropathy at last evaluation, 45% (146/326) had Grade ≥2 neuropathy. PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness, and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients. Of the patients who experienced neuropathy who had data regarding resolution (n= 296), 11% had complete resolution, and 89% had residual neuropathy at the time of their last evaluation. Of the patients with residual neuropathy at last evaluation, 50% (132/262) had Grade ≥2 neuropathy. Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade > 3 PN. Ocular disorders were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders. Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions. Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose. ADVERSE REACTIONS Most common adverse reactions, including laboratory abnormalities (≥20%): PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC: increased glucose, decreased hemoglobin, increased aspartate aminotransferase (AST), rash, increased alanine aminotransferase (ALT), fatigue, pruritus, increased creatinine, decreased sodium, decreased lymphocytes, peripheral neuropathy, increased potassium, alopecia, dysgeusia, diarrhea, decreased appetite, constipation, nausea, decreased phosphate, urinary tract infection, dry eye, and decreased weight. PADCEV in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC: increased AST, increased creatinine, rash, increased glucose, peripheral neuropathy, increased lipase, decreased lymphocytes, increased ALT, decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection, and decreased platelets. PADCEV as a single agent: increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, peripheral neuropathy, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, and dry skin. EV-303 Study: Patients with cisplatin-ineligible MIBC (PADCEV in combination with intravenous pembrolizumab) Neoadjuvant phase : Of a total of 167 patients, serious adverse reactions occurred in 27% of patients receiving PADCEV in combination with intravenous pembrolizumab. The most frequent (≥2%) serious adverse reactions were urinary tract infection (3.6%) and hematuria (2.4%). Fatal adverse reactions occurred in 1.2% of patients including myasthenia gravis and toxic epidermal necrolysis (0.6% each). Additional fatal adverse reactions were reported in 2.7% of patients in the post-surgery phase before adjuvant treatment started, including sepsis and intestinal obstruction (1.4% each). Adverse reactions leading to discontinuation of PADCEV occurred in 22% of patients. The most common adverse reactions (≥1%) leading to discontinuation of PADCEV were rash (4.8%), peripheral neuropathy (2.4%), and diarrhea, dysgeusia, fatigue, pruritus, and toxic epidermal necrolysis (1.2% each). Adverse reactions leading to dose interruption of PADCEV occurred in 29% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were rash (8%), neutropenia (3.6%), and hyperglycemia (3%), and fatigue and peripheral neuropathy (2.4% each). Adverse reactions leading to dose reduction of PADCEV occurred in 13% of patients. The most common adverse reactions (≥1%) leading to dose reduction of PADCEV were rash (4.8%), pruritus (1.8%), and peripheral neuropathy, increased alanine aminotransferase, increased aspartate aminotransferase, decreased appetite, fatigue, neutropenia, and decreased weight (1.2% each). Seven (4.2%) patients did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery were acute myocardial infarction, bile duct cancer, colon cancer, respiratory distress, urinary tract infection and deaths due to myasthenia gravis and toxic epidermal necrolysis (0.6% each). Of the 146 patients who received neoadjuvant treatment with PADCEV in combination with intravenous pembrolizumab and underwent RC, 6 (4.1%) patients experienced delay of surgery due to adverse reactions. Adjuvant phase : Of the 149 patients who underwent surgery, 100 patients received adjuvant treatment with PADCEV in combination with intravenous pembrolizumab. Of the 49 patients who did not receive adjuvant treatment, discontinuation of treatment with PADCEV in combination with intravenous pembrolizumab prior to the adjuvant phase was due to an adverse event in 21 patients. Serious adverse reactions occurred in 43% of patients receiving PADCEV in combination with pembrolizumab. The most frequent (≥2%) serious adverse reactions were urinary tract infection (8%), acute kidney injury and pyelonephritis (5% each), urosepsis (4%), and hypokalemia, intestinal obstruction, and sepsis (2% each). Fatal adverse reactions occurred in 7% of patients, including urosepsis, hemorrhage intracranial, death, myocardial infarction, multiple organ dysfunction syndrome, and pneumonia pseudomonal (1% each). Adverse reactions leading to discontinuation of PADCEV occurred in 26% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were peripheral neuropathy (5%) and rash (4%). Adverse reactions leading to dose interruption of PADCEV occurred in 36% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were rash (6%), diarrhea and urinary tract infection (5% each), fatigue (4%), pruritus (3%), and peripheral neuropathy and pyelonephritis (2% each). Adverse reactions leading to dose reduction of PADCEV occurred in 7% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV was weight decreased (2%). EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with intravenous pembrolizumab) Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with intravenous pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Fatal adverse reactions occurred in 3.9% of patients treated with PADCEV in combination with intravenous pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were PN (22%), rash (16%), COVID-19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV were rash (16%), PN (13%) and fatigue (2.7%). EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy) Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each). EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy) Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%). DRUG INTERACTIONS Effects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors) Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors. SPECIFIC POPULATIONS Lactation Advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose. Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment. Full Prescribing Information for PADCEV (enfortumab vedotin-ejfv) XTANDI Important Safety Information Indications XTANDI (enzalutamide) is indicated for the treatment of patients with: castration-resistant prostate cancer (CRPC) metastatic castration-sensitive prostate cancer (mCSPC) nonmetastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) Important Safety Information Warnings and Precautions Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer's disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions. Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease. Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo. Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI. Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets. Interference with Immunoassay Measurement of Digoxin XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving XTANDI and digoxin. Adverse Reactions (ARs) In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss. In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients. In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients. In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients. In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide. Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia. Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in 5x ULN, or if transaminase elevations are > 3x ULN and the total bilirubin level is > 2x ULN. If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution. CONTRAINDICATIONS VEOZAH is contraindicated in women with any of the following: • Known cirrhosis • Severe renal impairment or end-stage renal disease • Concomitant use with CYP1A2 inhibitors WARNINGS AND PRECAUTIONS Hepatotoxicity In 3 clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x ULN occurred in 2.3% of women receiving VEOZAH and 0.9% of women receiving placebo. No elevations in serum total bilirubin (> 2x ULN) occurred. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation. Women with cirrhosis were not studied. In the postmarketing setting, cases of drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin occurred within 40 days of starting VEOZAH. Patients reported a general sense of feeling unwell and symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine. The patients' signs and symptoms gradually resolved after discontinuation of VEOZAH. Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if ALT or AST is ≥ 2x ULN or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory. Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy. See BOXED WARNING for full hepatic laboratory testing protocol and discontinuation criteria. Exclude alternative causes of hepatic laboratory test elevations. ADVERSE REACTIONS The most common adverse reactions with VEOZAH ≥ 2% and > placebo (VEOZAH % vs. placebo %) are: abdominal pain (4.3% vs. 2.1%), diarrhea (3.9% vs. 2.6%), insomnia (3.9% vs. 1.8%), back pain (3.0% vs. 2.1%), hot flush (2.5% vs. 1.6%), and hepatic transaminase elevation (2.3% vs. 0.8%). Full Prescribing Information for VEOZAH (fezolinetant) View original content to download multimedia: SOURCE Astellas Pharma Inc.