黑逍遥散及肾四味对乳腺癌他莫昔芬治疗引起的类更年期症状的临床效果分析

目的：探讨黑逍遥散及肾四味对乳腺癌他莫昔芬治疗患者类更年期症状的临床效果。方法使用随机数字表法将100例经组织学检验确诊为乳腺癌的患者分为观察组和对照组,每组各50例。所有患者服用他莫昔芬,观察组同时服用中药黑逍遥散及肾四味,对照组口服维生素B1、B6及谷维素,连用4个月。分别于治疗前、治疗2个月、4个月后对比两组患者Kupperman评分,雌激素水平（E2、FSH）,血清肿瘤标志物（CA153和CA125）水平及生存质量评价。结果治疗2个月后,对照组和观察组症状改善总有效率分别为8.00%和60.00%,Kup-perman评分分别为（40.26±5.43）分和（25.30±5.12）分;治疗4个月后,对照组和观察组症状改善总有效率分别为24.00%和84.00%,观察组总有效率显著高于对照组（P<0.05）;两组Kupperman评分分别为（37.90±4.19）分和（15.59±6.36）分,观察组显著低于对照组（P<0.05）;治疗2个月和4个月后,两组E2和FSH水平,CA153和CA125水平的比较均无显著性差异（P>0.05）。结论黑逍遥散及肾四味对乳腺癌他莫昔芬治疗引起的类更年期症状具有良好的疗效,可显著提高患者生存质量,安全有效,且未增加肿瘤复发转移的风险,值得临床推荐。     

黑逍遥散联合肾四味对他莫昔芬治疗乳腺癌所致类更年期症状患者临床指标及生活质量的影响研究

目的：探讨黑逍遥散联合肾四味对他莫昔芬治疗乳腺癌所致类更年期症状患者的影响。方法使用随机数字表法将60例乳腺癌伴类更年期症状的患者分为对照组和观察组,每组各30例。对照组患者接受内分泌治疗及口服维生素B1、B6、谷维素,观察组患者接受内分泌治疗及黑逍遥散及肾四味加减。持续治疗4个月后对比两组患者治疗前、治疗2个月和治疗4个月时的性激素水平（雌二醇、卵泡刺激素、垂体泌乳素、黄体生成素）、血清肿瘤标志物（CA15-3和CA125）水平及治疗前后的生活质量。结果两组患者各观察时点的性激素水平及血清肿瘤标志物水平差异均无统计学意义（P＞0.05）。治疗后,观察组与对照组的总体健康状况评分（80.15±8.96 vs 45.69±11.24）、功能评分（55.25±11.78 vs 36.85±10.29）、症状及经济状态评分（40.14±17.58 vs 65.87±12.96）相比,观察组均优于对照组,差异具有统计学意义（P＜0.05）。结论黑逍遥散联合肾四味可有效改善经他莫昔芬治疗后伴有类更年期乳腺癌患者的生活质量,对其性激素及肿瘤标志物水平并无影响。     

乳腺癌患者精神心理状态与症状困扰的相关性分析

目的探讨乳腺癌患者精神心理状态与症状困扰的相关性。方法收集2017年6月至2018年3月山西白求恩医院收治的110例女性乳腺癌患者的一般资料,对患者的症状困扰评估采用抑郁自评量表(SDS),精神心理评估采用乳腺癌患者生命质量测定量表(FACT-B)和慢性疾病治疗功能评估-灵性量表(FACIT-SP);应用多重线性回归分析患者的症状困扰对其精神心理健康的影响。结果所有患者症状困扰得分为(19.94±5.78)分,精神心理健康得分为(50.68±10.64)分,其中FACT-B得分为(16.85±4.75)分,FACIT-SP得分为(33.83±8.33)分。多因素分析显示,与症状困扰得分≤18分患者相比,得分>18分患者的精神心理健康得分降低了5.15分(P=0.01);与家庭年收入<5.0万元患者相比,家庭年收入为(5.0~7.9)万元患者的精神健康得分增加了9.46分(P<0.01),家庭年收入≥8.0万元患者的精神健康得分增加了5.92分(P<0.01);与肿瘤分期Ⅰ期患者相比,Ⅱ期患者的精神心理健康得分降低了2.62分(P=0.02),Ⅲ期患者的精神心理健康得分降低了4.98分(P<0.01)。结论症状困扰是影响乳腺癌患者精神心理健康的独立危险因素,通过解决患者的症状困扰,可改善其精神心理健康状态。     

Ki-67阳性或阴性表达乳腺癌不同辅助治疗方案的远期疗效比较

目的 探讨不同Ki-67表达情况下,乳腺癌术后不同辅助化疗方案及辅助化疗后接受不同内分泌药物治疗的远期疗效。方法 收集2008年1月至2009年12月694例乳腺癌患者,术后均接受蒽环类或蒽环类序贯紫杉类方案化疗;再选取其中ER阳性且绝经的261例患者,均接受选择性雌激素受体调节剂（SERM）或芳香化酶抑制剂（AI）内分泌治疗。对Ki-67不同表达情况下,不同辅助化疗方案及辅助化疗后不同内分泌药物治疗与无病生存期（DFS）和总生存期（OS）的关系进行分析。结果（1） 527例Ki-67阳性乳腺癌患者的中位DFS和OS分别为37.0个月和38.0个月,其中蒽环类方案组和序贯紫杉类方案组的中位DFS分别为36.5个月和38.0个月（P=0.046）,OS分别为38.0个月和39.0个月（P=0.045）;167例Ki-67阴性患者的中位DFS和OS分别为49.4个月和51.5个月,蒽环类方案组和序贯紫杉类方案组的中位DFS和OS差异均无统计学意义。在Ki 67和ER表达的4种组合中,仅Ki-67+ER-表达组蒽环类方案与序贯紫杉类方案的中位DFS（30.5个月vs.35.9个月,P=0.030）和中位OS（39.2个月vs.42.1个月,P=0.160）的差异有统计学意义。（2）261例ER阳性且绝经的患者中,200例Ki-67阳性者的中位DFS和OS分别为38.0个月和39.0个月,另外61例Ki-67阴性患者的中位DFS和OS分别为52.0个月和53.3个月;无论Ki-67阳性或阴性表达,接受SERM或AI治疗患者的DFS和OS均无显著差异。结论 在Ki-67阳性乳腺癌术后辅助化疗中,蒽环类序贯紫杉类方案疗效优于蒽环类方案。在ER阳性接受内分泌治疗的绝经患者中,SERM和AI在不同Ki-67表达者中的疗效相当。     

哌柏西利联合内分泌治疗晚期激素受体阳性乳腺癌的真实世界研究

目的评价哌柏西利联合内分泌治疗HR+/HER2−晚期乳腺癌患者的疗效及安全性。方法回顾性分析2018年9月15日至2020年10月30日本中心83例采用哌柏西利联合内分泌治疗的HR+/HER2−晚期乳腺癌患者的临床资料,评估其临床疗效、无进展生存期(PFS)及不良反应。结果共纳入的83例HR+/HER2-晚期乳腺癌患者,中位随访时间为15.5个月,一线(n=25)和二线(n=38)采用哌柏西利联合内分泌治疗患者的ORR高于多线治疗患者(n=20),但差异无统计学意义(48.0%vs 44.7%vs 30.0%,P=0.466),3组患者的疾病控制率差异也无统计学意义(96.0%vs 89.5%vs 80.0%,P=0.337)。哌柏西利联合组全人群mPFS为13.0个月(95%CI:11.4~14.6个月),一线/二线治疗患者的mPFS较多线治疗患者延长(20.0个月vs 14.0个月vs 5.0个月,P<0.001),仅有骨转移的患者mPFS优于非骨转移患者(未达到vs 13.0个月;HR=0.42,95%CI:0.22~0.84,P=0.01);无内脏转移患者的mPFS优于存在内脏转移患者,但差异无统计学意义(20.0个月vs 13.0个月;HR=0.65,95%CI:0.35~1.22,P=0.38)。依维莫司联合内分泌治疗耐药患者应用哌柏西利治疗仍可获益(mPFS=5个月)。83例患者采用哌柏西利联合治疗后常见和严重的不良反应均为中性粒细胞减少,其中12例因不良反应下调剂量。结论哌柏西利联合内分泌治疗HR+/HER2-晚期乳腺癌患者的临床疗效显著,尤其是一/二线治疗取得较好疗效,安全性良好。     

卡培他滨联合多西他赛或长春瑞滨治疗蒽环类耐药晚期乳腺癌患者的生活质量:3期临床研究

目的对比接受卡培他滨联合多西他赛或长春瑞滨方案治疗的蒽环类耐药晚期乳腺癌患者的生活质量差异。方法本研究是一项前瞻性、开放性、单中心随机3期临床研究,纳入2010年4月至2013年2月在中国医学科学院北京协和医学院肿瘤医院接受多西他赛联合卡培他滨(TX)或长春瑞滨联合卡培他滨(NX)治疗的蒽环类耐药晚期乳腺癌患者206例,按治疗方案的不同分为TX组和NX组。TX组患者在第1天静脉滴注多西他赛75 mg/m~2+口服卡培他滨1 g/m~2,每天2次,第1~14天,每3周重复治疗;NX组在第1、8天静脉滴注长春瑞滨25 mg/m~2+口服卡培他滨1 g/m~2,每天2次,第1~14天,每3周重复治疗。治疗6~8个周期后,有效者继续卡培他滨维持治疗。共98例患者完成肿瘤患者生活质量评分表(QOL)及乳腺癌患者生活质量测定量表(FACT-B)评分,包括TX组48例和NX组50例。采用t检验分析2组患者治疗前后生活质量评分变化,率的比较采用χ~2检验,T分期及N分期比较采用秩和检验。结果 TX组治疗前后QOL评分分别为55.08±4.64、52.58±5.38,差异有统计学意义(t=4.417,P0.001);NX组治疗前后评分分别为53.22±4.95、50.94±5.29,差异有统计学意义(t=4.347,P0.001)。TX组及NX组治疗前后FACT-B量表评分比较,差异均无统计学意义(95.94±17.54比93.13±16.65,t=1.826,P=0.074;94.28±14.60比91.40±12.96,t=1.956,P=0.056)。TX组及NX组晚期乳腺癌患者治疗前后生活质量评分差值比较,差异无统计学意义(QOL量表:2.50±4.18比2.42±3.83,t=0.099,P=0.921;FACT-B量表:2.40±10.45比2.88±10.41,t=-0.230,P=0.819)。QOL量表评分显示:在食欲下降、疲乏、精神状态减退、睡眠受影响方面,TX组和NX组比较,差异均有统计学意义[58.33%(28/48)比36.00%(18/50),χ~2=4.904,P=0.027;54.17%(26/48)比34.00%(17/50),χ~2=4.045,P=0.044;33.33%(16/48)和16.00%(8/50)χ~2=3.979,P=0.046;31.25%(15/48)比14.00%(7/50),χ~2=4.186,P=0.041]。FACT-B量表评分显示:TX组和NX组恶心者分别占52.08%(28/48))和22.00%(11/50),差异有统计学意义(χ~2=9.537,P=0.002);表现疼痛症状的患者分别占29.17%(14/48)和40.00%(20/50),差异无统计学意义(χ~2=1.269,P=0.260)。根据治疗后疗效评估,有效组共78例,无效组20例,2组患者治疗前后生活质量评分差值比较,差异均无统计学意义(QOL量表:2.32±4.05比3.00±3.74,t=-0.679,P=0.499;FACT-B量表:1.90±10.84比5.55±7.90,t=-1.411,P=0.161)。有效组中,发生手足综合征和未发生手足综合征患者间治疗前后生活质量评分差值比较,差异无统计学意义(QOL量表:1.50±4.37比2.53±3.98,t=-0.907,P=0.367;FACT-B量表:0.25±7.52比2.32±11.56,t=-0.679,P=0.499)。无效组20例患者中无一例出现手足综合征。结论 TX和NX方案化疗对患者生活质量影响不大,化疗疗效及手足综合征对患者生活质量的影响不显著。     

自体细胞因子诱导的杀伤细胞治疗对辅助化疗后乳腺癌患者生活质量影响的前瞻性研究

目的 探讨自体细胞因子诱导的杀伤细胞(CIK)治疗对辅助化疗后乳腺癌患者生活质量的影响.方法 将给予以紫杉或蒽环类药物为基础的辅助化疗的乳腺癌术后患者,采用随机数字表法随机分为治疗组和对照组,治疗组给予自体CIK细胞治疗,对照组进行定期随访.所有激素受体阳性的患者均给予内分泌治疗,腋窝淋巴结转移阳性的患者行胸壁和区域淋巴结放疗.采用欧洲癌症研究和治疗组(EORTC)制定的乳腺癌患者生活质量量表QLQ-BR53分析患者的生活质量和不良反应.结果 功能领域方面,治疗组患者在CIK细胞治疗后3和6个月躯体功能评分分别为(83.43±14.87)分和(88.55 ±11.62)分,均高于基线值[(74.83±13.82)分,均P＜0.05)]；总生活质量评分分别为(83.30±19.09)分和(89.68-10.81)分,均高于基线值[(77.72±21.05)分,均P＜0.05].症状领域方面,治疗组患者的疲倦和恶心呕吐评分与基线值比较,差异均有统计学意义(均P＜0.05).对照组患者在随访3和6个月时,恶心呕吐评分分别为(26.67±22.56)分和(21.47±21.06)分,均低于基线值[(33.31 ±27.07)分,均P＜0.05].治疗组患者在CIK细胞治疗后3和6个月对未来担忧评分分别为(47.56 ±30.84)分和(42.33±26.95)分,均低于基线值[(57.41 ±30.63)分,均P＜0.05)]；治疗副反应评分分别为(31.95±27.52)分和(23.72±22.87)分,均低于基线值[(40.56±26.28)分,均P＜0.05)]；上肢肿胀评分分别为(45.26±25.42)分和(36.61±20.51)分,均低于基线值[(55.11 ±22.82)分,均P＜0.05)].对照组患者在随访3和6个月时,上肢肿胀评分分别为(44.85 ±28.94)分和(38.64 ±23.68)分,均低于基线值[(53.26±23.84)分,均P＜0.05]；在随访6个月时,脱发评分为(24.18±22.66)分,低于基线值[(35.92±22.08)分,P＜0.05].治疗组患者的躯体功能、社会功能和总生活质量、疲倦、失眠和对未来担忧情况评分与对照组比较,差异均有统计学意义(均P＜0.05).治疗组患者回输CIK后,出现一过性发热3例,下肢酸胀疼痛6例,对症处理后症状均缓解.结论 自体CIK细胞治疗能显著改善乳腺癌患者的生活质量,治疗相关性不良反应可耐受,对症处理后缓解,可在临床上推广使用.     

HR+/HER2-转移性乳腺癌多线治疗后的新选择——戈沙妥珠单抗：TROPiCS?鄄02研究结果解读

摘 要：内分泌治疗耐药且经多线治疗的HR+/HER2-转移性乳腺癌面临的全身治疗药物选择非常有限。TROPiCS-02研究旨在探讨戈沙妥珠单抗对比医生选择的化疗用于内分泌治疗耐药的HR+/HER2-转移性乳腺癌患者的生存获益。2019年5月至2021年4月期间，TROPiCS-02研究共入组了北美和欧洲91个肿瘤中心的543例HR+/HER2-转移性乳腺癌患者。入组患者按1∶1随机接受戈沙妥珠单抗治疗或医生选择的化疗（艾瑞布林、长春瑞滨、卡培他滨或者吉西他滨）。患者入组标准：晚期转移性HR+/HER2-乳腺癌；入组前至少接受过内分泌治疗、紫杉类化疗和一种CDK4/6抑制剂，晚期转移性病例至少接受2~4线化疗。主要研究终点是无进展生存期，次要研究终点包括总生存期、客观缓解率、患者报告结局和安全性等。截至2022年7月，中位随访12.5个月，相比较医生选择的化疗组：戈沙妥珠单抗治疗组无进展生存期显著获益（5.5个月 vs 4.0个月），进展或死亡风险减少34%（HR=0.66，95%CI：0.53~0.83，P=0.000 3）；显著的总生存期获益（14.4个月 vs 11.2个月，HR=0.79，95%CI：0.65~0.96，P=0.020)；显著的客观缓解率获益（21% vs 14%，OR=1.63，95%CI：1.03~2.56，P=0.035)；显著延长全球健康状况和生活质量恶化时间(4.3个月vs 3.0个月，HR= 0.75，95%CI：0.61~0.92，P=0.005 9)。药物毒副反应安全评估结果与之前研究报道相似。总之，戈沙妥珠单抗在治疗已经接受过治疗的内分泌抵抗性HR+/HER2-转移性乳腺癌患者中，显示出显著的无进展生存期和总生存期获益、更高的客观缓解率以及更好的健康状况和生活质量保持，药物毒副反应安全可管理。     

HR+/HER-2+晚期乳腺癌一线维持治疗的疗效分析

目的探讨激素受体阳性(HR+)/人表皮生长因子受体2阳性(HER-2+)的晚期乳腺癌患者经一线治疗达到疾病控制后,维持治疗与否对总生存期(OS)的影响。方法收集1999年1月1日至2018年3月1日HR+/HER-2+晚期乳腺癌患者的临床病理资料。根据一线治疗结束后是否维持治疗分为无维持治疗组与维持治疗组。生存分析采用Kaplan-Meier法,多因素分析用Cox比例风险模型。结果共纳入HR+/HER-2+乳腺癌患者84例,维持治疗组65例(77.4%),无维持治疗组19例(22.6%),两组中位OS分别为53.8个月和28.6个月,差异有统计学意义(P=0.015)。Cox多因素分析显示,一线维持治疗是影响HR+/HER-2+晚期乳腺癌患者OS的独立因素(HR=0.456,95%CI:0.238~0.873,P=0.018)。维持治疗组中,接受单纯靶向治疗、单纯内分泌治疗、单纯化疗、靶向联合化疗与靶向联合内分泌治疗的患者分别为15例、10例、6例、13例和21例,中位OS分别为37.0个月、未达到、45.9个月、53.8个月和90.3个月。5个维持治疗亚组中位OS的差异有统计学意义(P=0.026)。与无维持治疗组比较,靶向联合内分泌治疗和单纯内分泌治疗可显著延长HR+/HER-2+晚期乳腺癌患者的中位OS(P=0.005,P=0.023)。结论HR+/HER-2+晚期乳腺癌患者经一线治疗达到疾病控制后,接受维持治疗可延长生存。     

乳腺癌内分泌治疗患者焦虑情况与领悟社会支持和生活质量的相关性分析

目的 内分泌治疗已经成为乳腺癌综合治疗重要的一部分,NCCN(2015.V2)建议乳腺癌内分泌治疗时间为5～10年,由于治疗时间较长,患者治疗期间心理和生活质量都有可能受影响.通过对接受内分泌治疗乳腺癌患者的现场调研,探讨接受内分泌治疗乳腺癌患者的汉密尔顿焦虑评分、领悟社会支持评分及生活质量评分三者之间的相关性.方法 选取174例2009-06-05-2015-03-27在南京医科大学第一附属医院接受内分泌治疗的乳腺癌患者,采用汉密尔顿焦虑评价量表(Hamilton anxiety scale,HAMA)进行焦虑评估,领悟社会支持量表(perceived social support scale,PSSS)进行领悟社会支持力评估,生活质量评价量表SF-36进行生活治疗评估.通过SPSS 19.0软件,对3组量表评估数据进行相关性分析.结果 患者的HAMA评分为10.24±7.71,具有临床意义的焦虑症状者,即HAMA≥14分的患者有51例;PSSS评分为68.41±13.63,＜50分的有12例;SF-36评分为113.70±14.82.患者HAMA评分与PSSS评分呈线性负相关关系,R2线性=0.161,R=-0.401,P＜0.05;HAMA评分与SF-36评分,呈线性负相关关系,R2线性=0.186,R=-0.431,P＜0.05.结论 HAMA评分分别与PSSS评分、SF-36评分呈负相关关系,应根据焦虑评分状况积极加强对患者的心理干预,抗焦虑治疗,对患者家属进行健康宣教,加强社会支持,对提高临床治疗效果和患者身体恢复及生活质量水平具有重大意义.     

Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B.

Existing quality of life instruments do not include adequate items to measure the side effects and putative benefits of hormonal treatments given in breast cancer. We report the development and validation of an 18 item endocrine subscale (ES) to accompany a standardised breast cancer quality of life measure, the Functional Assessment of Cancer Therapy (FACT-B). The FACT-ES (FACT-B plus ES) was tested initially on 268 women with breast cancer receiving endocrine treatments. Alpha coefficients for all subscales demonstrated good internal consistency (range alpha = 0.65-0.87). Test-retest reliability of the ES indicated good stability (r = 0.93, p < 0.001). Advanced breast cancer patients' quality of life was high, showing the efficacy of endocrine therapy, but women with primary disease reported better physical, social, and functional well-being and fewer breast cancer concerns. Most frequently reported symptoms were loss of sexual interest (31%), weight gain (25%), and hot flushes (24%). Significant differences were found between treatment groups for hot flushes and vaginal dryness. Two assessments of the instrument's responsiveness to change were made; 32 women in a clinical trial of endocrine therapy and 18 women without breast cancer taking HRT completed the FACT-ES at baseline, 4, 8, and 12 weeks. Trial patients reported significantly more symptoms at 8 and 12 weeks than at baseline. Women taking HRT reported significantly fewer or less severe symptoms than at baseline. In conclusion the FACT-ES has acceptable validity and reliability and is sensitive to clinically significant change, making it suitable for clinical trials of endocrine therapy.     

Effects of Switching from Tamoxifen to Anastrozole on Tamoxifen-Related Endocrine Symptoms and Quality of Life

Objective:To determine the effects on menopausal symptoms and quality of life of switching from tamoxifen to anastrozole as adjuvant endocrine treatment for early breast cancer patients. Patients and methods:Forty-four women who had completed primary breast cancer treatment (surgery ± radiotherapy ± chemotherapy), were postmenopausal, and had switched from tamoxifen to anastrozole as adjuvant hormonal treatment because of tolerability issues were enrolled. Endocrine symptoms and health-related quality of life were assessed by the series of Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale (ES) questionnaires at the time of the switch and 12 months later, and by the ES alone at 3, 6, and 9 months after switching. Sample size was decided by the effect size method, with a standard deviation fixed at 0.5, the conventionally accepted value representative of an effect of medium value. To evaluate score modifications, one-way ANOVAs were applied. Results:Endocrine symptoms improved between baseline and 3 months and stabilized thereafter. Improvements in mean ES scores from baseline were +3 (95% CI 1, 5), +4 (95% CI 3, 6), +5 (95% CI 3, 7), and +4 (95% CI 3, 6) at 3, 6, 9, and 12 months, respectively. The FACT-ES global score showed a mean improvement over 12 months of 9 points (95% CI 6, 13; p < 0.0005). A statistically significant improvement in Trial Outcome Index scores from baseline to 12 months (+4 points [95% CI 2, 6; p < 0.0005]) and in the physical and breast cancer subscales (+2 [95% CI 1, 2; p < 0.001] and +1 [95% CI 1, 2; p < 0.001]) was also observed. Compared with tamoxifen treatment, patients receiving anastrozole reported significantly higher rates of mild arthritic and bone pain (27%vs 7%; p = 0.021) Conclusion:This study evaluated a small population of 44 patients who had switched from tamoxifen to enastrozole mainly because of gynecologic adverse effects with tamoxifen. However, the results of this study suggest that a change to anastrozole as adjuvant therapy should be considered for patients who develop endocrine symptoms while receiving tamoxifen to minimize those symptoms and improve quality of life.     

A randomised double-blind controlled trial of oral soy supplements versus placebo for treatment of menopausal symptoms in patients with early breast cancer

Menopausal symptoms are a major survivorship issue for patients treated for breast cancer. There are increasing concerns over the use of hormone replacement therapy (HRT) in this setting and a growing consumer interest in "natural" therapies. It had been suggested that soy phyto-oestrogens might be beneficial in the treatment of menopausal symptoms. Seventy-two patients with a histologically confirmed pre-existing diagnosis of breast cancer who were having menopausal symptoms were randomised between 12 weeks of treatment with soy capsules or placebo. Quality of life and menopausal symptom scores were assessed at baseline, 4, 8 and 12 weeks. There was no statistical difference in menopausal symptom scores or quality of life between the two arms of the study.     

乳腺癌患者化疗后的心理痛苦与其生活质量之间的关系分析

目的 探讨乳腺癌患者化疗后不同程度的心理痛苦与其生活质量之间的关系。方法以本院2015年3月至2016年3月62例完成6个周期标准化疗的乳腺癌术后患者为研究对象,在化疗后分别完成心理痛苦温度计（DT）及乳腺癌生活质量量表（FACT-B）的测查,根据DT是否≥4分分为高分组和低分组,比较两组间生活质量的差异,同时分析心理痛苦与生活质量的相关性。结果 62例患者中有2例未完成问卷调查剔除。60例低分组和高分组患者生活质量的评分分别为（124.3±11.2）分和（89.5±15.6）分,组间的差异有统计学意义（t=10.06,P＜0.05）。60例患者的心理痛苦评分与生活质量评分呈显著负相关（r=-0.949,P＜0.05）。结论 乳腺癌患者化疗后存在不同程度心理痛苦,且心理痛苦的评分与其生活质量密切相关。     

中国早期乳腺癌卵巢功能抑制临床应用专家共识（2021年版）

卵巢功能抑制（ovarian function suppression,OFS）已经应用于乳腺癌治疗数十年,早期辅助治疗研究证实,单独进行OFS能够降低50岁以下乳腺癌患者的复发风险,改善生存情况。鉴于新的循证医学数据不断累积,中国抗癌协会乳腺癌专业委员会遂召集国内乳腺癌专家,在《中国早期乳腺癌卵巢功能抑制临床应用专家共识（2018年版）》的基础上共同商讨制订了《中国早期乳腺癌卵巢功能抑制临床应用专家共识（2021年版） 》。2021年版共识建议,将药物去势[促性腺激素释放激素激动剂（gonadotropin releasing hormone agonist,GnRHa）]作为绝经前激素受体阳性的早期乳腺癌OFS的首选。中高危绝经前激素受体阳性乳腺癌患者推荐接受OFS的内分泌治疗;低危患者推荐选择性雌激素受体调节剂（selective estrogen receptor modulators,SERM）单药治疗;使用芳香化酶抑制剂（aromatase inhibitor,AI）代替SERM治疗的绝经前患者,需要同时接受OFS治疗。关于OFS联合方案,对绝经前激素受体阳性早期乳腺癌的中危和高危患者,或亚群处理效果模式图（subpopulation treatment effect pattern plot,STEPP）分析的较高风险患者推荐OFS联合AI治疗,OFS联合SERM治疗也是合理的选择。对存在SERM禁忌证的任何风险级别患者,推荐OFS联合AI治疗。关于OFS的使用时机,建议根据激素受体阳性乳腺癌患者化疗前的卵巢功能状态,决定辅助内分泌治疗方案。如果考虑卵巢保护,推荐GnRHa同步化疗,不影响患者的生存获益;如果不考虑卵巢保护,推荐GnRHa可以在化疗结束后直接序贯使用。已接受化疗的患者不推荐确认卵巢功能状态后再使用GnRHa。GnRHa辅助内分泌治疗的标准疗程应为5年。完成5年联合OFS的内分泌治疗后,如未绝经且耐受性良好,推荐继续5年联合OFS的内分泌治疗或5年SERM治疗。低危选择OFS替代化疗的患者,可考虑OFS联合内分泌治疗时长为2年。推荐与患者充分沟通可能出现的不良事件,选用合适的药物去势治疗方案。合理的安全管理能够有效地缓解不良反应,增加患者治疗的依从性。对于接受药物去势的患者,不常规推荐在药物去势治疗过程中监测雌激素水平并根据检测报告来决定是否继续药物去势。但在药物去势后,怀疑不完全的卵巢功能抑制时[包括改变用法如注射人员缺乏相关经验、更换剂型或出现某些可能提示卵巢功能恢复的生理变化如月经恢复和（或）更年期症状的周期性波动时],可以进行雌激素水平检测。绝经前乳腺癌患者,无论激素受体阳性或阴性,推荐在（新）辅助化疗前和化疗过程中使用OFS药物保护卵巢功能,降低卵巢功能早衰的发生风险,减少生育能力损害。推荐化疗前2周开始使用GnRHa,每28 d 1次,直至化疗结束后2周给予最后一剂药物。此外共识还建议,激素受体阳性乳腺癌患者抗肿瘤药物的临床试验,应尽可能纳入绝经前女性,在雌激素充分抑制的前提下,探索抗肿瘤药物对肿瘤生物学特性和患者长期生活质量的影响。     

Quality of life of postmenopausal women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial.

PURPOSE: To determine the quality of life (QoL) of women participating in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial during the first 2 years of treatment. PATIENTS AND METHODS: A total of 1,021 women were enrolled onto the QoL subprotocol. All had completed primary treatment (surgery +/- radiotherapy +/- chemotherapy) and were to receive 5 years of adjuvant treatment with anastrozole (n = 335), tamoxifen (n = 347), or a combination (n = 339) of both. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) plus endocrine subscale (ES) at baseline and 3, 6, 12, 18, and 24 months, or until disease recurrence. The primary end point was the FACT-B Trial Outcome Index (TOI). The secondary end point was the ES total score. Analyses of individual endocrine symptoms were also explored. RESULTS: Questionnaire completion approximated 85% of assessments available for analysis. Overall QoL for all groups improved from baseline during the 2-year period. There were no significant differences in TOI or ES scores across treatment groups. Endocrine symptoms increased between baseline and 3 months for all groups and stabilized thereafter. There were some small differences in side effect profiles. Compared with patients receiving tamoxifen only, patients receiving anastrozole only reported significantly fewer cold sweats and vaginal discharge, yet more vaginal dryness, painful intercourse, and loss of sexual interest. CONCLUSION: Two years of treatment with anastrozole, tamoxifen, or the combination had a similar overall QoL impact, showing gradual improvement over time. Endocrine-related symptoms for all three arms worsened initially and recovered partially during 2 years. The different symptoms experienced may assist in decision making about treatment and supportive care needs.     

子宫内膜癌术后性激素补充治疗的安全性分析

目的 分析子宫内膜癌术后性激素补充治疗的安全性.方法 回顾分析子宫内膜癌患者60例的临床资料,根据患者术后是否行性激素补充治疗,分为HRT组20例,对照组40例,对照组接受常规放化疗治疗.对比分析2组患者治疗疗效影响因素以及治疗安全性.结果 COX多因素分析结果显示:激素使用、病理分期、病理分级以及孕激素受体是子宫内膜癌术后治疗疗效的独立危险因素.HRT组术后复发率、复发时间以及围绝经期症状改善情况分别为5.0％、(12.3±0.5)个月及20.0％,显著优于对照组术后复发率、复发时间以及围绝经期症状改善情况[12.5％、(9.4±0.3)个月及7.5％],差异显著(P＜0.05).2组患者治疗后均无乳腺肿瘤发生(P＞0.05).结论 激素使用、患者病理分期、病理分级以及孕激素受体为子宫内膜癌治疗疗效的独立危险因素;子宫内膜癌术后性激素补充治疗可有效改善患者围绝经期症状,延长肿瘤复发时间,降低肿瘤复发率,临床上可推广使用.     

Cognitive function, fatigue, and menopausal symptoms in women receiving adjuvant chemotherapy for breast cancer.

PURPOSE: There is evidence that cognitive dysfunction, fatigue, and menopausal symptoms may occur in women receiving adjuvant chemotherapy for breast cancer. Here, we determine their incidence and severity, and interrelationships between them and quality of life. PATIENTS AND METHODS: In this study, 110 women receiving adjuvant chemotherapy each nominated a female relative, friend, or neighbor (matched by age) as a control; 100 eligible matched pairs were evaluated. Patients and controls completed the following assessments: the High-Sensitivity Cognitive Screen, and the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life scale with subscales for fatigue (FACT-F) and endocrine symptoms (FACT-ES). They also performed tests of attention and reaction time. RESULTS: Patients and controls were well matched for age and level of education. There was a higher incidence of moderate or severe cognitive impairment in the patient group (16% v 4%; P =.008). Patients experienced much more fatigue than controls (median FACT-F scores, 31 v 46; P <.0001) and more menopausal symptoms (median FACT-ES scores, 58 v 64; P <.0001). Self-reported quality of life of the patients was poorer than for controls, especially in physical and functional domains (median FACT-G scores, 77 v 93; P <.0001). There was strong correlation between fatigue, menopausal symptoms, and quality of life (P <.0001 for each pair), but none were significantly associated with the presence of cognitive dysfunction. CONCLUSION: Adjuvant chemotherapy causes cognitive dysfunction, fatigue, and menopausal symptoms in women with breast cancer. Priority should be given to the study of strategies that might reduce these toxic effects.