中国癌症杂志 ›› 2024, Vol. 34 ›› Issue (3): 316-333.doi: 10.19401/j.cnki.1007-3639.2024.03.010
• 指南与共识 • 上一篇
中国抗癌协会乳腺癌专业委员会
收稿日期:
2024-01-11
修回日期:
2024-02-22
出版日期:
2024-03-30
发布日期:
2024-04-10
Committee of Breast Cancer Society, China Anti-Cancer Association
Received:
2024-01-11
Revised:
2024-02-22
Published:
2024-03-30
Online:
2024-04-10
文章分享
摘要:
中国乳腺癌患者发病年龄较轻,60%的女性患者在诊断时为绝经前。与绝经后相比,未绝经女性卵巢功能旺盛,可持续大量分泌雌激素、促进乳腺癌细胞增殖。卵巢功能抑制(ovarian function suppression,OFS)已用于乳腺癌临床治疗数十年,大量循证证据表明,单用OFS和加用OFS均可降低未绝经女性乳腺癌的复发风险并改善生存。部分OFS研究的长期随访数据(SOFT/TEXT研究12和13年随访、STO-5研究20年随访、亚裔人群的ASTRRA研究8年随访)近期陆续公布,进一步证实对于早期乳腺癌患者加用OFS可显著降低10年以上的复发风险,提高治愈可能。monarchE和NATALEE研究显示,部分CDK4/6抑制剂叠加在绝经前早期乳腺癌患者含有药物去势[促性腺激素释放激素类似物(gonadotropin releasing hormone analog,GnRHa)]的辅助内分泌治疗方案时仍可进一步增加生存获益。中国抗癌协会乳腺癌专业委员会召集了国内乳腺癌治疗领域的临床专家,在2021年版的基础上共同商讨编制了《中国早期乳腺癌卵巢功能抑制临床应用专家共识(2024年版)》。本共识建议,GnRHa仍作为绝经前激素受体阳性早期乳腺癌OFS方式的首选。GnRHa联合内分泌治疗基础上添加特定CDK4/6抑制剂的激素受体阳性绝经前乳腺癌获益人群包括:淋巴结阳性,淋巴结阴性且满足任一条件[G3,G2伴Ki-67增殖指数≥20%,G2伴多基因检测(21基因评分、Prosigna PAM50、MammaPrint、EndoPredict)高危]。本共识也认可将2023年St.Gallen共识中有化疗指征的风险因素作为OFS适用判定标准之一。GnRHa用药推荐根据激素受体阳性乳腺癌患者化疗前的卵巢功能状态进行决策。如果考虑卵巢保护,推荐GnRHa同步化疗,不影响患者生存获益;如果不考虑卵巢保护,GnRHa同步化疗和GnRHa在化疗结束后序贯使用均被认可,后者更为推荐。围绝经期患者的内分泌治疗建议参照绝经前方案。GnRHa辅助内分泌治疗的时长建议为5年。中高危患者完成5年联合GnRHa的内分泌治疗后,如果未绝经且耐受性良好,可考虑继续2~5年联合GnRHa的内分泌治疗或单用2~5年选择性雌激素受体调节剂(selective estrogen receptor modulator,SERM)治疗。辅助治疗方案中添加GnRHa安全可耐受,推荐应用前和患者充分沟通药物的使用方法和可能的不良事件,安全性管理有助于提高患者的依从性。对于接受药物去势的患者,在去势过程中不推荐常规监测雌激素水平,如怀疑不完全的OFS(包括改变用法如注射人员缺乏该药物熟练注射经验、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或更年期症状的周期性波动时),可进行雌激素水平测定以辅助决策。绝经前乳腺癌患者如有需求,无论激素受体阳性或阴性,均可使用GnRHa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,推荐化疗前至少1周开始使用GnRHa,每28 d 1次,直至化疗结束后2周给予最后1剂。针对激素受体阳性乳腺癌患者开展的临床试验,不推荐仅纳入绝经后人群,也应当探索GnRHa应用条件下的绝经前人群,以明确试验药物对这类患者的实际效应。另外本共识还新增了早期/局部晚期乳腺癌患者OFS药物应用的全程管理路径,以期进一步助力临床决策。
中图分类号:
中国抗癌协会乳腺癌专业委员会. 中国早期乳腺癌卵巢功能抑制临床应用专家共识(2024年版)[J]. 中国癌症杂志, 2024, 34(3): 316-333.
Committee of Breast Cancer Society, China Anti-Cancer Association. Expert consensus on clinical applications of ovarian function suppression for Chinese women with early breast cancer (2024 edition)[J]. China Oncology, 2024, 34(3): 316-333.
表2
经治的乳腺癌患者绝经状态的判定标准"
子宫完整患者的判定标准 | 对于因各种原因导致子宫不完整或子宫切除患者的判定标准 |
---|---|
⑴ 年龄≥50岁,化疗后或在服用SERM药物期间闭经至少12个月,且E2及FSH水平连续测定至少3次均达到绝经后水平 | ⑴ 年龄≥50岁,化疗后满1年,且1年内至少连续3次测定E2及FSH水平均达到绝经后水平 |
⑵ 年龄在45~50岁,化疗后或在服用SERM药物期间闭经至少24个月,且E2及FSH水平连续测定至少3次均达到绝经后水平 | ⑵ 年龄在45~50岁,化疗后满2年,且2年内测定E2及FSH水平至少连续3次均达到绝经后水平 |
⑶ 年龄<45岁,由于卵巢功能恢复的概率较大,原则上不适用本标准 | ⑶ 年龄<45岁,由于卵巢功能恢复的概率较大,原则上不适用本标准 |
⑷ 上述标准中,年龄可参考患者家族女性平均停经年龄做出个体化调整 |
表3
绝经前激素受体阳性/HER2阴性早期乳腺癌的辅助内分泌治疗推荐临床路径"
危险度 | 判别要点 | 推荐方案 | |
---|---|---|---|
区域淋巴结转移 | 其他危险因素 | ||
高危 | ≥4枚阳性 | 任何情况 | OFS+AI/TAM+阿贝西利a OFS+AI OFS+AI+瑞波西利b |
1~3枚阳性 | 满足以下条件之一:G3,T>5 cm,多基因检测*高危 (有化疗指征患者c推荐含OFS治疗方案) | OFS+AI/TAM+阿贝西利a OFS+AI/TAM OFS+AI+瑞波西利b | |
中危 | 1~3枚阳性 | 不满足高危的其他情况 (有化疗指征患者c推荐含OFS治疗方案) | OFS+AI/TAM OFS+AI+瑞波西利b |
阴性 | T>5 cm且侵犯皮肤胸壁或炎性乳腺癌,或2 cm<T≤5 cm且同时满足以下条件之一:G3,G2伴Ki-67增殖指数≥20%,G2伴多基因检测高危* (有化疗指征患者c推荐含OFS治疗方案) | OFS+AI/TAM OFS+AI+瑞波西利b | |
阴性 | 不满足低危的其他情况 (有化疗指征患者c推荐含OFS治疗方案) | OFS+AI/TAM | |
低危 | 阴性 | 同时满足以下条件:T≤2 cm,G1,Ki-67增殖指数<20%,无脉管癌栓,>35岁,HER2阴性 | TAM |
表4
含GnRHa辅助内分泌治疗安全管理治疗推荐"
相关不良事件 | 药物治疗 | 非药物治疗 |
---|---|---|
血管舒缩症状:潮热,盗汗 | SSRI:帕罗西汀(不宜与SERM合用);SNRI:文拉法辛;加巴喷丁;可乐定;中医中药 | 针灸;合适的衣物 |
阴道症状:阴道干燥,阴道萎缩 | 阴道雌激素△:Ovestin(阴道雌三醇) | |
性功能障碍:性欲减退 | 非激素润滑剂,阴道保湿霜;阴道雌激素:Ovestin(阴道雌三醇) | 充分的医患沟通;放松心情 |
骨骼肌症状:骨质疏松,骨折 | 双膦酸盐,地舒单抗,维生素D和钙* | 负重练习;戒烟限酒;调整饮食,预防跌倒[ |
关节痛 | NSAID和COX-2抑制剂;维生素D | 减肥;全身抗阻力练习;物理治疗;针灸[ |
精神系统症状:情绪变化,如抑郁 | SSRI(如西酞普兰,依他普仑);SNRI(如文拉法辛) | 规律运动;均衡饮食;心理治疗 |
图1
早期/局部晚期乳腺癌患者OFS药物应用的全程管理路径 *:基于monarchE研究和NATALEE研究证据更新,其中瑞波西利未获批早期乳腺癌适应证,阿贝西利早期乳腺癌适应症为联合内分泌治疗(他莫昔芬或芳香化酶抑制剂)用于激素受体阳性、HER2阴性、淋巴结阳性、高复发风险的早期乳腺癌患者的辅助治疗,monarchE研究的B队列人群添加阿贝西利是否获益尚不明确;#:基于POEMS研究、PROMISE-GIM6研究、2018年J Clin Oncol的meta分析和2015年JAMA的随机对照临床试验证据更新。根据《中国抗癌协会乳腺癌诊治指南与规范(2024年版)》进行术后辅助化疗的推荐或豁免;当ER 1% ~ 10%低表达,或ER阴性/PR阳性时,考虑内分泌敏感性低,内分泌强化或延长的证据不充分;围绝经期患者应按照化疗前的激素水平、参照绝经前患者的治疗,需要联合OFS的患者,在2 ~ 5年OFS+内分泌治疗期间,如果明确判断达到了绝经状态,则方案转化为AI;患者存在BRCA1/2胚系突变情况治疗请参考OlympiA研究 [72],此处不再详细展开;STEPP复发风险评分工具:评分大于1.42分的患者为复发中高危风险人群,中高危风险人群选择5年OFS联合AI的获益优于OFS联合TAM或TAM单药。"
表6
绝经前激素受体阳性乳腺癌新辅助内分泌治疗部分研究汇总"
研究名称 | 入组标准 | 样本量 | 治疗方案 | 疗效 |
---|---|---|---|---|
STAGE[ | 绝经前激素受体阳性乳腺癌患者 | 204例 | 阿那曲唑 vs TAM | 与TAM相比,阿那曲唑组从基线至第24周的Ki-67增殖指数下降程度明显更大,其结果也显示,阿那曲唑组ORR显著优于TAM |
IMPACT[ | 激素受体阳性乳腺癌 | 330例 | 阿那曲唑、TAM或两药联合 | 阿那曲唑、TAM和两药联合组ORR分别为37%、36%和39%,差异无统计学意义 |
NCT02535221[ | 激素受体阳性/HER2阴性和淋巴结阴性绝经前乳腺癌患者 | 68例 | 戈舍瑞林+TAM序贯戈舍瑞林+阿那曲唑 vs 化疗 | 新辅助化疗和新辅助内分泌治疗治疗的临床缓解率分别为16.1%和35.1%,差异有统计学意义;新辅助化疗组和新辅助内分泌治疗组的保乳手术率差异无统计学意义 |
ADAPT/ADAPTcycle[ | 临床中高危激素受体阳性/HER2阴性早期乳腺癌 | ADAPT 3 666例,ADAPT cycle 2 272例 | AI/TAM±OFS | 绝经前患者进行Ki-67增殖指数判定后的首次前瞻性数据,与大型辅助研究相比:在TAM或AI中添加OFS能够显著提高绝经前患者的内分泌治疗应答率[内分泌应答:术前2 ~ 4周短期内分泌治疗(OFS>2周)后Ki-67增殖指数≤10%],与Al治疗的绝经后患者相当 |
ADAPTcycle[ | 临床中高危激素受体阳性/HER2阴性早期乳腺癌 | 4 334例 | TAM/AI+OFS vs TAM/AI | TAM或AI联合OFS可显著提高绝经前患者内分泌治疗反应的可能性,其发生率与AI治疗的绝经后患者相当 |
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