中国早期乳腺癌卵巢功能抑制临床应用专家共识（2024年版）

中国抗癌协会乳腺癌专业委员会

doi:10.19401/j.cnki.1007-3639.2024.03.010

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中国早期乳腺癌卵巢功能抑制临床应用专家共识（2024年版）

指南与共识 | 更新时间：2025-12-31

- 中国早期乳腺癌卵巢功能抑制临床应用专家共识（2024年版）
- Expert consensus on clinical applications of ovarian function suppression for Chinese women with early breast cancer (2024 edition)
- 中国癌症杂志 2024年34卷第3期页码：316-333
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2024.03.010
  中图分类号： R737.9
- 收稿：2024-01-11，
  
  修回：2024-02-22，
  
  纸质出版：2024-03-30
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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.

China Anti-Cancer Association Committee of Breast Cancer Society,. 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.
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. DOI： 10.19401/j.cnki.1007-3639.2024.03.010.

China Anti-Cancer Association Committee of Breast Cancer Society,. 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. DOI： 10.19401/j.cnki.1007-3639.2024.03.010.

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。

Abstract

In China

60% of breast cancer patients were premenopausal women at the time of diagnosis. Compared with postmenopausal women

premenopausal women have strong ovarian function and secrete estrogen to promote breast cancer growth. Ovarian function suppression (OFS) has been used in the treatment of breast cancer for decades

and a large body of evidence-based medical research confirmed that the application of OFS alone or combination therapy can reduce the recurrence risk and improve survival in premenopausal women with breast cancer. The long-term follow-up data of OFS studies have been published successively. SOFT and TEXT study reported the follow-up results of 12 and 13 years

the STO-5 study reported the follow-up data of 20 years

and the ASTRRA study based on Asian populations reported the follow-up data of 8 years. It is further confirmed that the application of OFS for patients with early breast cancer could significantly reduce the recurrence risk over ten years and improve the possibility of cure. MonarchE study and NATALEE study demonstrated that the application of CDK4/6 inhibitors in combination with endocrine therapy and gonadotropin releasing hormone analog (GnRHa) in premenopausal patients with early breast cancer has further improved the survival benefits. Committee of Breast Cancer Society

China Anti-Cancer Association in the field of breast cancer treatment in China jointly discussed and formulated the “Expert consensus on clinical applications of ovarian function suppression for Chinese women with early breast cancer (2024 edition)” based on the “Expert consensus on clinical applications of ovarian function suppression for Chinese women with early breast cancer (2021 edition)”. The consensus recommends that medical castration with GnRHa is the first choice for OFS in premenopausal hormone receptor-positive early breast cancer. CDK4/6 inhibitors in combination with endocrine therapy and GnRHa benefit the premenopausal hormone receptor-positive breast cancer population

including patients with node-positive breast cancer

and patients with node-negative breast cancer who meet one of any criteria (G3

G2 and Ki-67 proliferation index≥20%

G2 and 21-gene assay recurrence score ≥26

G2 and Prosigna PAM50 high risk

G2 and MammaPrint high risk

G2 and EndoPredict high risk). Chemotherapy eligibility (high risk of recurrence) in the 2023 St. Gallen consensus will also be as one of the risk factors to determine whether OFS is applicable for premenopausal hormone receptor positive breast cancer patients. Adjuvant endocrine therapy plan is decided based on the status of ovarian function before chemotherapy for hormone receptor-positive breast cancer. If ovarian protection is considered

GnRHa concurrent chemotherapy is recommended

which does not affect the survival benefit of patients. If ovarian protection is not considered

it is recommended that GnRHa can be used with start of chemotherapy or sequentially after chemotherapy

the latter is more recommended. Endocrine therapy for perimenopausal patients is recommended to refer to the premenopausal regimen. The recommended duration of GnRHa in adjuvant endocrine therapy intermediate- and high-risk patients is 5 years. After 5 years’ endocrine therapy combined with GnRHa

if they are not menopausal and well tolerated

they may consider continuing 2 to 5 years of endocrine therapy combined with GnRHa or using selective estrogen receptor modulators (SERM) alone for 2 to 5 years. Adding GnRHa to the adjuvant treatment regimen is safe and tolerable. It is recommended to fully communicate with patients about the use of the drug and possible adverse events before use. Safety management can improve patient adherence. For patients undergoing medical castration

it is not routinely recommended to monitor estrogen levels during medical castration. However

estrogen testing may be performed for clinical decision making when incomplete ovarian suppression is suspected (including changes in usage such as lack of injection experience by the injection provider

changes in dosage forms

or certain physiological changes that may indicate the recovery of ovarian function

such as symptoms of menopause fluctuating periodically). For premenopausal breast cancer patients

whether hormone receptor-positive or hormone receptor-negative

it is recommended to use GnRHa drugs to protect ovarian function

reduce the risk of premature ovarian failure

and reduce fertility damage. It is recommended to start using GnRHa at least 1 week before chemotherapy

once every 28 d

until 2 weeks after the last dose of chemotherapy. Clinical trials conducted on patients with hormone receptor-positive breast cancer are not recommended to include only postmenopausal people. Premenopausal people under GnRHa application conditions should also be explored to clarify the actual effect of experimental drugs on these patients. In addition

this consensus also adds a full management path for OFS drug application in patients with early/locally advanced breast cancer

in order to further assist clinical decision-making.

关键词

Keywords

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