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北京大学学报（医学版） ›› 2025, Vol. 57 ›› Issue (2): 291-297. doi: 10.19723/j.issn.1671-167X.2025.02.011

• 论著 • 上一篇    下一篇

同步应用戈舍瑞林对年轻乳腺癌患者新辅助化疗疗效的影响

刘苗雨1, 王思源1, 裴林2, 王殊1,*()   

  1. 1. 北京大学人民医院乳腺中心，北京 100044
    2. 北京大学人民医院检验科，北京 100044
  • 收稿日期:2021-08-29 出版日期:2025-04-18 发布日期:2025-04-12
  • 通讯作者: 王殊 E-mail:wangshu@pkuph.edu.cn

Impact of concurrent use of goserelin on the efficacy of neoadjuvant chemotherapy in young breast cancer patients

Miaoyu LIU1, Siyuan WANG1, Lin PEI2, Shu WANG1,*()   

  1. 1. Breast Center, Peking University People's Hospital, Beijing 100044, China
    2. Clinical Laboratory, Peking University People's Hospital, Beijing 100044, China
  • Received:2021-08-29 Online:2025-04-18 Published:2025-04-12
  • Contact: Shu WANG E-mail:wangshu@pkuph.edu.cn

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摘要：

目的: 探究在年轻乳腺癌患者中, 同步应用戈舍瑞林保护卵巢功能对新辅助化疗(neoadjuvant chemotherapy, NAC)病理完全缓解(pathologic complete response, pCR)率和客观缓解率(objective response rate, ORR)的影响。方法: 从2016年1月至2020年5月入组18~45岁临床分期为ⅡA~ⅢC期的乳腺癌患者, 根据患者意愿选择是否在NAC期间同步应用戈舍瑞林保护卵巢功能, 分为戈舍瑞林组及化疗组, 比较两组pCR率和ORR, 并对不同分子分型的患者进行亚组分析。结果: 共纳入93例患者(戈舍瑞林组31例, 化疗组62例), 经过倾向评分加权(propensity score weighting, PSW)调整, 两组患者年龄、术前临床分期、术后病理分期、病理类型、激素受体状态、人类表皮生长因子受体2(human epidermal growth factor receptor 2, HER2)和Ki-67的表达、分子分型和化疗方案等基线资料均匹配。戈舍瑞林组和化疗组患者的pCR率差异无统计学意义, 分别为29.0%和25.8%(P=0.741);两组之间的ORR差异亦无统计学意义(90.3%vs. 87.1%, P=0.746)。亚组分析表明, 对于激素受体阳性的患者, 戈舍瑞林组和化疗组之间的pCR率和ORR差异均无统计学意义(pCR率分别为6.3%和7.7%, P=0.852;ORR分别为87.5%和82.1%, P=0.839);对于激素受体阴性的患者, 戈舍瑞林组和化疗组之间的pCR率和ORR差异亦无统计学意义(pCR率分别为53.3%和56.5%, P=0.847;ORR分别为93.3%和95.7%, P=0.975)。化疗结束后1年, 戈舍瑞林组化疗诱导闭经(chemotherapy-induced amenorrhea, CIA)发生率明显低于化疗组(9.5% vs. 33.3%, P=0.036)。结论: 对于临床分期为ⅡA~ⅢC期的年轻乳腺癌患者, 同步应用戈舍瑞林可能不影响NAC后的pCR率和ORR, 但仍需扩大样本量并进行更久的随访以评估戈舍瑞林保护卵巢功能对年轻患者长期生存的影响。

关键词: 乳腺癌, 年轻, 新辅助化疗, 戈舍瑞林

Abstract:

Objective: To explore the effect of concurrent administration of goserelin for ovarian function protection on the pathological complete response (pCR) rate and objective response rate (ORR) of neoadjuvant chemotherapy (NAC) in young breast cancer patients. Methods: The study enrolled breast cancer patients aged 18-45 with clinical stages ⅡA~ⅢC from January 2016 to May 2020. According to patients' willingness, they were divided into two groups: Those who chose to receive goserelin to protect ovarian function during NAC (goserelin group) and those who did not (chemotherapy group). The pCR rate and ORR were compared between the two groups, and subgroup analysis was conducted for patients with different molecular subtypes. Results: A total of 93 patients were included in this study (31 in the goserelin group and 62 in the chemotherapy group). After propensity score weighting (PSW) adjustment, baseline data such as age, preoperative clinical stage, postoperative pathological stage, pa-thological type, hormone receptor status, human epidermal growth factor receptor 2 (HER2) and Ki-67 expression, molecular subtypes, and chemotherapy regimens were well-matched between the two groups. There was no significant difference in the pCR rate between the goserelin group and the chemotherapy group, with rates of 29.0% and 25.8%, respectively (P=0.741). Similarly, there was no significant difference in ORR between the two groups (90.3% vs. 87.1%, P=0.746). Subgroup analysis revealed that among the patients with hormone receptor-positive tumors, there were no significant differences in pCR rate (6.3% vs. 7.7%, P=0.852) or ORR (87.5% vs. 82.1%, P=0.839) between the goserelin and chemotherapy groups. Among the patients with hormone receptor-negative tumors, there were also no significant differences in pCR rate (53.3% vs. 56.5%, P=0.847) or ORR (93.3% vs. 95.7%, P=0.975) between the two groups. One year after the completion of chemotherapy, the incidence of chemotherapy-induced amenorrhea (CIA) was significantly lower in the goserelin group compared with the chemotherapy group (9.5% vs. 33.3%, P=0.036). Conclusion: For young breast cancer patients with clinical stages of ⅡA~ⅢC, there was no statistical difference in pCR rate and ORR whether or not using goserelin during NAC. However, it is still necessary to expand the sample size and carry out a longer follow-up to evaluate the effect of goserelin on the long-term survival of young patients.

Key words: Breast cancer, young, Neoadjuvant chemotherapy, Goserelin

中图分类号: 

  • R737.9

表1

戈舍瑞林组及化疗组患者基线临床病理特征"

Items Goserelin group
(n=31)		 Chemotherapy group
(n =62)		 P value
Age/years 0.668
  ≤35 16 29
  ＞35 15 33
Clinical tumor stage 1.000
  cT1 6 11
  cT2 22 44
  cT3-4 3 7
Clinical node stage 0.100
  cN0 7 4
  cN1 14 35
  cN2-3 10 23
Clinical stage 0.650
  Ⅱ 21 38
  Ⅲ 10 24
Surgery ＜0.010
  Breast conserving surgery 8 3
  Total mastectomy 23 59
Pathological tumor stage 1.000
  pT0 13 26
  pT1 14 29
  pT2 4 7
  pT3 0 0
Pathological node stage 0.923
  pN0 15 33
  pN1 10 18
  pN2 3 7
  pN3 3 4
Pathological stage 0.384
  0 5 16
  Ⅰ 10 11
  Ⅱ 10 24
  Ⅲ 6 11
Hormone receptors 1.000
  ER+ and/or PR+ 17 35
  ER- and PR- 14 27
HER2 0.655
  Positive 11 26
  Negative 20 36
Ki-67 0.105
  ≥20% 22 53
  ＜20% 9 9
Subtype 0.312
  Luminal A 6 5
  Luminal B 10 34
HER2 over expression 5 11
  Triple negative 10 12
Targeted therapya 0.123
  No 22 41
  Single target therapy 7 8
  Double target therapy 2 13
Chemotherapy 0.494
  AT/A-T(6-8 cycles) 22 39
  Others(6 cycles) 9 23

表2

不同分型化疗组及戈舍瑞林组的pCR率比较"

Items Luminal A Luminal B HER2 over expression Triple negative
Chemotherapy group 0%(0/5) 8.8%(3/34) 81.8%(9/11) 33.3%(4/12)
Goserelin group 0%(0/6) 10.0%(1/10) 60.0%(3/5) 50.0%(5/10)
P value 0.87 0.35 0.43

表3

不同分型化疗组及戈舍瑞林组的ORR比较"

Luminal A Luminal B HER2 over expression Triple negative
Chemotherapy group 100.0%(5/5) 79.4%(27/34) 100.0%(11/11) 91.7%(11/12)
Goserelin group 100.0%(6/6) 80.0%(8/10) 100.0%(5/5) 90.0%(9/10)
P value 0.91 0.95

表4

影响NAC后pCR率的单因素Logistic回归分析结果"

Items P value OR 95%CI
Age/years 0.566
  ≥35 1
  ＜35 1.316 0.516-3.360
Clinical tumor stage 0.062
  cT1 1
  cT2 0.319 0.096-1.058
  cT3-4 0.133 0.022-0.814
Clinical node stage 0.737
  cN0 1
  cN1 1.806 0.348-9.358
  cN2 or cN3 1.957 0.357-10.737
Clinical stage 0.912
  Ⅱ 1
  Ⅲ 1.056 0.404-2.761
Hormone receptors 0
  ER- and PR- 1
  ER+ and/or PR+ 0.071 0.021-0.234
HER2 0.056
  Negative 1
  Positive 2.525 0.977-6.523
Ki-67 0.034
  ＜20% 1
  ≥20% 9.388 1.186-74.289
Chemotherapy 0.974
  AT/A-T(6-8 cycles) 1
  Others(6 cycles) 0.984 0.369-2.267
Group 0.616
  Chemotherapy 1
  Goserelin 1.282 0.486-3.379

表5

影响NAC后pCR率的多因素Logistic回归分析结果"

Items P value OR 95%CI
Clinical tumor stage 0.008
  cT1 1
  cT2 0.031 0.003-0.355
  cT3-4 0.140 0.001-0.229
Hormone receptors 0.001
  ER- and PR- 1
  ER+ and/or PR+ 0.024 0.003-0.205
HER2 0.027
  Negative 1
  Positive 4.432 1.181-16.633
Ki-67 0.095
  ＜20% 1
  ≥20% 7.344 0.706-76.371
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[1] 王思源,王殊. 抗缪勒管激素用于戈舍瑞林在年轻乳腺癌患者化疗期间保护卵巢储备功能的评价[J]. 北京大学学报（医学版）, 2019, 51(3): 536-541.
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ISSN 1671-167X
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