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不同乳腺癌他莫昔芬治疗长期结局

  雌激素受体阳性早期乳腺癌患者的短期远处复发死亡风险较低,长期远处复发死亡风险较高。不过,影响长期远处复发死亡风险的肿瘤生物学因素以及内分泌治疗相关获益尚不明确。

  2019年8月8日,《美国医学会杂志》肿瘤学分册在线发表瑞典卡罗林学院、林雪平大学、美国旧金山加利福尼亚大学、巴克老年研究所、北卡罗来纳大学教堂山分校莱恩伯格综合癌症中心的研究报告,比较了他莫昔芬治疗管腔A型管腔B型乳腺癌患者的长期生存结局。

  该研究于2017~2018年通过瑞典国家登记中心数据库对1976~1990年斯德哥尔摩他莫昔芬研究(STO-3)462例绝经后淋巴结阴性早期乳腺癌患者术后随机接受至少2年辅助他莫昔芬治疗或非内分泌治疗、若未复发再次随机接受3年他莫昔芬治疗或非内分泌治疗、截至2012年12月31日的长期随访完整数据、2014年采用免疫组织化学和安捷伦微阵列对肿瘤组织切片进行评定的结果进行二次分析,本文仅分析管腔A型或管腔B型乳腺癌患者。按管腔A型或管腔B型以及研究分组,通过生存曲线分析远处无复发生存,通过时间相关可变参数模型对患者特征和肿瘤特征进行校正后推算随着时间变化的远处无复发风险比。

  结果,该研究他莫昔芬治疗组管腔A型患者183例、管腔B型患者64例,非内分泌治疗组管腔A型患者153例、管腔B型患者62例。乳腺癌确诊时年龄45~73岁。

  两组患者的远处无复发生存差异显著,无论管腔A型患者(336例,对数秩P<0.001)还是管腔B型患者(126例,对数秩P=0.04)。

  管腔A型管腔B型患者相比,25年远处无复发生存率:

  • 他莫昔芬治疗患者:87%比67%(95%置信区间:82%~93%、56%~82%)

  • 非内分泌治疗患者:70%比54%(95%置信区间:62%~79%、42%~70%)

  他莫昔芬治疗非内分泌治疗相比,乳腺癌确诊后5、10、15、20、25年远处复发或死亡风险:

  • 管腔A型患者:低67%、低53%、低43%、低35%、低29%(校正后风险比:0.33、0.47、0.57、0.65、0.71,95%置信区间:0.20~0.54、0.31~0.72、0.35~0.94、0.37~1.15、0.38~1.33)

  • 管腔B型患者:低62%、低34%、高 4%、高39%、高58%(校正后风险比:0.38、0.66、1.04、1.39、1.58,95%置信区间:0.24~0.59、0.37~1.18、0.38~2.82、0.35~5.51、0.35~7.15)

  因此,该研究结果表明,管腔A型与管腔B型早期乳腺癌患者相比,远处转移长期风险较高,他莫昔芬治疗获益保持时间较长。

JAMA Oncol. 2019 Aug 8. [Epub ahead of print]

Assessment of Long-term Distant Recurrence-Free Survival Associated With Tamoxifen Therapy in Postmenopausal Patients With Luminal A or Luminal B Breast Cancer.

Nancy Y. Yu, Adina Iftimi, Christina Yau, Nicholas P. Tobin, Laura van't Veer, Katherine A. Hoadley, Christopher C. Benz, Bo Nordenskjold, Tommy Fornander, Olle Stal, Kamila Czene, Laura J. Esserman, Linda S. Lindstrom.

Karolinska Institutet, Stockholm, Sweden; University of California, San Francisco, San Francisco; Buck Institute for Research on Aging, Novato, California; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill; Linkoping University, Linkoping, Sweden.

This secondary analysis of the Stockholm Tamoxifen (STO-3) clinical trial, which was conducted from 1976 to 1990, assessed the long-term survival associated with tamoxifen therapy in postmenopausal patients with luminal A or B breast cancer tumor subtypes.

QUESTION: What is the long-term survival associated with tamoxifen therapy for postmenopausal patients with luminal A or luminal B subtype tumors?

FINDINGS: This secondary analysis of the Stockholm Tamoxifen (STO-3) trial of 462 postmenopausal patients with lymph node-negative breast cancer found that patients with luminal A or luminal B tumor subtypes had a long-term risk of distant metastatic breast cancer and benefited from tamoxifen therapy for 15 years and 5 years after diagnosis, respectively.

MEANING: Patients with luminal A tumor subtype appeared to have a long-term benefit from tamoxifen therapy, and patients with luminal B subtype appeared to have an early benefit from therapy, when the risk of distant metastatic disease was high.


IMPORTANCE: Patients with estrogen receptor (ER)-positive breast cancer have a long-term risk for fatal disease. However, the tumor biological factors that influence the long-term risk and the benefit associated with endocrine therapy are not well understood.

OBJECTIVE: To compare the long-term survival from tamoxifen therapy for patients with luminal A or luminal B tumor subtype.

DESIGN, SETTING, AND PARTICIPANTS: Secondary analysis of patients from the Stockholm Tamoxifen (STO-3) trial conducted from 1976 to 1990, which randomized postmenopausal patients with lymph node-negative breast cancer to receive adjuvant tamoxifen or no endocrine therapy. Tumor tissue sections were assessed in 2014 using immunohistochemistry and Agilent microarrays. Only patients with luminal A or B subtype tumors were evaluated. Complete long-term follow-up data up to the end of the STO-3 trial on December 31, 2012, were obtained from the Swedish National registers. Data analysis for the secondary analysis was conducted in 2017 and 2018.

INTERVENTIONS: Patients were randomized to receive at least 2 years of tamoxifen therapy or no endocrine therapy; patients without recurrence who reconsented were further randomized to 3 additional years of tamoxifen therapy or no endocrine therapy.

MAIN OUTCOMES AND MEASURES: Distant recurrence-free interval (DRFI) by luminal A and luminal B subtype and trial arm was assessed by Kaplan-Meier analyses and time-dependent flexible parametric models to estimate time-varying hazard ratios (HRs) that were adjusted for patient and tumor characteristics.

RESULTS: In the STO-3 treated trial arm, 183 patients had luminal A tumors and 64 patients had luminal B tumors. In the untreated arm, 153 patients had luminal A tumors and 62 had luminal B tumors. Age at diagnosis ranged from 45 to 73 years. A statistically significant difference in DRFI by trial arm was observed (log rank, P<0.001 [luminal A subtype, n=336], P=0.04 [luminal B subtype, n=126]): the 25-year DRFI for luminal A vs luminal B subtypes was 87% (95% CI, 82%-93%) vs 67% (95% CI, 56%-82%) for treated patients, and 70% (95% CI, 62%-79%) vs 54% (95% CI, 42%-70%) for untreated patients, respectively. Patients with luminal A tumors significantly benefited from tamoxifen therapy for 15 years after diagnosis (HR, 0.57; 95% CI, 0.35-0.94), and those with luminal B tumors benefited from tamoxifen therapy for 5 years (HR, 0.38; 95% CI, 0.24-0.59).

CONCLUSIONS AND RELEVANCE: Patients with luminal A subtype tumors had a long-term risk of distant metastatic disease, which was reduced by tamoxifen treatment, whereas patients with luminal B tumors had an early risk of distant metastatic disease, and tamoxifen benefit attenuated over time.

DOI: 10.1001/jamaoncol.2019.1856

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