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Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study.
Wang, Xinguang; Fan, Zhaoqing; Wang, Xing; He, Yingjian; Liu, Yiqiang; Wang, Xiang; Zhang, Bailin; Jiang, Zefei; Wang, Tao; Yu, Zhigang; Wang, Fei; Liu, Yinhua; Li, Yanping; Zhang, Jianguo; Luo, Bin; Jiang, Hongchuan; Wang, Tianfeng; Xie, Yuntao; Li, Jinfeng; Ouyang, Tao.
Afiliação
  • Wang X; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China.
  • Fan Z; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China.
  • Wang X; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China.
  • He Y; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China.
  • Liu Y; Department of Pathology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.
  • Wang X; Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Zhang B; Department of Breast Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Jiang Z; Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
  • Wang T; Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
  • Yu Z; Department of Breast Surgery, Cheeloo College of Medicine, The Second Hospital, Shandong University, Shandong, China.
  • Wang F; Department of Breast Surgery, Cheeloo College of Medicine, The Second Hospital, Shandong University, Shandong, China.
  • Liu Y; Breast Disease Center, Peking University First Hospital, Beijing, China.
  • Li Y; Department of Breast Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Zhang J; Department of Breast Surgery, The Second Hospital of Harbin Medical University, Heilongjiang, China.
  • Luo B; Department of General Surgery, Clinical School of Medicine, Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.
  • Jiang H; Department of Breast Surgery, Beijing Chao Yang Hospital, Capital Medical University, Beijing, China.
  • Wang T; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China.
  • Xie Y; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China.
  • Li J; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China.
  • Ouyang T; Breast Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, China. breastcenter666@163.com.
Breast Cancer Res Treat ; 195(3): 301-310, 2022 Oct.
Article em En | MEDLINE | ID: mdl-35917052
ABSTRACT

PURPOSE:

For estrogen receptor (ER)-positive breast cancer, neoadjuvant endocrine therapy (NET) has been shown to be as effective as neoadjuvant chemotherapy (NACT). We evaluated the prognostic significance of Preoperative Endocrine Prognostic Index (PEPI).

METHODS:

We conducted a prospective, multi-center, non-randomized, controlled trial that enrolled postmenopausal early-stage strongly ER-positive (≥ 50%) and HER2-negative breast cancer patients. All patients were given 4-month NET before surgery. The primary objective was to investigate the 5-year recurrence-free survival (RFS) in patients who had PEPI 0-1 or pathological complete response (pCR) without chemotherapy. Patients who had PEPI 0-1 or pCR were recommended to receive adjuvant endocrine therapy only and patients had PEPI ≥ 2 may receive adjuvant chemotherapy at the discretion of the treating physician.

RESULTS:

A total of 410 patients were included and 352 patients constituted the per-protocol population. Overall, 9 patients (2.5%) had pCR (ypT0/is ypN0), 128 patients (36.4%) had PEPI = 0, and 56 patients (15.9%) had PEPI = 1. After a median follow-up of 60 months (4-104 months), patients who had PEPI 0-1 or pCR showed an improved 5-year RFS [99.5% (95% CI 98.5-99.9%) for PEPI 0-1 or pCR group vs. 93.7% (95% CI 89.6-97.8%) for PEPI ≥ 2 group, P = 0.028]. No survival difference was detected between patients received adjuvant chemotherapy vs. no chemotherapy among PEPI ≥ 2 cases.

CONCLUSION:

PEPI 0-1 or pCR may be used to define a group of ER-positive and HER2-negative postmenopausal early breast cancer patients with low relapse risk for whom adjuvant chemotherapy can be safely withheld. Studies on the identification and alternative treatment options for endocrine-resistant tumors are warranted. CLINICAL TRIAL REGISTRATION NCT01613560.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Terapia Neoadjuvante Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies Limite: Female / Humans Idioma: En Revista: Breast Cancer Res Treat Ano de publicação: 2022 Tipo de documento: Article País de afiliação: China

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Terapia Neoadjuvante Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies Limite: Female / Humans Idioma: En Revista: Breast Cancer Res Treat Ano de publicação: 2022 Tipo de documento: Article País de afiliação: China