Estrogen receptor, Progesterone receptor, HER2 status and Ki67 index and responsiveness to adjuvant tamoxifen in postmenopausal high-risk breast cancer patients enrolled in the DBCG 77C trial
| Autor: | Knoop, Ann, Lænkholm, Anne Vibeke, Jensen, M. B., Nielsen, K. V., Andersen, J., Nielsen, D., Ejlertsen, B., Danish Breast Canc Cooperative, Grp |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Oncology
Cancer Research Antineoplastic Agents Hormonal/therapeutic use Breast Menopausal Tamoxifen Subtypes Randomised adjuvant phase III trial INTERNATIONAL EXPERT CONSENSUS GROWTH-FACTOR RECEPTOR COOPERATIVE-GROUP DBCG PROGNOSTIC VALUE PREDICTIVE-VALUE PRIMARY THERAPY FOLLOW-UP WOMEN EXPRESSION LETROZOLE Receptors Progesterone/metabolism Receptor ErbB-2 Receptor ErbB-2/metabolism Estrogen receptor Tamoxifen/administration & dosage Randomised adjuvant phase III trial Risk Factors Medicine Breast skin and connective tissue diseases In Situ Hybridization Fluorescence Subtypes education.field_of_study Hazard ratio Middle Aged Immunohistochemistry Intention to Treat Analysis Postmenopause Treatment Outcome Receptors Estrogen Chemotherapy Adjuvant Female Receptors Estrogen/metabolism Receptors Progesterone medicine.drug Adult medicine.medical_specialty Antineoplastic Agents Hormonal Population Breast Neoplasms Disease-Free Survival Breast cancer Breast Neoplasms/drug therapy Internal medicine Progesterone receptor Humans Ki-67 Antigen/metabolism education Survival analysis Aged Gynecology Intention-to-treat analysis business.industry medicine.disease Survival Analysis Menopausal Tamoxifen Ki-67 Antigen business Follow-Up Studies |
| Zdroj: | Knoop, A S, Lænkholm, A-V, Jensen, M-B, Nielsen, K V, Andersen, J, Nielsen, D, Ejlertsen, B & Danish Breast Cancer Cooperative Group 2014, ' Estrogen receptor, Progesterone receptor, HER2 status and Ki67 index and responsiveness to adjuvant tamoxifen in postmenopausal high-risk breast cancer patients enrolled in the DBCG 77C trial ', European journal of cancer (Oxford, England : 1990), vol. 50, no. 8, pp. 1412-21 . https://doi.org/10.1016/j.ejca.2014.02.022 Knoop, A, Lænkholm, A V, Jensen, M B, Nielsen, K V, Andersen, J, Nielsen, D, Ejlertsen, B & Danish Breast Canc Cooperative, G 2014, ' Estrogen receptor, Progesterone receptor, HER2 status and Ki67 index and responsiveness to adjuvant tamoxifen in postmenopausal high-risk breast cancer patients enrolled in the DBCG 77C trial ', European Journal of Cancer, vol. 50, no. 8, pp. 1412-1421 . https://doi.org/10.1016/j.ejca.2014.02.022 |
| DOI: | 10.1016/j.ejca.2014.02.022 |
| Popis: | Background: The DBCG 77C trial compared one year of tamoxifen in postmenopausal, steroid-receptor unknown, high-risk breast cancer patients to no adjuvant systemic therapy. After a potential follow-up of 30 years we report overall efficacy of the study and results according to subtypes subsequently assessed by immunohistochemistry and fluorescent in situ hybridisation (FISH). Methods: Between 1977 and 1982, 1716 postmenopausal patients with tumours larger than 5 cm or positive axillary nodes were randomly assigned to no systemic therapy or tamoxifen 30 mg daily for one year. Archival tumour tissue from 1515 patients was analysed and the hormone receptor positive (estrogen receptor (ER) and/or progesterone receptor (PR)) cancers were defined as luminal A if Ki67 low and HER2-negative; as luminal B if Ki67 high or HER2-positive; and otherwise as non-luminal-HER2 positive or triple negative. Findings: In the intent-to-treat (ITT) population one year of tamoxifen improved the disease-free-survival (DFS) (hazard ratio (HR) = 0.87; 95% confidence interval (CI) 0.77-0.98), the Breast Cancer Recurrence Rate (BCRR) (HR = 0.79; 0.69-0.90) and reduced the breast-cancer-specific-mortality (BCM) (HR = 0.83; 0.73-0.93). BCRR were improved significantly by tamoxifen in luminal A (HR = 0.66; 0.53-0.84) and luminal B/HER2- (HR = 0.54; 0.39-0.74) but not in the other subsets, and with similar results for BCM with 30 years follow-up. Interpretation: One year of treatment with tamoxifen significantly improves BCRR and BCM in postmenopausal patients with ER positive breast cancers. The relative benefit from tamoxifen was not significantly different in luminal A and B subtypes. Funding: The Danish Breast Cancer Cooperative Group (DBCG) prepared the original protocol (DBCG 77C) and was the sponsor of the study. Funding was not provided to the participating departments. The biomarker study was supported by grants from the Clinical Institute, Odense University. (C) 2014 Elsevier Ltd. All rights reserved. The DBCG 77C trial compared one year of tamoxifen in postmenopausal, steroid-receptor unknown, high-risk breast cancer patients to no adjuvant systemic therapy. After a potential follow-up of 30 years we report overall efficacy of the study and results according to subtypes subsequently assessed by immunohistochemistry and fluorescent in situ hybridisation (FISH). Methods Between 1977 and 1982, 1716 postmenopausal patients with tumours larger than 5 cm or positive axillary nodes were randomly assigned to no systemic therapy or tamoxifen 30 mg daily for one year. Archival tumour tissue from 1515 patients was analysed and the hormone receptor positive (estrogen receptor (ER) and/or progesterone receptor (PR)) cancers were defined as luminal A if Ki67 low and HER2-negative; as luminal B if Ki67 high or HER2-positive; and otherwise as non-luminal-HER2 positive or triple negative. Findings In the intent-to-treat (ITT) population one year of tamoxifen improved the disease-free-survival (DFS) (hazard ratio (HR) = 0.87; 95% confidence interval (CI) 0.77-0.98), the Breast Cancer Recurrence Rate (BCRR) (HR = 0.79; 0.69-0.90) and reduced the breast-cancer-specific-mortality (BCM) (HR = 0.83; 0.73-0.93). BCRR were improved significantly by tamoxifen in luminal A (HR = 0.66; 0.53-0.84) and luminal B/HER2- (HR = 0.54; 0.39-0.74) but not in the other subsets, and with similar results for BCM with 30 years follow-up. Interpretation One year of treatment with tamoxifen significantly improves BCRR and BCM in postmenopausal patients with ER positive breast cancers. The relative benefit from tamoxifen was not significantly different in luminal A and B subtypes. Funding The Danish Breast Cancer Cooperative Group (DBCG) prepared the original protocol (DBCG 77C) and was the sponsor of the study. Funding was not provided to the participating departments. The biomarker study was supported by grants from the Clinical Institute, Odense University. |
| Databáze: | OpenAIRE |
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