Journal
BREAST CANCER RESEARCH AND TREATMENT
Volume 154, Issue 2, Pages 275-286Publisher
SPRINGER
DOI: 10.1007/s10549-015-3612-z
Keywords
Estrogen receptor; Exemestane; Ki-67; Ovarian function suppression; Progesterone receptor; Tamoxifen
Categories
Funding
- Pfizer
- International Breast Cancer Study Group
- US National Cancer Institute
- Frontier Science and Technology Research Foundation
- Swiss Group for Clinical Cancer Research (SAKK)
- Cancer Research Switzerland/Oncosuisse
- Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK)
- US National Cancer Institute (NCI) [US NIH CA75362]
- Susan G. Komen for the Cure Promise Grant [KG080081]
- Breast Cancer Research Foundation
- NHMRC [351161, 510788]
- US NIH [CA32102, U10-CA180821, CA21115, CA16116, U10-CA-12027, U10-CA-69651, U10-CA-37377, U10-CA-69974, CA077202, CCSRI 015469, 021039]
- CRUK [CRUKE/03/022, CRUKE/03/023, A15955]
- NIHR RM/ICR Biomedical Research Centre
- NIHR Cambridge Biomedical Research Centre
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The SOFT and TEXT randomized phase III trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor-positive (HR+) early breast cancer. We investigated the prognostic and predictive value of centrally assessed levels of estrogen receptor (ER), progesterone receptor (PgR), and Ki-67 expression in women with HER2-negative disease. Of 5707 women enrolled, 4115 with HER2-negative (HR+/HER2-) disease had ER, PgR, and Ki-67 centrally assessed by immunohistochemistry. Breast cancer-free interval (BCFI) was defined from randomization to first invasive local, regional, or distant recurrence or contralateral breast cancer. The prognostic and predictive values of ER, PgR and Ki-67 expression levels were assessed using Cox modeling and STEPP methodology. In this HR+/HER2- population, the median ER, PgR, and Ki-67 expressions were 95, 90, and 18 % immunostained cells. As most patients had strongly ER-positive tumors, the predictive value of ER levels could not be investigated. Lower PgR and higher Ki-67 expression were associated with reduced BCFI. There was no consistent evidence of heterogeneity of the relative treatment effects according to PgR or Ki-67 expression levels, though there was a greater 5-year absolute benefit of exemestane + ovarian function suppression (OFS) versus tamoxifen with or without OFS at lower levels of PgR and higher levels of Ki-67. Women with poor prognostic features of low PgR and/or high Ki-67 have greater absolute benefit from exemestane + OFS versus tamoxifen + OFS or tamoxifen alone, but individually PgR and Ki-67 are of limited predictive value for selecting adjuvant endocrine therapy for premenopausal women with HR+/HER2- early breast cancer.
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