Final results of the randomized phase 2 LEO trial and bone protective effects of everolimus for premenopausal hormone receptor‐positive, HER2‐negative metastatic breast cancer

The phase 2 LEO study showed that everolimus (EVE) plus letrozole (LET) with ovarian suppression increased progression‐free survival (PFS) in tamoxifen‐exposed premenopausal women with hormone receptor‐positive, HER2‐negative metastatic breast cancer with visceral metastases. Here we report final su...

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Bibliographic Details
Published in:International journal of cancer 2021-08, Vol.149 (4), p.917-924
Main Authors: Jeong, Hyehyun, Jeong, Jae Ho, Kim, Jeong Eun, Ahn, Jin‐Hee, Jung, Kyung Hae, Koh, Su‐Jin, Cheon, Jaekyung, Sohn, Joohyuk, Kim, Gun Min, Lee, Keun Seok, Sim, Sung Hoon, Park, In Hae, Kim, Sung‐Bae
Format: Article
Language:English
Subjects:
Arm
Bone turnover
bone turnover markers
Breast cancer
Cancer
ErbB-2 protein
everolimus
hormone receptor‐positive
Inhibitor drugs
Medical research
Metastases
Metastasis
Ovaries
Patients
Population studies
premenopausal women
Survival
Tamoxifen
Targeted cancer therapy
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Summary:The phase 2 LEO study showed that everolimus (EVE) plus letrozole (LET) with ovarian suppression increased progression‐free survival (PFS) in tamoxifen‐exposed premenopausal women with hormone receptor‐positive, HER2‐negative metastatic breast cancer with visceral metastases. Here we report final survival outcomes from the LEO study, and the results of exploratory analyses of bone turnover marker changes and bone‐specific progressive disease. Patients who were exposed to or progressed on tamoxifen as adjuvant/palliative treatments were randomly assigned (2:1) to the EVE (leuprorelin + LET + EVE, n = 92) or LET (leuprorelin + LET, n = 45) arm. In a median 51‐months of follow‐up, the median PFS was 17.5 and 13.8 months in the EVE and LET arms, respectively (P = .245). Patients in the EVE arm with baseline visceral (median PFS 16.4 vs 9.5 months, P = .040) and bone (median PFS 17.1 vs 10.9, P = .003) metastases had greater PFS compared to the LET arm. No differences in overall survival (OS) were observed (median OS, 48.3 vs 50.8 months, P = .948). The 1‐year cumulative incidences of bone‐specific disease progression were 6.0% and 23.4% in the EVE and LET arms, respectively (hazard ratio 0.26, P 
ISSN:0020-7136
1097-0215
DOI:10.1002/ijc.33613