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
- 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
- Issue Date
- 15-8월-2021
- Publisher
- WILEY
- Keywords
- bone turnover markers; breast cancer; everolimus; hormone receptor& #8208; positive; premenopausal women
- Citation
- INTERNATIONAL JOURNAL OF CANCER, v.149, no.4, pp.917 - 924
- Indexed
- SCIE
SCOPUS
- Journal Title
- INTERNATIONAL JOURNAL OF CANCER
- Volume
- 149
- Number
- 4
- Start Page
- 917
- End Page
- 924
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/136848
- DOI
- 10.1002/ijc.33613
- ISSN
- 0020-7136
- Abstract
- 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 < .001). Bone turnover markers at 6 and 12 weeks after treatment decreased in the EVE arm but were increased or stationary in the LET arm. Skeletal-related events occurred in 6.5% and 11.1% of patients in the EVE and LET arms, respectively. EVE + LET with ovarian suppression prolonged PFS in patients with baseline visceral or bone metastases and offered bone-protective effects in the overall study population. However, these clinical benefits did not translate into an OS benefit.
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