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Leuprorelin combined with letrozole with/without everolimus in ovarian-suppressed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer: The LEO study

 Jae Ho Jeong  ;  Jeong Eun Kim  ;  Jin-Hee Ahn  ;  Kyung Hae Jung  ;  Su-Jin Koh  ;  Jaekyung Cheon  ;  Joohyuk Sohn  ;  Gun Min Kim  ;  Keun Seok Lee  ;  Sung Hoon Sim  ;  In Hae Park  ;  Sung-Bae Kim 
 EUROPEAN JOURNAL OF CANCER, Vol.144 : 341-350, 2021-02 
Journal Title
Issue Date
Adult ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use* ; Breast Neoplasms / drug therapy* ; Breast Neoplasms / metabolism ; Breast Neoplasms / pathology ; Everolimus / administration & dosage ; Female ; Follow-Up Studies ; Gonadotropin-Releasing Hormone / agonists ; Humans ; Letrozole / administration & dosage ; Leuprolide / administration & dosage ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Recurrence, Local / drug therapy* ; Neoplasm Recurrence, Local / metabolism ; Neoplasm Recurrence, Local / pathology ; Premenopause ; Primary Ovarian Insufficiency / drug therapy* ; Primary Ovarian Insufficiency / pathology ; Prognosis ; Receptor, ErbB-2 / metabolism* ; Receptors, Estrogen / metabolism* ; Receptors, Progesterone / metabolism* ; Survival Rate ; Tamoxifen / administration & dosage ; Young Adult
Breast cancer ; Everolimus ; Hormone receptor-positive ; Premenopausal women
Purpose: In the randomised phase II LEO trial, we investigated the effect of adding everolimus (EVE) to letrozole (LET) in ovarian-suppressed premenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) recurrent/metastatic breast cancer.

Methods: Patients with progression or prior exposure to tamoxifen with or without gonadotropin-releasing hormone agonists, either sequentially or concurrently, in adjuvant or metastatic setting were randomly assigned (2:1) to the EVE arm (leuprorelin + LET + EVE) or the LET arm (leuprorelin + LET) until disease progression or unacceptable toxicity. The primary end-point was progression-free survival (PFS). Secondary end-points included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety.

Results: Between January 2014 and October 2018, 137 patients were enrolled (median age, 44 years [range, 24-56]). Of them, 75% had endocrine-sensitive disease, and 61% had visceral metastasis. With the median follow-up of 32.4 months, the median PFS was 18.1 months in the EVE arm and 13.8 months in the LET arm (HR 0.73, P = 0.137). Among patients with visceral metastases, the median PFS was significantly longer in the EVE arm (16.4 versus 9.5 months, P = 0.048). The median OS was not reached in both arms. The CBR was significantly higher in the EVE arm (83% versus 62%, P = 0.010). The ORR was similar between the two arms. The most common grade 3/4 adverse events in the EVE arm were neutropenia, alanine aminotransferase elevation and anaemia.

Conclusions: EVE plus LET with ovarian-suppression resulted in longer PFS in tamoxifen-exposed HR+, HER2- metastatic breast cancer patients with visceral metastasis.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Gun Min(김건민) ORCID logo https://orcid.org/0000-0001-9167-8682
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
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