Samsung Medical Center, Seoul, Republic of Korea
Ji-Yeon Kim , Seock-Ah Im , Kyung Hae Jung , Jungsil Ro , Joohyuk Sohn , Jee Hyun Kim , Yeon Hee Park , Tae Yong Kim , Sung-Bae Kim , Keun-Seok Lee , Gun Min Kim , Se Hyun Kim , Jin Seok Ahn , Kyung-Hun Lee , Jin-Hee Ahn , In Hae Park , Young-Hyuck Im
Background: Endocrine therapy(ET) is the preferred treatment for HR(+) MBC. For premenopausal patients who were pretreated with T, ovarian function suppression with G ± aromatase inhibitor(A.I.) is a reasonable option. Fulvestrant yields favorable outcomes in postmenopausal women with MBC. We investigated the efficacy and safety of F+G and A+G in comparison with G alone in premenopausal women with HR(+), T-pretreated MBC. Methods: In this multicenter, open-label, randomized phase 2 study, women > 18 years with HR(+), T-pretreated MBC were stratified by presence of visceral metastasis and recurrence within or after 1 year of completion of adjuvant T. Premenopausal women with T-pretreated MBC eligible for ET were randomly assigned (1:1:1) to F+G (F 500 mg IM + G 3.6 mg SC Q 4 wks), or A +G (A 1 mg P.O. qd + G 3.6 mg SC Q 4 wks) or G (G 3.6 mg SC Q 4 wks). The primary endpoint was time to progression(TTP), analyzed by intention to treat with log-rank test. Secondary endpoints included overall survival, overall response rate, clinical benefit rate and toxicities according to NCI CTCAE v3.0 (ClinicalTrials.gov, No. NCT01266213). Results: Of 138 eligible pts, 44 were randomly assigned to F+G, 47 to A+G, 47 to G. The median duration of follow-up was 28.8 months(mo) and median age was 43 (range; 23.0-55.0). The median TTP was 16.3 mo(95% C.I. 7.5-25.1) for F+G, 14.5 mo(95% C.I. 11.0-18.0) for A+G, and 13.5 mo(95% C.I. 10.3-16.8) for G alone, respectively. For the comparison of each experimental arm to control arm, 24-mo TTP were analyzed: F+G vs G(%±SE): 40.5±7.5 vs. 25.3±7.0, one-sided P = 0.048, A+G vs G(%±SE): 23.9±7.2 vs. 25.3±7.0, one-sided P = 0.304. Grade 3/4 toxicities were rarely observed. Most common adverse events were grade 1 joint stiffness and arthralgia which were more frequently observed in F+G compared to A+G and G (P = 0.018 and 0.015, respectively). Conclusions: The combination of F+G as well as G ±A.I. might be a valid option for HR(+) premenopausal women with T-pretreated MBC and further investigation is warranted. Clinical trial information: NCT01266213
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