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Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study)
DC Field | Value | Language |
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dc.contributor.author | Kim, Ji-Yeon | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Jung, Kyung Hae | - |
dc.contributor.author | Ro, Jungsil | - |
dc.contributor.author | Sohn, Joohyuk | - |
dc.contributor.author | Kim, Jee Hyun | - |
dc.contributor.author | Park, Yeon Hee | - |
dc.contributor.author | Kim, Tae-Yong | - |
dc.contributor.author | Kim, Sung-Bae | - |
dc.contributor.author | Lee, Keun Seok | - |
dc.contributor.author | Kim, Gun Min | - |
dc.contributor.author | Kim, Se Hyun | - |
dc.contributor.author | Kim, Seonwoo | - |
dc.contributor.author | Ahn, Jin Seok | - |
dc.contributor.author | Lee, Kyung-Hun | - |
dc.contributor.author | Ahn, Jin-Hee | - |
dc.contributor.author | Park, In Hae | - |
dc.contributor.author | Im, Young-Hyuck | - |
dc.date.accessioned | 2022-03-22T09:24:08Z | - |
dc.date.available | 2022-03-22T09:24:08Z | - |
dc.date.created | 2019-06-19 | - |
dc.date.created | 2019-06-19 | - |
dc.date.created | 2019-06-19 | - |
dc.date.created | 2019-06-19 | - |
dc.date.issued | 2018-11 | - |
dc.identifier.citation | European Journal of Cancer, Vol.103, pp.127-136 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.other | 76117 | - |
dc.identifier.uri | https://hdl.handle.net/10371/177315 | - |
dc.description.abstract | Background: We investigated the efficacy and safety of fulvestrant plus goserelin (F + G) versus anastrozole plus goserelin (A + G) in comparison with goserelin (G) alone in premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), tamoxifen-pretreated metastatic breast cancer (MBC). Patients and methods: In this multicentre, open-label, randomised phase II study, premenopausal women aged >= 18 years with HR+, HER2-, tamoxifen-pretreated MBC were randomly assigned (1: 1: 1) to F + G, A + G or G alone. The primary end-point was time to progression (TTP). Secondary end-points included overall survival, overall response rate, clinical benefit rate and toxicity. Results: Of 138 eligible patients, 44 were randomly assigned to receive F + G, 47 to A + G and 47 to G alone. The median follow-up duration was 32.2 months (interquartile range: 23.69-40.86) and the median age was 43.0 years (range 23.0-55.0). The median TTP was 16.3 months (95% confidence interval [CI] 7.5-25.1) for F + G, 14.5 months (95% CI 11.0-18.0) for A + G and 13.5 months (95% CI 10.3-16.8) for G alone. Compared with G alone, the hazard ratios were 0.608 for F + G (95% CI, 0.370-0.998; p = 0.049) and 0.982 for A + G (95% CI, 0.624-1.546; p = 0.937). In terms of visceral metastasis, a stratification factor, there were no TTP differences according to treatment arm. Grade III or IV toxicities were rarely observed. Of the common adverse events, grade I arthralgia and joint stiffness were more frequently observed in the F + G than in the A + G or G-alone groups (p < 0.05, respectively). Conclusions: F + G provides a promising new option for the treatment of premenopausal women with HR+, HER2-, tamoxifen-pretreated MBC. Trial registration: ClinicalTrials.gov number NCT01266213 and Korean Cancer Study Group (KCSG) Breast cancer protocol number BR10-04. (C) 2018 Elsevier Ltd. All rights reserved. | - |
dc.language | 영어 | - |
dc.publisher | Pergamon Press Ltd. | - |
dc.title | Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study) | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1016/j.ejca.2018.08.004 | - |
dc.citation.journaltitle | European Journal of Cancer | - |
dc.identifier.wosid | 000447292100015 | - |
dc.identifier.scopusid | 2-s2.0-85053216444 | - |
dc.citation.endpage | 136 | - |
dc.citation.startpage | 127 | - |
dc.citation.volume | 103 | - |
dc.identifier.sci | 000447292100015 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.contributor.affiliatedAuthor | Kim, Jee Hyun | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | INTERNATIONAL CONSENSUS GUIDELINES | - |
dc.subject.keywordPlus | ENDOCRINE THERAPY | - |
dc.subject.keywordPlus | POSTMENOPAUSAL WOMEN | - |
dc.subject.keywordPlus | AMERICAN SOCIETY | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | 500 MG | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | 1ST | - |
dc.subject.keywordAuthor | Metastatic breast cancer | - |
dc.subject.keywordAuthor | Premenopausal | - |
dc.subject.keywordAuthor | Fulvestrant | - |
dc.subject.keywordAuthor | Endocrine therapy | - |
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