Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 이경은 | - |
dc.date.accessioned | 2024-02-15T05:11:51Z | - |
dc.date.available | 2024-02-15T05:11:51Z | - |
dc.date.issued | 2023 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.other | OAK-34355 | - |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/267783 | - |
dc.description.abstract | Aim: We evaluated the efficacy and safety of nivolumab and eribulin combination therapy for metastatic breast cancer (BC) in Asian populations. Methods: In this parallel phase II study, adult patients with histologically confirmed recurrent/metastatic hormone receptor-positive/HER2-negative (HR+HER2-) or triple-negative BC (TNBC) were prospectively enroled from 10 academic hospitals in Korea (ClinicalTrials.gov Identifier: NCT04061863). They received nivolumab (360 mg) on day 1 plus eribulin (1.4 mg/m2) on days 1 and 8 every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was the investigator-assessed 6-month progression-free survival (PFS) rate in each subtype. Secondary endpoints included investigator-assessed objective response rate (ORR) as per Response Evaluation Criteria in Advanced Solid Tumors version 1.1, disease control rate, overall survival, and treatment toxicity. The association between PD-L1 expression and efficacy was investigated. Results: Forty-five patients with HR+HER2- BC and 45 with TNBC were enroled. Their median age was 51 (range, 31–71) years, and 74 (82.2%) received one or two prior treatments before enrolment. Six-month PFS was 47.2% and 25.1% in the HR+HER2- and TNBC cohorts, respectively. Median PFS was 5.6 (95% confidence interval [CI]: 5.3–7.4) and 3.0 (95% CI: 2.1–5.2) months in the HR+HER2- and TNBC groups, respectively. ORRs were 53.3% (complete response [CR]: 0, partial response [PR]: 24) and 28.9% (CR: 1, PR: 12). Patients with PD-L1+ tumours (PD-L1 expression ≥1%) and PD-L1- tumours (ORR 50% versus 53.8% in HR+HER2-, 30.8% versus 29.0% in TNBC) had similar ORRs. Neutropenia was the most common grade 3/4 adverse event; the most common immune-related adverse events (AEs) were grades 1/2 hypothyroidism and pruritus. Five patients discontinued therapy because of immune-related AEs. Conclusion: Nivolumab plus eribulin showed promising efficacy and tolerable safety in previously treated HER2- metastatic BC. Trial registration: NCT04061863 © 2023 The Authors | - |
dc.language | English | - |
dc.publisher | Elsevier Ltd | - |
dc.subject | Advanced breast cancer | - |
dc.subject | Clinical trial | - |
dc.subject | Eribulin | - |
dc.subject | Immune checkpoint inhibitors | - |
dc.subject | Luminal breast cancer | - |
dc.subject | Metastatic breast cancer | - |
dc.subject | Nivolumab | - |
dc.title | Clinical activity of nivolumab in combination with eribulin in HER2-negative metastatic breast cancer: A phase IB/II study (KCSG BR18-16) | - |
dc.type | Article | - |
dc.relation.volume | 195 | - |
dc.relation.index | SCIE | - |
dc.relation.index | SCOPUS | - |
dc.relation.journaltitle | European Journal of Cancer | - |
dc.identifier.doi | 10.1016/j.ejca.2023.113386 | - |
dc.identifier.wosid | WOS:001096718200001 | - |
dc.identifier.scopusid | 2-s2.0-85174605166 | - |
dc.author.google | Kim | - |
dc.author.google | Se Hyun | - |
dc.author.google | Im | - |
dc.author.google | Seock-Ah | - |
dc.author.google | Koung Jin | - |
dc.author.google | Lee | - |
dc.author.google | Kyung-Hun | - |
dc.author.google | Min Hwan | - |
dc.author.google | Sohn | - |
dc.author.google | Joohyuk | - |
dc.author.google | Park | - |
dc.author.google | Yeon Hee | - |
dc.author.google | Ji-Yeon | - |
dc.author.google | Jeong | - |
dc.author.google | Suh | - |
dc.author.google | Jae Ho | - |
dc.author.google | Kyoung Eun | - |
dc.author.google | Choi | - |
dc.author.google | In Sil | - |
dc.author.google | Kyong Hwa | - |
dc.author.google | Hee-Jun | - |
dc.author.google | Cho | - |
dc.author.google | Eun Kyung | - |
dc.author.google | So Yeon | - |
dc.author.google | Milim | - |
dc.author.google | Jee Hyun | - |
dc.contributor.scopusid | 이경은(7501517217;58364338700) | - |
dc.date.modifydate | 20240208145437 | - |