Clinical activity of nivolumab in combination with eribulin in HER2-negative metastatic breast cancer: A phase IB/II study (KCSG BR18-16)
DC Field | Value | Language |
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dc.contributor.author | Kim, Se Hyun | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Suh, Koung Jin | - |
dc.contributor.author | Lee, Kyung-Hun | - |
dc.contributor.author | Kim, Min Hwan | - |
dc.contributor.author | Sohn, Joohyuk | - |
dc.contributor.author | Park, Yeon Hee | - |
dc.contributor.author | Kim, Ji-Yeon | - |
dc.contributor.author | Jeong, Jae Ho | - |
dc.contributor.author | Lee, Kyoung Eun | - |
dc.contributor.author | Choi, In Sil | - |
dc.contributor.author | Park, Kyong Hwa | - |
dc.contributor.author | Kim, Hee-Jun | - |
dc.contributor.author | Cho, Eun Kyung | - |
dc.contributor.author | Park, So Yeon | - |
dc.contributor.author | Kim, Milim | - |
dc.contributor.author | Kim, Jee Hyun | - |
dc.date.accessioned | 2023-12-15T15:09:50Z | - |
dc.date.available | 2023-12-15T15:09:50Z | - |
dc.date.issued | 2023-12 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.issn | 1879-0852 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/89577 | - |
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. | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | ELSEVIER SCI LTD | - |
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.identifier.wosid | 001096718200001 | - |
dc.identifier.doi | 10.1016/j.ejca.2023.113386 | - |
dc.identifier.bibliographicCitation | EUROPEAN JOURNAL OF CANCER, v.195 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.scopusid | 2-s2.0-85174605166 | - |
dc.citation.title | EUROPEAN JOURNAL OF CANCER | - |
dc.citation.volume | 195 | - |
dc.type.docType | Article | - |
dc.publisher.location | 영국 | - |
dc.subject.keywordAuthor | Advanced breast cancer | - |
dc.subject.keywordAuthor | Metastatic breast cancer | - |
dc.subject.keywordAuthor | Nivolumab | - |
dc.subject.keywordAuthor | Immune checkpoint inhibitors | - |
dc.subject.keywordAuthor | Eribulin | - |
dc.subject.keywordAuthor | Clinical trial | - |
dc.subject.keywordAuthor | Luminal breast cancer | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | LOCALLY RECURRENT | - |
dc.subject.keywordPlus | PEMBROLIZUMAB | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | CHOICE | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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