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Clinical activity of nivolumab in combination with eribulin in HER2-negative metastatic breast cancer: A phase IB/II study (KCSG BR18-16).

التفاصيل البيبلوغرافية
العنوان: Clinical activity of nivolumab in combination with eribulin in HER2-negative metastatic breast cancer: A phase IB/II study (KCSG BR18-16).
المؤلفون: Kim SH; Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea., Im SA; Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, South Korea., Suh KJ; Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea., Lee KH; Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, South Korea., Kim MH; Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea., Sohn J; Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea., Park YH; Hematology-Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea., Kim JY; Hematology-Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea., Jeong JH; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea., Lee KE; Department of Hematology and Oncology, Ewha Womans University Hospital, Seoul, South Korea., Choi IS; Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, South Korea., Park KH; Division of Medical Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, South Korea., Kim HJ; Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea., Cho EK; Division of Medical Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea., Park SY; Department of Pathology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea., Kim M; Department of Pathology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea; Department of Pathology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea., Kim JH; Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea. Electronic address: jhkimmd@snu.ac.kr.
المصدر: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2023 Dec; Vol. 195, pp. 113386. Date of Electronic Publication: 2023 Oct 14.
نوع المنشور: Clinical Trial, Phase II; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE
أسماء مطبوعة: Publication: Oxford : Elsevier Science Ltd
Original Publication: Oxford ; New York : Pergamon Press, c1990-
مواضيع طبية MeSH: Breast Neoplasms*/pathology , Triple Negative Breast Neoplasms*/drug therapy, Adult ; Female ; Humans ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; B7-H1 Antigen ; Nivolumab/therapeutic use ; Receptor, ErbB-2/metabolism ; Aged
مستخلص: 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/m 2 ) 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.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ono Pharmaceutical Co. provided the study drug (nivolumab) and provided funding to Seoul National University Bundang Hospital for study conduct. Eisai Korea inc. provided the study drug (eribulin) for study conduct. The companies were not involved in trial data analysis and manuscript writing. SHK has a consulting or advisory role with Ono Pharmaceutical. SI reports receiving research grant from AstraZeneca, Daewoong Pharm, Eisai, Roche, and Pfizer and personal consultation fees from AstraZeneca, Eisai, GSK, Hanmi, Lilly, MSD, Idience, Novartis, Roche, and Pfizer. The research group received drugs from Eisai and Boryung. KL reports receiving honorarium from AstraZeneca, Daiichi-Sankyo, Eli Lilly, Novartis, Pfizer, Roche. JS reports receiving research funding from MSD, Roche, Novartis, Lilly, Pfizer, Daiichi Sankyo, AstraZeneca, GlaxoSmithKline, Sanofi, and Boehringer Ingelheim. KHP has a consulting or advisory role with Eisai, Eli Lilly, Novartis, Daiichi Sankyo/Astra Zeneca, Pfizer, IMBDx, Celltrion and Roche and has received research funding from Astra Zeneca. JHK has a consulting or advisory role with Bixink, Eisai, Yuhan, Novartis, Daiichi Sankyo/Astra Zeneca, Pfizer, and Roche and has received research funding from Ono Pharmaceutical and Roche. All remaining authors have declared no conflicts of interest.
(Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
فهرسة مساهمة: Keywords: Advanced breast cancer; Clinical trial; Eribulin; Immune checkpoint inhibitors; Luminal breast cancer; Metastatic breast cancer; Nivolumab
سلسلة جزيئية: ClinicalTrials.gov NCT04061863
المشرفين على المادة: 0 (B7-H1 Antigen)
LR24G6354G (eribulin)
31YO63LBSN (Nivolumab)
EC 2.7.10.1 (Receptor, ErbB-2)
تواريخ الأحداث: Date Created: 20231027 Date Completed: 20231130 Latest Revision: 20231205
رمز التحديث: 20231215
DOI: 10.1016/j.ejca.2023.113386
PMID: 37890351
قاعدة البيانات: MEDLINE
الوصف
تدمد:1879-0852
DOI:10.1016/j.ejca.2023.113386