한빛사 논문
Chang Gon Kim1, Nam Suk Sim2, Jeong Eun Kim3, Kum-Hee Yun1, Young Han Lee4, Seung Hyun Kim5, Wooyeol Baek6, Yoon Dae Han7, Sang Kyum Kim8, Jee Hung Kim9, Yoon Woo Koh2, Inkyung Jung10, Su Jin Shin11, Sun Young Rha1, Jin-Hee Ahn3*, Hyo Song Kim1*
1Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Yonsei Cancer Center, Seoul, Republic of Korea. 2Department of Otorhinolaryngology, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea. 3Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. 4Department of Radiology, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea. 5Department of Orthopedic Surgery, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea. 6Department of Plastic and Reconstructive Surgery, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea. 7Department of Surgery, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea. 8Department of Pathology, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea. 9Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea. 10Division of Biostatistics, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Republic of Korea. 11Department of Pathology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.
C.G. Kim and N.S. Sim contributed equally to this article.
*Corresponding authors
Abstract
Purpose: Monotherapy with eribulin or gemcitabine has been found to be moderately effective in treating soft-tissue sarcomas (STS). In this study, we evaluated the efficacy and safety of eribulin-gemcitabine combination therapy for the two most common histologic types of STS, liposarcoma and leiomyosarcoma. Patients and methods: In this non-randomized, multicenter, phase II study, we included patients with progressive disease who had received one or two courses of chemotherapy that included doxorubicin. Patients were administered 1.4 mg/m2 eribulin and 1,000 mg/m2 gemcitabine on days 1 and 8 every 3 weeks. The primary endpoint was progression-free survival rate at 12 weeks (PFSR12wks), with null and alternative hypotheses of PFSR12wks {less than or equal to}20.0% and {greater than or equal to}40.0%, respectively. Exploratory biomarker analyses with next-generation sequencing (NGS) were performed on pretreatment tumor samples. Results: Among the 37 patients included, the overall PFSR12wks was 73.0%, achieving the primary endpoint. The objective response rate, disease control rate, median progression-free survival, and median overall survival were 16.2%, 78.4%, 5.6 months, and 31.9 months, respectively, without differences according to histologic type. New safety signals and treatment-related deaths were not documented. NGS-based transcriptome analysis revealed that functional enrichment in the transforming growth factor-ß pathway was mostly associated with a poor outcome, whereas single genetic alterations largely failed to predict treatment outcome. Conclusions: Eribulin-gemcitabine combination therapy showed promising activity and an acceptable safety profile in patients with liposarcoma or leiomyosarcoma. Gene expression profiling with pathway enrichment analysis would have possibilities to have predictive value for survival outcome, necessitating further investigation to confirm.
논문정보
관련 링크
연구자 키워드
연구자 ID
관련분야 연구자보기
관련분야 논문보기