Phase II Clinical Trial of Eribulin-Gemcitabine Combination Therapy in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma

Chang Gon Kim, Nam Suk Sim, Jeong Eun Kim, Kum Hee Yun, Young Han Lee, Seung Hyun Kim, Wooyeol Baek, Yoon Dae Han, Sang Kyum Kim, Jee Hung Kim, Yoon Woo Koh, Inkyung Jung, Su Jin Shin, Sun Young Rha, Jin Hee Ahn, Hyo Song Kim

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)


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 nonrandomized, 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 ≤20.0% and ≥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 TGFb 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.

Original languageEnglish
Pages (from-to)3225-3234
Number of pages10
JournalClinical Cancer Research
Issue number15
Publication statusPublished - 2022 Aug 1

Bibliographical note

Funding Information:
We thank all the patients and their caregivers who participated in this study. We would like to express our sincere appreciation for kindly providing eribulin mesylate (HALAVEN, Eisai Korea Inc.) and gemcitabine (Gemtan, Chong Kun Dang Pharm.) for use in our study free of cost. The companies were not involved in designing the study, data collection, analysis, writing the manuscript, or process of paper submission. This work was supported by the by the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT; grant no. 2021R1A2C1094530).

Funding Information:
S.Y. Rha reports grants and other support from MSD, BMS, Daiichi-Sankyo, Eli Lilly and Company, Indivumed, and Merck outside the submitted work. No disclosures were reported by the other authors.

Publisher Copyright:
© 2022 American Association for Cancer Research.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research


Dive into the research topics of 'Phase II Clinical Trial of Eribulin-Gemcitabine Combination Therapy in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma'. Together they form a unique fingerprint.

Cite this