Eribulin versus dacarbazine in patients with leiomyosarcoma : subgroup analysis from a phase 3, open-label, randomised study
| Autor: | Yan Jia, Sebastian Bauer, D. R. D'Adamo, Jean-Yves Blay, Robert G. Maki, Anders Krarup-Hansen, Patrick Schöffski, Charlotte Benson |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Leiomyosarcoma
Eribulin Mesylate Adult Male Cancer Research medicine.medical_specialty Dacarbazine Medizin Phases of clinical research MESYLATE Subgroup analysis Gastroenterology Article 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine PROGNOSTIC-FACTORS Internal medicine SURVEILLANCE medicine EPIDEMIOLOGY Humans MESILATE Prospective Studies Furans Aged Science & Technology business.industry Hazard ratio SITE Sarcoma Ketones Middle Aged medicine.disease E7389 Gemcitabine SOFT-TISSUE SARCOMA chemistry Oncology GEMCITABINE 030220 oncology & carcinogenesis Female business Life Sciences & Biomedicine Eribulin medicine.drug |
| Zdroj: | British Journal of Cancer Blay, J Y, Schöffski, P, Bauer, S, Krarup-Hansen, A, Benson, C, D’Adamo, D R, Jia, Y & Maki, R G 2019, ' Eribulin versus dacarbazine in patients with leiomyosarcoma : subgroup analysis from a phase 3, open-label, randomised study ', British Journal of Cancer, vol. 120, no. 11, pp. 1026-1032 . https://doi.org/10.1038/s41416-019-0462-1 |
| DOI: | 10.1038/s41416-019-0462-1 |
| Popis: | BACKGROUND: This subgroup analysis of a phase 3 study compares outcomes for eribulin versus dacarbazine in patients with leiomyosarcoma. METHODS: Patients ≥18 years old with advanced liposarcoma or leiomyosarcoma, ECOG PS ≤2, and ≥2 prior treatment regimens were randomly assigned (1:1) to eribulin mesylate (1.4 mg/m² intravenously on day 1 and day 8) or dacarbazine (either 850, 1000, or 1200 mg/m² intravenously) every 21 days until disease progression. The primary end point was OS; additional end points were progression-free survival (PFS) and objective response rate (ORR). RESULTS: 309 Patients with leiomyosarcoma were included (eribulin, n = 157; dacarbazine, n = 152). Median age was 57 years; 42% of patients had uterine disease and 57% had nonuterine disease. Median OS was 12.7 versus 13.0 months for eribulin versus dacarbazine, respectively (hazard ratio [HR] = 0.93 [95% CI 0.71-1.20]; P = 0.57). Median PFS (2.2 vs 2.6 months, HR = 1.07 [95% CI 0.84-1.38]; P = 0.58) and ORR (5% vs 7%) were similar between eribulin- and dacarbazine-treated patients. Grade ≥3 TEAEs occurred in 69% of patients receiving eribulin and 59% of patients receiving dacarbazine. CONCLUSIONS: Efficacy of eribulin in patients with leiomyosarcoma was comparable to that of dacarbazine. Both agents had manageable safety profiles. ispartof: BRITISH JOURNAL OF CANCER vol:120 issue:11 pages:1026-1032 ispartof: location:England status: published |
| Databáze: | OpenAIRE |
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