Lancet Publishes First Trial To Show Overall Survival Benefit Of Halaven® (eribulin) in People With Soft Tissue Sarcoma Sub-Types - Seite 3

Global Phase III Clinical Study 309^[1]

The primary endpoint of the study was to compare overall survival between patients treated with eribulin mesilate (1.4 mg/m² intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/m², 1000 mg/m², or 1200 mg/m² [dose dependent on centre and clinician] intravenously on day 1). The additional endpoints included progression free survival and quality of life.^[1]

Patients were aged ≥18 years with advanced high/intermediate grade leiomyosarcoma or dedifferentiated, myxoid, round cell or pleomorphic variants of adipocytic sarcoma (ADI) incurable by surgery and/or radiotherapy were enrolled. Patients had ECOG status ≤2 and had received ≥2 standard systemic treatment regimens including an anthracycline. Patients were randomized 1:1 to eribulin mesilate (1.4 mg/m2, IV on D1 and D8) or dacarbazine (850-1200 mg/m2, IV on D1) every 21 days until disease progression.

Overall, 452 patients (67% female; 79% <65 years) were randomized (228 eribulin; 224 dacarbazine). Median OS for eribulin and dacarbazine was 13.5 and 11.5 months, respectively (HR=0.768, 95% CI 0.618-0.954; P=0.017). PFS was 2.6 months in both arms (HR=0.877, 95% CI 0.710-1.085; P=0.229). PFS rate at week 12 was 33% and 29% for eribulin and dacarbazine, respectively. Eribulin had a toxicity profile consistent with prior experience, with no unexpected or new safety findings. In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known profile of eribulin.

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References 

1. Schöffski P et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016.  
2. Cancer Research UK, Soft Tissue Sarcoma Incidence Statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/soft-tissue-sarcoma/incidence/ Accessed: November 2015
3. Young R, Woll P. Eribulin - a new active agent for L-sarcoma. The Lancet. 2016
4. Macmillan. What are soft tissue sarcomas? Available at:       http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx. Accessed: November 2015
5. Fletcher et al. World Health Organization Classification of Tumours of Soft Tissue and Bone (4th Edition). Lyon: IARC Press, 2013
6. ESMO Guidance. Available at: http://annonc.oxfordjournals.org/content/25/suppl_3/iii102.full.pdf+html Accessed: November 2015
7. National Cancer Institute. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adult-soft-tissue-sarcoma/HealthProfessional/page1. Accessed November 2015
8. Matsuda S., et al. Soft-Tissue Sarcoma Surveillance Counterpoint: Japan. Current Clinical Oncology. 2013; 233-34
9. Tsujii H, et al. Carbon-Ion Radiotherapy: Principles, Practices, and Treatment Planning. Springer. 2014; (XII)312:37
10. SPC Halaven (updated November 2015). Available at: http://www.medicines.org.uk/emc/medicine/24382 Accessed: December 2015
11. R. Pollock. Soft Tissue Sarcomas, A Volume in the American Cancer Society Atlas of Clinical Oncology Series. 2012