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Cesne AL , Judson I , Maki R , Grosso F , Schuetze S , Mehren MV , Chawla SP , Demetri GD , Nieto A , Tanovic A , Blay JY
Trabectedin is a feasible treatment for soft tissue sarcoma patients regardless of patient age: a retrospective pooled analysis of five phase II trials
British Journal of Cancer. 2013 Oct;109(7) :1717-1724
PMID: WOS:000325216700002    PMCID: PMC 3790176   
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Abstract
Background: This retrospective pooled analysis assessed the effect of age on the efficacy and safety of trabectedin in young and elderly patients with recurrent advanced soft tissue sarcoma (STS). Methods: Data from 350 adults with STS treated in five phase II trials with trabectedin were divided in the younger (< 60 years; n = 267) and the older cohort (>= 60 years; n = 83). Results: The response rate did not differ with age (younger: 10.1% vs elderly 9.6%). No significant differences were found in median progression-free survival (PFS) in younger (2.5 months) and older (3.7 months) cohort with a comparable PFS rates at 3 (45.1% vs 55.1%) and 6 months (29.5% vs 36.4%). Similar median overall survival was observed in both cohorts (13.0 vs 14.0 months). Reversible neutropenia and aspartate aminotransferase/alanine aminotransferase elevation were the most common abnormalities. A higher incidence of grade 3/4 neutropenia (43.6% vs 60.2%) and fatigue (6.3% vs 14.4%) was observed in older patients. In 24 patients aged >= 70 years, no significant differences in efficacy or safety outcomes were found. Conclusion: This analysis demonstrated that trabectedin is a feasible treatment in young and elderly patients with STS, with meaningful clinical benefits and an acceptable safety profile, essential in palliative treatment of elderly patients.
Notes
Cesne, A. L. Judson, I. Maki, R. Grosso, F. Schuetze, S. Mehren, M. V. Chawla, S. P. Demetri, G. D. Nieto, A. Tanovic, A. Blay, J-Y