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Efficacy and tolerability of trabectedin in elderly patients with sarcoma: subgroup analysis from a phase III, randomized controlled study of trabectedin or dacarbazine in patients wits advanced liposarcoma or leiomyosarcoma
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Efficacy and tolerability of trabectedin in elderly patients with sarcoma: subgroup analysis from a phase III, randomized controlled study of trabectedin or dacarbazine in patients wits advanced liposarcoma or leiomyosarcoma

R. L. Jones, G. D. Demetri, S. M. Schuetze, M. Milhem, A. Elias, B. A. Van Tine, J. Hamm, S. McCarthy, G. Wang, T. Parekh, …
Annals of oncology, Vol.29(9), pp.1995-2002
09/01/2018
DOI: 10.1093/annonc/mdy253
PMCID: PMC6454486
PMID: 30084934
url
https://doi.org/10.1093/annonc/mdy253View
Published (Version of record) Open Access

Abstract

Background: Treatment options for soft tissue sarcoma (STS) patients aged >= 65 years (elderly) can be limited by concerns regarding the increased risk of toxicity associated with standard systemic therapies. Irabectedin has demonstrated improved disease control in a phase III trial (ET743-SAR-3007) of patients with advanced liposarcoma or leiomyosarcoma after failure of anthracycline-based chemotherapy. Since previous retrospective analyses have suggested that trabectedin has similar safety and efficacy outcomes regardless of patient age, we carried out a subgroup analysis of the safety and efficacy observed in elderly patients enrolled in this trial. Patients and methods: Patients were randomized 2 : 1 to trabectedin (n = 384) or dacarbazine (n = 193) administered intravenously every-3 ,veeks. The primary end point was overall survival (OS); secondary end points were progression-free survival (PFS), time-to progression, objective response rate (ORR), duration of response, symptom severity, and safety. A post hoc analysis was conducted in the elderly patient subgroup. Results: Among 131 (trabectedin = 94; dacarbazine = 37) elderly patients, disease characteristics were well-balanced and consistent with those of the total study population. Treatment exposure was longer in patients treated with trabectedin versus dacarbazine (median four versus two cycles, respectively), with a significantly higher proportion receiving prolonged therapy (>= 6 cycles) in the trabectedin arm (43% versus 23%, respectively; P = 0.04). Elderly patients treated with trabectedin showed significantly improved PFS [4.9 versus 15 months, respectively; hazard ratio (HR)=0.40; P= 0.0002] but no statistically significant improvement in OS (15.1 versus 8.0 months, respectively; HR = 0.72; P= 0.18) or ORR (9% versus 3%, respectively; P= 0A3). The safety profile for elderly trabectedin-treated patients was comparable to that of the overall trabectedin-treated study population. Conclusions: This subgroup analysis of the elderly population of ET743-SAR-3007 suggests that elderly patients with STS and good performance status can expect clinical benefit from trabectedin similar to that observed in younger patients.
 Life Sciences & Biomedicine Oncology Science & Technology

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