Published in:
01-08-2011 | Original Article
Clinical benefit of early phase clinical trial participation for advanced sarcoma patients
Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2011
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Purpose
Standard systemic treatment options for patients with advanced sarcoma are limited. Depending on the histological subtype, patients receive differing lines of therapy usually consisting of doxorubicin, ifosfamide and/or trabectedin. After progression on conventional therapies, some patients are offered more experimental options including Phase I clinical trials. The aim of this study was to evaluate the clinical benefit for sarcoma patients treated within the Phase I Unit of a single referral centre.
Methods
The response, toxicity and outcome of sarcoma patients treated within Phase I clinical trials at the Royal Marsden between August 1998 and December 2010 were analysed.
Results
One hundred and thirty-three patients were treated. The median number of prior systemic therapies was 3 (range 0–6). The median age of these patients was 48.0 years (range 12.5–81.9), with a male/female ratio of 71/62. One patient (0.8%) achieved a complete response and 2 (1.6%) partial responses. The non-progression rate at 3 and 6 months was 31.5% (95% CI, 23.4–39.6%) and 11.0% (95% CI 5.6–16.5%), respectively. The median progression-free survival was 2.1 months (95% CI, 1.7–2.5), and median overall survival was 7.6 months (95% CI, 4.8–10.4). Twenty-four (18.0%) patients experienced grade 3 or 4 toxicity, and 16 (12.0%) stopped trial treatment due to toxicity.
Conclusion
Phase I clinical trials could be considered a therapeutic option in sarcoma patients with no remaining standard treatment due to the low risk of toxicity and the potential for clinical benefit.