Clinical benefit of early phase clinical trial participation for advanced sarcoma patients View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-08

AUTHORS

Robin L. Jones, David Olmos, Khin Thway, Cyril Fisher, Nina Tunariu, Sophie Postel-Vinay, Michelle Scurr, Johann de Bono, Stan B. Kaye, Ian R. Judson

ABSTRACT

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. More... »

PAGES

423-429

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-010-1484-9

DOI

http://dx.doi.org/10.1007/s00280-010-1484-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1024504475

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21069341


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