TY - JOUR
T1 - Clinical benefit of early phase clinical trial participation for advanced sarcoma patients
AU - Jones, Robin L.
AU - Olmos, David
AU - Thway, Khin
AU - Fisher, Cyril
AU - Tunariu, Nina
AU - Postel-Vinay, Sophie
AU - Scurr, Michelle
AU - De Bono, Johann
AU - Kaye, Stan B.
AU - Judson, Ian R.
N1 - Funding Information:
Acknowledgments Dr Robin Jones is supported by the Bob and Eileen Gilman Family Sarcoma Research Program. David Olmos is supported by a research fellowship from the Spanish Society of Medical Oncology (SEOM).
PY - 2011/8/1
Y1 - 2011/8/1
N2 - 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.
AB - 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.
KW - Overall survival
KW - Phase I
KW - Progression-free survival
KW - Response
KW - Sarcoma
KW - Toxicity
UR - http://www.scopus.com/inward/record.url?scp=79960921969&partnerID=8YFLogxK
U2 - 10.1007/s00280-010-1484-9
DO - 10.1007/s00280-010-1484-9
M3 - Article
C2 - 21069341
AN - SCOPUS:79960921969
SN - 0344-5704
VL - 68
SP - 423
EP - 429
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 2
ER -