Title |
Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma
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Published in |
British Journal of Cancer, June 2015
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DOI | 10.1038/bjc.2015.196 |
Pubmed ID | |
Authors |
M E Gore, C Szczylik, C Porta, S Bracarda, G A Bjarnason, S Oudard, S-H Lee, J Haanen, D Castellano, E Vrdoljak, P Schöffski, P Mainwaring, R E Hawkins, L Crinò, T M Kim, G Carteni, W E E Eberhardt, K Zhang, K Fly, E Matczak, M J Lechuga, S Hariharan, R Bukowski |
Abstract |
We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials. Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on-2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice. A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15-17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8-10.0) and 18.7 months (95% CI: 17.5-19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand-foot syndrome (each 7%). Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results.British Journal of Cancer advance online publication, 18 June 2015; doi:10.1038/bjc.2015.196 www.bjcancer.com. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Spain | 1 | 14% |
United States | 1 | 14% |
Unknown | 5 | 71% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 5 | 71% |
Practitioners (doctors, other healthcare professionals) | 2 | 29% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Switzerland | 1 | 1% |
Unknown | 90 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 17 | 19% |
Other | 9 | 10% |
Student > Ph. D. Student | 9 | 10% |
Student > Bachelor | 8 | 9% |
Student > Master | 8 | 9% |
Other | 16 | 18% |
Unknown | 24 | 26% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 41 | 45% |
Pharmacology, Toxicology and Pharmaceutical Science | 7 | 8% |
Biochemistry, Genetics and Molecular Biology | 5 | 5% |
Agricultural and Biological Sciences | 5 | 5% |
Nursing and Health Professions | 2 | 2% |
Other | 3 | 3% |
Unknown | 28 | 31% |