Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma

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. MatczakM. J. Lechuga, S. Hariharan, R. Bukowski

Research output: Contribution to journalArticlepeer-review


BACKGROUND: 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.

METHODS: 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.

RESULTS: 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%).

CONCLUSION: 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.

Original languageEnglish
Pages (from-to)12-19
Number of pages8
JournalBritish Journal of Cancer
Issue number1
Publication statusPublished - Jun 30 2015

ASJC Scopus subject areas

  • Medicine(all)


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