Abstract
A global, open-label, expanded-access trial (EAT) provided sunitinib treatment on a compassionate-use basis to patients with metastatic renal cell carcinoma (mRCC) between 2005 and 2011. This retrospective analysis examines outcomes in patients from Central and East European (CEE) countries participating in the global EAT. Sunitinib (starting dose 50 mg orally once daily, with dose reduction for toxicity) was administered in repeated 6-week cycles (4 weeks on and 2 weeks off) until occurrence of disease progression or unacceptable toxicity. Tumor assessments were guided by Response Evaluation Criteria in Solid Tumors (RECIST) criteria but were performed according to local standards of care. In total, 401 CEE patients received sunitinib (median treatment duration 9.6 months), of whom 378 were evaluable for tumor response. The most frequent grade ≥3 toxicities were fatigue (7.5 %), hypertension (7.0 %), thrombocytopenia (6.5 %), diarrhea (4.2 %), nausea and hand-foot syndrome (both 3.7 %) and neutropenia (3.0 %). Median overall survival was 30.7 months (95 % CI 23.3, ‒ months). Overall survival tended to be longer in cytokine-naïve than cytokine-experienced patients (median 60.8 vs. 27.5 months; P = 0.1324). Among patients with evaluable tumors, 4.0 % achieved a complete and 14.6 % a partial response [objective response rate (ORR) 18.5 % (95 % CI 14.7, 22.8 %)]. Median progression-free survival was 11.6 months (95 % CI 10.3, 12.8 months). Sunitinib demonstrates safety and effectiveness in real-world mRCC patients in CEE countries. Expanded-access program patients showed a lower tumor response rate but similar survival outcomes to patients in the pivotal Phase III clinical trial of sunitinib in mRCC.
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Acknowledgments
This study was sponsored by Pfizer Inc. Medical writing support was provided by Andrew Fitton, PhD, of Engage Scientific Solutions and was funded by Pfizer Inc.
Eduard Vrdoljak has received funding for clinical trials from Roche and Pfizer Inc,, and has received consultancy fees/honoraria from Pfizer Inc., Roche, Glaxo, Novartis and Bayer. Lajos Géczi has received consultancy fees/honoraria from Pfizer Inc., Sanofi-Aventis, Novartis and Bayer. Jozef Mardiak has received research funding from Novartis, and consultancy fees/honoraria from Pfizer Inc., Roche and Novartis. Tudor-Eliade Ciuleanuhas received consultancy fees/honoraria from Pfizer Inc., and has acted as a consultant and/or speakers’ bureau member for Pfizer Inc., Amgen, Sandoz, Merck, Roche, Bristol Myers Squibb, Novartis, Lilly, AstraZeneca, Janssen and Bayer. Laszlo Torday has received funding for clinical trials from Roche, Imatics Research, Amgen, Astra Zeneca, Astellas, Bayer, Helsinn and Pfizer Inc., and consulting honoraria from Pfizer, Roche, Bayer and Novartis. Sophie Leyman, Ke Zhang and Peter Sajben were full-time employees of Pfizer Inc. during the conduct of this study.
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Vrdoljak, E., Géczi, L., Mardiak, J. et al. Central and Eastern European Experience with Sunitinib in Metastatic Renal Cell Carcinoma: A Sub-analysis of the Global Expanded-Access Trial. Pathol. Oncol. Res. 21, 775–782 (2015). https://doi.org/10.1007/s12253-014-9889-0
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DOI: https://doi.org/10.1007/s12253-014-9889-0