Abstract Aims Our aim was to evaluate first-line treatment of meta- static renal cell carcinoma (mRCC) with sorafenib in patients unwilling to receive immunotherapy or with early intolerance to immunotherapy. Patients and methods Patients had clear-cell mRCC with good or intermediate risk status, were unsuited to cy- tokine therapy due to preference or intolerance (based on <4 weeks prior immunotherapy) and had not received anti- angiogenic agents. Patients received sorafenib 400 mg twice daily until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Results Twenty-six evaluable patients were enrolled at six centres between March and July 2006. The most common metastatic sites were lung and bone; nine patients had one or two metastatic lesions. Median PFS was 7.5 months (95% confidence interval [CI] 5.1–17.5) and overall sur- vival (OS) 15.4 months (95% CI 12.9–17.4). Among 21 patients evaluable for response, 19 (90.5%) experienced disease control (including one complete response; four par- tial responses; 14 stable disease). The majority of adverse events were grade 1–2 (87.3%). The most common were asthenia (53.0%) and diarrhoea (50.0%). Conclusion In patients with mRCC who were unwilling to receive or intolerant to immunotherapy, treatment with sorafenib led to a high rate of disease control with tox- icities that were generally mild and manageable. The PFS achieved in this essentially treatment-naïve population compares favourably with that obtained in the randomised first-line phase II study. Keywords Angiogenesis inhibitors · Cytokines · Renal cell carcinoma · Sorafenib Introduction Renal cell carcinoma (RCC) represents 2–3% of all can- cers in adults. In the European Union in 2006, there were 63,000 cases of RCC diagnosed and 26,000 deaths from J. Bellmunt () Medical Oncology Service, University Hospital del Mar Paseo Marítimo, 25–29 ES-08003 Barcelona, Spain e-mail: jbellmunt@imas.imim.es J. Bellmunt · J. Carles Department of Medical Oncology Municipal Institute for Medical Research, Hospital del Mar Barcelona, Spain P. Maroto-Rey Department of Medical Oncology, Sant Pau Hospital Barcelona, Spain J.M. Trigo Department of Medical Oncology, Vall d’Hebron University Hospital Barcelona, Spain V. Guillem Department of Haematology and Oncology, University of Valencia Valencia, Spain J.A. López-Martín Department of Medical Oncology, University Hospital 12 de Octubre Madrid, Spain A. Antón-Torres University Hospital Miguel Servet Zaragoza, Spain L. Urruticoechea Bayer Schering Pharma, Sant Joan Despí, Barcelona, Spain Clin Transl Oncol (2010) 12:503-508 DOI 10.1007/s12094-010-0544-2 RESEARCH ARTICLES A phase II trial of first-line sorafenib in patients with metastatic renal cell carcinoma unwilling to receive or with early intolerance to immunotherapy: SOGUG Study 06-01 Joaquim Bellmunt · Pablo Maroto-Rey · José M. Trigo · Joan Carles · Vicente Guillem · José A. López-Martín · Antonio Antón-Torres · Leyrer Urruticoechea Received: 30 December 2009 / Accepted: 6 February 2010