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Long-Term Response to Sunitinib Therapy for Metastatic Renal Cell Carcinoma
Authors:Ana M. Molina  Xiaoyu Jia  Darren R. Feldman  James J. Hsieh  Michelle S. Ginsberg  Susanne Velasco  Sujata Patil  Robert J. Motzer
Affiliation:1. Genitourinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY;2. Department of Medical Imaging, Memorial Sloan-Kettering Cancer Center, New York, NY;3. Department of Biostatistics and Epidemiology, Memorial Sloan-Kettering Cancer Center, New York, NY;4. Department of Medicine, Weill Medical College of Cornell University, New York, NY;1. Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada;2. Department of Biochemistry, Carver College of Medicine, University of Iowa, Iowa City, IA, USA;3. Department of Pathology, Duke University School of Medicine, Durham, NC, USA;4. China Medical University, Shenyang, China;1. Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA;2. Department of Medicine, Stanford University, Stanford, CA, USA;3. Department of Surgery, Division of Urology, The University of Texas Medical Branch, Galveston, TX, USA;1. CNRS, Grenoble INP, TIMC-IMAG, CHU de Grenoble-Alpes, University Grenoble-Alpes, Grenoble, France;2. Pôle cancer et maladies du sang, CHU de Grenoble-Alpes, Grenoble, France;3. Unité d’oncologie thoracique, pôle thorax et vaisseaux, service hospitalier universitaire pneumologie physiologie, CHU de Grenoble-Alpes, Grenoble, France;4. Inserm U 1209, CNRS UMR 5309, Institute for Advanced Biosciences, Immunobiology and Immunotherapy in Chronic Diseases, Université Grenoble-Alpes, 38000 Grenoble, France;5. R&D Laboratory, établissement français du sang Auvergne-Rhône-Alpes, 38000 Grenoble, France;6. School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland;7. Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Geneva, Switzerland;8. Université Grenoble-Alpes, Grenoble, France;1. Melanoma Institute Australia, The University of Sydney, North Sydney, New South Wales, Australia;2. Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia;3. Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia;4. Mater Hospital, North Sydney, New South Wales, Australia;5. Sydney Head & Neck Cancer Institute, Chris O''Brien Lifehouse Cancer Centre, Camperdown, Australia;6. Westmead Hospital, Westmead, New South Wales, Australia;7. Royal North Shore Hospital, St Leonards, New South Wales, Australia;8. Department of Radiation Oncology, Chris O''Brien Lifehouse Cancer Centre, Camperdown, Australia;1. Centro Oncologico Veterinario, Sasso Marconi, BO, Italy;2. Department of Veterinary Sciences and Public Health, University of Milan, Milan, Italy;3. Department of Veterinary Medical Sciences, University of Bologna, Bologna, Italy;4. Department of Veterinary Sciences, University of Turin, Turin, Italy;5. Urodelia, St Lys, France;6. Department of Comparative Biomedicine and Food Science, University of Padova, Agripolis Legnaro, Italy;1. Department of Radiation Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands;2. Department of Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands;3. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA;4. Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, USA;5. Central Diagnostic Laboratory, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands;6. Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
Abstract:BackgroundSunitinib achieves objective response and prolongs progression-free survival (PFS) in patients with metastatic renal cell carcinoma (RCC). A subset of patients achieves long-term responses. The characteristics of patients who achieved long-term response (defined as patients achieving ongoing complete response [CR] or remaining progression free for > 18 months while receiving sunitinib) are reported.Patients and MethodsA database of 186 patients treated with sunitinib alone (n = 89) or in combination (n = 97) in 9 clinical trials was reviewed; all had 1 year or more follow-up from sunitinib start to data cutoff for analysis. Median PFS was 10.8 months (95% CI, 8.3-13.3); median overall survival (OS) was 30.4 months (95% CI, 21.5-36.8 months) for the 186 patients. Thirty-four patients were identified as long-term responders because they either had durable CR or remained progression free while receiving sunitinib for > 18 months.ResultsBest response for 34 long-term responders was CR in 3 patients, partial response (PR) in 24 patients, and stable disease in 7 patients. The median duration of sunitinib therapy was 24.9 months (range, 18.1-73.9 months). The median PFS among the long-term responders was 17.4 months (95% CI, 7-29.9 months) at a landmark PFS analysis performed after 18 months from treatment start. Univariate analysis from the 186 patients identified bone metastasis, lung metastasis, and intermediate/poor risk groups as adverse prognostic factors for long-term response.ConclusionSunitinib achieves long-term response in a subset of patients with metastatic RCC. Lack of bone metastasis or lung metastasis and good MSKCC risk status may predict long-term response.
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