naa a22 4500 510763405 CHVBK 20180411083147.0 cr unu---uuuuu 180411e20130901xx s 000 0 eng 10.1007/s12094-012-0991-z doi (NATIONALLICENCE)springer-10.1007/s12094-012-0991-z Phase II trial of sequential subcutaneous interleukin-2 plus interferon alpha followed by sorafenib in renal cell carcinoma (RCC) [Elektronische Daten] [J. Maroto, X. del Muro, B. Mellado, J. Perez-Gracia, R. Andrés, J. Cruz, E. Gallardo, M. Domenech, J. Arranz, J. Meana] Purpose: Immunotherapy (IL-2 and INF-α) was the treatment of choice for advanced renal cell carcinoma (RCC) until antiangiogenic therapy with tyrosin kinase inhibitors was developed in the early 2000s. This clinical trial explored the efficacy and toxicity of sequential treatment of IL-2 plus INF-α followed by sorafenib. Methods: Eligibility criteria included measurable, non-resectable, histologically confirmed predominantly clear cell RCC, no prior systemic treatment, and ECOG PS 0-2. The treatment regimen was a 6-week cycle of subcutaneous IL-2 at 9×106 IU on days 1-6 of weeks 1, 2, 4 and 5 plus s.c. INF-α at 6×106 IU on days 1, 3 and 5 of weeks 1-6. Responders received 6 additional weeks of this regimen. All patients received oral sorafenib (400mg bid) after immunotherapy until disease progression. The primary endpoint was progression-free survival. Results: Forty-one patients were enrolled, median age 57years. ECOG was 0/1 in 17/20 patients, 35 patients had prior nephrectomy and 18 patients pure clear cell cancer. Median PFS was 7.4months (95% CI 6.5-13.1) and OS was 16.6months (95% CI not reached). In 36 patients evaluable for response, ORR was 44.4% and control rate was 94.4%. Most adverse events (AEs) were Grade 1 or 2 toxicities (84.7%). During immunotherapy the most common AEs were pyrexia (82.9%), asthenia (56.1%) and anorexia (46.3%), whereas during sorafenib were diarrhoea (48.8%) and hand-foot syndrome (46.3%). Conclusions: A sequential regimen of IL-2 and INF-α followed by sorafenib showed effectiveness and manageable toxicity in patients with advanced RCC. Federación de Sociedades Españolas de Oncología (FESEO), 2013 Sequential treatment nationallicence Immunotherapy nationallicence Sorafenib nationallicence Renal cell carcinoma nationallicence Maroto J. Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08025, Barcelona, Spain aut del Muro X. Institut Català d'Oncologia, Barcelona, Spain aut Mellado B. Hospital Clínic i Provincial de Barcelona, Barcelona, Spain aut Perez-Gracia J. Oncology Department, Clinica Universidad de Navarra, Navarra, Spain aut Andrés R. Hospital Universitario Lozano Blesa, Zaragoza, Spain aut Cruz J. Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain aut Gallardo E. Corporació Sanitària Parc Taulí de Sabadell, Sabadell, Spain aut Domenech M. ALTHAIA Xarxa Assistencial de Manresa, Barcelona, Spain aut Arranz J. Hospital Gregorio Marañon, Madrid, Spain aut Meana J. Hospital General Universitario de Alicante, Alicante, Spain aut Clinical and Translational Oncology Springer Milan 15/9(2013-09-01), 698-704 1699-048X 15:9<698 2013 15 12094 https://doi.org/10.1007/s12094-012-0991-z text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s12094-012-0991-z text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Maroto J. Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08025, Barcelona, Spain aut NATIONALLICENCE 700 1- del Muro X. Institut Català d'Oncologia, Barcelona, Spain aut NATIONALLICENCE 700 1- Mellado B. Hospital Clínic i Provincial de Barcelona, Barcelona, Spain aut NATIONALLICENCE 700 1- Perez-Gracia J. Oncology Department, Clinica Universidad de Navarra, Navarra, Spain aut NATIONALLICENCE 700 1- Andrés R. Hospital Universitario Lozano Blesa, Zaragoza, Spain aut NATIONALLICENCE 700 1- Cruz J. Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain aut NATIONALLICENCE 700 1- Gallardo E. Corporació Sanitària Parc Taulí de Sabadell, Sabadell, Spain aut NATIONALLICENCE 700 1- Domenech M. ALTHAIA Xarxa Assistencial de Manresa, Barcelona, Spain aut NATIONALLICENCE 700 1- Arranz J. Hospital Gregorio Marañon, Madrid, Spain aut NATIONALLICENCE 700 1- Meana J. Hospital General Universitario de Alicante, Alicante, Spain aut NATIONALLICENCE 773 0- Clinical and Translational Oncology Springer Milan 15/9(2013-09-01), 698-704 1699-048X 15:9<698 2013 15 12094 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer