Phase II trial of sequential subcutaneous interleu

Authors: J P Maroto X G del Muro B Mellado J L PerezGracia R Andrés J Cruz E Gallardo M Domenech J Á Arranz J A Meana

Publish Date: 2013/01/29

Volume: 15, Issue: 9, Pages: 698-704

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Abstract

Immunotherapy IL2 and INFα 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 IL2 plus INFα followed by sorafenibEligibility criteria included measurable nonresectable histologically confirmed predominantly clear cell RCC no prior systemic treatment and ECOG PS 0–2 The treatment regimen was a 6week cycle of subcutaneous IL2 at 9 × 106 IU on days 1–6 of weeks 1 2 4 and 5 plus sc INFα 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 400 mg bid after immunotherapy until disease progression The primary endpoint was progressionfree survivalFortyone patients were enrolled median age 57 years ECOG was 0/1 in 17/20 patients 35 patients had prior nephrectomy and 18 patients pure clear cell cancer Median PFS was 74 months 95  CI 65–131 and OS was 166 months 95  CI not reached In 36 patients evaluable for response ORR was 444  and control rate was 944  Most adverse events AEs were Grade 1 or 2 toxicities 847  During immunotherapy the most common AEs were pyrexia 829  asthenia 561  and anorexia 463  whereas during sorafenib were diarrhoea 488  and hand–foot syndrome 463 

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