Alexandr Poprach1, Zbynek Bortlicek2, Bohuslav Melichar3, Radek Lakomy1, Marek Svoboda1, Igor Kiss1, Milada Zemanova4, Ondrej Fiala5, Katerina Kubackova6, Oldrich Coufal1, Tomas Pavlik2, Ladislav Dusek2, Rostislav Vyzula1, Tomas Buchler7. 1. Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Zluty kopec 7, 656 53 Brno, Czech Republic. 2. Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 126/3, 625 00 Brno, Czech Republic. 3. Department of Oncology, Palacky University Medical School and Teaching Hospital, I.P. Pavlova 6, 775 20 Olomouc, Czech Republic. 4. Department of Oncology, General University Hospital and Charles University First Faculty of Medicine, U Nemocnice 499/2, 128 08 Prague, Czech Republic. 5. Department of Oncology, University Hospital, Svobody 80, 304 60 Pilsen, Czech Republic. 6. Department of Oncology, Motol University Hospital and Charles University Second Faculty of Medicine,V uvalu 84/1, 150 00 Prague, Czech Republic. 7. Department of Oncology and First Faculty of Medicine, Thomayer Hospital and Charles University, Videnska 800, 140 59 Prague, Czech Republic. Electronic address: tomas.buchler@ftn.cz.
Abstract
AIM: The aim of this retrospective, registry-based study was to analyse treatment outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib and renal insufficiency (RI). METHODS: The cohort included 790 patients treated with sunitinib between 2006 and 2013. At the start of sunitinib therapy 22, 234, and 534 patients had severe (glomerular filtration rate [GFR] <30ml/min/1.73m(2)), moderate (GFR 30-60 ml/min/1.73m(2)) or mild RI/normal renal function (GFR >60ml/min/1.73m(2)), respectively. RESULTS: For the three groups defined above, median progression-free survival (PFS) (95% confidence interval [CI]) was 5.3 months (0.1-18.5), 8.1 months (6.2-9.9) and 11.3 months (9.4-13.2) (p=0.244), and median overall survival (OS) was 26.3 months (1.2-51.4), 21.2 months (13.2-29.1) and 26.3 months (22.6-29.9) (p=0.443), respectively. The disease control rates were 45.5%, 56.4% and 59.2%, respectively (p=0.374). No unexpected toxicity was reported in the patients with RI, but the treatment was more frequently discontinued because of adverse events and the duration of therapy was significantly shorter in these patients (p=0.007). CONCLUSIONS: Duration of first-line targeted treatment for mRCC was significantly shorter for patients with RI, and may have translated into a trend to shorter PFS. These results highlight the need for optimal management of side-effects in patients with mRCC and RI.
AIM: The aim of this retrospective, registry-based study was to analyse treatment outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib and renal insufficiency (RI). METHODS: The cohort included 790 patients treated with sunitinib between 2006 and 2013. At the start of sunitinib therapy 22, 234, and 534 patients had severe (glomerular filtration rate [GFR] <30ml/min/1.73m(2)), moderate (GFR 30-60 ml/min/1.73m(2)) or mild RI/normal renal function (GFR >60ml/min/1.73m(2)), respectively. RESULTS: For the three groups defined above, median progression-free survival (PFS) (95% confidence interval [CI]) was 5.3 months (0.1-18.5), 8.1 months (6.2-9.9) and 11.3 months (9.4-13.2) (p=0.244), and median overall survival (OS) was 26.3 months (1.2-51.4), 21.2 months (13.2-29.1) and 26.3 months (22.6-29.9) (p=0.443), respectively. The disease control rates were 45.5%, 56.4% and 59.2%, respectively (p=0.374). No unexpected toxicity was reported in the patients with RI, but the treatment was more frequently discontinued because of adverse events and the duration of therapy was significantly shorter in these patients (p=0.007). CONCLUSIONS: Duration of first-line targeted treatment for mRCC was significantly shorter for patients with RI, and may have translated into a trend to shorter PFS. These results highlight the need for optimal management of side-effects in patients with mRCC and RI.
Authors: Silvia Salerno; Elisabetta Barresi; Aída Nelly García-Argáez; Sabrina Taliani; Francesca Simorini; Giorgio Amendola; Stefano Tomassi; Sandro Cosconati; Ettore Novellino; Federico Da Settimo; Anna Maria Marini; Lisa Dalla Via Journal: ACS Med Chem Lett Date: 2019-01-17 Impact factor: 4.345