Clinical Research Papers:
Efficacy and safety of sorafenib for advanced renal cell carcinoma: real-world data of patients with renal impairment
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Katsunori Tatsugami1, Mototsugu Oya2, Koki Kabu3 and Hideyuki Akaza4
1Department of Urology, Graduate School of Medical Science, Kyushu University, Higashi-ku, Fukuoka City 812-8582, Japan
2Department of Urology, Keio University School of Medicine, Shinjuku-ku, Tokyo 160-8582, Japan
3Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Chiyoda-ku, Tokyo 100-8265, Japan
4Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies/Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Meguro-ku, Tokyo 153-8904, Japan
Katsunori Tatsugami, email: [email protected]
Keywords: sorafenib; advanced RCC; eGFR; real-world data; propensity score matching
Received: January 12, 2018 Accepted: February 23, 2018 Published: April 10, 2018
Background: We retrospectively analysed the efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with renal impairment.
Methods: Patients were divided into two groups by an estimated glomerular filtration rate (eGFR) cut-off of 45 mL/min/1.73 m2. Background factors considered to affect prognosis were well balanced by propensity score matching between the groups. Demographics, dose modification, adverse events, tumour response, progression-free survival, and renal function (eGFR) were evaluated.
Results: Among 935 and 2008 patients with an eGFR of <45 and ≥45, respectively, 613 pairs were matched. The mean starting dose was significantly lower in patients with an eGFR of <45; however, the mean daily dose, median treatment duration, progression-free survival, and tumour response were similar between the groups. In terms of safety, no significant differences were found in serious adverse events, although cytopaenia (16.6% vs 10.6%) and renal dysfunction (4.4% vs 0.7%) were higher in patients with an eGFR of <45 than ≥45 in all adverse events. There were also no differences in dose modification, including dose reduction, dose interruption, and treatment discontinuation.
Conclusion: Throughout the 12-month observation period, sorafenib in patients with an eGFR of <45 and ≥45 showed similar safety and efficacy, and treatment was continued without affecting renal function.
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