Real world prospective experience of axitinib in metastatic renal cell carcinoma in a large comprehensive cancer centre.

Axitinib has shown activity in metastatic renal cell carcinoma (mRCC) in a large phase III clinical trial and was approved in patients who failed first-line therapy. This drug has been available in France since November 2012. The objective is to report efficacy and safety of axitinib in mRCC outside of clinical trials.

A prospective evaluation of mRCC patients treated by axitinib in second or further next-line therapy at Gustave Roussy was conducted from 2012 to 2015. Objective response rate (ORR), progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS) and toxicities were analysed. The correlation between clinical markers and ORR, PFS, TTF and OS were explored.

One-hundred and sixty patients with mRCC, received axitinib in second (40%) or further next-line therapy (60%). International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group classification was good, intermediate and poor in 13%, 54% and 32%, respectively. Dose titration (DT) to 7 mg twice a day (bid) was performed in 38% and to 10 mg bid in 19% of the patients. Hypertension was the most common adverse event, (grade (G)3: 39%; G4: 2%). ORR occurred in 32% (n = 33, only partial response). Median PFS, TTF and OS were 8.3, 5.8 and 16.4 months, respectively. IMDC risk group and DT at 2 weeks are associated to ORR while grade 3 hypertension is marginally associated. IMDC risk group and grade 3 hypertension are significantly associated with better PFS, TTF and OS while DT at 2 weeks is associated to PFS and TTF.

Efficacy of axitinib in routine practice is similar to that previously reported, not only in second- but also in further next-lines of therapy.

European journal of cancer (Oxford, England : 1990). 2017 May 13 [Epub ahead of print]

Margarida Matias, Gwénaël Le Teuff, Laurence Albiges, Annalisa Guida, Caroline Brard, Giulia Bacciarelo, Yohann Loriot, Christophe Massard, Nathalie Lassau, Karim Fizazi, Bernard Escudier

Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: ., Department of Biostatistics and Epidemiology, Gustave Roussy, Université Paris-Saclay, Villejuif, F-94805, France; Université Paris-Saclay, University of Paris-Sud, UVSQ, CESP, INSERM, Villejuif, F-94085, France. Electronic address: ., Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: ., Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: ., Department of Biostatistics and Epidemiology, Gustave Roussy, Université Paris-Saclay, Villejuif, F-94805, France; Université Paris-Saclay, University of Paris-Sud, UVSQ, CESP, INSERM, Villejuif, F-94085, France. Electronic address: ., Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: ., Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: ., Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: ., Department of Imaging and IR4M UMR808, Gustave Roussy, F-94805, Villejuif, France; Université Paris-Sud, IR4M UMR808, Villejuif, F-94085, France. Electronic address: ., Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: ., Department of Medical Oncology, Gustave Roussy, F-94805, Villejuif, France. Electronic address: .