828P - Rechallenge with axtinib in metastatic renal cell carcinoma (mRCC) - Experience from Gustave Roussy

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Renal Cell Cancer
Presenter Margarida Matias
Citation Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373
Authors M. Matias, A. Guida, L. Albiges, Y. Loriot, C. Massard, K. Fizazi, B. Escudier
  • Department Of Medical Oncology, Institut Gustave Roussy, 94805 Villejuif Cedex - Villejuif/FR

Abstract

Background

Axitinib (Ax) is used in routine practice in mRCC patients (pts) since 2012 in France. Efficacy in real word setting is well known, but no experience with rechallenge has been reported so far. That is the purpose of our study.

Methods

mRCC pts treated at Gustave Roussy with Ax in 2nd or further line between 11/12 and 11/15 were analysed, in order to determine rechallenge (Rech). Rech was defined as reintroduction of Ax after interruption ≥ 2 months (mo), independently whether they receive or not another systemic therapy (ST) in this period. Collected data included patient's characteristics, outcome and toxicities. If pts performed ≥ 1 Rech, only 1st Rech was considered.

Results

Among 108 mRCC pts treated with Ax from 11/12 and 11/15, Rech was performed in 12 pts (2 pts had a second Rech): in 8 cases, without any ST in between, and in 4 after another ST. Median age at Rech was 63 years (46-74) with 75% men. IMDC risk group was good, intermediate and poor in 20, 47 and 33% respectively. Reason for interruption was toxicity (5 pts), intercurrent problem (4 pts), progressive disease (PD) (2 pts) and drug holiday (1 pt). Median duration of interruption was 2.6 mo (2-8.3). Median Ax duration before Rech was 5.7 mo (2.4-13.5) with 33% partial response (PR) and 10.2 mo PFS. At the time of Rech, 9 pts had PD, while 3 had recovered from toxicity without PD. Median duration of Rech was 13.1 mo (1.6-13.6), with 27% PR and 6.9 mo PFS. Median OS is not yet achieved with a median follow-up of 17.2 mo (6.2-25.7). Grade (G) 2 and G3 adverse effects occurred in 75 and 50% of pts, mostly due to hypertension (25, 50 and 8% for G2, G3 and G4 HT). No other G4 toxicities occurred. In general, toxicities were easy manageable with standard measures.

Conclusions

Rechallenge with Ax is feasible and demonstrates efficacy with acceptable safety profile. Such Rech can be a therapeutic option for the management of mRCC pts.

Clinical trial identification

Legal entity responsible for the study

Institut Gustave Roussy

Funding

Institut Gustave Roussy

Disclosure

L. Albiges: Consulting/ advisory Board: Novartis, Pfizer, Amgen, Bayer, BMS, Ceruleon (compensated - myself ). Research funding: Novartis, Pfizer (myself ). B. Escudier: Honorarium from Pfizer, Novartis, Exelixis, BMS, Roche. All other authors have declared no conflicts of interest.