Highlights
- •Our study reports the efficacy and safety of axitinib in patients with mRCC in routine practice.
- •The results mimick those previously reported in clinical trials.
- •IMDC risk group, grade 3–4 hypertension and dose titration at 2 weeks are associated with better outcome.
Abstract
Background
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.
Methods
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.
Results
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.
Conclusion
Efficacy of axitinib in routine practice is similar to that previously reported, not
only in second- but also in further next-lines of therapy.
Keywords
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Article info
Publication history
Published online: May 13, 2017
Accepted:
April 10,
2017
Received in revised form:
April 7,
2017
Received:
January 21,
2017
Identification
Copyright
© 2017 Elsevier Ltd. All rights reserved.
