Efficacy and tolerability of axitinib in metastatic renal cell carcinoma (mRCC): Comparison of Czech clinical registry and AXIS trial data

Background: The present retrospective analysis was conducted to evaluate the efficacy of axitinib, a potent and specific inhibitor of vascular endothelial growth factor receptors 1, 2 and 3, as second-line therapy for mRCC in real-world clinical practice. The database of the Czech Clinical Registry of Renal Cell Cancer Patients was used, to which healthcare providers are obliged to provide data on innovative products.

Materials and Method: Data of patients included in the registry were analyzed and the outcomes were compared with the results of the Phase III AXIS trial (Rini et al. Lancet 2011;378:1931–9.).

Results: A total of 97 patients, 58 males and 39 females (mean age 63 years) with progressive disease after sunitinib were included in the present analysis. Patients had a performance status of 0 (54%) or 1 (46%), and all but one had clear cell RCC. Dose escalation was performed in 4 (4%) of patients and the mean axitinib dose was 9.4mg/day. The median progression-free survival (PFS) of 6.2 months (95%CI 5.1–9.6) for patients included in the registry was significantly longer compared to PFS of 4.8 months reported in the AXIS trial (p=0.045). PFS prolongation despite the omission of dose titration could be explained by less frequent radiology evaluations and patient selection. The response rate and disease control rate were 15% and 45%, respectively, but the response was not evaluable in 35% of patients. Median overall survival has not been reached; one year survival rate was 67% (95%CI 38–85%). Axitinib was well tolerated and no life-threatening adverse events were recorded. At the time of this analysis, treatment was ongoing in 54 patients.

Conclusion: Axitinib is an effective and well-tolerated second-line therapy for patients with mRCC in a real-world clinical practice setting. The PFS observed was longer than in AXIS; this was observed despite the absence of dose escalation.

The present analysis was created based on data from registry organized by NRC and technically supported by IBA MU.

Conflict of interest: Other Substantive Relationships: Professor Melichar: honoraria for lectures (Pfizer). Dr Büchler: honoraria for lectures (Pfizer). Dr Kubáčková: honoraria for lectures and travel grant (Pfizer).