Axitinib in advanced renal cell carcinoma: real-life data and dose modification audit

Rosemeen Parkar; Ekaterini Boleti

doi:10.7861/clinmedicine.19-2-s54

Aims

To assess the general tolerability of axitinib use in advanced renal cell carcinoma in a real-world setting.
To audit our axitinib dose modification practice.

Methods

Using our electronic patient records and prescribing systems, 43 patients with advanced renal cell carcinoma, who had received axitinib between the years 2014 and 2017, were identified.

Results

31 patients had clear cell carcinoma, 11 had papillary carcinoma, and one had extensive sarcomatoid features. There were 17 women and 26 men between the ages of 37 and 86 years (median of 69 years).

Five patients received axitinib as first-line treatment within the A PREDICT trial. 33 patients received axitinib as second-line treatment, having had sunitinib (n=17), pazopanib (n=14), everolimus (n=1) or interferon alpha (n=1) as their first-line treatment.

Four patients had axitinib as their third-line treatment and one as their fourth-line treatment after failure of previous systemic treatments.

39 patients (90.7%) were commenced on the 5 mg twice daily dose of axitinib, three (6.9%) on 3 mg due to borderline performance status, and one on 7 mg for reasons not documented. Fatigue, hypothyroidism, hypertension and anorexia were the most commonly reported side effects. 28 patients (65%) reported fatigue, with 18 (41.9%) requiring either treatment breaks or steroid use. 20 patients (46.5%) had clinical and biochemical hypothyroidism requiring treatment. 14 patients (32.5%) had reported grade 2–3 hypertension requiring treatment. Grade 1–2 diarrhoea was reported in seven patients (16.3%). Two patients (4.65%) had a grade 2 palmar–plantar syndrome.

Doses were escalated in 15 cases only. The maximum dose of 10 mg was reached in only two cases. Dose reduction was reported in 13 cases, mainly due to grade 3 diarrhoea and fatigue. In the remaining 15 patients (34.8%), who had experienced grade 1 side effects, no dose modifications were made.

Conclusions

Side effects experienced by our patients are similar to those in the summary of product characteristics. Patients were commenced on appropriate dosing schedules, but a group of patients would have benefited from a dose escalation. Review points are being added to the electronic prescribing system to ensure that doses are modified appropriately.