Alternate Schedule of Sunitinib Dosing May Be Used in Asian and Non-Asian Patients with mRCC

Treatment optimisation strategy of sunitinib shows similar safety in Asian versus non-Asian patients with mRCC

Administration of sunitinib for treatment of metastatic renal cell cancer (mRCC) via an alternate schedule is similarly safe and effective in Asian and non-Asian patient populations, investigators reported during the ESMO Asia 2017 in Singapore, an Annual Congress that is organised by the European Society for Medical Oncology.

The findings were compiled in a poster presentation from a meta-analysis of the safety and efficacy associated with using an alternate schedule of sunitinib for the treatment of mRCC in Asian compared to non-Asian patients. The alternate schedule comprises 2 weeks of sunitinib followed by one week off that may be delivered in the first-line or after a switch from the traditional schedule, which consists of sunitinib daily for 4 weeks followed by 2 weeks off-treatment.

Sunitinib is an oral, multi-targeted tyrosine kinase inhibitor that has been approved internationally for the treatment of mRCC as both first- and second-line.

The analysis identified 1132 studies using the alternate schedule of sunitinib in patients with RCCthat were published in English and appearedin the Embase, Medline, and Cochrane Library databases over the past five years.

Of the 1132 studies retrieved, 9 of the 14 articles assessed for eligibility were included in the analysis. Of these, 7 studies delivered sunitinib by the alternate schedule in a switch setting from the traditional schedule, one study was on sunitinib administered as an alternated schedule in an upfront setting, and one study included both settings.

According to hypothesis testing for equality of medians by the Kruskal Wallis test, no significant differences were observed in the incidence of adverse events experienced with the alternate sunitinib schedule between the Asian and non-Asian patient populations. The Kruskal-Wallis chi-squared value regarding the safety of an alternate schedule of sunitinib for anaemia, fatigue, hypertension, hypothyroidism, anorexia and hand-foot syndrome was median 4.59 (p = 0.58), 4.59 (p = 0.49), 5.33 (p = 0.37), 4.59 (p = 0.59), 4.59 (p = 0. 55), and 5.9 (p = 0.30) in Asian and non-Asian patients, respectively.

Overall and progression-free survival did not differ statistically between Asian and non-Asian patients with alternate sunitinib schedule

This analysis also found that overall survival (OS) did not differ statistically between Asian and non-Asian patients receiving sunitinib on an alternate schedule; median OS was 31.25 months (95% confidence interval [CI] 22.85, 39.66 months) in Asian patients compared to and 24.97 months (95% CI 14.18, 35.59) in non-Asian patients (p = 0.40)

Similar median progression-free survival (PFS) was also observed between Asian and non-Asian patients receiving alternate schedule sunitinib, where PFS was 14.51 months (95% CI 9.55, 19.48) and 15.80 months (95% CI (10.77, 20.59), respectively (p = 0.43).

Conclusions

These findings support the use of an alternate schedule for the delivery of sunitinib in Asian and non-Asian patients with mRCC and indicate that this schedule of sunitinib provides similar safety, OS, and PFS irrespective of the genomic diversity within these different racial populations.

Disclosure

This study was sponsored by Pfizer.

Reference

281P – Kapse P, et al. Comparative evaluation of safety and efficacy of alternate schedule of Sunitinib in non-Asian and Asian patient population for treatment of metastatic renal cell cancer: A Meta-analysis.