Abstract B202: Hand-foot syndrome, the main side effect of patients with metastatic renal cell carcinoma treated with sunitinib.

Abstract

Abstract Background: Hand-foot syndrome (HFS) and related skin toxicities are common side effects of tyrosine kinase inhibitors such as sunitinib (SU), a multitargeted inhibitor of VEGF and PDGF receptors plus other receptor tyrosine kinases. In the treatment of naïve metastatic renal cancer carcinoma (mRCC) patients (pts), sunitinib showed superior progression-free survival (PFS) and objective response rate (ORR) over interferon-alfa, with a median PFS of 11 mo and median overall survival (OS) of 26.4 mo, establishing SU as a reference standard of care (Motzer et al, 2009). In this analysis, correlations between SU-associated HFS and efficacy endpoints were investigated in mRCC pts from January 2009 to January 2011 in the first- and second-line treatment settings. Methods: A total of 23 patients who received single-agent SU as 50 mg/d on a 4-week-on/2-week-off schedule (n=17; 73.9%) or 37.5 mg (n=6; 26%). Median PFS and OS were estimated and compared between pts with vs without HFS. Adverse events were recorded regularly. Results: Of 23 pts, 9 (39%) developed any-grade HFS, compared with 14 (60.8%) who did not. Most HFS (58%) initially occurred during the first 3 treatment cycles. Pts who developed HFS had significantly better ORR (55% vs. 32%), PFS (12 vs. 8 mo), and OS (23 vs. 11 mo) than pts who did not develop HFS.Conclusions: In mRCC pts, SU-associated HFS was significantly and independently associated with improved clinical outcomes. Overall, pts who did not develop HFS still had substantial benefit from SU. However, the presence of HFS identified a subset of pts that manifested highly favorable efficacy results with SU. This is suggesting that development of HFS may serve as a predictive biomarker of SU efficacy. Citation Information: Mol Cancer Ther 2013;12(11 Suppl):B202. Citation Format: Assia Bensalem, Kamel Bouzid. Hand-foot syndrome, the main side effect of patients with metastatic renal cell carcinoma treated with sunitinib. [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2013 Oct 19-23; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2013;12(11 Suppl):Abstract nr B202.