Predictive factors for severe toxicity of sunitinib in unselected patients with advanced renal cell cancer

• Published in: British journal of cancer 2008-07, Vol.99 (2), p.259-265
• Main Authors: van der Veldt, A A M, Boven, E, Helgason, H H, van Wouwe, M, Berkhof, J, de Gast, G, Mallo, H, Tillier, C N, van den Eertwegh, A J M, Haanen, J B A G
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cancer Research; Carcinoma, Renal Cell - drug therapy; Clinical Study; Disease-Free Survival; Dose-Response Relationship, Drug; Drug Resistance; Epidemiology; Female; Humans; Indoles - adverse effects; Indoles - therapeutic use; Kidney Neoplasms - drug therapy; Kidneys; Male; Medical sciences; Middle Aged; Molecular Medicine; Nephrology. Urinary tract diseases; Oncology; Pyrroles - adverse effects; Pyrroles - therapeutic use; Risk Factors; Tumors; Tumors of the urinary system
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6604456

Sunitinib has been registered for the treatment of advanced renal cell cancer (RCC). As patient inclusion was highly selective in previous studies, experience with sunitinib in general oncological practice remains to be reported. We determined the efficacy and safety of sunitinib in patients with advanced RCC included in an expanded access programme. ECOG performance status >1, histology other than clear cell and presence of brain metastases were no exclusion criteria. Eighty-two patients were treated: 23% reached a partial response, 50% had stable disease, 20% progressed and six patients were not evaluable. Median progression-free survival (PFS) was 9 months and median overall survival (OS) was 15 months. Importantly, 47 patients (57%) needed a dose reduction, 35 (43%) because of treatment-related adverse events, 10 (12%) because of continuous dosing, and two because of both. Stomatitis, fatigue, hand–foot syndrome and a combination of grade 1–2 adverse events were the most frequent reasons for dose reduction. In 40 patients (49%), there was severe toxicity, defined as dose reduction or permanent discontinuation, which was highly correlated with low body surface area, high age and female gender. On the basis of age and gender, a model was developed that could predict the probability of severe toxicity.