e15606 Background: The multi-target tyrosine-kinase inhibitor sunitinib has been widely used in first or subsequent lines of treatment for metastatic renal cell carcinoma (mRCC). Since results of registrative clinical trials may be overestimated due to patient selection, outcome data of sunitinib in the routine clinical practice are warranted. Methods: We retrospectively reviewed clinical data of all consecutive mRCC patients starting sunitinib from March 2006 to September 2012 at our Institution. Results: Eligible were 106 pts, median age 63 years (range 27-89), 70% males, 89% clear cell histology, 87% prior nephrectomy. Sunitinib was prescribed either as first (70%) or second or further line of treatment after cytokines or targeted therapies. Patients received a median of 8 sunitinib cycles (1-49). Median PFS and OS in the first line were 15.0 mo (95% CI= 9.8-20) and 35 mo. PFS and OS in the second or further line were 15 mo (11.7-18.2) and 25 mo. Motzer risk score retained its prognostic relevance both in the first and in the second of further line. Patients who received at least 4 cycles at standard dose (50 mg/d 4 wks on/2wks off) had a significantly better PFS and OS compared to patients who did not (PFS 23.0 vs 12.0 mo p=0.012, OS 49.0 vs 16.0 mo p=0.006). First line pts progressing within three months from starting sunitinib were 18.9% (primary refractory), while 25.7% pts were treated for more than 24 mo (long term responders). Grade 3 or 4 toxicities have been recorded in 35% of pts but only 7 pts (6.6%) discontinued the treatment due to unacceptable toxicities. Conclusions: Sunitinib is active and feasible in a broader population of mRCC pts, with apparently superior PFS and OS results compared to pivotal trials. Better management of drug toxicities, less strict criteria for radiological progression, and availability of further sequential treatments may explain such results. Pts receiving at least 4 full dose cycles achieved statistically significant better outcomes.
