First-line sunitinib in type I and II papillary renal cell carcinoma (PRCC): SUPAP, a phase II study of the French Genito-Urinary Group (GETUG) and the Group of Early Phase trials (GEP).

5146 Background: Sunitinib (Su) has been approved in metastatic clear cell carcinoma due to high objective response rates (ORR) and a prolonged progression-free survival (PFS). Subgroups analysis of previous studies hypothesized that Su may be active in PRCC. Type I and II papillary RCC pts have a poor prognosis, with limited effective agents. METHODS SUPAP is a single-arm prospective study using a 2-stage design including 21 patients (pts) to achieve a 20% ORR and if ≥ 2 pts have an OR, 20 additional pts will be included. SUPAP is exploring type I and II PRCC separately with an identical design. Main eligibility criteria included type I or II PRCC confirmed by central pathological review, PS 0-1, measurable disease, first line of treatment. Sunitinib was given at 50 mg/d, 4/6 weeks. Primary endpoint was ORR, while safety and time to progression were secondary endpoints. RESULTS From 10/07 to 11/08, 5 pts with type I and 23 pts with II PRCC were included. The median age was 65 years old. 25 (89%) pts had a nephrectomy. PS was 0 in 14 (56%) pts and 1 in 11 (44%) pts. Using the MSKCC scoring system : 5, 14 and 4 pts were in the favorable, intermediate or poor risk group, 4 undetermined. With a median follow-up of 5 months (0.7-12), 22/28 pts were evaluable for response rate and toxicity. In type II PRCC, 1/23 pts had a partial response (PR), 13/23 pts had a stable disease (SD) with 4 pts with a SD ≥ 12 weeks, 5/23 pts were progressive, 3/23 pts were too early for evaluation and 1/23 was not evaluable. In type I PRCC, none had a partial response (PR), 3/5 pts had stable disease (SD) and 2/5 pts were too early for evaluation. A cardiac infarction occurred during treatment and was considered as related to Su. Toxicity of sunitinib was similar as reported in pivotal phase III with Su in metastatic RCC. 12 pts required a dose reduction at any time mainly for non-hematologic toxicities. CONCLUSIONS Although some activity has been observed, response rate was lower than in clear cell tumors. Updated data will be presented at the meeting. [Table: see text].