Durable disease stabilization and antitumor activity with OSI-774 in renal cell carcinoma: A phase II, pharmacokinetic (PK) and biological correlative study with FDG-PET imaging

3050 Background: EGFR is over-expressed in >80% of renal neoplasms and is implicated in tumor initiation and progression. Antitumor activity against RCC in the phase I study of OSI-774, a selective oral quinazoline inhibitor of EGFR tyrosine kinase (EGFR-TK) activity, has lead to a 2-stage Phase II evaluation in patients (pts) with advanced RCC. Methods: OSI-774 (150mg) was administered daily using 28-day courses, until disease progression. A single dose reduction to 100 mg daily was allowed for ≥ grade-3 toxicity. Primary end point was objective response rate (CR+PR+SD). Secondary endpoints were progression free survival (PFS), overall survival, toxicity and response correlation with post-receptor effects of EGFR-TK inhibition. Results: One patient in the initial 19 patients had a partial response necessitating expanded accrual to stage 2. A total of thirty pts; 23♂/ 7♀; median age -57 (range 38–73); ECOG PS- 0(8)/ 1(18)/ 2(4); received 152 courses (median-3; range 1–15). Tumor histology was: clear cell ...