7147 POSTER The REACT Expanded-access Program of Everolimus in Patients With Metastatic Renal Cell Carcinoma Refractory to VEGF-targeted Therapy: Subgroup Analyses by Prior Therapy

Abstract

PF and 32 docetaxel-PF. Grade 3 hematologic toxicity was observed in 4 pts, grade 3 renal and neurotoxicity occurred in 1 pt each. Median PFS and OS in the whole series were 6 (1−73) and 9.5 mos (1−73) respectively. Positive p53 staining significantly associated with better OS and PFS at univariate analysis (Log-Rank test p = 0.0421 and p = 0.0483, respectively). Adjuvant setting: 17 pts (4 bilateral pN+ and 11 pelvic pN+) underwent adjuvant TPF. Median PFS and OS were 10 mos (1−73) and 13 mos (1−73). 10 pts (59%) were alive with 17 mos (1−73) of median follow-up (f-u). Neoadjuvant setting: 16 pts with cN2/3 SCC (9 cN3) were treated, either at diagnosis (11) or following recurrence after prior lymphadenectomy (5). Median PFS was 4 mos (1−46). 3 pts achieved a complete response (CR) and 6 pts achieved a partial response (PR, RR = 62%). OS was 5 mos (3−46). 11/16 pts underwent surgery that was radical in 9 (82%). 3 pathologic-CR (27%) have been achieved. 8 pts (50%) were alive with a median f-u of 9 mos (3−46). Metastatic setting: 7 pts were treated. 2 pts had a PR and 1 a SD that lasted a median of 5 mos (3−8), and all died of disease. Median PFS and OS were 2 mos (1−8) and 5 mos (2−12). Conclusion: Perioperative TPF was effective in advanced penile SCC, either in A or NA setting. It deserves further investigation including earlier stages (probably all cN+), combined with surgery. Neoadjuvant TPF allowed to obtain a significant number of responses in very advanced pts and to perform radical surgery even in nodal relapses after prior intervention. Mature results on the predictive role of biomarkers will be available in Sept 2011.