Phase II study of therapy selected by tumor molecular profiling in patients with previously treated metastatic pancreatic cancer. A study of the Stand Up to Cancer (SU2C) study consortium

The study accrued 49 subjects, and 48 underwent a tumor biopsy. and MP based therapy was administered to 35 patients. Study therapy was not given in 13 subjects either due to insufficient tumor on biopsy (n=8) or due to worsening cancer related symptoms after biopsy (n=5) . The demographics of evaluable patients (n=35) are M/F (59%/41%), with and age range was 34-78 (median 63 years). Time from first diagnosis of mPC to biopsy ranged from 5.8-26.7 months (median 16.1 months). Patients had 1-6 prior regimens with a median of 2. The most common IHC targets were topoisomerase 1 or 2, thymidylate synthase, ERCC1 and SPARC. Only commercially available agents were prescribed. Common regimens/agents recommended were FOLFIRI, FOLFOX, irinotecan and doxorubicin. Response rate was 9% , overall median survival of 6 months and 1 year survival was 21%. Eligible mPC patients had progressive disease following > 1 systemic therapy and a metastatic lesion amenable to percutaneous biopsy. The study required 35 evaluable patients (power of 86%) for detecting a true one year survival rate of > 20% versus the null hypothesis survival rate of < 5%. Patients underwent a percutaneous biopsy, treatment selection was based on the Target Now® IHC assay (Caris Life Sciences, Irving, TX). Samples also underwent array comparative genomic hybridization (aCGH) and microarray analysis (MA).