Abstract #LB-259: A pilot study utilizing molecular profiling of patients\#8217; tumors to find potential targets and select treatments for their refractory cancers

Introduction: Unfortunately, the majority of patients with metastatic cancer eventually run out of treatment options for their tumors. This prospective study was designed to determine whether molecular profiling of patients\#8217; tumors at this stage in their disease could provide any clinical benefit. Methods: To be eligible, patients must have metastatic cancer and at least two prior lines of systemic therapy, have measurable or evaluable disease, have clear documentation of progression on their last treatment prior to study entry, and undergo or have available a tumor biopsy for molecular profiling. Patients\#8217; tissue samples were submitted for molecular profiling in two formats, including formalin-fixed for immunohistochemistry assays and immediately frozen tissue for oligonucleotide microarray gene expression assays. The primary objective was to compare progression free survival (PFS) using a treatment regimen selected by molecular profiling with the PFS for the most recent regimen on which the patient progressed (i.e., patients were their own controls). The molecular profiling approach was deemed of clinical benefit for the individual patient who had a PFS ratio (PFS on molecular profiling selected therapy/PFS on prior therapy) of \#8805;1.3. Results: Nine sites in the U.S. submitted tumor samples. Of 86 patients, 66 received treatment based on molecular profiling. The results of patients treated with a regimen selected by molecular profiling are outlined in Table 1 below. Conclusion: This prospective study demonstrated that: a) it is possible to measure molecular targets in patients9 tumors from nine different centers; and b) this approach may provide clinical benefit for some patients (provide a longer PFS treated by molecular profiling results than the PFS they had on their prior treatment regimen). Supported by a grant from the Stardust Foundation. >$$table_{24A86976-7E01-48CD-B1FF-14EBA7D6B8A3}$$ > Citation Information: In: Proc Am Assoc Cancer Res; 2009 Apr 18-22; Denver, CO. Philadelphia (PA): AACR; 2009. Abstract nr LB-259.