Application of a drug-induced apoptosis assay to identify treatment strategies in recurrent or metastatic XXXX .

@entity1 @entity5 @entity0
BACKGROUND: A drug-induced apoptosis assay has been developed to determine which chemotherapy drugs or regimens can produce higher cell killing in vitro. This study was done to determine if this assay could be performed in @entity1 with recurrent or metastatic @entity0 @entity1 , to characterize the patterns of drug-induced apoptosis, and to evaluate the clinical utility of the assay. A secondary goal was to correlate assay use with clinical outcomes. METHODS: In a prospective, non-blinded, multi institutional controlled trial, 30 evaluable @entity1 with recurrent or metastatic @entity0 who were treated with chemotherapy had @entity5 samples submitted for the MiCK drug-induced apoptosis assay. After receiving results within 72 hours after biopsy, physicians could use the test to determine therapy (users), or elect to not use the test (non-users). RESULTS: The assay was able to characterize drug-induced apoptosis in @entity5 specimens from @entity0 @entity1 and identified which drugs or combinations gave highest levels of apoptosis. Patterns of drug activity were also analyzed in triple negative @entity0 . Different drugs from a single class of agents often produced significantly different amounts of apoptosis. Physician frequently (73%) used the assay to help select chemotherapy treatments in @entity1 , @entity1 whose physicians were users had a higher response (CR+PR) rate compared to non-users (38.1% vs 0%, p = 0.04) and a higher disease control (CR+PR+Stable) rate (81% vs 25%, p<0.01). Time to relapse was longer in users 7.4 mo compared to non-users 2.2 mo (p<0.01). CONCLUSIONS: The MiCK assay can be performed in @entity0 specimens, and results are often used by physicians in @entity0 @entity1 with recurrent or metastatic disease. These results from a good laboratory phase II study can be the basis for a future larger prospective multicenter study to more definitively establish the value of the assay. TRIAL REGISTRATION: Clinicaltrials.gov NCT00901264.
