Abstract
241 Background: The timing and sequencing of combination therapy is becoming of outmost importance for the treatment of mCRPC patients. As a result our hypothesis has been to layer on enzalutamide very quickly after the completion of sipuleucel-T. Methods: We collected the data of 84 patients with chemo-naïve mCRPC treated with sipuleucel-T at our practice from September 2011 to January 2014. Prior to the initiation of treatment the baseline status was recorded in all patients. We then selected and analyzed outcomes of 19 patients who received sequential enzalutamide treatment after completion of sipuleucel-T. The average timing for the initiation of enzalutamide was 2.5±1.6 months after completion of the immune therapy. We believe this to be a very unique cohort as all of these patients were treated with enzalutamide off label (i.e. pre-chemo). Results: The median time of enzalutamide therapy was 5.4 months (range: 1-13). In our cohort of 19 patients: 1 case showed radiographic full regression of metastatic lesions in bone, lung and lymph nodes. Another case showed radiographic full regression of bony metastatic lesions. 2 other cases – showed a partial regression radiographically of bony metastatic disease. 13 cases showed stable disease according to RECIST-criteria. The remaining 2 patients were deceased due to progression of mCRPC. The patients with full and partial response were in the lowest quartile of our cohort as defined as a PSA ≤ 3.87 ng/ml. On the contrary, all cases of progression and death were documented in highest (last) quartile as defined by a PSA level more than 84 ng/ml. Conclusions: Our experience demonstrates a promising effect using sequential sipuleucel-T immunotherapy followed by enzalutamide for mCRPC. To our knowledge this will be the first case of complete radiographic regression of lung, bone, and extensive lymph node disease. Currently there are studies undergoing that will hopefully validate our experience with using enzalutamide at the initiation of sipuleucel-T.
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