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Bone Scans Associated with Prolonged Overall Survival in Patients with Metastatic Castrate Resistant Prostate Cancer Treated with Sipuleucel-T
Ron S. Israeli, MD1, Adam S. Kibel, MD2, Albert Azose, MD3, Robert B. Sims, MD4, Todd DeVries, PhD4, E. David Crawford, MD5.
1Staten Island Urologic Oncology, Staten Island, NY, USA, 2Dana-Farber Cancer Institute, Boston, MA, USA, 3Seattle Radiologists, Seattle, WA, USA, 4Dendreon, Seattle, WA, USA, 5University of Colorado, Denver, CO, USA.
BACKGROUND: The Phase 3 IMPACT trial reported a 22% reduction in risk of death with sipuleucel−T in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (mCRPC). In this analysis, baseline bone metastasis burden and changes following treatment were assessed as predictors of overall survival (OS).
METHODS: 111/512 IMPACT patients had bone scans at baseline and weeks 6, 10, 14 and 18, with no additional CRPC treatment. Sipuleucel−T patients who were among the 20 longest or shortest survivors had bone scans reviewed by a blinded board certified nuclear radiologist to predict long or short OS.
RESULTS: 26 sipuleucel−T patients were assessed: n=16 in the long OS group (median OS=54.2 months; Halabi predicted=27.1 months); n=10 in the short OS group (median OS=10.8 months; Halabi predicted=17.9 months). Long/short OS was correctly predicted in 76%/67% of patients (81% sensitivity, 60% specificity, 73% crude agreement [P=0.029 vs uninformed 50% rate of correct prediction]). Patients with long OS prediction had: <7 baseline lesions, an increase of ≤2 lesions at week 10, and an increase of ≤5 lesions at week 18.
CONCLUSIONS: Patients receiving sipuleucel−T with low baseline tumor burden found on bone scans and slow rate of progression may have an increased likelihood of prolonged OS.
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