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A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in Metastatic Castration-resistant Prostate Cancer Following
Phillip H Kuo1, Michael J Morris1, Jacob Hesterman1
1From the University of Arizona, Tucson, Ariz (P.H.K.); Memorial Sloan-Kettering Cancer Center, New York, NY (M.J.M.); Invicro, Needham, Mass (J.H.); Mayo Clinic, Rochester, Minn (A.T.K., O.S.); Department of Nuclear Medicine, University Hospital Münster, Münster, Germany (K.R.); West German Cancer Center, Münster and Essen, Germany (K.R.); Dana-Farber Cancer Institute, Boston, Mass (X.X.W.); Astera Cancer Care, East Brunswick, NJ (B.F.); Indiana University Simon Comprehensive Cancer Center, Indianapolis, Ind (N.A.); Miami Cancer Institute, Baptist Health South Florida, Miami, Fla (R.G.); Washington University, St. Louis, Mo (J.M.M.); British Columbia Cancer Agency, Vancouver, British Columbia, Canada (K.C.); The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom (J.d.B.); Gustave Roussy Institute, University of Paris-Saclay, Villejuif, France (K.F.); Rostock University Medical Center, Rostock, Germany (B.K.); Weill Cornell Medicine, New York, NY (S.T.T.); Novartis Pharmaceuticals, East Hanover, NJ (S.G.); Novartis Pharmaceuticals, Indianapolis, Ind (M.B.); Novartis Pharmaceuticals, Cambridge, Mass (C.C.W.); Novartis Pharmaceuticals, Geneva, Switzerland (A.M.C.); Novartis Pharmaceuticals, St. George, Utah (T.B.); Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (A.J.A.); and University Hospital Essen and German Cancer Consortium, Hufelandstr. 55, 45147 Essen, Germany (K.H.).
None:
Background Lutetium 177 [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) is a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). Quantitative PSMA PET/CT analysis could provide information on 177Lu-PSMA-617 treatment benefits. Purpose To explore the association between quantitative baseline gallium 68 [68Ga]Ga-PSMA-11 (68Ga-PSMA-11) PET/CT parameters and treatment response and outcomes in the VISION trial. Materials and Methods This was an exploratory secondary analysis of the VISION trial. Eligible participants were randomized (June 2018 to October 2019) in a 2:1 ratio to 177Lu-PSMA-617 therapy (7.4 GBq every 6 weeks for up to six cycles) plus standard of care (SOC) or to SOC only. Baseline 68Ga-PSMA-11 PET parameters, including the mean and maximum standardized uptake value (SUVmean and SUVmax), PSMA-positive tumor volume, and tumor load, were extracted from five anatomic regions and the whole body. Associations of quantitative PET parameters with radiographic progression-free survival (rPFS), overall survival (OS), objective response rate, and prostate-specific antigen response were investigated using univariable and multivariable analyses (with treatment as the only other covariate). Outcomes were assessed in subgroups based on SUVmean quartiles. Results Quantitative PET parameters were well balanced between study arms for the 826 participants included. The median whole-body tumor SUVmean was 7.6 (IQR, 5.8-9.9). Whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy, with a hazard ratio (HR) range of 0.86-1.43 for all outcomes (all P < .001). A 1-unit whole-body tumor SUVmean increase was associated with a 12% and 10% decrease in risk of an rPFS event and death, respectively. 177Lu-PSMA-617 plus SOC prolonged rPFS and OS in all SUVmean quartiles versus SOC only, with no identifiable optimum among participants receiving 177Lu-PSMA-617. Higher baseline PSMA-positive tumor volume and tumor load were associated with worse rPFS (HR range, 1.44-1.53 [P < .05] and 1.02-1.03 [P < .001], respectively) and OS (HR range, 1.36-2.12 [P < .006] and 1.04 [P < .001], respectively). Conclusion Baseline 68Ga-PSMA-11 PET/CT whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy in participants in the VISION trial. Improvements in rPFS and OS with 177Lu-PSMA-617 plus SOC were greater among participants with higher whole-body tumor SUVmean, with evidence for benefit at all SUVmean levels. ClinicalTrials.gov identifier: NCT03511664 Published under a CC BY 4.0 license. Supplemental material is available for this article.
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