MP34-20 METASTASIS-FREE SURVIVAL (MFS) IN NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) PATIENTS (PTS) WITH PROSTATE-SPECIFIC ANTIGEN (PSA) DECLINE TO < 0.2 NG/ML FOLLOWING APALUTAMIDE (APA) TREATMENT: POST HOC RESULTS FROM THE PHASE 3 SPARTAN STUDY
Bibliographic record
Abstract
You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) IV (MP34)1 Apr 2019MP34-20 METASTASIS-FREE SURVIVAL (MFS) IN NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) PATIENTS (PTS) WITH PROSTATE-SPECIFIC ANTIGEN (PSA) DECLINE TO < 0.2 NG/ML FOLLOWING APALUTAMIDE (APA) TREATMENT: POST HOC RESULTS FROM THE PHASE 3 SPARTAN STUDY Julie N. Graff*, Fred Saad, Boris A. Hadaschik, Paul N. Mainwaring, Hiroji Uemura, Simon Chowdhury, Stéphane Oudard, David Olmos, Ji Youl Lee, Angela Lopez-Gitlitz, Amitabha Bhaumik, Anil Londhe, Shinta Cheng, Mary B. Todd, Matthew R. Smith, and Eric J. Small Julie N. Graff*Julie N. Graff* More articles by this author , Fred SaadFred Saad More articles by this author , Boris A. HadaschikBoris A. Hadaschik More articles by this author , Paul N. MainwaringPaul N. Mainwaring More articles by this author , Hiroji UemuraHiroji Uemura More articles by this author , Simon ChowdhurySimon Chowdhury More articles by this author , Stéphane OudardStéphane Oudard More articles by this author , David OlmosDavid Olmos More articles by this author , Ji Youl LeeJi Youl Lee More articles by this author , Angela Lopez-GitlitzAngela Lopez-Gitlitz More articles by this author , Amitabha BhaumikAmitabha Bhaumik More articles by this author , Anil LondheAnil Londhe More articles by this author , Shinta ChengShinta Cheng More articles by this author , Mary B. ToddMary B. Todd More articles by this author , Matthew R. SmithMatthew R. Smith More articles by this author , and Eric J. SmallEric J. Small More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555927.90500.b0AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: APA, a next-generation androgen receptor inhibitor, added to androgen deprivation therapy (ADT) improved MFS by > 2 years (median 40.5 vs 16.2 mo; p < 0.0001) in high-risk pts with nmCRPC in the phase 3 SPARTAN study. In this post hoc analysis, we examined clinical outcomes in APA-treated pts whose PSA declined to < 0.2 ng/mL. METHODS: In SPARTAN, pts with nmCRPC with PSA doubling time of ≤ 10 months were randomized 2:1 to APA (240 mg QD) + ADT or placebo (PBO) + ADT. MFS, time to metastasis (mets) (TTM), and location of mets were evaluated as a function of PSA status (PSA decline to < 0.2 ng/mL at any time during the study, vs PSA not declining to < 0.2 ng/mL). Cox proportional hazard analysis estimated HRs and 95% CI. RESULTS: Following treatment with APA, PSA declined to < 0.2 ng/mL in 319/806 (40%) pts; 1 PBO pt had a decline in PSA to < 0.2 ng/mL. APA pts with a PSA decline to < 0.2 ng/mL had a 76% risk reduction for MFS (Figure) and TTM. Compared with pts who received PBO, the APA pts with PSA that declined to < 0.2 ng/mL had an 88% risk reduction for MFS and TTM. When mets developed, depth of PSA decline (to < 0.2 ng/mL vs not reaching < 0.2 ng/mL) was not associated with location of mets (bone: 53% vs 58%; nodes: 27% vs 31%). CONCLUSIONS: In nmCRPC pts treated with APA, a PSA decline to < 0.2 ng/mL occurred in 40% of pts, and was associated with an improvement in clinical end points, including MFS. Depth of PSA decline was not associated with a specific metastatic pattern. Source of Funding: Janssen Research & Development Portland, OR; Montréal, Canada; Essen, Germany; Brisbane, Australia; Yokohama, Japan; London, United Kingdom; Paris, France; Madrid, Spain; Seoul, Korea, Republic of; Los Angeles, CA; Yardley, PA; Titusville, NJ; Raritan, NJ; Boston, MA; San Francisco, CA© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e503-e503 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Julie N. Graff* More articles by this author Fred Saad More articles by this author Boris A. Hadaschik More articles by this author Paul N. Mainwaring More articles by this author Hiroji Uemura More articles by this author Simon Chowdhury More articles by this author Stéphane Oudard More articles by this author David Olmos More articles by this author Ji Youl Lee More articles by this author Angela Lopez-Gitlitz More articles by this author Amitabha Bhaumik More articles by this author Anil Londhe More articles by this author Shinta Cheng More articles by this author Mary B. Todd More articles by this author Matthew R. Smith More articles by this author Eric J. Small More articles by this author Expand All Advertisement PDF downloadLoading ...
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".