LBA-12 CALGB 90203 (ALLIANCE): RADICAL PROSTATECTOMY WITH OR WITHOUT NEOADJUVANT CHEMOHORMONAL THERAPY IN MEN WITH CLINICALLY LOCALIZED, HIGH RISK PROSTATE CANCER
Bibliographic record
Abstract
You have accessJournal of UrologySunday Next Frontier (LBA)1 Apr 2019LBA-12 CALGB 90203 (ALLIANCE): RADICAL PROSTATECTOMY WITH OR WITHOUT NEOADJUVANT CHEMOHORMONAL THERAPY IN MEN WITH CLINICALLY LOCALIZED, HIGH RISK PROSTATE CANCER James A. Eastham*, Glenn Heller, Susan Halabi, J. Paul Monk, Himisha Beltran, Martin Gleave, Christopher P. Evans, Steven K. Clinton, Russell Z. Szmulewitz, Jonathan Coleman, David W. Hillman, Colleen Watt, Olwen M. Hahn, Mary-Ellen Taplin, Eric J. Small, James Mohler, and Michael J. Morris James A. Eastham*James A. Eastham* More articles by this author , Glenn HellerGlenn Heller More articles by this author , Susan HalabiSusan Halabi More articles by this author , J. Paul MonkJ. Paul Monk More articles by this author , Himisha BeltranHimisha Beltran More articles by this author , Martin GleaveMartin Gleave More articles by this author , Christopher P. EvansChristopher P. Evans More articles by this author , Steven K. ClintonSteven K. Clinton More articles by this author , Russell Z. SzmulewitzRussell Z. Szmulewitz More articles by this author , Jonathan ColemanJonathan Coleman More articles by this author , David W. HillmanDavid W. Hillman More articles by this author , Colleen WattColleen Watt More articles by this author , Olwen M. HahnOlwen M. Hahn More articles by this author , Mary-Ellen TaplinMary-Ellen Taplin More articles by this author , Eric J. SmallEric J. Small More articles by this author , James MohlerJames Mohler More articles by this author , and Michael J. MorrisMichael J. Morris More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000557504.00464.d6AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Radical prostatectomy (RP) is a mainstay of treatment for men with clinically localized, high risk prostate cancer (CLHRPC). We assessed whether chemohormonal therapy with androgen deprivation therapy (ADT) plus docetaxel followed by RP would result in improved biochemical progression free survival (bPFS) than RP alone. METHODS: CALGB 90203 (Alliance) is a Phase III study which randomly assigned in a 1:1 fashion men with CLHRPC (biopsy Gleason Grade Group 4 or 5 or Kattan pre-op nomogram bPFS < 60%) to RP alone or RP plus neoadjuvant ADT plus docetaxel (75 mg per square meter of body-surface area every 3 weeks for 6 cycles). The primary objective was to test the hypothesis that 3-year bPFS would be longer in the neoadjuvant chemohormonal therapy arm. Secondary endpoints included overall bPFS and overall survival (OS). The events for the bPFS endpoint are progression, defined as a serum PSA level > 0.2 ng/ml and rising on 2 separate occasions at least 3 months after RP, and death. RESULTS: A total of 788 men (median age, 62; range: 32-83 years) were randomized. With a median follow-up of 5.1 years (range 0-11.2 years), no difference was seen in 3-year bPFS in men receiving neoadjuvant chemohormonal therapy and RP compared to RP alone (0.87 vs 0.82; p = 0.13; Figure). Expanding to the entire follow-up period, the bPFS rate was improved for the neoadjuvant arm (HR = 0.66; 95%CI: 0.47-0.94; Figure), however, the interpretation for the bPFS analyses was problematic due to 42% of patients not being evaluable for the primary endpoint because of receiving additional treatment prior to meeting the primary endpoint. An OS treatment evaluation provided evidence that patients randomized to neoadjuvant chemohormonal therapy and RP in this study had an improved OS rate relative to the RP-alone arm (HR = 0.67; 95% CI: 0.43-1.06). CONCLUSIONS: Neoadjuvant ADT plus docetaxel followed by RP did not increase 3-year bPFS compared to RP alone in men with CLHRPC. There was evidence that over time, bPFS and OS were improved in the men receiving neoadjuvant chemohormonal therapy and RP versus the men receiving RP alone. However, the 42% non-evaluable rate for bPFS tempers enthusiasm for the bPFS endpoint results. Source of Funding: U10CA180821, U10CA180882, U10CA180863 (CCTG), U10CA180888 (SWOG), and Sanofi-Aventis. ClinicalTrials.gov Identifier: NCT00430183. New York, NY; Durham, NC; Columbus, OH; New York, NY; Vancouver, Canada; Sacramento, CA; Columbus, OH; Chicago, IL; New York, NY; Rochester, MN; Chicago, IL; Boston, MA; San Francisco, CA; Buffalo, NY; New York, NY© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e997-e997 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information James A. Eastham* More articles by this author Glenn Heller More articles by this author Susan Halabi More articles by this author J. Paul Monk More articles by this author Himisha Beltran More articles by this author Martin Gleave More articles by this author Christopher P. Evans More articles by this author Steven K. Clinton More articles by this author Russell Z. Szmulewitz More articles by this author Jonathan Coleman More articles by this author David W. Hillman More articles by this author Colleen Watt More articles by this author Olwen M. Hahn More articles by this author Mary-Ellen Taplin More articles by this author Eric J. Small More articles by this author James Mohler More articles by this author Michael J. Morris 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) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.037 | 0.005 |
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".