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SWOG S1011: A phase III surgical trial to evaluate the benefit of a standard versus an extended lymphadenectomy performed at time of radical cystectomy for muscle invasive urothelial cancer.

2023· article· en· W4379337291 on OpenAlexaffabout
Seth P. Lerner, Catherine M. Tangen, Robert S. Svatek, Siamak Daneshmand, Kamal S. Pohar, Eila C. Skinner, Anne Schuckman, Arthur I. Sagalowsky, Norm D. Smith, Ashish M. Kamat, Wassim Kassouf, Melissa Plets, Rick Bangs, Theresa M. Koppie, Ajjai Alva, Francisco G. La Rosa, Sumanta K. Pal, Adam S. Kibel, Daniel Canter, Ian M. Thompson

Bibliographic record

VenueJournal of Clinical Oncology · 2023
Typearticle
Languageen
FieldMedicine
TopicBladder and Urothelial Cancer Treatments
Canadian institutionsMcGill University Health Centre
FundersNational Institutes of Health
KeywordsMedicineCystectomyBladder cancerLymphadenectomySurgeryRandomized controlled trialHazard ratioUrothelial cancerUrologyCancerInternal medicineConfidence interval

Abstract

fetched live from OpenAlex

4508 Background: S1011 tested the hypothesis that an extended lymphadenectomy (ELND) is associated with improved disease-free and overall survival (DFS, OS) compared to standard (S) LND in patients with localized muscle invasive bladder cancer (MIBC) undergoing radical cystectomy (RC)(NCT01224665). Methods: Eligible patients with cT2-4a N0-2 were stratified by receipt and type of neoadjuvant chemotherapy (NAC), T2 vs T3-4a and PS 0-1 vs 2. Patients were randomized 1:1 after intraoperative exploration determined they did not have disease outside the pelvis. All patients then underwent a standard bilateral pelvic LND including external and internal iliac and obturator LNs. If randomized to the experimental arm additional ELND up to at least the aortic bifurcation including common iliac (CI), pre-sciatic, and pre-sacral nodes was performed. We hypothesized that patients in the ELND arm would have a 10% improvement in 3-year DFS compared to an estimated 55% for patients in the SLND arm (HR = 0.72). Assuming a 1-sided a=0.025 and 85% power, 564 eligible randomized patients were required. Final analysis was to occur at 184 DFS events in the SLND arm or after max follow-up (6 yrs) using a stratified logrank(LR) test with a=0.022 to account for interim testing. Hazard ratios from Cox model are adjusted for strat factors. Secondary endpoints included OS and safety. Results: 36 surgeons at 27 sites in US and Canada were credentialed prior to enrolling patients, 658 were registered from 8/11-2/17, and 618 eligible patients were randomized to ELND (n=292) or SLND (n=300). Median f/up was 6.1 years in both arms. Median age was 69, 21% female, and 9% non-White. Clinical stage was balanced in both arms: T2 (71%) and T3-4a (29%). NAC was given to 57% in both. Pathologic T stage was

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.011
Threshold uncertainty score0.038

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.001
Meta-epidemiology (narrow)0.0020.000
Meta-epidemiology (broad)0.0020.002
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0020.003
Insufficient payload (model declined to judge)0.0110.001

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.

Opus teacher head0.166
GPT teacher head0.509
Teacher spread0.344 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

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".

Quick stats

Citations39
Published2023
Admission routes2
Has abstractyes

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