Evidence map›Paper›PMID 18367117›Full record

Trial reportUrologic oncology

Failure to achieve a complete response to induction BCG therapy is associated with increased risk of disease worsening and death in patients with high risk non-muscle invasive bladder cancer.

Seth P Lerner, Catherine M Tangen, Heidi Sucharew, David Wood, E David Crawford

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Urologic oncology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Review
  8. Article
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  16. Strategies for Overcoming Immune Evasion in Bladder Cancer.International journal of molecular sciences · 2024
    Review
  17. Article
  18. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Seth P LernerScott Department of Urology, Baylor College of Medicine, Houston, TX 77030, USA. slerner@bcm.tmc.edu
Catherine M Tangen
Heidi Sucharew
David Wood
E David Crawford

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
Targeting Ral GTPases in Bladder CancerP50CA091846 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DINNEY, COLIN P.N., MCCONKEY, DAVID J. · 2001 to 2018
$37.4M
ZOLENDRONIC ACID IN CHILDREN W/ SEVERE OSTEOGENESIS IMPERFECTAM01RR000188 · NCRR · BAYLOR COLLEGE OF MEDICINE · PI LOUIS, CHRYSTAL U · 1985 to 2011
$30.6M
Markers of Genetic Susceptibility to Bladder CancerR01CA074880 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI WU, XIFENG · 1999 to 2008
$3.1M
MVAC IN ORGAN-CONFINED BLADDER CANCER BASED P53 STATUSR01CA071921 · NCI · YALE UNIVERSITY · PI COTE, RICHARD JAMES · 1997 to 2006
$3.0M
Genetic Susceptibility Modifiers in Renal Cell CarcinomaR01CA098897 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI WU, XIFENG · 2003 to 2007
$2.5M
PHASE II CLINICAL TRIAL OF CELECOXIB OR (NSAID) IN BLADDN01CN085186 · CN · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI SABICHI, ANITA L · 1998 to 2000
$801k
PHASE III STUDY OF FENRETINIDE IN BLADDER CARCINOFENESISU01CA077150 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI LIPPMAN, SCOTT M · 1997 to 2001
$450k
NCI NIH HHS 1R01CA71921-01NCI NIH HHS 1UO1CA77150-01NCI NIH HHS 2PC50CA091846-06S2NCI NIH HHS 5 R01 CA074880 08NCI NIH HHS 5 R01 CA098897 04NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA038926NCI NIH HHS N01 CN085186NCI NIH HHS N01-CN-85186NCI NIH HHS P50 CA091846NCI NIH HHS R01 CA071921NCI NIH HHS R01 CA074880NCI NIH HHS R01 CA098897NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA038926NCRR NIH HHS M01 RR000188
6 · The paper itself

Abstract

purposeThe Southwest Oncology Group conducted a randomized trial of induction bacillus Calmette-Guérin (BCG) with or without maintenance BCG. In these additional retrospective analyses, our goal was to evaluate the association of a complete response (CR) or remaining with no evidence of disease (NED) vs. no CR during induction therapy with subsequent survival after adjusting for other potential confounders. Among all patients randomized to maintenance treatment, we also wanted to identify combinations of baseline covariates in order to define prognostic groups for subsequent worsening-free survival.

methodsOutcome measures of worsening-free and overall survival were assessed using Kaplan Meier estimates and proportional hazards regression models. For the classification and regression tree (CART) analysis, 434 patients randomized to maintenance vs. no therapy with complete covariate information were included.

resultsOf the 593 evaluable patients, 341 were not randomized to maintenance BCG. Patients who achieved a prior complete response during induction BCG had a 5-year survival probability of 77% compared with 62% for patients who did not [hazard ratio (HR) 0.60; 95% confidence interval (CI) 0.44, 0.81; P = 0.0008]. Prior CR retained significance when adjusted for age, gender, prior intravesical chemotherapy, and papillary disease versus CIS (HR = 0.63; 95% CI: 0.46, 0.86; P = 0.003). CART analysis identified 4 prognostic groups. Older patients (> or =62 years old) previously treated with intravesical chemotherapy who failed to achieve a CR had a 5-fold higher risk of a worsening event relative to those who are younger (<67 years old) and achieve a CR (HR = 5.09; 95% CI: 3.37, 7.68; P < 0.0001).

conclusionFailure to achieve a complete response after induction BCG is associated with a significant risk of a worsening event and death for patients with CIS or Ta or T1 bladder cancer at increased risk of recurrence.

Indexed as

AgedBCG VaccineDisease-Free SurvivalFemaleHumansImmunotherapyMaleMiddle AgedNeoplasm InvasivenessPrognosisProportional Hazards ModelsRegression AnalysisRiskTreatment OutcomeUrinary Bladder NeoplasmsBCG Vaccine

Identifiers

PMID18367117
PMCPMC2695968

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.