Evidence map›Paper›PMID 24565955›Full record

Trial reportJournal of the National Cancer Institute2014

Serum biomarkers of bone metabolism in castration-resistant prostate cancer patients with skeletal metastases: results from SWOG 0421.

Primo N Lara, Benjamin Ely, David I Quinn, Philip C Mack, Catherine Tangen, Erik Gertz, Przemyslaw W Twardowski, Amir Goldkorn, Maha Hussain, Nicholas J Vogelzang and 2 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the National Cancer Institute, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% of its field
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

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Observational
  9. Review
  10. Endothelin and the tumor microenvironment: a finger in every pie.Clinical science (London, England : 1979) · 2024
    Review
  11. Flare phenomenon visualized byAnnals of nuclear medicine · 2024
    Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Emerging Biomarker-Guided Therapies in Prostate Cancer.Current oncology (Toronto, Ont.) · 2022
    Review
  20. Review
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

12 authors at 7 institutions in 1 country.

Primo N LaraAffiliations of authors: University of California Davis Comprehensive Cancer Center, Sacramento, CA (PNL, PCM); Southwest Oncology Group Statistical Center, Seattle, WA (BE, CT); University of Southern California Norris Cancer Center, Los Angeles, CA (DIQ, AG); USDA Western Human Nutrition Center at University of California Davis, Davis, CA (EG, MVL); City of Hope, Duarte, CA (PT); University of Michigan, Ann Arbor, MI (MH), US Oncology, Las Vegas, NV (NJV); Cancer Treatment and Research Center, University of Texas, San Antonio, TX (IT).
Benjamin Ely
David I Quinn
Philip C Mack
Catherine Tangen
Erik Gertz
Przemyslaw W Twardowski
Amir Goldkorn
Maha Hussain
Nicholas J Vogelzang
Ian M Thompson
Marta D Van Loan
University of California, Davis · USSouthern California University for Professional Studies · USSWOG Cancer Research Network · USCity Of Hope National Medical Center · USThe University of Texas at San Antonio · USThe US Oncology Network · USUniversity of Michigan–Ann Arbor · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Laura Marcu · 2002 to 2026
$84.9M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
Biochemical markers of bone turnover in metastatic prostate cancerR01CA120469 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI LARA, PRIMO N. · 2006 to 2010
$1.0M
NCI NIH HHS 5R01-CA120469NCI NIH HHS CA32102NCI NIH HHS CA38926NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888
6 · The paper itself

Abstract

backgroundPrior studies suggest that elevated markers of bone turnover are prognostic for poor survival in castration-resistant prostate cancer (CRPC). The predictive role of these markers relative to bone-targeted therapy is unknown. We prospectively evaluated the prognostic and predictive value of bone biomarkers in sera from CRPC patients treated on a placebo-controlled phase III trial of docetaxel with or without the bone targeted endothelin-A receptor antagonist atrasentan (SWOG S0421).

methodsMarkers for bone resorption (N-telopeptide and pyridinoline) and formation (C-terminal collagen propeptide and bone alkaline phosphatase) were assayed in pretreatment and serial sera. Cox proportional hazards regression models were fit for overall survival. Models were fit with main effects for marker levels and with/without terms for marker-treatment interaction, adjusted for clinical variables, to assess the prognostic and predictive value of atrasentan. Analysis was adjusted for multiple comparisons. Two-sided P values were calculated using the Wald test.

resultsSera from 778 patients were analyzed. Elevated baseline levels of each of the markers were associated with worse survival (P < .001). Increasing marker levels by week nine of therapy were also associated with subsequent poor survival (P < .001). Patients with the highest marker levels (upper 25th percentile for all markers) not only had a poor prognosis (hazard ratio [HR] = 4.3; 95% confidence interval [CI] = 2.41 to 7.65; P < .001) but also had a survival benefit from atrasentan (HR = 0.33; 95% CI = 0.15 to 0.71; median survival = 13 [atrasentan] vs 5 months [placebo]; P interaction = .005).

conclusionsSerum bone metabolism markers have statistically significant independent prognostic value in CRPC. Importantly, a small group of patients (6%) with highly elevated markers of bone turnover appear to preferentially benefit from atrasentan therapy.

Indexed as

Bone RemodelingAdultAgedAged, 80 and overAlkaline PhosphataseAmino AcidsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsAtrasentanBiomarkers, TumorBone NeoplasmsCollagen Type IDisease-Free SurvivalDocetaxelDouble-Blind MethodEndothelin A Receptor AntagonistsAlkaline PhosphataseAmino AcidsAntineoplastic AgentsAtrasentanBiomarkers, TumorCollagen Type Icollagen type I trimeric cross-linked peptideDocetaxelEndothelin A Receptor AntagonistsPeptide FragmentsPeptidesProcollagenprocollagen type I carboxy terminal peptidepyridinolinePyrrolidinesTaxoids

Identifiers

PMID24565955
PMCPMC3982883
OpenAlexW2166775256

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.