Evidence map›Paper›PMID 22202581›Full record

Trial reportAnnals of surgery2012

Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma.

Sojun Hoshimoto, Mark B Faries, Donald L Morton, Tatsushi Shingai, Christine Kuo, He-Jing Wang, Robert Elashoff, Nicola Mozzillo, Mark C Kelley, John F Thompson and 2 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgery, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
3.3field-weighted citation impact, top 7% 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

39 citing papers in PubMed, 91 citations in OpenAlex.

  1. Trial
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  9. Article
  10. Circulating tumor cells: biology and clinical significance.Signal transduction and targeted therapy · 2021
    Review
  11. A Bayesian network meta-analysis of comparison of cancer therapeutic vaccines for melanoma.Journal of the European Academy of Dermatology and Venereology : JEADV · 2021
    Review
  12. Review
  13. Article
  14. Article
  15. Article
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  17. Observational
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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

12 authors at 6 institutions in 4 countries.

Sojun HoshimotoDepartment of Molecular Oncology, John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA 90404, USA.
Mark B Faries
Donald L Morton
Tatsushi Shingai
Christine Kuo
He-Jing Wang
Robert Elashoff
Nicola Mozzillo
Mark C Kelley
John F Thompson
Jeffrey E Lee
Dave S B Hoon
Saint John's Health Center · USApplied Biomathematics (United States) · USIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITRoyal Prince Alfred Hospital · AUUniversity of California, Los Angeles · USVanderbilt University · US

Funding

TUMOR ANTIGENS THAT ELICIT HUMORAL IMMUNE RESPONSES IN CANCER PATIENTSP01CA012582 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MORTON, DONALD L · 1985 to 2010
$40.8M
NCI NIH HHS P01 CA012582NCI NIH HHS P0 CA012582
6 · The paper itself

Abstract

objectiveTo verify circulating tumor cell (CTC) prognostic utility in stage IV resected melanoma patients in a prospective international phase III clinical trial.

backgroundOur studies of melanoma patients in phase II clinical trials demonstrated prognostic significance for CTCs in patients with AJCC stage IV melanoma. CTCs were assessed to determine prognostic utility in follow-up of disease-free stage IV patients pre- and during treatment.

methodsAfter complete metastasectomy, patients were prospectively enrolled in a randomized trial of adjuvant therapy with a whole-cell melanoma vaccine, Canvaxin, plus Bacille Calmette-Guerin (BCG) versus placebo plus BCG. Blood specimens obtained pretreatment (n = 244) and during treatment (n = 214) were evaluated by quantitative real-time reverse-transcriptase polymerase chain reaction (qPCR) for expression of MART-1, MAGE-A3, and PAX3 mRNA biomarkers. Univariate and multivariate Cox analyses examined CTC biomarker expression with respect to clinicopathological variables.

resultsCTC biomarker(s) (≥ 1) was detected in 54% of patients pretreatment and in 86% of patients over the first 3 months. With a median follow-up of 21.9 months, 71% of patients recurred and 48% expired. CTC levels were not associated with known prognostic factors or treatment arm. In multivariate analysis, pretreatment CTC (> 0 vs. 0 biomarker) status was significantly associated with disease-free survival (DFS; HR 1.64, P = 0.002) and overall survival (OS; HR 1.53, P = 0.028). Serial CTC (>0 vs. 0 biomarker) status was also significantly associated with DFS (HR 1.91, P = 0.02) and OS (HR 2.57, P = 0.012).

conclusionCTC assessment can provide prognostic discrimination before and during adjuvant treatment for resected stage IV melanoma patients.

Indexed as

AdultAgedAntigens, NeoplasmBiomarkers, TumorCancer VaccinesChemotherapy, AdjuvantDouble-Blind MethodFemaleHumansMaleMART-1 AntigenMelanomaMiddle AgedMultivariate AnalysisNeoplasm ProteinsNeoplasm StagingAntigens, NeoplasmBiomarkers, TumorCancer VaccinesCanvaxinMAGEA3 protein, humanMART-1 AntigenNeoplasm ProteinsPaired Box Transcription FactorsPAX3 protein, humanPAX3 Transcription Factor

Identifiers

PMID22202581
PMCPMC3320770
OpenAlexW2036468894

What OpenQuestion holds

Textmetadata
LicenceTDM
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.