Evidence map›Paper›PMID 19884554›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Randomized phase III trial of gemcitabine-based chemotherapy with in situ RRM1 and ERCC1 protein levels for response prediction in non-small-cell lung cancer.

Craig Reynolds, Coleman Obasaju, Michael J Schell, Xueli Li, Zhong Zheng, David Boulware, John R Caton, Linda C Demarco, Mark A O'Rourke, Gail Shaw Wright and 6 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 4 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

85 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Review
  18. Article
  19. Review
  20. Review

25 more citing papers are in PubMed but not listed here.

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

16 authors.

Craig ReynoldsUS Oncology, The Woodlands, TX, USA.
Coleman Obasaju
Michael J Schell
Xueli Li
Zhong Zheng
David Boulware
John R Caton
Linda C Demarco
Mark A O'Rourke
Gail Shaw Wright
Kristi A Boehm
Lina Asmar
Jane Bromund
Guangbin Peng
Matthew J Monberg
Gerold Bepler

Funding

RRM1/PTEN Axis in Non-Small Cell Lung CancerR01CA102726 · NCI · H. LEE MOFFITT CANCER CTR &RES INST · PI BEPLER, GEROLD · 2003 to 2007
$2.6M
NCI NIH HHS R01 CA102726
6 · The paper itself

Abstract

purposeWe evaluated the efficacy of gemcitabine versus gemcitabine and carboplatin in patients with advanced non-small-cell lung cancer (NSCLC) and a performance status (PS) of 2 and assessed if tumoral RRM1 and ERCC1 protein levels are predictive of response to therapy. PATIENTS AND

methodsA randomized phase III trial was conducted in community-based oncology practices. Tumor specimens were collected a priori and shipped to a single laboratory for blinded determination of in situ RRM1 and ERCC1 protein expression levels by an automated quantitative immunofluorescent-based technology.

resultsOne hundred seventy patients were randomly assigned. Overall median survival was 5.1 months for gemcitabine and 6.7 months for gemcitabine and carboplatin (P = .24). RRM1 (range, 5.3 to 105.6; median, 34.1) and ERCC1 (range, 5.2 to 131.3; median, 34.7) values were significantly and inversely correlated with disease response (r = -0.41; P = .001 for RRM1; r = -0.39; P = .003 for ERCC1; ie, response was better for patients with low levels of expression). A model for response prediction that included RRM1, ERCC1, and treatment arm, was highly predictive of the treatment response observed (P = .0005). We did not find statistically significant associations between survival and RRM1 or ERCC1 levels.

conclusionSingle-agent chemotherapy remains the standard of care for patients with advanced NSCLC and poor PS. Quantitative analysis of RRM1 and ERCC1 protein expression in routinely collected tumor specimens in community oncology practices is predictive of response to gemcitabine and gemcitabine and carboplatin therapy. Oncologists should consider including in situ expression analysis for these proteins into their therapeutic decisions.

Indexed as

AgedAged, 80 and overAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDeoxycytidineDNA-Binding ProteinsDNA RepairEndonucleasesFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedAntimetabolites, AntineoplasticCarboplatinDeoxycytidineDNA-Binding ProteinsEndonucleasesERCC1 protein, humanGemcitabineRibonucleoside Diphosphate ReductaseRRM1 protein, humanTumor Suppressor Proteins

Identifiers

PMID19884554
PMCPMC2793001

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.