Evidence map›Paper›PMID 19933915›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10.

Charles A Butts, Keyue Ding, Lesley Seymour, Philip Twumasi-Ankrah, Barbara Graham, David Gandara, David H Johnson, Kenneth A Kesler, Mark Green, Mark Vincent and 6 more

4 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 175 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
175citing papers in PubMed, 9 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.

NCT00002583 phase3completednot on this map

A Phase III Prospective Randomized Study of Adjuvant Chemotherapy With Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer With Companion Tumour Marker Evaluation

TypeinterventionalSponsorNCIC Clinical Trials GroupRan1994 to 2009Enrolled482ConditionsLung CancerArmscisplatin, vinorelbine ditartrate
NCT02259621 phase2active not recruitingnot on this mapstarted 2014, after this paper: background citation

Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable Non-Small-Cell Lung Cancer.

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2014 to 2027Enrolled39ConditionsNon-Small Cell Lung CancerArmsNivolumab, Carboplatin, Paclitaxel, Ipilimumab
NCT03380468 phase2 / phase3unknown statusnot on this mapstarted 2018, after this paper: background citation

Adjuvant Chemotherapy Versus Observation in Fully Resected Stage I Lung Adenocarcinoma With High Risk of Post-operative Recurrence

TypeinterventionalSponsorFudan UniversityRan2018 to 2025Enrolled300ConditionsLung NeoplasmsArmscisplatin plus pemetrexed
NCT06115239 unknown statusnot on this mapstarted 2024, after this paper: background citation

Evaluation of Changes in Quality of Life in Patients With Non-small Cell Lung Carcinoma Undergoing Lung Resection Before and After Receiving Adjuvant Treatment Using the EORTC-LC29 Questionnaire

TypeobservationalSponsorUniversity of SalamancaRan2024 to 2026Enrolled200ConditionsCarcinoma, Non-Small-Cell Lung, Quality of LifeArmsQuestionnaires
3 · Its place in the literature

Who cites it

175 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Adjuvant chemotherapy for resected early-stage non-small cell lung cancer.The Cochrane database of systematic reviews · 2015
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Lung cancer.BMJ clinical evidence · 2010
    Pooled it
  7. Pooled it
  8. SEOM clinical guidelines for the treatment of non-small-cell lung cancer: an updated edition.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2010
    Guideline
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

115 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.

Charles A ButtsCross Cancer Institute, 11560 University Ave, Edmonton, Alberta, Canada, T6G 1Z2. charlesb@cancerboard.ab.ca
Keyue Ding
Lesley Seymour
Philip Twumasi-Ankrah
Barbara Graham
David Gandara
David H Johnson
Kenneth A Kesler
Mark Green
Mark Vincent
Yvon Cormier
Glenwood Goss
Brian Findlay
Michael Johnston
Ming-Sound Tsao
Frances A Shepherd

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PURPOSE Adjuvant cisplatin-based chemotherapy (ACT) is now an accepted standard for completely resected stage II and III A non-small-cell lung cancer (NSCLC). Long-term follow-up is important to document persistent benefit and late toxicity. We report here updated overall survival (OS) and disease-specific survival (DSS) data. PATIENTS AND METHODS Patients with completely resected stage IB (T2N0, n = 219) or II (T1-2N1, n = 263) NSCLC were randomly assigned to receive 4 cycles of vinorelbine/cisplatin or observation. All efficacy analyses were performed on an intention-to-treat basis. Results Median follow-up was 9.3 years (range, 5.8 to 13.8; 33 lost to follow-up); there were 271 deaths in 482 randomly assigned patients. ACT continues to show a benefit (hazard ratio [HR], 0.78; 95% CI, 0.61 to 0.99; P = .04). There was a trend for interaction with disease stage (P = .09; HR for stage II, 0.68; 95% CI, 0.5 to 0.92; P = .01; stage IB, HR, 1.03; 95% CI, 0.7 to 1.52; P = .87). ACT resulted in significantly prolonged DSS (HR, 0.73; 95% CI, 0.55 to 0.97; P = .03). Observation was associated with significantly higher risk of death from lung cancer (P = .02), with no difference in rates of death from other causes or second primary malignancies between the arms. CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy. This benefit appears to be confined to N1 patients. There was no increase in death from other causes in the chemotherapy arm.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCisplatinFemaleGenes, rasHumansLung NeoplasmsMaleMiddle AgedMutationNeoplasms, Second PrimaryNeoplasm StagingVinblastineVinorelbineCisplatinVinblastineVinorelbine

Identifiers

PMID19933915
PMCPMC2799232

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.