Evidence map›Paper›PMID 23232491›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2013

A randomized phase II study of gemcitabine and carboplatin with or without cediranib as first-line therapy in advanced non-small-cell lung cancer: North Central Cancer Treatment Group Study N0528.

Grace K Dy, Sumithra J Mandrekar, Garth D Nelson, Jeffrey P Meyers, Araba A Adjei, Helen J Ross, Rafat H Ansari, Alan P Lyss, Philip J Stella, Steven E Schild and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00326599 (A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer), which is not on this map. Cited by 19 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 7 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.

NCT00326599 phase2completednot on this map

A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2007 to 2010Enrolled101ConditionsLung CancerArmscarboplatin, cediranib maleate, gemcitabine hydrochloride
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
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  6. The protein kinase C (PKC) inhibitors combined with chemotherapy in the treatment of advanced non-small cell lung cancer: meta-analysis of randomized controlled trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2015
    Pooled it
  7. Pooled it
  8. Anti-Angiogenic Therapy inInternational journal of molecular sciences · 2022
    Review
  9. Statistical Models in Clinical Studies.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2021
    Article
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  13. 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

12 authors.

Grace K DyDepartment of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA.
Sumithra J Mandrekar
Garth D Nelson
Jeffrey P Meyers
Araba A Adjei
Helen J Ross
Rafat H Ansari
Alan P Lyss
Philip J Stella
Steven E Schild
Julian R Molina
Alex A Adjei

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
NCI NIH HHS U10 CA025224
6 · The paper itself

Abstract

introductionThe purpose of this study was to assess the safety and efficacy of gemcitabine and carboplatin with (arm A) or without (arm B) daily oral cediranib as first-line therapy for advanced non-small-cell lung cancer.

methodsA lead-in phase to determine the tolerability of gemcitabine 1000 mg/m on days 1 and 8, and carboplatin on day 1 at area under curve 5 administered every 21 days with cediranib 45 mg once daily was followed by a 2 (A):1 (B) randomized phase II study. The primary end point was confirmed overall response rate (ORR) with 6-month progression-free survival (PFS6) rate in arm A as secondary end point. Polymorphisms in genes encoding cediranib targets and transport were correlated with treatment outcome.

resultsOn the basis of the safety assessment, cediranib 30 mg daily was used in the phase II portion. A total of 58 and 29 evaluable patients were accrued to arms A and B. Patients in A experienced more grade 3+ nonhematologic adverse events, 71% versus 45% (p = 0.01). The ORR was 19% (A) versus 20% (B) (p = 1.0). PFS6 in A was 48% (95% confidence interval: 35%-62%), thus meeting the protocol-specified threshold of at least 40%. The median overall survival was 12.0 versus 9.9 months (p = 0.10). FGFR1 rs7012413, FGFR2 rs2912791, and VEGFR3 rs11748431 polymorphisms were significantly associated with decreased overall survival (hazard ratio 2.78-5.01, p = 0.0002-0.0095).

conclusionsThe trial did not meet its primary end point of ORR but met its secondary end point of PFS6. The combination with cediranib 30 mg daily resulted in increased toxicity. Pharmacogenetic analysis revealed an association of FGFR and VEGFR variants with survival.

Indexed as

AgedAged, 80 and overAnemiaAnorexiaAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDeoxycytidineDisease-Free SurvivalDyspneaFatigueFemaleGemcitabineHumansHypothyroidismIndolesCarboplatincediranibDeoxycytidineFGFR1 protein, humanFGFR2 protein, humanGemcitabineIndolesQuinazolinesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 2Vascular Endothelial Growth Factor Receptor-3

Identifiers

PMID23232491
PMCPMC4193613

What OpenQuestion holds

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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.