Evidence map›Paper›PMID 24766732›Full record

Trial reportBMC cancer2014

Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer.

Chandra P Belani, Nobuyuki Yamamoto, Igor M Bondarenko, Artem Poltoratskiy, Silvia Novello, Jie Tang, Paul Bycott, Andreas G Niethammer, Antonella Ingrosso, Sinil Kim and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00768755 (Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib), which is not on this map. Cited by 31 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 9 pooled it
7.0field-weighted citation impact, top 3% 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.

NCT00768755 phase1 / phase2completednot on this map

Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib (AG-013736) As First-Line Treatment For Patients With Non-Squamous Non-Small Cell Lung Cancer

TypeinterventionalSponsorPfizerRan2009 to 2012Enrolled180ConditionsCarcinoma, Non-Small Cell LungArmsaxitinib, chemotherapy
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 9 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
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  14. Anti-Angiogenic Therapy inInternational journal of molecular sciences · 2022
    Review
  15. Review
  16. Article
  17. Antiangiogenic therapies in non-small-cell lung cancer.Current oncology (Toronto, Ont.) · 2018
    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

11 authors at 7 institutions in 5 countries.

Chandra P BelaniPenn State Milton S, Hershey Medical Center, Penn State Hershey Cancer Institute, Hershey, PA, USA. cbelani@hmc.psu.edu.
Nobuyuki Yamamoto
Igor M Bondarenko
Artem Poltoratskiy
Silvia Novello
Jie Tang
Paul Bycott
Andreas G Niethammer
Antonella Ingrosso
Sinil Kim
Giorgio V Scagliotti
Pfizer (United States) · USUniversity of Turin · ITDnipropetrovsk State Medical Academy · UAPenn State Milton S. Hershey Medical Center · USPfizer (Italy) · ITSaint Petersburg State Pediatric Medical University · RUWakayama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy and safety of axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 in combination with pemetrexed and cisplatin was evaluated in patients with advanced non-squamous non-small-cell lung cancer (NSCLC).

methodsOverall, 170 patients were randomly assigned to receive axitinib at a starting dose of 5-mg twice daily continuously plus pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) on day 1 of up to six 21-day cycles (arm I); axitinib on days 2 through 19 of each cycle plus pemetrexed/cisplatin (arm II); or pemetrexed/cisplatin alone (arm III). The primary endpoint was progression-free survival (PFS).

resultsMedian PFS was 8.0, 7.9, and 7.1 months in arms I, II, and III, respectively (hazard ratio: arms I vs. III, 0.89 [P = 0.36] and arms II vs. III, 1.02 [P = 0.54]). Median overall survival was 17.0 months (arm I), 14.7 months (arm II), and 15.9 months (arm III). Objective response rates (ORRs) for axitinib-containing arms were 45.5% (arm I) and 39.7% (arm II) compared with 26.3% for pemetrexed/cisplatin alone (arm III). Gastrointestinal disorders and fatigue were frequently reported across all treatment arms. The most common all-causality grade ≥3 adverse events were hypertension in axitinib-containing arms (20% and 17%, arms I and II, respectively) and fatigue with pemetrexed/cisplatin alone (16%).

conclusionAxitinib in combination with pemetrexed/cisplatin was generally well tolerated. Axitinib combinations resulted in non-significant differences in PFS and numerically higher ORR compared with chemotherapy alone in advanced NSCLC.

trial registrationClinicalTrials.gov: NCT00768755 (October 7, 2008).

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsAxitinibCarcinoma, Non-Small-Cell LungCisplatinDisease-Free SurvivalFemaleGlutamatesGuanineHumansImidazolesIndazolesMaleMiddle AgedPemetrexedAxitinibCisplatinGlutamatesGuanineImidazolesIndazolesPemetrexedVascular Endothelial Growth Factor A

Identifiers

PMID24766732
PMCPMC4017965
OpenAlexW2110810263

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.