Evidence map›Paper›PMID 25170639›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2014

A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with stage IIIB/IV non-small-cell lung cancer.

D Ross Camidge, Eamon M Berge, Robert C Doebele, Marc S Ballas, Thierry Jahan, Missak Haigentz, David Hoffman, James Spicer, Howard West, Pablo Lee and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung 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 NCT03904108 (Phase-II Trial of Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT03904108 phase2terminatednot on this mapstarted 2019, after this paper: background citation

Phase-II Trial of Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy

TypeinterventionalSponsorROGER S KERESZTES MDRan2019 to 2020Enrolled3ConditionsCarcinoma, Non-Small-Cell LungArmsRamucirumab
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Antiangiogenic therapies in non-small-cell lung cancer.Current oncology (Toronto, Ont.) · 2018
    Review
  12. Review
  13. Angiogenesis Inhibitors in NSCLC.International journal of molecular sciences · 2017
    Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. [Recombinant Human Endostatin in the Treatment of Advanced Lung Squamous Cell Carcinoma].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2016
    Article
  20. Review
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

15 authors at 8 institutions in 2 countries.

D Ross Camidge*University of Colorado Anschutz Medical Campus, Aurora, CO; †New York University School of Medicine, New York, NY; ‡University of California San Francisco, San Francisco, CA; §Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; ‖Tower Hematology Oncology Medical Group, Beverly Hills, CA; ¶King's College London, Guy's Hospital, London, United Kingdom; #Swedish Cancer Institute, Seattle, WA; **ImClone Systems, a Wholly-owned Subsidiary of Eli Lilly and Company, Bridgewater, NJ; and ††Cedar Sinai Medical Center, Los Angeles, CA.
Eamon M Berge
Robert C Doebele
Marc S Ballas
Thierry Jahan
Missak Haigentz
David Hoffman
James Spicer
Howard West
Pablo Lee
Ling Yang
Adarsh Joshi
Ling Gao
Sergey Yurasov
Alain Mita
Eli Lilly (United States) · USUniversity of Colorado Anschutz Medical Campus · USAlbert Einstein College of Medicine · USCedars-Sinai Medical Center · USGuy's Hospital · GBNew York University · USTower Cancer Research Foundation · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe objective of this study was to determine whether the addition of ramucirumab to first-line paclitaxel-carboplatin chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) resulted in a 6-month progression-free survival (PFS) rate that compares favorably with the historic rate for bevacizumab combined with paclitaxel-carboplatin in this patient population.

methodsIn this phase II, single-arm, open-label, multicenter study, 40 patients with advanced NSCLC received ramucirumab (10 mg/kg intravenous [IV]) followed by paclitaxel (200 mg/m IV) and carboplatin area under the curve = 6 on day 1 every 21 days as first-line therapy. Therapy continued for up to six cycles. Patients not experiencing withdrawal criteria may have continued ramucirumab monotherapy every 3 weeks. The primary endpoint was PFS at 6 months, with 80% power to detect a 6-month PFS rate of at least 55%.

resultsThe 6-month PFS rate was 59.0% and the objective response rate was 55.0%. The most common treatment-related adverse events were fatigue, peripheral neuropathy, nausea, epistaxis, and myalgia. Single-nucleotide polymorphism (SNP) rs2981582 on the FGFR-2gene had significant associations with improved overall survival, PFS, and best overall response (p values without multiplicity adjustment were 0.0059, 0.0429, and 0.0392, respectively).

conclusionRamucirumab in combination with paclitaxel-carboplatin resulted in a 6-month PFS rate and safety profile that compared favorably with the historical control. In addition, no deaths were associated with this treatment. Furthermore, we describe an association of SNP on FGFR-2 gene with survival and response. These findings warrant further clinical investigation in patients with NSCLC.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDisease-Free SurvivalFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPaclitaxelRamucirumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarboplatinPaclitaxelRamucirumab

Identifiers

PMID25170639
PMCPMC4165478
OpenAlexW2016641845

What OpenQuestion holds

Textmetadata
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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.