Evidence map›Paper›PMID 31958290›Full record

Trial reportESMO open2020

Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy.

Edward B Garon, Giorgio Vittorio Scagliotti, Oliver Gautschi, Martin Reck, Michael Thomas, Lara Iglesias Docampo, Haralabos Kalofonos, Joo-Hang Kim, Steven Gans, Odd Terje Brustugun and 10 more

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

Trial report in ESMO open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01168973 (A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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.

NCT01168973 phase3completednot on this map

A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2010 to 2016Enrolled1,253ConditionsNon-Small Cell Lung CancerArmsRamucirumab, Placebo (for Ramucirumab), Docetaxel
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
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

20 authors at 15 institutions in 11 countries.

Edward B GaronHematology-Oncology, David Geffen School of Medicine, Los Angeles, California, USA egaron@mednet.ucla.edu.
Giorgio Vittorio ScagliottiOncology, San Luigi Hospital, University of Turin, Orbassano, Italy.
Oliver GautschiMedical Oncology, Luzerner Kantonsspital, Luzern, Switzerland.
Martin ReckLungenClinic, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany.
Michael ThomasThoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg University Hospital, Heidelberg, Germany.
Lara Iglesias DocampoMedical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Haralabos KalofonosMedical Oncology, University General Hospital of Patras, Patras, Greece.
Joo-Hang KimHemato-Oncology, Bundang CHA Medical Center, Seongnam, South Korea.
Steven GansRespiratory Diseases, Hospital Saint Jansdal, Harderwijk, The Netherlands.
Odd Terje BrustugunOncology, Drammen Hospital, Drammen, Norway.
Sergey V OrlovMedical, Saint Petersburg State University, Sankt-Peterburg, Russian Federation.
Gebra Cuyun CarterOncology, Eli Lilly and Co, Indianapolis, Indiana, USA.
Annamaria H ZimmermannStatistics-Oncology, Eli Lilly and Co, Indianapolis, Indiana, USA.
Ana B OtonOncology, Eli Lilly and Co, Indianapolis, Indiana, USA.
Ekaterine AlexandrisOncology, Eli Lilly and Co, Indianapolis, Indiana, USA.
Pablo LeeOncology, Eli Lilly and Co, New York City, New York, USA.
Katharina WolffOncology, Eli Lilly and Co, Bad Homburg, Germany.
Victoria Jennifer StefaniakOncology, Eli Lilly and Co, Indianapolis, Indiana, USA.
Mark A SocinskiThoracic Oncology, AdventHealth Cancer Institute, Orlando, Florida, USA.
Maurice PérolMedical Oncology, Centre Leon Berard, Lyon, France.
Eli Lilly (United States) · USCentre Léon Bérard · FRCHA University Bundang Medical Center · KRDrammen Hospital · NOEli Lilly (Germany) · DEFlorida Hospital Cancer Institute · USGeneral University Hospital of Patras · GRGerman Center for Lung Research · DEHospital Universitario 12 De Octubre · ESLuzerner Kantonsspital · CHRijnstate Hospital · NLSt Petersburg University · RUUniversity Hospital Heidelberg · DEUniversity of California, Los Angeles · USUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNon-small-cell lung cancer (NSCLC) is a heterogeneous disease. Front-line therapy may affect responses to subsequent treatment regimens, thus influencing second-line therapy decision making. In the randomised phase 3 REVEL study, second-line ramucirumab plus docetaxel (ram+doc) versus docetaxel (doc) improved survival of patients with metastatic NSCLC. We explore efficacy, safety and quality-of-life (QoL) in REVEL based on front-line therapy.

methodsPatients were grouped by specific front-line therapy received. Overall survival (OS), progression-free survival (PFS), objective response rate, safety and QoL were assessed descriptively. Kaplan-Meier estimation and Cox proportional hazards modelling were used; frequencies reported in percentages.

resultsBaseline characteristics of 1253 patients were generally well balanced between treatment arms within each front-line therapy subgroup. For patients with non-squamous disease (n=912), induction therapies included platinum-based chemotherapy plus a taxane (n=227; 25%) or pemetrexed (n=449; 49%), with (n=172; 19%) or without bevacizumab. For patients with squamous disease (n=328), induction therapies included platinum-based chemotherapy plus gemcitabine (n=176; 54%) or a taxane (n=69; 21%). A highly selected subgroup (n=127; 14%) received pemetrexed continuation maintenance therapy. Ram+doc improved median OS and PFS versus doc across front-line therapy subgroups, as reflected by HRs ranging from 0.78 to 0.91 and 0.66 to 0.92, respectively, similar to results in the overall intention-to-treat cohort (HRs: 0.86 and 0.76, respectively). High-grade treatment-emergent adverse events of special interest (including neutropenia, febrile neutropenia, leucopenia and hypertension) were generally higher in ram+doc-treated patients relative to doc-treated patients regardless of front-line therapy. No clear differences in safety or QoL were seen across front-line therapy subgroups; outcomes were consistent with those reported in the overall intention-to-treat cohort.

conclusionsResults of this exploratory analysis suggest that second-line ram+doc may be effective regardless of prior treatment with platinum-based chemotherapy plus a taxane, pemetrexed, gemcitabine or bevacizumab. Overall, ram+doc is clinically beneficial across a wide range of patients with metastatic NSCLC who have progressed after various front-line therapies. TRIAL REGISTRATION NUMBER: NCT01168973.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDisease ProgressionDocetaxelFemaleHumansLung NeoplasmsNeoplasm StagingPlatinumRamucirumabAntibodies, Monoclonal, HumanizedDocetaxelPlatinumRamucirumabchemotherapymetastaticnon-squamoussquamousvascular endothelial growth factor receptor

Identifiers

PMID31958290
PMCPMC7003392
OpenAlexW3000544176

What OpenQuestion holds

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LicenceCC BY-NC
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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.