Evidence map›Paper›PMID 27296105›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2016

Outcome and Biomarker Analysis from a Multicenter Phase 2 Study of Ipilimumab in Combination with Carboplatin and Etoposide as First-Line Therapy for Extensive-Stage SCLC.

Edurne Arriola, Matthew Wheater, Ian Galea, Nadia Cross, Tom Maishman, Debbie Hamid, Louise Stanton, Judith Cave, Tom Geldart, Clive Mulatero and 6 more

Open access · bronzeAbstract 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, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 4 pooled it
5.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 4 syntheses or guidelines pooled it, 114 citations in OpenAlex.

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  12. State of the art in treatment of small cell lung cancer.Therapeutic advances in medical oncology · 2025
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15 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 at 7 institutions in 1 country.

Edurne ArriolaUniversity of Southampton, Southampton, United Kingdom. Electronic address: e.arriola-aperribay@soton.ac.uk.
Matthew WheaterUniversity Hospital Southampton, Southampton, United Kingdom.
Ian GaleaClinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.
Nadia CrossSouthampton Clinical Trials Unit, University of Southampton, United Kingdom.
Tom MaishmanSouthampton Clinical Trials Unit, University of Southampton, United Kingdom.
Debbie HamidSouthampton Clinical Trials Unit, University of Southampton, United Kingdom.
Louise StantonSouthampton Clinical Trials Unit, University of Southampton, United Kingdom.
Judith CaveUniversity Hospital Southampton, Southampton, United Kingdom.
Tom GeldartRoyal Bournemouth and Christchurch Hospitals National Health Service Trust, Bournemouth, United Kingdom.
Clive MulateroSt. James's University Hospital, Leeds, United Kingdom.
Vannessa PotterNottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
Sarah DansonSheffield Experimental Cancer Medicine Centre, Weston Park Hospital, Sheffield, United Kingdom.
Pennella J WollSheffield Experimental Cancer Medicine Centre, Weston Park Hospital, Sheffield, United Kingdom.
Richard GriffithsThe Clatterbridge Cancer Centre National Health Service Foundation Trust, Wirral, United Kingdom.
Luke NolanUniversity Hospital Southampton, Southampton, United Kingdom.
Christian OttensmeierUniversity of Southampton, Southampton, United Kingdom.
University of Southampton · GBNIHR Evaluation Trials and Studies Coordinating Centre · GBUniversity Hospital Southampton NHS Foundation Trust · GBNational Health Service · GBWeston Park Cancer Centre · GBClatterbridge Cancer Centre NHS Foundation Trust · GBSt James's University Hospital · GB

Funding

Cancer Research UK 15956Cancer Research UK 20622Cancer Research UK C491/A12135
6 · The paper itself

Abstract

objectivesOur aim was to evaluate the safety and efficacy of ipilimumab combined with standard first-line chemotherapy for patients with extensive-stage SCLC.

methodsPatients with chemotherapy-naive extensive-stage SCLC were treated with carboplatin and etoposide for up to six cycles. Ipilimumab, 10 mg/kg, was given on day 1 of cycles 3 to 6 and every 12 weeks. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, and immune-related response criteria. The primary end point was 1-year progression-free survival (PFS) according to RECIST. Secondary end points included PFS according to immune-related PFS and overall survival. Autoantibody serum levels were evaluated and correlated with clinical outcomes.

resultsA total of 42 patients were enrolled between September 2011 and April 2014; 39 were evaluable for safety and 38 for efficacy. Six of 38 patients (15.8% [95% confidence interval (CI): 7.4-30.4]) were alive and progression-free at 1-year by RECIST. Median PFS was 6.9 months (95% CI: 5.5-7.9). Median immune-related PFS was 7.3 months (95% CI: 5.5-8.8). Median overall survival was 17.0 months (95% CI: 7.9-24.3). Of the patients evaluable for response, 21 of 29 (72.4%) achieved an objective response by RECIST and 28 of 33 (84.8%) achieved an objective response by the immune-related response criteria. All patients experienced at least one adverse event; at least one grade 3 or higher toxicity developed in 35 of 39 patients (89.7%); in 27 patients (69.2%) this was related to ipilimumab. Five deaths were reported to be related to ipilimumab. Positivity of an autoimmune profile at baseline was associated with improved outcomes and severe neurological toxicity.

conclusionsIpilimumab in combination with carboplatin and etoposide might benefit a subgroup of patients with advanced SCLC. Autoantibody analysis correlates with treatment benefit and toxicity and warrants further investigation.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsAutoantibodiesBiomarkers, TumorCarboplatinEtoposideFemaleHumansIpilimumabLung NeoplasmsMaleMiddle AgedNeoplasm StagingAntibodies, MonoclonalAutoantibodiesBiomarkers, TumorCarboplatinEtoposideIpilimumabAutoantibodiesBiomarkerCTLA-4 immunotherapyIpilimumabSmall cell lung cancer

Identifiers

PMID27296105
PMCPMC5063510
OpenAlexW2417109937

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.