Evidence map›Paper›PMID 29775808›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2018

Phase II Study of Maintenance Pembrolizumab in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC).

Shirish M Gadgeel, Nathan A Pennell, Mary Jo Fidler, Balazs Halmos, Philip Bonomi, James Stevenson, Bryan Schneider, Ammar Sukari, Jaclyn Ventimiglia, Wei Chen and 4 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 116 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing 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.

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

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

  1. Pooled it
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  8. Trial
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  10. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
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  13. Trial
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  15. Review
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  17. The Five-Decade Journey of Small Cell Lung Cancer.Cancer communications (London, England) · 2026
    Review
  18. The LDH-H3K18La-Nur77 Axis Potentiates Immune Escape in Small Cell Lung Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
  19. Review
  20. Article

56 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Shirish M GadgeelKarmanos Cancer Institute/Wayne State University, Detroit, Michigan. Electronic address: sgadgeel@med.umich.edu.
Nathan A PennellCleveland Clinic, Cleveland, Ohio.
Mary Jo FidlerRush University Medical Center, Chicago, Illinois.
Balazs HalmosMontefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Philip BonomiRush University Medical Center, Chicago, Illinois.
James StevensonCleveland Clinic, Cleveland, Ohio.
Bryan SchneiderUniversity of Michigan, Ann Arbor, Michigan.
Ammar SukariKarmanos Cancer Institute/Wayne State University, Detroit, Michigan.
Jaclyn VentimigliaKarmanos Cancer Institute/Wayne State University, Detroit, Michigan.
Wei ChenKarmanos Cancer Institute/Wayne State University, Detroit, Michigan.
Cathy GalassoKarmanos Cancer Institute/Wayne State University, Detroit, Michigan.
Antoinette WozniakKarmanos Cancer Institute/Wayne State University, Detroit, Michigan.
Julie BoernerKarmanos Cancer Institute/Wayne State University, Detroit, Michigan.
Gregory P KalemkerianUniversity of Michigan, Ann Arbor, Michigan.

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA022453
6 · The paper itself

Abstract

objectiveThe aim of this study was to assess the efficacy of maintenance pembrolizumab in patients with extensive-stage SCLC after treatment with platinum and etoposide.

methodsPatients with extensive-stage SCLC with a response or stable disease after induction chemotherapy were eligible. Pembrolizumab at a dose of 200 mg administered intravenously every 3 weeks was initiated within 8 weeks of the last cycle of chemotherapy. The primary end point of the study was progression-free survival (PFS) from study registration, with overall survival (OS) as a key secondary end point. Available tumor tissue was assessed for expression of programmed death ligand 1 (PD-L1) both in the tumor cells and in the surrounding stroma. Blood for circulating tumor cells was collected before the first, second, and third cycles of pembrolizumab.

resultsOf the 45 patients enrolled, 56% were male and 22% had treated brain metastases. The median PFS was 1.4 months (95% confidence interval [CI]: 1.3-2.8), with a 1-year PFS of 13%. The median OS was 9.6 months (95% CI: 7.0-12), with a 1-year OS of 37%. Of the 30 tumors that could be assessed, three had PD-L1 expression (≥1%) in the tumor cells. A total of 20 tumors could be assessed for PD-L1 expression in the stroma. The median PFS in the eight patients with tumors positive for expression of PD-L1 at the stromal interface was 6.5 months (95% CI: 1.1-12.8) compared with 1.3 months (95% CI: 0.6-2.5) in 12 patients with tumors negative for this marker. No unexpected toxicities were observed.

conclusionMaintenance pembrolizumab did not appear to improve median PFS compared with the historical data. However, the 1-year PFS rate of 13% and OS rate of 37% suggest that a subset of patients did benefit from pembrolizumab.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalFemaleHumansLung NeoplasmsMaleProgression-Free SurvivalSmall Cell Lung CarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalpembrolizumabMaintenanceMetastaticPembrolizumabSCLC

Identifiers

PMID29775808
PMCPMC6833950

What OpenQuestion holds

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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.