Evidence map›Paper›PMID 33002543›Full record

Trial reportInternational journal of radiation oncology, biology, physics2021

Prospective Single-Arm Phase 1 and 2 Study: Ipilimumab and Nivolumab With Thoracic Radiation Therapy After Platinum Chemotherapy in Extensive-Stage Small Cell Lung Cancer.

Bradford A Perez, Sungjune Kim, Minhsuan Wang, Ahmad M Karimi, Chase Powell, Jiannong Li, Thomas J Dilling, Alberto Chiappori, Kujtim Latifi, Trevor Rose and 15 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 7% 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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  16. Progress in radiotherapy for small-cell lung cancer.Precision radiation oncology · 2023
    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

25 authors at 2 institutions in 2 countries.

Bradford A PerezDepartment of Radiation Oncology, H Lee Moffitt Cancer Center and Research Institute; Department of Immunology, H Lee Moffitt Cancer Center and Research Institute; Department of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute. Electronic address: bradford.perez@moffitt.org.
Sungjune KimDepartment of Radiation Oncology, H Lee Moffitt Cancer Center and Research Institute; Department of Immunology, H Lee Moffitt Cancer Center and Research Institute.
Minhsuan WangDepartment of Immunology, H Lee Moffitt Cancer Center and Research Institute.
Ahmad M KarimiDepartment of Radiation Oncology, H Lee Moffitt Cancer Center and Research Institute.
Chase PowellDepartment of Immunology, H Lee Moffitt Cancer Center and Research Institute.
Jiannong LiDepartment of Biostatistics, H Lee Moffitt Cancer Center and Research Institute.
Thomas J DillingDepartment of Radiation Oncology, H Lee Moffitt Cancer Center and Research Institute; Department of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Alberto ChiapporiDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Kujtim LatifiDepartment of Radiation Oncology, H Lee Moffitt Cancer Center and Research Institute.
Trevor RoseDepartment of Radiology, H Lee Moffitt Cancer Center and Research Institute.
Austin LannonClinical Trials Office, H Lee Moffitt Cancer Center and Research Institute.
Gretchen MacMillanClinical Trials Office, H Lee Moffitt Cancer Center and Research Institute.
James SallerDepartment of Pathology, H Lee Moffitt Cancer Center and Research Institute.
G Daniel GrassDepartment of Radiation Oncology, H Lee Moffitt Cancer Center and Research Institute.
Stephen RosenbergDepartment of Radiation Oncology, H Lee Moffitt Cancer Center and Research Institute; Department of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Jhanelle GrayDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Eric HauraDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Ben CreelanDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Tawee TanvetyanonDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Andreas SaltosDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Michael ShafiqueDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute.
Theresa A BoyleDepartment of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute; Department of Pathology, H Lee Moffitt Cancer Center and Research Institute.
Michael J SchellDepartment of Biostatistics, H Lee Moffitt Cancer Center and Research Institute.
Jose R Conejo-GarciaDepartment of Immunology, H Lee Moffitt Cancer Center and Research Institute.
Scott J AntoniaDepartment of Medical Oncology, Duke Cancer Institute, Duke University Medical Center.
Moffitt Cancer Center · USCancer Institute (WIA) · IN

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
Vascular Leukocytes Influence the Tumor MicroenvironmentR01CA124515 · NCI · WISTAR INSTITUTE · PI Jose R Conejo-Garcia · 2007 to 2026
$7.1M
Targeting the adenosine A2A receptor immune checkpoint in lung cancer patientsR01CA201124 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI BEG, AMER AZIZ · 2016 to 2018
$1.2M
Finding Synergy with Radiation Therapy and Immunotherapy for Patients with Lung CancerK08CA231454 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI PEREZ, BRADFORD A. · 2019 to 2023
$1.2M
NCI NIH HHS K08 CA231454NCI NIH HHS P30 CA076292NCI NIH HHS R01 CA124515NCI NIH HHS R01 CA201124
6 · The paper itself

Abstract

purposeConsolidative thoracic radiation therapy (TRT) has been shown to improve outcomes for patients with extensive stage small cell lung cancer. We hypothesized that the addition of ipilimumab (IPI) and nivolumab (NIVO) after TRT would improve outcomes for patients with extensive stage small cell lung cancer. METHODS AND MATERIALS: Eligibility required stable disease or better after platinum doublet chemotherapy. Study therapy included consolidative TRT to 30 Gy in 10 fractions, targeting residual primary tumor and initially involved regional lymph nodes. Two weeks after TRT, patients received concurrent IPI (3 mg/kg) and NIVO (1 mg/kg) every 3 weeks for 4 doses followed by NIVO monotherapy (480 mg) every 4 weeks until progression or up to 1 year.

resultsThe study enrolled 21 patients, with 6-month progression-free survival (PFS) of 24% (90% confidence interval [CI], 11%-40%) and a median PFS of 4.5 months (95% CI, 2.7%-4.6%). The 12-month overall survival (OS) was 48% (95% CI, 29%-64%) with a median OS of 11.7 months (95% CI, 4.7%-16.0%). Fifty-two percent of patients had ≥1 possibly related grade 3 to 4 immune-related adverse event. Grade 3 pulmonary and gastrointestinal immune-related adverse events were recorded in 19% and 24% of patients, respectively. Exploratory analysis showed increased cytotoxic T cell (CD3+CD8+) tumor infiltration was associated with favorable PFS (P = .01) and OS (P = .02). Reduction in peripheral blood CD3+CD8+ from baseline to after first dose of IPI/NIVO was associated with improved PFS (P = .02) and OS (P = .02).

conclusionsConsolidative IPI and NIVO after platinum-based chemotherapy and TRT demonstrated a toxicity profile consistent with the known adverse events attributable to IPI and NIVO. Although the study regimen did not significantly improve PFS, the OS was higher than historic expectations. CD3+CD8+ tumor infiltration and migration may identify patients most likely to have improved outcomes in small cell lung cancer.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyFemaleHumansIpilimumabLung NeoplasmsMaleMiddle AgedNeoplasm StagingNivolumabPlatinumProgression-Free SurvivalProspective StudiesSmall Cell Lung CarcinomaThoraxIpilimumabNivolumabPlatinum

Identifiers

PMID33002543
PMCPMC8465780
OpenAlexW3087788304

What OpenQuestion holds

Textmetadata
LicenceTDM
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.