Evidence map›Paper›PMID 26723241›Full record

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

Positive Interaction between Prophylactic Cranial Irradiation and Maintenance Sunitinib for Untreated Extensive-Stage Small Cell Lung Cancer Patients After Standard Chemotherapy: A Secondary Analysis of CALGB 30504 (ALLIANCE).

Joseph K Salama, Lin Gu, Xiaofei Wang, Herbert H Pang, Jeffrey A Bogart, Jeffrey Crawford, Steven E Schild, Everett E Vokes, Neal E Ready

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
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 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 32% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. What is the current role of prophylactic cranial irradiation in the treatment algorithm for small cell lung cancer?Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2023
    Review
  5. Review
  6. 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

9 authors at 5 institutions in 2 countries.

Joseph K SalamaDepartment of Radiation Oncology, Duke University, Durham, NC, USA. Electronic address: joseph.salama@duke.edu.
Lin GuAlliance Statistics and Data Center, Duke University, Durham, NC, USA.
Xiaofei WangAlliance Statistics and Data Center, Duke University, Durham, NC, USA.
Herbert H PangAlliance Statistics and Data Center, Duke University, Durham, NC, USA; School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong, Pok Fu Lam, Hong Kong SAR, People's Republic of China.
Jeffrey A BogartDepartment of Radiation Oncology, SUNY Upstate Medical Center, Syracuse, NY, USA.
Jeffrey CrawfordSection of Medical Oncology, Department of Medicine, Duke University, Durham, NC, USA.
Steven E SchildDepartment of Radiation Oncology, Mayo Clinic, Scottsdale, AZ, USA.
Everett E VokesSection of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, IL, USA.
Neal E ReadySection of Medical Oncology, Department of Medicine, Duke University, Durham, NC, USA.
Duke University · USDuke Medical Center · USMayo Clinic in Arizona · USSUNY Upstate Medical University · USUniversity of Chicago · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Re-Engineering Translational Research at the University of ChicagoUL1TR000430 · NCATS · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2012 to 2016
$20.2M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCATS NIH HHS UL1 TR000430NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA180821NCI NIH HHS U10CA180821NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180882NCI NIH HHS U10CA180882
6 · The paper itself

Abstract

backgroundProphylactic cranial irradiation (PCI) has become a standard option for patients with extensive-stage small cell lung cancer (ES-SCLC). The Cancer and Leukemia Group B 30504 trial was a randomized phase II study of the effect of sunitinib versus placebo in ES-SCLC patients responding to platinum-based systemic therapy. The study required preenrollment brain imaging. PCI was provided at the discretion of treating physicians. We performed a secondary analysis of the Cancer and Leukemia Group B trial to determine the impact of PCI on patients with ES-SCLC.

methodsFisher's exact test and the Wilcoxon rank-sum test were conducted to identify the differences between patients receiving PCI and patients not receiving PCI. Kaplan-Meier analyses described progression-free survival (PFS) and overall survival (OS) for patients in the PCI and non-PCI groups.

resultsA total of 85 patients received maintenance therapy (41 received placebo and 44 received sunitinib). Patient characteristics were balanced between the PCI and non-PCI groups. The patients receiving PCI plus sunitinib had a nonsignificant 2.7-month improvement in PFS (5.0 months versus 2.3 months, p = 0.14, hazard risk [HR] = 0.62, 95% confidence interval [CI]: 0.33-1.18) trending toward improved OS (8.9 months versus 5.4 months, p = 0.053, HR = 0.47, 95% CI: 0.22-1.03). PCI was associated with a trend toward improved median PFS (2.9 months versus 2.2 months, p = 0.096, HR = 0.69, 95% CI: 0.45-1.07) but not median OS (8.3 months in the PCI group versus 8.7 months in the non-PCI group, p = 0.76, HR = 1.07, 95% CI: 0.67-1.71). The patients receiving placebo had no improvement in PFS or OS with PCI.

conclusionsTrends toward improved PFS and OS were seen in patients receiving PCI and sunitinib, thus supporting the need for further prospective research evaluating the integration of maintenance systemic therapy and PCI for patients with ES-SCLC. Improved outcomes for patients with ES-SCLC after induction chemotherapy may require PCI, thoracic radiotherapy, and maintenance systemic therapy to achieve control of both intracranial and extracranial disease.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCisplatinCranial IrradiationDisease-Free SurvivalEtoposideFemaleHumansIndolesLung NeoplasmsMaintenance ChemotherapyMaleMiddle AgedPlacebosCarboplatinCisplatinEtoposideIndolesPlacebosPyrrolesSunitinibExtensive-stage small cell lung cancerMaintenance chemotherapyProphylactic cranial irradiationSunitinibSurvival

Identifiers

PMID26723241
PMCPMC4775320
OpenAlexW2288972787

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.