Evidence map›Paper›PMID 22982658›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2012

A double-blind randomized discontinuation phase-II study of sorafenib (BAY 43-9006) in previously treated non-small-cell lung cancer patients: eastern cooperative oncology group study E2501.

Heather A Wakelee, Ju-Whei Lee, Nasser H Hanna, Anne M Traynor, David P Carbone, Joan H Schiller

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 5 pooled it
5.6field-weighted citation impact, top 4% 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

27 citing papers in PubMed, 5 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
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  16. Antiangiogenic therapies in non-small-cell lung cancer.Current oncology (Toronto, Ont.) · 2018
    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

6 authors at 6 institutions in 1 country.

Heather A WakeleeDepartment of Medicine, Division of Oncology, Stanford Cancer Institute, Stanford University, Stanford, CA, USA. hwakelee@stanford.edu
Ju-Whei Lee
Nasser H Hanna
Anne M Traynor
David P Carbone
Joan H Schiller
Dana-Farber Cancer Institute · USIndiana University Melvin and Bren Simon Comprehensive Cancer CenterStanford Medicine · USThe University of Texas Southwestern Medical Center · USUniversity of Wisconsin–Madison · USVanderbilt University · US

Funding

ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
EASTERN COOPERATIVE ONCOLOGY GROUP--WISCONSIN STUDIESU10CA021076 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI KAHL, BRAD · 1985 to 2013
$8.2M
ONCOLOGYU10CA049957 · NCI · VANDERBILT UNIVERSITY · PI BERLIN, JORDAN D · 1989 to 2013
$5.4M
ONCOLOGYU10CA049883 · NCI · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI MILLER, KATHY D. · 1989 to 2013
$4.0M
NCI NIH HHS CA21076NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA49883NCI NIH HHS CA49957NCI NIH HHS CA66636NCI NIH HHS U10 CA021076NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA049883NCI NIH HHS U10 CA049957NCI NIH HHS U10 CA066636
6 · The paper itself

Abstract

introductionSorafenib is a raf kinase and angiogenesis inhibitor with activity in multiple cancers. This phase-II study in heavily pretreated non-small-cell lung cancer (NSCLC) patients (≥ 2 prior therapies) used a randomized discontinuation design.

methodsPatients received 400 mg of sorafenib orally twice daily for two cycles (2 months) (step 1). Responding patients on step 1 continued on sorafenib; progressing patients went off study, and patients with stable disease were randomized to placebo or sorafenib (step 2), with crossover from placebo allowed upon progression. The primary endpoint of this study was the proportion of patients having stable or responding disease 2 months after randomization.

resultsThere were 299 patients evaluated for step 1; of these, 81 eligible patients were randomized on step 2 and received sorafenib (n = 50) or placebo (n = 31). The 2-month disease control rates after randomization were 54% and 23% for patients initially receiving sorafenib and placebo, respectively, p = 0.005. The hazard ratio for progression on step 2 was 0.51 (95% [confidence interval] CI 0.30, 0.87, p = 0.014) favoring sorafenib. A trend in favor of overall survival with sorafenib was also observed (13.7 versus 9.0 months from time of randomization), hazard ratio 0.67 (95% CI 0.40-1.11), p = 0.117. A dispensing error occurred, which resulted in the unblinding of some patients, but not before completion of the 8-week initial step 2 therapy. Toxicities were manageable and as expected.

conclusionsThe results of this randomized discontinuation trial suggest that sorafenib has single-agent activity in a heavily pretreated, enriched patient population with advanced NSCLC. These results support further investigation with sorafenib as a single agent in larger, randomized studies in NSCLC.

Indexed as

AdenocarcinomaAdenocarcinoma, Bronchiolo-AlveolarAdultAgedAged, 80 and overAntineoplastic AgentsBenzenesulfonatesCarcinoma, Large CellCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCross-Over StudiesDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansAntineoplastic AgentsBenzenesulfonatesNiacinamidePhenylurea CompoundsPyridinesSorafenib

Identifiers

PMID22982658
PMCPMC3444827
OpenAlexW2038501887

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.