Evidence map›Paper›PMID 25031274›Full record

Trial reportJournal of the National Cancer Institute2014

Randomized trial of erlotinib plus whole-brain radiotherapy for NSCLC patients with multiple brain metastases.

Siow Ming Lee, Conrad R Lewanski, Nicholas Counsell, Christian Ottensmeier, Andrew Bates, Nirali Patel, Christina Wadsworth, Yenting Ngai, Allan Hackshaw, Corinne Faivre-Finn

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the National Cancer Institute, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 7 pooled it
12.6field-weighted citation impact, top 1% 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

67 citing papers in PubMed, 7 syntheses or guidelines pooled it, 117 citations in OpenAlex.

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7 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

10 authors at 4 institutions in 1 country.

Siow Ming LeeAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK. sm.lee@uclh.nhs.uk.
Conrad R LewanskiAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Nicholas CounsellAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Christian OttensmeierAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Andrew BatesAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Nirali PatelAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Christina WadsworthAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Yenting NgaiAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Allan HackshawAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
Corinne Faivre-FinnAffiliations of authors: Department of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, UK (SML, NP); Department of Oncology, Charing Cross Hospital, London, UK (CRL); Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK (NC, CW, YN, AH); Department of Oncology, Southampton General Hospital, Southampton, UK (CO, AB); Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester (CFF), UK.
CRUK Lung Cancer Centre of Excellence · GBUniversity College London · GBCharing Cross Hospital · GBSouthampton General Hospital · GB

Funding

Cancer Research UK 15953Cancer Research UK C1438/A10010Cancer Research UK C1438/A6406
6 · The paper itself

Abstract

backgroundMedian survival of non-small cell lung cancer (NSCLC) patients with brain metastases is poor. We examined concurrent erlotinib and whole brain radiotherapy (WBRT) followed by maintenance erlotinib in patients with untreated brain metastases, given the potential radiosensitizing properties of erlotinib and its direct effect on brain metastases and systemic activity.

methodsEighty NSCLC patients with KPS of 70 and greater and multiple brain metastases were randomly assigned to placebo (n = 40) or erlotinib (100mg, n = 40) given concurrently with WBRT (20 Gy in 5 fractions). Following WBRT, patients continued with placebo or erlotinib (150 mg) until disease progression. The primary end point was neurological progression-free survival (nPFS); hazard ratios (HRs) were calculated using Cox regression. All P values were two-sided.

resultsFifteen patients (37.5%) from each arm were alive and without neurological progression 2 months after WBRT. Median nPFS was 1.6 months in both arms; nPFS HR 0.95 (95% CI = 0.59 to 1.54; P = .84). Median overall survival (OS) was 2.9 and 3.4 months in the placebo and erlotinib arms; HR 0.95 (95% CI = 0.58 to 1.55; P = .83). The frequency of epidermal growth factor receptor (EGFR) mutations was low with only 1 of 35 (2.9%) patients with available samples had activating EGFR-mutations. Grade 3/4 adverse event rates were similar between the two groups (70.0% in each arm), except for rash 20.0% (erlotinib) vs 5.0% (placebo), and fatigue 17.5% vs 35.0%. No statistically significant quality of life differences were found.

conclusionsOur study showed no advantage in nPFS or OS for concurrent erlotinib and WBRT followed by maintenance erlotinib in patients with predominantly EGFR wild-type NSCLC and multiple brain metastases compared to placebo. Future studies should focus on the role of erlotinib with or without WBRT in patients with EGFR mutations.

Indexed as

Cranial IrradiationAdultAgedAntineoplastic AgentsBrain NeoplasmsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodErbB ReceptorsErlotinib HydrochlorideFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleAntineoplastic AgentsEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideProtein Kinase InhibitorsQuinazolines

Identifiers

PMID25031274
PMCPMC4112798
OpenAlexW2109986616

What OpenQuestion holds

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Registered trials

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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.