Evidence map›Paper›PMID 30121602›Full record

Trial reportBMJ open2018

Is time to progression associated with post-progression survival in previously treated metastatic non-small cell lung cancer with BRAF V600E mutation? A secondary analysis of phase II clinical trial data.

Junlong Li, Medha Sasane, Jie Zhang, Jing Zhao, Marie Louise Ricculli, Zhiwen Yao, Suman Redhu, James Signorovitch

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01336634 (A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT01336634 phase2completednot on this map

A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2021Enrolled177ConditionsCancerArmsDabrafenib, Trametinib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. [Progress of BRAF Gene Alteration in Non-small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2024
    Review
  2. Review
  3. Review
  4. Article
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

8 authors.

Junlong LiAnalysis Group Inc., Boston, Massachusetts, USA.
Medha SasaneNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Jie ZhangNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Jing ZhaoAnalysis Group Inc., Boston, Massachusetts, USA.
Marie Louise RicculliAnalysis Group Inc., New York City, New York, USA.
Zhiwen YaoAnalysis Group Inc., Boston, Massachusetts, USA.
Suman RedhuNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
James SignorovitchAnalysis Group Inc., Boston, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveLonger time to progression (TTP) is associated with prolonged post-progression survival (PPS) in anaplastic lymphoma kinase+non-small cell lung cancer (NSCLC). This study evaluated whether TTP is associated with PPS among previously treated patients with metastatic v-Raf murine sarcoma viral oncogene homolog B V600E NSCLC receiving dabrafenib as monotherapy or in combination with trametinib.

designSecondary analysis of phase II clinical trial data.

settingPatients who experienced disease progression treated with dabrafenib monotherapy or in combination with trametinib as second line or later in an open-label, non-randomised, phase II study. PRIMARY OUTCOME MEASURES: The primary outcome was the TTP-PPS association. PPS was assessed with Kaplan-Meier analysis among patients with shorter versus longer TTP (< or ≥6 months). The TTP-PPS association was quantified in the Cox models adjusting for clinical covariates.

resultsOf the 84 included patients who progressed on dabrafenib monotherapy (n=57) or combination therapy (n=27), 60 (71%) died during post-progression follow-up. Patients with TTP ≥6 months experienced significantly longer PPS compared with those with TTP <6 months (median PPS: 9.5 vs 2.7 months, log-rank p<0.001). Each 3 months of longer TTP was associated with a 32% lower hazard of death following progression (HR 0.68, 95% CI 0.52 to 0.88) in the multivariable Cox model. Similar associations were seen in each treatment arm.

conclusionA longer TTP duration after treatment with dabrafenib monotherapy or combination therapy was associated with significantly longer PPS duration. TRIAL REGISTRATION NUMBER: NCT01336634; Post-results.

Indexed as

Disease ProgressionAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungFemaleHumansImidazolesLung NeoplasmsMaleMutationOximesProtein Kinase InhibitorsProto-Oncogene Proteins B-rafPyridonesPyrimidinonesBRAF protein, humandabrafenibImidazolesOximesProtein Kinase InhibitorsProto-Oncogene Proteins B-rafPyridonesPyrimidinonestrametinibBRAF V600E NSCLCdabrafeniboncologypost-progression survivaltime to progressiontrametinib

Identifiers

PMID30121602
PMCPMC6104743

What OpenQuestion holds

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Registered trials

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.