Evidence map›Paper›PMID 32103736›Full record

ArticleBMC cancer2020

Risk factors for severe rash with use of vemurafenib alone or in combination with cobimetinib for advanced melanoma: pooled analysis of clinical trials.

Ashley M Hopkins, Akash D Rathod, Andrew Rowland, Ganessan Kichenadasse, Michael J Sorich

Open access · goldAbstract read
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 44% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  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

5 authors at 1 institution in 1 country.

Ashley M HopkinsCollege of Medicine and Public Health, Flinders University, Adelaide, 5042, Australia. ashley.hopkins@flinders.edu.au.ORCID http://orcid.org/0000-0001-7652-4378
Akash D RathodCollege of Medicine and Public Health, Flinders University, Adelaide, 5042, Australia.
Andrew RowlandCollege of Medicine and Public Health, Flinders University, Adelaide, 5042, Australia.
Ganessan KichenadasseCollege of Medicine and Public Health, Flinders University, Adelaide, 5042, Australia.
Michael J SorichCollege of Medicine and Public Health, Flinders University, Adelaide, 5042, Australia. michael.sorich@flinders.edu.au.
Flinders University · AU

Funding

Cancer Council SA's Beat Cancer Project on behalf of its donors and the State Government of South Australia through the Department of Health XXXXXXNational Breast Cancer Foundation, Australia PF-17-007
6 · The paper itself

Abstract

backgroundRash is one of the most common severe adverse events associated with use of vemurafenib for the treatment of melanoma, either as monotherapy or in combination with cobimetinib. The study aimed to identify pre-treatment patient characteristics predictive of developing severe rash with vemurafenib therapy.

methodsThis was a secondary pooled analysis of individual patient data from the BRIM-2, BRIM-3 and coBRIM clinical trials, including all patients treated with vemurafenib alone and vemurafenib plus cobimetinib. Patient age, sex, performance status, body weight, body mass index, liver function markers and estimated glomerular filtration rate were assessed for association with development of severe (grade 3 or 4) rash using logistic regression.

resultsOf 962 patients treated with vemurafenib, 150 (16%) patients experienced severe rash. Female sex was identified as a significant risk factor for severe rash development (P < 0.001), having a two-fold increased risk compared to males (22% vs 11%, odds ratio [OR] 2.17; 95% CI 1.52 to 3.09). Low body weight was also associated with increased risk of severe rash (P = 0.002), but this association was not significant after adjustment for sex. The association between sex and risk of severe rash was consistent across clinical trials and treatments (vemurafenib monotherapy, vemurafenib plus cobimetinib).

conclusionFemales had approximately two-fold increased risk of developing severe rash compared to males in clinical trials of vemurafenib alone or in combination with cobimetinib.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsAustraliaAzetidinesClinical Trials as TopicExanthemaFemaleHumansIncidenceMaleMelanomaMiddle AgedNeoplasm StagingPiperidinesRisk FactorsAzetidinescobimetinibPiperidinesVemurafenibBRAF inhibitorPredictorsRisk factorSevere rashToxicityVemurafenib

Identifiers

PMID32103736
PMCPMC7045585
OpenAlexW3010238254

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.