Evidence map›Paper›PMID 41649539›Full record

ReviewEuropean journal of clinical pharmacology2026

Assessing patient risk, benefit, and outcomes in drug development: a decade of sorafenib clinical trials.

Logan Corwin, Joanna George, Eli Paul, Tim Smith, Griffin K Hughes, Ryan McIntire, Brooke Gardner, Andriana Peña, Chase Ladd, Kirstien Minley and 4 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in European journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Logan CorwinOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA. corwin.research@gmail.com.
Joanna GeorgeOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Eli PaulOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Tim SmithOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Griffin K HughesOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Ryan McIntireOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Brooke GardnerOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Andriana PeñaOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Chase LaddOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Kirstien MinleyOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.
Kate RileyDepartment of Internal Medicine, Oklahoma State University Medical Center, Tulsa, OK, USA.
Alyson HaslamDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
Vinay PrasadDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
Matt VassarOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17Th St., Tulsa, OK, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPharmaceutical companies frequently explore previously approved cancer drugs for new indications, which may expose trial participants to uncertain benefit and potential harm. Sorafenib has been investigated across numerous cancer types despite limited evidence supporting many off-label uses. This study evaluates sorafenib’s reported risk–benefit profile in clinical trials published during the past decade.

objectiveTo assess the portfolio of sorafenib trials by examining reported efficacy and safety outcomes over the last ten years.

methodsA literature search of bibliographic databases was conducted on May 25, 2023, to identify adult clinical trials evaluating sorafenib’s antitumor activity. Eligible studies were published within the prior decade and reported objective response criteria. Screening and data extraction were performed in duplicate. Extracted variables included trial characteristics, objective response rate (ORR), grade 3–5 adverse event (AE) rates, median progression-free survival, and median overall survival. Primary endpoints were categorized as positive, negative, or indeterminate based on author-defined criteria.

resultsSince sorafenib’s most recent FDA approval in 2013, investigators have examined its activity in more than 32 off-label indications. Across 154 trials, 12,226 participants were evaluable for AE grading, with 11,003 grade 3–5 AEs reported. Cumulative trends demonstrated persistently low ORR and increasing cumulative rates of severe AEs over time across off-label indications.

conclusionThis descriptive portfolio review highlights that, across published trials of sorafenib monotherapy in non-FDA-approved indications, reported objective responses were infrequent while severe AEs were common. These findings underscore the importance of transparent reporting and careful consideration of the existing evidence base when designing or interpreting future sorafenib trials in off-label settings. Key words: Sorafenib, Off-label indications, Risk-benefit analysis, Clinical trial portfolio, Adverse events

Indexed as

Antineoplastic AgentsDrug DevelopmentNeoplasmsSorafenibClinical Trials as TopicHumansOff-Label UseRisk AssessmentAntineoplastic AgentsSorafenibAdverse eventsClinical trial portfolioOff-label indicationsRisk-benefit analysisSorafenib

Identifiers

PMID41649539

What Socratic holds

Textmetadata
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 Socratic graph.