Evidence map›Paper›PMID 29913438›Full record

ArticleOncology2018

Race-, Age-, and Gender-Based Characteristics and Toxicities of Targeted Therapies on Phase I Trials.

Taofeek K Owonikoko, Adeniyi K Busari, Sungjin Kim, Zhengjia Chen, Adebowale Akintayo, Colleen Lewis, Bradley C Carthon, Olatunji B Alese, Bassel F El-Rayes, Suresh S Ramalingam and 1 more

Open access · bronzeAbstract read
In one paragraph

Article in Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 19% 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

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. 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

11 authors at 1 institution in 1 country.

Taofeek K OwonikokoDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.
Adeniyi K BusariWinship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Sungjin KimWinship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Zhengjia ChenWinship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Adebowale AkintayoWinship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Colleen LewisWinship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Bradley C CarthonDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.
Olatunji B AleseDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.
Bassel F El-RayesDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.
Suresh S RamalingamDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.
R Donald HarveyDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.
Emory University · US

Funding

Winship Cancer Institute Cancer Center Support GrantP30CA138292 · NCI · EMORY UNIVERSITY · PI Suresh S Ramalingam · 2009 to 2026
$47.5M
Novel systemic therapy to improve clinical outcome in small cell lung cancerK23CA164015 · NCI · EMORY UNIVERSITY · PI OWONIKOKO, TAOFEEK K · 2011 to 2015
$815k
NCI NIH HHS K23 CA164015NCI NIH HHS P30 CA138292
6 · The paper itself

Abstract

backgroundThe impact of age-, gender-, and race-based differences on safety and efficacy in phase I clinical trials has not been well studied.

methodsWe analyzed data from phase I clinical trials evaluating targeted biologic agents in patients with advanced solid malignancies. Race and gender distribution of enrolled patients was compared to the referral population demographics at the city, metro, and state levels. The association between age, gender, and race with type, frequency, and severity of treatment-emergent toxicities and clinical benefit was assessed using univariate and multivariable models.

resultsData from 117 eligible patients - Blacks/Caucasians/Others (27/85/5); male/female (66/51) - were obtained. Blacks were younger than Caucasian patients (median age of 56 vs. 62 years, p = 0.004). Nausea/vomiting was more frequent in female patients (43 vs. 24%, p = 0.03), while hematologic toxicity was more likely in Whites. While median time on treatment was comparable (113 vs. 91; p = 0.840), the median overall survival was significantly shorter for Blacks versus Caucasians (7.4 vs. 11.4 months; p = 0.0227). Black race (HR 2.11; 95% CI 1.24-3.60; p = 0.006) and older age (HR 1.03; 95% CI 1.00-1.06; p = 0.029) were associated with an increased risk of death.

conclusionsAge-, gender-, and race-based disparities were observed with specific toxicity and survival outcomes on phase I clinical trials of anticancer agents.

Indexed as

Clinical Trials, Phase I as TopicAge FactorsBiological FactorsFemaleGender IdentityHumansMaleMiddle AgedNeoplasmsRacial GroupsBiological FactorsGenderPhase I studyRaceTargeted therapyTolerabilityToxicity

Identifiers

PMID29913438
PMCPMC6113074
OpenAlexW2809008033

What OpenQuestion holds

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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.