Sex Differences in Hazard Ratio During Drug Treatment of Non–small-cell Lung Cancer in Major Clinical Trials

A Focused Data Review and Meta-analysis

Lishi Wang, Yanhong Cao, Mingji Ren, Amei Chen, Jinglin Cui, Dia Jun Sun, Weikuan Gu

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose Understanding how sex impacts the efficacy of anticancer agents is a crucial step toward personalized and precision medicine. This review and meta-analysis evaluated sex differences in hazard ratios (HRs) of progression-free survival and overall survival in representative Phase III clinical trials of non–small-cell lung cancer (NSCLC). Methods Data were extracted from 24 large-scale clinical trials that included 12,000 male and 7000 female patients. The data were examined for HR differences between subgroups by sex, smoking status, and age, and for potential sex–smoking status, sex–age, and sex–drug interactions, during cancer treatment. Findings Summarized information revealed variations in the influences of sex, smoking status, and age on the efficacy of drugs used for the treatment of NSCLC. The male and female subgroups had different HR values. Smoking status, age, and the percentage of female patients in a treatment group had no influence on the sex HR. The sex difference was supported by a set of data collected from all journals. Implications The findings from this meta-analysis are important for assessing potential toxicity during drug treatment in both sexes. The outcomes measures of a drug in clinical application should be specified by subpopulation, such as males versus females, as a first step in personalized medicine.

Original languageEnglish (US)
Pages (from-to)34-54
Number of pages21
JournalClinical Therapeutics
Volume39
Issue number1
DOIs
StatePublished - Jan 1 2017

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Non-Small Cell Lung Carcinoma
Sex Characteristics
Precision Medicine
Meta-Analysis
Clinical Trials
Smoking
Pharmaceutical Preparations
Phase III Clinical Trials
Sex Ratio
Therapeutics
Drug-Related Side Effects and Adverse Reactions
Antineoplastic Agents
Disease-Free Survival
Outcome Assessment (Health Care)
Survival
Neoplasms

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Sex Differences in Hazard Ratio During Drug Treatment of Non–small-cell Lung Cancer in Major Clinical Trials : A Focused Data Review and Meta-analysis. / Wang, Lishi; Cao, Yanhong; Ren, Mingji; Chen, Amei; Cui, Jinglin; Sun, Dia Jun; Gu, Weikuan.

In: Clinical Therapeutics, Vol. 39, No. 1, 01.01.2017, p. 34-54.

Research output: Contribution to journalArticle

Wang, Lishi ; Cao, Yanhong ; Ren, Mingji ; Chen, Amei ; Cui, Jinglin ; Sun, Dia Jun ; Gu, Weikuan. / Sex Differences in Hazard Ratio During Drug Treatment of Non–small-cell Lung Cancer in Major Clinical Trials : A Focused Data Review and Meta-analysis. In: Clinical Therapeutics. 2017 ; Vol. 39, No. 1. pp. 34-54.
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