Study
PLCO
(Learn more about this study)
Project ID
PLCO-367
Initial CDAS Request Approval
May 22, 2018
Title
Influence of Gender and Hormonal Status on Lung Cancer Incidence and Mortality from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial
Summary
Lung Cancer is the leading cause of cancer-related deaths in the US with significant disparities noted for women. It affects female nonsmokers disproportionately with 20% of women with lung cancer having never smoked compared to only 2%-6% in men. In Asian populations, the rate of lung cancer in female never smokers is even higher at 60%-80%, compared to 10%-15% for Asian men. Studies examining gender differences in lung cancer have yielded mixed results. Hormonal replacement therapy (HRT) has been associated with decreased incidence of lung cancer in some studies and decreased incidence in others. Many studies have used age alone as a surrogate for hormonal status dividing women into pre/post-menopausal groups based on the average age of menopause yet the results fail to show a discrete pattern. With regards to outcomes, female gender has been associated with improved overall survival in stage-matched studies providing evidence for the protective role of estrogen. , Additional studies have supported the potential protective role of estrogens by providing a molecular basis for these clinical observations. Strong expression of Estrogen Receptor beta has been associated with improved progression-free survival after treatment with Tyrosine Kinase Inhibitors with particular potential for application in Asian females with a high prevalence of EGFR receptor mutations.
Aims
In this proposal, we will analyze data from the PLCO trial to examine associations between gender and hormonal status with lung cancer incidence and mortality. We would include all lung cancer screened patients: 154,901 participants aged 55 through 74 years without prior history of lung cancer. Women will be divided into groups for separate analyses based on hormone replacement therapy status at the time of randomization: never, current, or former. We will compare outcomes among females based on hormonal replacement status and additional comparison of females using males as a reference group. Our primary outcomes will be lung cancer incidence, disease- specific mortality, and all-cause mortality.
Collaborators
PI:
Leah M Backhus, MD MPH FACS, Associate Professor, Stanford University, Department of Cardiothoracic Surgery
Collaborators:
Hao He, Ph.D, Senior Biostatistician, Stanford University, Department of Cardiothoracic Surgery
