Abstract | Background: Investigators have used administrative claims to better understand cancer outcomes when a research question cannot feasibly be examined within a study. The Prostate Cancer Prevention Trial (PCPT) showed that seven years of finasteride reduced prostate cancer (PC) risk by 25% in men age 55 years or older. However, it was unclear whether the observed reduction in PC for finasteride participants would be maintained after finasteride discontinuation. Methods: We examined PC diagnoses identified by PCPT study records and Medicare claims ( finasteride = 9423, placebo = 9457). A Medicare-defined PC diagnosis algorithm was defined using diagnosis and procedure codes. Multivariable Cox regression was used to examine time to PC within prespecified follow-up windows (<6.5, 6.5-7.5, and >7.5 years) using time-dependent covariates interacting with intervention assignment to account for the PCPT protocol-specified end-of-study biopsy at seven years. All statistical tests were two-sided. Results: Median follow-up using the linked database was 16 years. Overall, finasteride arm participants had a 21.1% decrease in the hazard ratio of PC (hazard ratio [HR] = 0.79, 95% confidence interval [CI] = 0.74 to 0.84, P < .001). The beneficial effect of finasteride in reducing the hazard ratio of PC was most pronounced in the first 7.5 years (HR = 0.71, 95% CI = 0.66 to 0.77, P < .001), consistent with the original study findings; after 7.5 years, there was no increased risk of PC for finasteride arm participants (HR = 1.10, 95% CI = 0.96 to 1.26, P = .18). Conclusions:
Finasteride provides a substantial reduction in PC through 16 years of follow-up. There was no strong evidence that the benefit of finasteride diminished after the end-of-study follow-up. Utilizing Medicare claims to augment PCPT follow-up illustrates how the novel use of secondary data sources can enhance the ability to detect long-term outcomes from prospective studies.
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Authors | Joseph M Unger, Dawn L Hershman, Cathee Till, Catherine M Tangen, William E Barlow, Scott D Ramsey, Phyllis J Goodman, Ian M Thompson Jr |
Journal | Journal of the National Cancer Institute
(J Natl Cancer Inst)
Vol. 110
Issue 11
Pg. 1208-1215
(11 01 2018)
ISSN: 1460-2105 [Electronic] United States |
PMID | 29534197
(Publication Type: Journal Article, Research Support, N.I.H., Extramural)
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Chemical References |
- 5-alpha Reductase Inhibitors
- Finasteride
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Topics |
- 5-alpha Reductase Inhibitors
(administration & dosage, adverse effects)
- Adult
- Aged
- Biopsy
- Case-Control Studies
- Finasteride
(administration & dosage, adverse effects)
- Follow-Up Studies
- Humans
- Incidence
- Male
- Medicare
- Middle Aged
- Proportional Hazards Models
- Prostatic Neoplasms
(diagnosis, epidemiology, etiology, prevention & control)
- Public Health Surveillance
- United States
(epidemiology)
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