Hormone therapies up ILD events in men with prostate cancer

Hormone therapy drugs, such as bicalutamide, flutamide, nilutamide, goserelin, degarelix, and apalutamide, appear to increase the likelihood of developing interstitial lung disease (ILD) events in patients with prostate cancer, reports a study.

A team of investigators identified men diagnosed with prostate cancer using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2004 to 2020. Participants were then grouped based on the primary suspected drugs: hormone therapy group, positive control group (taxanes), and negative control group.

Reporting odds ratio (ROR), a disproportionate method, was used to examine the relationship between ILD events and target drugs.

Of the 85,403 patients identified, 69,894 were included in the hormone therapy group (628 ILD event cases), 2,302 in the positive control group (158 ILD cases), and 13,207 in the negative control group (72 ILD event cases).

Interestingly, 394 ILD event cases (62.74 percent) in the hormone therapy group were from the Japanese population, and 78.68 percent of ILD events occurred 1 year after hormone treatment.

On disproportionality analysis, ILD events significantly correlated with nilutamide (ROR, 32.14, 95 percent confidence interval [CI], 11.03‒93.63), flutamide (ROR, 9.93, 95 percent CI, 3.62‒27.21), bicalutamide (ROR, 8.19, 95 percent CI, 6.01‒11.16), goserelin (ROR, 3.74, 95 percent CI, 2.61‒5.37), degarelix (ROR, 2.41, 95 percent CI, 1.55‒3.75), and apalutamide (ROR, 1.94, 95 percent CI, 1.01‒3.75).

“Based on this FAERS pharmacovigilance analysis, the association between ILD events and hormone therapy drugs, including bicalutamide, flutamide, nilutamide, goserelin, degarelix, and apalutamide, should not be ignored, especially in the Japanese population,” the investigators said.

“Lung function of prostate cancer patients should be monitored when receiving the hormone therapy drugs mentioned above, especially for the first year postmedication,” they added.