PARP inhibitors (PARPis) were associated with an increased risk of pneumonitis in clinical trials, according to a study published in Gynecologic Oncology.

The study authors noted that PARPis are used to treat multiple cancer types, including ovarian, breast, pancreatic, and prostate cancers. Although there was a low incidence of pneumonitis in clinical trials of PARPis, the trials may have been underpowered to assess this association.

The aim of the current study was to evaluate the association between PARPis and pneumonitis in randomized controlled trials and in real-world practice.

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The study included a meta-analysis of data from 5571 patients who were enrolled in 16 phase 2 and 3 clinical trials. All trials were designed to test a PARPi and had a control arm. The primary endpoint was the risk of pneumonitis between trial arms.

The researchers also conducted a retrospective evaluation of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2004 to 2020, looking for cases of PARPi-associated pneumonitis and determining patient outcomes.

In clinical trials, patients treated with PARPis had a significantly increased risk of pneumonitis when compared with patients in control arms (odds ratio, 2.68; 95% CI, 1.31-5.47; P =.007). The overall incidence of pneumonitis was 0.79% across PARPi arms and 0.24% across control arms.

In the FAERS database, there were 84 cases of pneumonitis associated with a PARPi. The median time to pneumonitis was 81 days, and 87% of cases occurred within 6 months of treatment initiation. The fatality rate was 16%.

“PARPis increased the risk of pneumonitis that can result in serious outcomes and tend to occur early,” the authors concluded. “Early recognition and management of PARPi-pneumonitis is of vital importance in clinical practice.”


Ma Z, Sun X, Zhao Z, et al. Risk of pneumonitis in cancer patients treated with PARP inhibitors: a meta-analysis of randomized controlled trials and a pharmacovigilance study of the FAERS database. Gynecol Oncol. Published online May 19, 2021. doi:10.1016/j.ygyno.2021.05.012