RT Journal Article
SR Electronic
T1 Interstitial lung disease in patients treated with poly (ADP-ribose) polymerase inhibitors (PARPi): analysis of results from clinical trials and the FDA Adverse Events Reporting System database
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 1237
OP 1246
DO 10.1136/ijgc-2022-004042
VO 33
IS 8
A1 He, Zhichao
A1 Mo, Jiayao
A1 Jiang, Wei
A1 Zhu, Jianhong
A1 Yang, Shan
A1 Gao, Siyuan
A1 Lam, Kakei
A1 Li, Yu
A1 Qiu, Kaifeng
A1 Huang, Min
A1 Wu, Junyan
YR 2023
UL http://ijgc.bmj.com/content/33/8/1237.abstract
AB Objective To evaluate the risk of interstitial lung disease associated with poly (ADP-ribose) polymerase inhibitors (PARPi) and characterize its clinical features.Methods We systematically reviewed phase III randomized clinical trials of interstitial lung disease related to PARPi and calculated Peto odds ratios (ORs) with 95% confidence intervals (CIs). Pharmacovigilance studies were conducted by collecting cases of PARPi-related interstitial lung disease from the FDA Adverse Events Reporting System and assessing disproportionalities by reporting ORs and information components.Results A total of five randomized clinical trials involving 2980 patients were included. Although PARPi showed a tendency to increase the risk of interstitial lung disease compared with controls, this difference was not significant (Peto OR: 4.92; 95% CI: 0.92 to 26.35). A total of 170 cases of interstitial lung disease related to PARPi were included, with a median latency of 99 days. PARPi had a significantly increased reporting of interstitial lung disease (reporting OR: 2.86; 95% CI: 2.46 to 3.33; information component (IC): 1.49; 95% CI: 1.28 to 1.74). Our sensitivity analyses showed strong robustness of the disproportionalities between PARPi as a class, olaparib, and interstitial lung disease. Some 91.9% of patients experienced discontinuation, 51.6% achieved remission, and no deaths were reported.Conclusion Our pharmacovigilance study suggested increased reporting of interstitial lung disease related to PARPi particularly olaparib.Data are available in a public, open access repository.