PT  - JOURNAL ARTICLE
AU  - He, Zhichao
AU  - Mo, Jiayao
AU  - Jiang, Wei
AU  - Zhu, Jianhong
AU  - Yang, Shan
AU  - Gao, Siyuan
AU  - Lam, Kakei
AU  - Li, Yu
AU  - Qiu, Kaifeng
AU  - Huang, Min
AU  - Wu, Junyan
TI  - 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
AID  - 10.1136/ijgc-2022-004042
DP  - 2023 Aug 01
TA  - International Journal of Gynecologic Cancer
PG  - 1237--1246
VI  - 33
IP  - 8
4099  - http://ijgc.bmj.com/content/33/8/1237.short
4100  - http://ijgc.bmj.com/content/33/8/1237.full
SO  - Int J Gynecol Cancer2023 Aug 01; 33
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.