Evaluation of Lung Toxicity With Lenalidomide Using the Pharmacovigilance Database

Area of Science:

• Pharmacovigilance
• Oncology
• Pulmonology

Background:

• Lenalidomide (LND) is an oral anticancer drug for hematologic malignancies.
• Common LND adverse events include myelosuppression, thrombosis, and pneumonia.
• The incidence and timing of LND-related lung toxicity are not well-defined.

Purpose of the Study:

• To evaluate the incidence and onset timing of LND-related lung toxicity.
• To analyze outcome details of LND-induced lung toxicities.
• To utilize the Japanese Adverse Drug Event Report (JADER) database for safety signal detection.

Main Methods:

• Analysis of LND adverse drug reactions (ADRs) from April 2004 to March 2021.
• Estimation of safety signals using reported odds ratios (RORs) and 95% confidence intervals (CIs).
• Assessment of the timing of onset for lung toxicity signs.

Main Results:

• 908 lung toxicities were reported among 10,929 LND ADRs.
• Pneumonia (559 cases, ROR=3.89) and bacterial pneumonia (38 cases, ROR=2.02) were frequent and significant.
• Median onset for pneumonia was 84 days; for bacterial pneumonia, it was 74 days.
• Outcomes for patients with LND-related pneumonia were poor, with 10-20% mortality.

Conclusions:

• Pneumonia and bacterial pneumonia are significant LND-related lung toxicities.
• These lung toxicities may be linked to LND-induced immunosuppression.
• Monitoring respiratory symptoms within the first 3 months of LND treatment is important.