Abstract
BackgroundThis study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan.MethodsSpontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data.ResultsOf 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had ≥ 1 symptom at diagnosis, commonly dyspnea/shortness of breath (59%), cough (44%), and/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status.ConclusionAdvanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit–risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.
Highlights
Abemaciclib is a selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor used in the management of hormone receptor positive (HR +), human epidermal growth factor receptor 2 negative (HER2-) unresectable or recurrent breast cancer
During the first year after the launch of abemaciclib in Japan, approximately 4700 patients were exposed to abemaciclib, and interstitial lung disease (ILD) was reported for 82 patients (85 events) (82 of 4700; 1.7%) in Japan
CT, computed tomography; DAD, diffuse alveolar damage; GGO, ground glass opacity; ILD, interstitial lung disease; ILDAC; ILD adjudication committee; N, number of cases; NSIP, non-specific interstitial pneumonia; OP, organizing pneumonia a Classification of cases is by the imaging pattern most representative of the case, as evaluated by the ILDAC
Summary
Abemaciclib is a selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor used in the management of hormone receptor positive (HR +), human epidermal growth factor receptor 2 negative (HER2-) unresectable or recurrent breast cancer. ILD is a well-recognized potential complication of many different therapeutic agents [5], with drug-induced ILD accounting for an estimated 3–5% of prevalent cases of ILD [5]. Anti-cancer agents are the most common causes of drug-induced ILD [5, 6]. Methods Spontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data. Results Of 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Conclusion Advanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit–risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD
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