Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan
| Autor: | Masashi Takahashi, Shiho Mori, Keisuke Tomii, Junji Tsurutani, Satoshi Noma, Hiroya Asou, Yoshio Taguchi, Sachi Sakaguchi, Yucherng Chen |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
medicine.medical_specialty Aminopyridines Antineoplastic Agents Breast Neoplasms Interstitial lung disease chemistry.chemical_compound Breast cancer Japan Surgical oncology Internal medicine medicine Product Surveillance Postmarketing Humans Pharmacology (medical) Radiology Nuclear Medicine and imaging Diffuse alveolar damage Adverse effect Abemaciclib Aged Aged 80 and over business.industry Age Factors General Medicine Middle Aged medicine.disease Metastatic breast cancer Oncology chemistry Radiological weapon Benzimidazoles Female Original Article business Lung Diseases Interstitial Tomography X-Ray Computed Cyclin-dependent kinase 4/6 |
| Zdroj: | Breast Cancer (Tokyo, Japan) |
| ISSN: | 1880-4233 |
| Popis: | Background This 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. 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. 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. Results Of 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. 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. |
| Databáze: | OpenAIRE |
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