기타학회
| Evaluation of the Appropriateness, Efficacy, and Safety of Lurbinectedin in Patients with Metastatic Small Cell Lung Cancer | ||
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Introduction Lurbinectedin, a second-line treatment for metastatic small cell lung cancer, received accelerated approval from the United States Food and Drug Administration (FDA) in June 2020. In South Korea, it has been approved since September 2022 for patients who have experienced disease progression following first-line platinum-based chemotherapy. This study aimed to evaluate the real-world appropriateness of lurbinectedin prescription, as well as its clinical efficacy and safety profile, in patients treated at a tertiary care institution.
Method We conducted a retrospective review of electronic medical records among patients who received lurbinectedin between June 2023 and March 2024. Prescription appropriateness was assessed based on regulatory indications, dosing and administration guidelines. Efficacy endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR). Safety was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Results During the study period, 98 prescriptions were issued to 30 patients, all of which met the approved indication. Eighty-one prescriptions (82.7%) adhered to the approved dosing regimen. The median PFS was 2.76 months (95% confidence interval: 2.29–3.23), and the median OS was 8.12 months (95% confidence interval: 1.60–14.64). The ORR and DCR were 6.7% and 33.3%, respectively. OS was significantly shorter in patients with ECOG ≥2 compared with those with ECOG ≤1 (median, 76 vs 319 days; p=0.027). A total of 260 adverse events were recorded, most commonly anemia (100%), hypoalbuminemia (76.7%) and lymphopenia (60.0%).
Conclusion In this real-world study, lurbinectedin demonstrated its potential as a viable treatment option for patients with metastatic small cell lung cancer who had progressed after first-line platinum-based chemotherapy. ECOG performance status and advanced age were associated with poorer survival outcomes. To ensure the safe and effective use of lurbinectedin, continued monitoring of prescription appropriateness and treatment outcomes is warranted. |
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