역형성 림프종 인산화효소(ALK)-양성 전이성 비소세포폐암 환자에서 Lorlatinib의 유효성 및 안전성 평가
Evaluation of the Effectiveness and Safety of Lorlatinib in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non-Small Cell Lung Cancer
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Background : Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) approved by the Food and Drug Administration (FDA) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). It has been shown to reduce disease progression and mortality risk compared to conventional treatments. This study aimed to evaluate the appropriateness of lorlatinib prescriptions, as well as its effectiveness and safety. Methods : From June 2022 to October 2023, the medical records of 58 patients treated with lorlatinib at a tertiary hospital in South Korea were retrospectively analyzed. We assessed the appropriateness of indications and prescribed doses. Effectiveness was evaluated using progression-free survival (PFS), calculated via the Kaplan-Meier method. Adverse drug reactions (ADRs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Results : During the study period, a total of 266 prescriptions were made for the 58 patients. All cases met the criteria for indication justification. Of these, 259 cases (97.4%) adhered to the approved dosages and administration guidelines, while 7 cases (2.6%) involved deviations related to dose adjustments for ADRs. The median PFS was 16.3 months (95% CI, 11.3–21.1 months). No significant associations were found between PFS and clinical factors such as age, sex, smoking status, number of prior treatments, or brain metastases. Among 333 reported ADRs in 55 patients, the most common were anemia (67.2%), hypercholesterolemia (63.8%), and hypertriglyceridemia (48.3%). Lipid-lowering therapy, primarily with rosuvastatin 10mg, was initiated in 38 patients. Two patients discontinued lorlatinib due to ADRs, primarily pneumonia and cognitive effects. Conclusion : This study confirms the effectiveness of lorlatinib through observed PFS. Although ADRs were diverse, the rate of drug discontinuation due to these reactions was low, and most ADRs were manageable with supportive care. Continuous prescription monitoring and active pharmacist intervention are recommended to ensure the safe and effective use of lorlatinib, particularly in preventing and managing ADRs.
Abstract
Background : Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) approved by the Food and Drug Administration (FDA) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). It has been shown to reduce disease progression and mortality risk compared to conventional treatments. This study aimed to evaluate the appropriateness of lorlatinib prescriptions, as well as its effectiveness and safety. Methods : From June 2022 to October 2023, the medical records of 58 patients treated with lorlatinib at a tertiary hospital in South Korea were retrospectively analyzed. We assessed the appropriateness of indications and prescribed doses. Effectiveness was evaluated using progression-free survival (PFS), calculated via the Kaplan-Meier method. Adverse drug reactions (ADRs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Results : During the study period, a total of 266 prescriptions were made for the 58 patients. All cases met the criteria for indication justification. Of these, 259 cases (97.4%) adhered to the approved dosages and administration guidelines, while 7 cases (2.6%) involved deviations related to dose adjustments for ADRs. The median PFS was 16.3 months (95% CI, 11.3–21.1 months). No significant associations were found between PFS and clinical factors such as age, sex, smoking status, number of prior treatments, or brain metastases. Among 333 reported ADRs in 55 patients, the most common were anemia (67.2%), hypercholesterolemia (63.8%), and hypertriglyceridemia (48.3%). Lipid-lowering therapy, primarily with rosuvastatin 10mg, was initiated in 38 patients. Two patients discontinued lorlatinib due to ADRs, primarily pneumonia and cognitive effects. Conclusion : This study confirms the effectiveness of lorlatinib through observed PFS. Although ADRs were diverse, the rate of drug discontinuation due to these reactions was low, and most ADRs were manageable with supportive care. Continuous prescription monitoring and active pharmacist intervention are recommended to ensure the safe and effective use of lorlatinib, particularly in preventing and managing ADRs.