Evaluation of the Effectiveness and Safety of Lorlatinib in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non-Small Cell Lung Cancer

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