Real-world baseline characteristics and diagnostic path of Polish patients with ALK-positive NSCLC eligible for brigatinib treatment: Interim results from the ENTIRETY study.

Abstract

e20640 Background: In anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (ALK+ NSCLC), early diagnosis, patient characteristics, and early treatment with second-third-generation ALK inhibitors influence survival. However, real-world data on characteristics and diagnostic paths of Polish patients with ALK+ NSCLC receiving treatment are limited. Methods: ENTIRETY (NCT05735327) is a multicenter, noninterventional, prospective study assessing the management of patients with ALK+ NSCLC in Poland receiving brigatinib as first-line therapy. This interim analysis assessed patient characteristics and quality of life at baseline and the path from symptom onset to diagnosis. Results: Between May 2023-July 2024, 52 patients (median age: 63 years; male: 61.5%) were enrolled and received ≥1 brigatinib dose; 9 (17.3%) had CNS metastases. Patients w/ CNS metastases were younger than those w/o (median age: 51 vs 64 years). Overall, 69.2% of patients had comorbidities (66.7% w/ CNS metastases, 69.8% w/o). Most (63.5%) had multiple metastases (stage IVB; 77.8% w/ CNS metastases, 60.5% w/o). The median EQ-5D-5L VAS score was 60 overall, 60 for patients w/ CNS metastases, and 65 for those w/o, indicating moderate overall health. QLQ-C30 data showed lower median emotional and social functioning scores in patients w/ CNS metastases (66.7, 66.7, respectively) vs those w/o (75.0, 83.3, respectively). Cognitive functioning scores were normal in both groups (median: 100). Overall, median symptom scores for fatigue, dyspnea, and insomnia were 33.3, each. Median time interval was 10.0 days from material collection to pathomorphological result, 22.5 days from ALK confirmation to brigatinib treatment, and 52.5 days from diagnosis to study enrollment (Table 1). Conclusions: These findings enhance our understanding of the characteristics and diagnostic path of Polish patients with ALK+ NSCLC receiving brigatinib treatment. Patient flow*. From To Median (IQR) time (days) Imputed data; n Non-imputed data; n Symptom onset First GP visit 8.5 (0.0, 23.5); 52 7.5 (1.2, 30.8); 14 First GP visit First specialist visit 15.0 (2.5, 31.5); 52 29.0 (12.2, 30.8); 16 Material collection Pathomorphological result - 10.0 (6.8, 15.2); 52 # Material collection ALK rearrangement confirmation - 29.0 (20.0, 45.8); 52 # ALK rearrangement confirmation Brigatinib treatment 22.5 (13.8, 38.0); 52 15.0 (13.0, 48.0); 21 Symptom onset Disease diagnosis 89.0 (45.2, 177.2); 52 101.0 (39.0, 140.5); 20 Disease diagnosis Study enrollment 52.5 (35.8, 233.8); 52 52.0 (37.0, 229.0); 49 *Data based on patient-reported questionnaire unless noted otherwise. # Based on patients’ medical history (with no missing values). ALK = Anaplastic Lymphoma Kinase; GP = General Practitioner; IQR = Interquartile Range; n = Number of Patients.