Abstract
Background
Little is known about real‐world treatment and outcomes of patients with anaplastic lymphoma kinase‐positive (ALK+) advanced non‐small cell lung cancer (NSCLC).
Patients and Methods
This retrospective study of the Flatiron Health EHR‐derived deidentified database included patients with a lung cancer diagnosis and confirmed advanced NSCLC who received ALK tyrosine kinase inhibitor (TKI) therapy (January 1, 2011, through June 30, 2018). Patient characteristics and treatment patterns were characterized. Real‐world progression‐free survival (rwPFS) and time to discontinuation were calculated using the Kaplan‐Meier method.
Results
First‐line ALK TKI therapy was administered to 581 patients (27.5% had brain metastasis on or prior to initiation) and second‐line ALK TKI therapy to 254 patients post crizotinib (45.7% had brain metastasis on or prior to second‐line ALK TKI initiation). Crizotinib (84.6%; n = 492) was the most commonly administered first‐line ALK TKI therapy. For second‐line ALK TKI post crizotinib (n = 254), 49.6% received ceritinib, 41.7% received alectinib, 5.9% received crizotinib retreatment, and 2.8% received brigatinib. Median (95% confidence interval [CI]) rwPFS was 7.47 (6.48–8.32) months for first‐line and 7.30 (5.72–8.42) months for second‐line ALK TKI. Median (95% CI) rwPFS was significantly longer among first‐line ALK TKI patients without than with brain metastasis (8.52 [7.57–10.59] vs. 4.97 [3.75–5.99] months; p < .0001) and patients with brain metastasis on or prior to first‐line ALK TKI therapy had a significantly increased risk of progression (hazard ratio ± SE, 1.976 ± 0.112; p < .0001).
Conclusion
Median rwPFS in patients with advanced ALK+ NSCLC was < 8 months for first‐ and second‐line ALK TKI therapy and was even shorter in patients with brain metastasis, highlighting the need for more effective treatments in this patient population.
Implications for Practice
Results presented herein describe real‐world treatment of advanced ALK+ NSCLC with ALK TKI therapies from January 2011 through June 2018. Crizotinib was the most commonly prescribed first‐line ALK TKI therapy in this patient population, but the majority of data analyzed were obtained prior to Food and Drug Administration approval of alectinib and ceritinib in the first‐line ALK TKI setting. Physicians should monitor patients closely to help identify when a change in treatment should occur.
Patients with non‐small cell lung cancer (NSCLC) characterized by ALK rearrangements may benefit from ALK tyrosine kinase inhibitor (TKI) therapies. This article summarizes the characteristics of patients with ALK+ advanced NSCLC treated with ALK TKI therapy, describes treatment pathways and duration for these patients, and examines real‐world progression‐free survival and treatment discontinuation for patients receiving first‐line and second‐line ALK TKI therapy overall and for the subgroups of patients with and without pre‐existing brain metastasis at ALK TKI initiation.
