The percentage of ALK-positive cells and the efficacy of first-line alectinib in advanced non-small cell lung cancer: is it a novel factor for stratification? (Turkish Oncology Group Study)
Yükleniyor...
Tarih
2022
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Springer
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
Introduction: Alectinib is an effective second-generation ALK tyrosine kinase inhibitor (TKI) used in the first-line treatment of patients with advanced ALK-positive NSCLC. Recent studies demonstrated that the percentage of ALK-positive tumor cells in patient groups receiving crizotinib might affect outcomes. This study aimed to investigate whether the percentage of ALK-positive cells had a predictive effect in patients with advanced NSCLC who received first-line Alectinib as ALK-TKI. Materials and methods: This retrospective study included patients with advanced-stage NSCLC who received alectinib as a first-line ALK-TKI and whose percentage of ALK-positive cells was determined by FISH at 27 different centers. Patients who received any ALK-TKI before alectinib were not included in the study. Patients were separated into two groups according to the median (40%) value of the percentage of ALK-positive cells (high-positive group ? 40% and low-positive group < 40%). The primary endpoint was PFS, and the secondary endpoints were OS, ORR, and PFS of the subgroups based on different threshold values for the percentage of ALK-positive cells. Results: 211 patients were enrolled (48.3% female, 51.7% male) to study. 37% (n = 78) of the patients had received chemotherapy previously. After a median of 19.4 months of follow-up, the median PFS was not reached in the high-positive group (n = 113), but it was 10.8 months in the low-positive group (n = 98) (HR 0.39; 95% CI 0.25-0.60, p < 0.001). The median OS in the high-positive group was not reached, whereas it was 22.8 months in the low-positive group (HR 0.37; 95% CI 0.22-0.63, p < 0.001). ORR was significantly higher in the high-positive group (87.2 vs. 68.5%; p = 0.002). According to the cut-off values of < 20%, 20-39%, 40-59%, and ? 60%, the median PFS was 4.5, 17.1, and 26 months, respectively, and could not be reached in the ? 60% group. Conclusion: Our study demonstrated that the efficacy of alectinib varies significantly across patient subgroups with different percentages of ALK-positive cells. If these findings are prospectively validated, the percentage of ALK-positive cells may be used as a stratification factor in randomized trials comparing different ALK-TKIs.
Açıklama
Anahtar Kelimeler
Alectinib, Break-Apart, Percentage of ALK-Positive Cells, Predictive, Response
Kaynak
Journal of Cancer Research and Clinical Oncology
WoS Q Değeri
Q2
Scopus Q Değeri
Q1
Cilt
Sayı
Künye
Hizal M, Bilgin B, Paksoy N, Atcı MM, Kahraman S, Kılıçkap S, Güven DC, Keskinkılıç M, Ayhan M, Eren Ö, Mustafayev FNA, Yaman Ş, Bayram E, Ertürk İ, Özcan E, Korkmaz M, Akagündüz B, Erdem D, Telli TA, Aksoy A, Üskent N, Baytemür NK, Gülmez A, Aydın D, Şakalar T, Arak H, Tatlı AM, Ergün Y, Ak N, Ünal Ç, Özgün MA, Yalçın B, Öztop İ, Algın E, Sakin A, Aydıner A, Yumuk PF, Şendur MAN. The percentage of ALK-positive cells and the efficacy of first-line alectinib in advanced non-small cell lung cancer: is it a novel factor for stratification? (Turkish Oncology Group Study). J Cancer Res Clin Oncol. 2022 Sep 1. doi: 10.1007/s00432-022-04252-2. Epub ahead of print. PMID: 36048274.
