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).
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Hizal Mutlu, Bilgin Burak, Paksoy Nail, Atcı Muhammed Mustafa, Kahraman Seda, Kılıçkap Saadettin, Güven Deniz Can, Keskinkılıç Merve, Ayhan Murat, Eren Önder, Mustafayev Fatma Nihan Akkoç, Yaman Şebnem, Bayram Ertuğrul, Ertürk İsmail, Özcan Erkan, Korkmaz Mustafa, Akagündüz Baran, Erdem Dilek, Telli Tuğba Akın, Aksoy Asude, Üskent Necdet, Baytemür Naziyet Köse, Gülmez Ahmet, Aydın Dinçer, Şakalar Teoman, Arak Hacı, Tatlı Ali Murat, Ergün Yakup, Ak Naziye, Ünal Çağlar, Özgün Mehmet Alpaslan, Yalçın Bülent, Öztop İlhan, Algın Efnan, Sakin Abdullah, Aydıner Adnan, Yumuk Perran Fulden, Şendur Mehmet Ali Nahit
Аннотация
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.