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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dc.authoridSaadettin Kılıçkap / 0000-0003-1637-7390en_US
dc.authorscopusidSaadettin Kılıçkap / 8665552100
dc.authorwosidSaadettin Kılıçkap / AAP-3732-2021en_US
dc.contributor.authorKılıçkap, Saadettin
dc.contributor.authorPaksoy, Nil
dc.contributor.authorBilgin, Burak
dc.contributor.authorSakin, Abdullah
dc.contributor.authorÖzcan, Erkan
dc.contributor.authorTatlı, Ali Murat
dc.contributor.authorHızal, Mutlu
dc.contributor.authorPaksoy, Nail
dc.contributor.authorKahraman, Sedat
dc.date.accessioned2022-09-16T08:39:38Z
dc.date.available2022-09-16T08:39:38Z
dc.date.issued2022en_US
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümüen_US
dc.description.abstractIntroduction: 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.en_US
dc.identifier.citationHizal 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.en_US
dc.identifier.doi10.1007/s00432-022-04252-2en_US
dc.identifier.issn0171-5216en_US
dc.identifier.pmid36048274en_US
dc.identifier.scopus2-s2.0-85137039744en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttp://doi.org/10.1007/s00432-022-04252-2
dc.identifier.urihttps://hdl.handle.net/20.500.12713/3143
dc.identifier.wosWOS:000849293900006en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.institutionauthorKılıçkap, Saadettin
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.relation.ispartofJournal of Cancer Research and Clinical Oncologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectAlectiniben_US
dc.subjectBreak-Aparten_US
dc.subjectPercentage of ALK-Positive Cellsen_US
dc.subjectPredictiveen_US
dc.subjectResponseen_US
dc.titleThe 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)en_US
dc.typeArticleen_US

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