Evaluation of the efficacy and safety of nivolumab in the second- or later-line treatment of patients with locally advanced/metastatic non-small cell lung cancer in Türkiye: a retrospective multicenter non-interventional registry study

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dc.authorscopusidSaadettin Kılıçkap / 8665552100
dc.authorwosidSaadettin Kılıçkap / AAP-3732-2021
dc.contributor.authorKaradurmuş, Nuri
dc.contributor.authorKaplan, Muhammet Ali
dc.contributor.authorŞendur, Mehmet Ali Nahit
dc.contributor.authorUrun, Yuksel
dc.contributor.authorDemirci, Umut
dc.contributor.authorKaraca, Şaziye Burçak
dc.contributor.authorAydın, Sabin Göktaş
dc.contributor.authorAykan, Musa Barış
dc.contributor.authorBilici, Ahmet
dc.contributor.authorSezer, Ahmet
dc.contributor.authorYılmaz, Ülkü
dc.contributor.authorAbalı, Hüseyin
dc.contributor.authorYumuk, Perran Fulden
dc.contributor.authorDeğirmencioğlu, Serkan
dc.contributor.authorDemirkazık, Ahmet
dc.contributor.authorPaydaş, Semra
dc.contributor.authorMirili, Cem
dc.contributor.authorTurna, Hande
dc.contributor.authorKargı, Ayşegül
dc.contributor.authorÖzdoğan, Mustafa
dc.contributor.authorGüven, Deniz Can
dc.contributor.authorÖzgüroğlu, Mustafa
dc.contributor.authorKılıçkap, Saadettin
dc.date.accessioned2025-04-18T09:52:09Z
dc.date.available2025-04-18T09:52:09Z
dc.date.issued2024
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü
dc.description.abstractObjectiveTo evaluate the efficacy and safety of nivolumab in the second-line (2L) or later-line (LL) treatment of patients with locally advanced/metastatic non-small cell lung cancer (NSCLC) in real-life setting in T & uuml;rkiye.MethodsThis study was designed as a national, multi-center, retrospective study. The study population was evaluated in two groups for the line of nivolumab therapy: those receiving nivolumab in the 2L (Group 2L) and third-line (3L) or LL (Group 3L/LL). Efficacy was evaluated based on one-year overall survival (OS) and progression-free survival (PFS). Safety was evaluated based on treatment-related adverse events (AEs) and nivolumab discontinuation rate.ResultsOf 244 patients, 52.9% were in Group 2L and 47.1% were in Group 3L/LL. Demographic and clinical characteristics did not differ between the groups. In Group 2L and Group 3L/LL, one-year OS and PFS rates were 60.8% and 61.4% (p = 0.592) and 31.2% and 21.3% (p = 0.078), respectively. The objective response rate (ORR) was 34.7% in Group 2L and 27.3% in Group 3L/LL (p = 0.262). The percentage of patients reporting at least one AE in Groups 2L and 3L/LL was 34.9% and 43.5%, respectively (p = 0.169). Fatigue was the most common (16.4%) treatment-related AE in each group. The groups were comparable regarding the AE frequency. Nivolumab was discontinued in 61 patients in Group 2L and 53 patients in Group 3L/LL, with the most common reason being disease progression (57.4% and 66.0%, respectively).ConclusionNivolumab is safe and effective in the 2L or 3L/LL treatment of locally advanced/metastatic NSCLC and associated with acceptable AEs in real-life setting. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer (around 85% of all lung cancers). Patients with NSCLC are usually diagnosed at advanced or metastatic stages. When cancer cells spread to other areas from where they first formed, it is called metastatic cancer. Surgery may not be a treatment option for such patients. Currently, immunotherapeutic agents are used in the treatment of NSCLC. Nivolumab is one of the approved immunotherapeutic agents in the treatment of patients with metastatic NSCLC, who have failed after receiving chemotherapy. Our study explored the efficacy and safety of nivolumab in real-life setting in T & uuml;rkiye. Nivolumab effectiveness was evaluated by overall survival (OS) and progression-free survival (PFS) rates. OS indicates the proportion of patients who are still alive at a given time after diagnosis or treatment initiation. PFS refers to "the length of time during and after cancer treatment that a person lives with the disease but does not get worse." In the present study, one-year OS for 244 patients who received nivolumab was 61.1% and one-year PFS was 26.4%. Nivolumab safety was evaluated based on the frequency of adverse events observed during nivolumab therapy. Of the patients 38.9% had at least one side effect, with fatigue being the most common (16.4%). Our results support the earlier studies and showed that nivolumab was a safe and effective agent and is associated with acceptable side effects.
dc.description.sponsorshipBMS Turkiye
dc.identifier.citationKaradurmus, N., Kaplan, M. A., Sendur, M. A. N., Urun, Y., Demirci, U., Karaca, S. B., ... & Kilickap, S. (2024). Evaluation of the efficacy and safety of nivolumab in the second-or later-line treatment of patients with locally advanced/metastatic non-small cell lung cancer in Türkiye: a retrospective multicenter non-interventional registry study. Current Medical Research and Opinion, (just-accepted), 1-21.
dc.identifier.doi10.1080/03007995.2024.2359026
dc.identifier.endpage1178
dc.identifier.issn0300-7995
dc.identifier.issn1473-4877
dc.identifier.issue7
dc.identifier.pmid38809230
dc.identifier.scopus2-s2.0-85196674989
dc.identifier.scopusqualityQ1
dc.identifier.startpage1171
dc.identifier.urihttp://dx.doi.org/10.1080/03007995.2024.2359026
dc.identifier.urihttps://hdl.handle.net/20.500.12713/6885
dc.identifier.volume40
dc.identifier.wosWOS:001261713400001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.institutionauthorKılıçkap, Saadettin
dc.institutionauthoridSaadettin Kılıçkap / 0000-0003-1637-7390
dc.language.isoen
dc.publisherTaylor & francis LTD
dc.relation.ispartofCurrent medical research and opinion
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectNivolumab
dc.subjectNon-Small Cell Lung Cancer
dc.subjectSecond-Line Therapy
dc.subjectEfficacy
dc.subjectSafety
dc.titleEvaluation of the efficacy and safety of nivolumab in the second- or later-line treatment of patients with locally advanced/metastatic non-small cell lung cancer in Türkiye: a retrospective multicenter non-interventional registry study
dc.typeArticle

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