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    Atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer: A real-life data of the Turkish Oncology Group
    (Springer, 2022) Gürbüz, Mustafa; Kutlu, Yasin; Akkuş, Erman; Köksoy, Elif Berna; Köse, Naziyet; Öven, Bala Başak; Uluç, Başak Oyan; Demiray, Atike Gökçen; Erdem, Dilek; Demir, Bilgin; Turhal, Nazım Serdar; Uskent, Necdet; Akbaş, Sinem; Selçukbiricik, Fatih; İnal, Ali; Bilici, Ahmet; Kılıçkap, Saadettin
    Purpose Atezolizumab has been shown to be efective and safe in randomized trial in the frst-line treatment of extensivestage small cell lung cancer (SCLC). However, there are limited real-life data on atezolizumab. In this study, we aimed to determine the real-life efcacy and safety of atezolizumab combined with chemotherapy in the frst-line treatment of extensive-stage SCLC. Methods This trial is a retrospective multicenter study of the Turkish Oncology Group, which included extensive-stage SCLC patients who received atezolizumab combined with chemotherapy in a frst-line treatment. The characteristics of the patients, treatment and response rates, and PFS and OS are presented. Factors associated with PFS and OS were analyzed by univariate and multivariate analysis. Results A total of 213 patients at the 30 oncology centers were included. The median number of chemotherapy cycle was 5 (1–8) and atezolizumab cycle was 7 (1–32). After median 11.9 months of follow-up, median PFS and OS was 6.8 months (95%CI 5.7–7.8), and 11.9 months (95%CI 11–12.7), respectively. The ORR was 61.9%. ECOG-PS (p=0.002) and number of metastatic sites (p=0.001) were associated with PFS and pack-year of smoking (p=0.05), while ECOG-PS (p=0.03) and number of metastatic sites (p=0.001) were associated with OS. Hematological side efects were common and toxicities were manageable. Conclusion This real-life data confrm the efcacy and safety of atezolizumab in combination with chemotherapy in frstline treatment of extensive-stage SCLC.
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    Objective Response Rate is a Surrogate Marker for Long-Term Overall Survival in Metastatic Urothelial Carcinoma Patients Treated With Immune Checkpoint Inhibitors
    (Elsevier Inc., 2024) Tural, Deniz; Arslan, Çağatay; Selçukbiricik, Fatih; Ölmez, Ömer Fatih; Erman, Mustafa; Ürün, Yüksel; Erdem, Dilek; Kılıçkap, Saadettin
    Background: This study aimed to evaluate the utility of RECIST criteria-based objective response rate (ORR) as a potential surrogate endpoint for long-term overall survival (OS) in patients with metastatic urothelial carcinoma who were treated with immune checkpoint inhibitors (ICIs). Methods: The primary endpoint was overall ORR and OS, duration of treatment (DoR) with ICIs. ORR was analyzed using Fisher's exact test. Median follow-up and OS were estimated by using the Kaplan–Meier method. Results: The median follow-up was 58 (1.15-71) months. Progression developed in 94 (47%) patients during the first 3 months of ICIs therapy. The treatment response to ICIs included complete response (CR), partial response (PR) and stable disease in 10% (n = 20), 23% (n = 46), and 20% (n = 41) of patients, respectively. The responder and nonresponder groups differed in terms of certain baseline characteristics, such as Bellmunt risk factors, and neutrophil-to-lymphocyte ratio (NLR). The 5-year OS rates for patients with CR and PR were 73% and 23%, respectively. The median DoR for CR, PR, and SD were 51.8 months (44.5-59.1), 20.7 months (16.7-24.6), and 8.8 months (5.5-12.1), respectively. Overall, 16(80%) patients with CR and 14(30%) patients with PR had an ongoing response at the time of the analysis. In the univariate analysis, NLR > 3, liver metastases, ECOG PS ≥ 1, and hemoglobin levels < 10 mg/dl, as well as the PR and CR, were all significantly associated with OS. In multivariate analysis, presence of liver metastases (HR 2.3; 95% CI, 1.3-4.2; P < .004) was found to be an independent determinant of short OS, while PR (HR 0.3; 95% CI, 0.15-0.5; P < .001) and CR (HR 0.06; 95% CI, 0.014-0.27; P < .001) were associated with improved OS. Conclusions: In conclusion, this 5-year analysis of real-world data in the setting of metastatic urothelial cancer indicated a significant correlation between ORR, especially CR, and OS in patients who received ICIs. Therefore, identifying a potential surrogate marker for survival in patients treated with ICIs would represent an important advance in the early identification of patients’ response or resistance to ICIs. © 2024 Elsevier Inc.
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    Real-life comparison of afatinib and erlotinib in non-small cell lung cancer with rare EGFR exon 18 and exon 20 mutations: a Turkish Oncology Group (TOG) study
    (Springer, 2022) Tatlı , Ali Murat; Erdem, Dilek; Göker, Erdem; Çelik, Emir; Demirci, Nebi Serkan; Sakin, Abdullah; Atçı , Muhammed Mustafa; Bayram, Ertuğrul; Akın Telli, Tuğba; Bilgin, Burak; Bilici, Ahmet; Akangündüz , Baran; Ballı, Sevinç; Demirkazık, Ahmet; Selçukbiricik, Fatih; Menekşe, Serkan; Çavdar, Eyyüp; Öztürk, Akın; Türkmen Bekmez, Esma; Turhal, Serdal; Kılıçkap, Sadettin; Yıldırım, Hasan Çağrı; Oyan, Başak; Aksoy, Asude; Paksoy Türköz, Fatma; Kut, Engin; Katgı, Nuran; Sakalar, Teoman; Akyol, Murat; Ellez, Halil İbrahim; Topçu, Atakan; Erdoğan, Atike Pınar; Pılancı, Kezban Nur; Hedem, Engin; Arak, Hacı; Akdeniz, Nadiye; Alan, Özkan; Yapar, Burcu; Nart, Deniz; Yumuk, Perran Fulden
    Objectives To compare the survival of frst- and second-generation tyrosine kinase inhibitors (TKIs) in patients with rare EGFR exon 18 and exon 20 mutation-positive non-small cell lung cancer (NSCLC). Materials and methods We retrospectively evaluated survival characteristics of 125 patients with EGFR exon 18 and exon 20 mutated NSCLC who received erlotinib or afatinib as frst line treatment between 2012 and 2021 from 34 oncology centres. Since exon 20 insertion is associated with TKI resistance, these 18 patients were excluded from the study. Results EGFR exon 18 mutations were seen in 60%, exon 20 mutations in 16%, and complex mutations in 24% of the patients with NSCLC who were evaluated for the study. There were 75 patients in erlotinib treated arm and 50 patients in afatinib arm. Patients treated with erlotinib had progression-free survival time (PFS) of 8.0 months and PFS was 7.0 months in the afatinib arm (p=0.869), while overall survival time (OS) was 20.0 vs 24.8 months, respectively (p=0.190). PFS of exon 18 mutated arm was 7.0 months, exon 20 mutated arm was 4.3 months, and complex mutation positive group was 17.3 months, and this was statistically signifcant (p=0.036). The longest OS was 32.5 months, seen in the complex mutations group, which was not statistically diferent than exon 18 and in exon 20 mutated groups (21.0 and 21.2 months, respectively) (p=0.323). Conclusion In this patient group, especially patients with complex mutations are as sensitive to EGFR TKI treatment similar to classical mutations, and in patients with rare exon 18 and exon 20 EGFR mutation both frst- and second-generation EGFR-TKIs should be considered, especially as frst- and second-line options.