A national, multicenter, non-interventional, observational study on treatment patterns in patients with metastatic renal cell carcinoma in Turkey – NOTES study
Authors Yalcin Ş, Yildiz R, Dane F, Karaoğlu A, Öksüzoğlu B, Özyilkan Ö, Sevinç A, Özdemir F, Turna H, Uslu R, Ulay E
Received 11 August 2017
Accepted for publication 16 December 2017
Published 5 March 2018 Volume 2018:11 Pages 1223—1228
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Editor who approved publication: Dr Ingrid Espinoza
Şuayib Yalçın,1 Ramazan Yildiz,2 Faysal Dane,3 Aziz Karaoğlu,4 Berna Öksüzoğlu,5 Özgür Özyılkan,6 Alper Sevinç,7 Feyyaz Özdemir,8 Hande Turna,9 Rüçhan Uslu,10 Esat Ulay11
1Hacettepe University, Department of Medical Oncology, Ankara, Turkey; 2Gazi University, Department of Medical Oncology, Ankara, Turkey; 3Marmara University, Department of Medical Oncology, İstanbul, Turkey; 4Dokuz Eylül University, Department of Medical Oncology, İzmir, Turkey; 5Ankara Oncology Hospital, Clinic of Medical Oncology, Ankara, Turkey; 6Başkent University, Department of Medical Oncology, Ankara, Turkey; 7Medical Park Gaziantep Hospital, Medical Oncology Unit, Gaziantep, Turkey; 8Karadeniz Technical University, Department of Medical Oncology, Trabzon, Turkey; 9İstanbul University, Department of Medical Oncology, İstanbul, Turkey; 10Ege University, Department of Medical Oncology, İzmir, Turkey; 11Novartis Oncology, İstanbul, Turkey
Introduction: The introduction of targeted therapies in renal cell carcinoma has significantly improved its prognosis and treatment outcomes in recent years. Such treatment options are targeted therapies of the vascular endothelial growth factor (VEGF) pathway and the mammalian target of the rapamycin pathway. With the use of tyrosine kinase inhibitors (TKIs) and mammalian target of the rapamycin inhibitors, overall survival has increased up to 2 years. In Turkey, due to applicable reimbursement conditions for patients with metastatic renal cell carcinoma (mRCC), interferon use is mandated as a first-line treatment, thus providing information on the use of everolimus only after initial interferon and second-line VEGF-targeted treatments such as VEGF-TKI.
Patients and methods: To provide a first real-life data set in Turkey, we conducted a prospective, non-interventional, observational study and assessed the efficacy and safety of everolimus after two lines of treatment including interferon. A total of 100 patients with histologically confirmed mRCC were enrolled in the study from 11 centers between June 2012 and March 2014 (70 males and 30 females). Efficacy was assessed on the basis of progression-free survival and overall survival; safety of everolimus was assessed on the basis of adverse event occurrence.
Results: The study results showed that the median progression-free survival with everolimus treatment was 8.1 months (95% CI: 5.1–11.1) and the median overall survival was 17.6 months (95% CI: 10.1–25.1), thus indicating a better overall response based on survival durations than those from the randomized Phase III REnal Cell cancer treatment with Oral RAD001 given Daily study results (4.9 and 14.8 months, respectively).
Conclusion: The study showed that everolimus treatment is a safe and effective treatment option in the treatment of mRCC after VEGF-TKI, with an acceptable safety and tolerability profile in real-life settings.
Keywords: metastatic renal cell carcinoma, mTOR inhibitors, everolimus, observational study, real-life setting, treatment patterns
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