Browsing by Author "Geredeli, Caglayan"

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Real-World Practices in RAS Wild-Type Metastatic Colorectal Cancer Patients Treated with Targeted Agents in the First-Line a Nationwide Onco-Colon Turkey Registry
(2026) Özçelik, Melike; Bilir, Cemil; Çiçin, Irfan; Geredeli, Caglayan; Bozkurt, Oktay; Çelik, Sinemis; Sakin, Abdullah
Amaç: Anti-EGFR ajanlarının etkinliği metastatik kolorektal kanserde (mKRK) gösterilmiştir. Gerçek yaşam verileri, klinik çalışmaların dışında kalan hastalara ait bulguları ortaya koymak açısından özellikle önemlidir. Bu nedenle, RAS vahşi tip mKRK’li hastalarda gerçek yaşam verilerini araştırmayı amaçladık. Yöntemler: Ocak 2016 ile Nisan 2019 tarihleri arasında mKRK tanısı alan hastalara ait tıbbi kayıtlar 28 merkezden toplandı. Hastalar, birinci basamak biyolojik tedavilere göre anti-EGFR grubu (Grup A (panitumumab) ve B (setuksimab)) ve anti- VEGF grubu (Grup C) olarak karşılaştırıldı. Bulgular: Belgelenmiş RAS vahşi tip mKRK’li toplam 1064 hasta değerlendirildi. Bu hastaların sırasıyla %33’ü panitumu- mab, %37’si setuksimab ve %30’u birinci basamakta anti-VEGF içeren rejimlerle tedavi edildi. Genel yanıt oranı Grup A, B ve C’de sırasıyla %46,4, %41,9 ve %41,5 idi (p = 0,170). Medyan genel sağkalım (OS) Grup A, B ve C’de sırasıyla 26, 27 ve 23 ay olarak bulundu (p = 0,044). Panitumumab, setuksimab ve bevacizumab alan hastaların medyan progresyonsuz sağka- lımı (PFS) sırasıyla 11,6, 11,0 ve 9,6 ay idi (p = 0,012). Çok değişkenli analizde, performans durumu (PS) 0-1 ve BRAF vahşi tip durumu OS için bağımsız prognostik faktörler olarak; yalnızca BRAF vahşi tip durumu ise PFS için bağımsız prognostik faktör olarak bulundu (p<0,05). Sonuç: Bu gerçek yaşam verilerinin analizi, RAS vahşi tip mKRK’de anti-EGFR ajanlarının karşılaştırılabilir etkinliğini doğ- rulamaktadır. Ancak, bu hastalarda anti-EGFR tedavisi, anti-VEGF tedavisine kıyasla PFS ve OS avantajı sağlamaktadır. Ayrıca, BRAF vahşi tip tümörlere sahip hastalarda PFS ve OS daha iyi bulunmuştur.
Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Colorectal, Gastroesophageal, and Pancreatic Cancers: A Global, Phase 3, Randomized, Placebo-Controlled Trial (RCT)
(Lippincott Williams & Wilkins, 2025) Munoz, Cesar; Soff, Gerald A.; Korantzis, Ippokratis; Al-Samkari, Hanny; Gonzalez Astorga, Beatriz; Arslan, Cagatay; Geredeli, Caglayan
Romiplostim versus Placebo for Chemotherapy-Induced Thrombocytopenia
(Massachusetts Medical Soc, 2026) Munoz, Cesar; Soff, Gerald A.; Korantzis, Ippokratis; Astorga, Beatriz Gonzalez; Al-Samkari, Hanny; Arslan, Cagatay; Geredeli, Caglayan
Background Chemotherapy-induced thrombocytopenia (CIT) is a common complication of chemotherapy that is associated with bleeding, reduced relative dose intensity, and potentially worse outcomes. No widely available therapies are approved for CIT. Methods We conducted a phase 3, international, double-blind, randomized, placebo-controlled trial involving patients with persistent CIT (platelet count, <= 85 & times;109 per liter on trial day 1) who were receiving oxaliplatin-based multiagent cytotoxic chemotherapy for gastrointestinal cancers. Patients were randomly assigned in a 2:1 ratio to receive romiplostim or placebo for three chemotherapy cycles. The primary end point was the absence of CIT-induced modifications of the chemotherapy dose (reduction, delay, omission, or discontinuation) in both the second and third chemotherapy cycles. Results Of the 165 patients who underwent randomization (109 in the romiplostim group and 56 in the placebo group), 75% had colorectal cancer, 13% had gastroesophageal cancer, and 12% had pancreatic cancer; 72% of the patients in the romiplostim group and 61% of those in the placebo group had stage 4 disease. The percentage of patients with no CIT-induced modifications of the chemotherapy dose was 84% (92 of 109 patients) with romiplostim and 36% (20 of 56 patients) with placebo, which corresponded to an odds ratio of 10.16 (95% confidence interval [CI], 4.44 to 23.72; P<0.001) and a risk ratio of 2.77 (95% CI, 1.78 to 4.30; P<0.001). Adverse events of grade 3 or higher occurred in 37% of the patients who received romiplostim and in 22% of those who received placebo, which primarily reflected chemotherapy effects. Adverse events that were considered by the investigator to be related to romiplostim or placebo occurred in 12% of patients who received romiplostim and in 7% who received placebo, with the most frequent being nausea (2% in each group) and headache (2% in the romiplostim group); none were serious or led to death or discontinuation of romiplostim, placebo, or chemotherapy. Thromboembolic events occurred in 2% of patients who received romiplostim and in no patients who received placebo. Conclusions In this phase 3, placebo-controlled trial, romiplostim was efficacious in treating CIT. (Funded by Amgen and the Biomedical Advanced Research and Development Authority; RECITE ClinicalTrials.gov number, NCT03362177.)
Citation - WoS: 1
Two Randomized Controlled Trials of Romiplostim for Chemotherapy-Induced Thrombocytopenia in Patients With Solid Tumors
(Amer Soc Hematology, 2022) Al-Samkari, Hanny; Geredeli, Caglayan; Arslan, Cagatay; Korantzis, Ippokratis; Dogu, Gamze Gokoz; Nechaeva, Marina; Fernandez, Mercedes Salgado
[Abstract Not Available]