Metastatik Kolorektal Kanserli Hastalarda Regorafenib ile Tek Merkez Gerçek Yaşam Deneyimi

Öz

Amaç: Rutin klinik uygulamada regorafenibin klinik yararını değerlendirmektir.Gereç ve Yöntemler: Ocak 2016 - Kasım 2018 tarihleri arasında regorafenib alan 45 metastatik kolorektal kanser hastasının verilerini retrospektif olarak değerlendirdik.Bulgular: Tüm hastaların ortanca yaşı 54 ve %66.7'si erkek hastaydı. Yirmi hastanın %44.4 performans durumu 2 iken, 25 hastada %55.6 0-1 idi. Otuz altı hastanın %80 primer tümörü rezekeydi ve hastaların %53.3'ünde KRAS mutasyonu vardı. Tüm hastalarda regorafenib başlangıç dozu 160 mg idi ve hastaların %28.9' una doz redüksiyonu uygulanmış olduğu görüldü. Regorafenib tedavisini hastaların %66.7'si 3. basamakta almış iken, %33.3ʼünde 4. basamak veya daha sonrasında almıştı. Regorafenib ile elde edilen en iyi yanıt progresif hastalık %46.7 ve stabil hastalık %35.6 idi. Ortanca progresyonsuz sağkalım 3.1 ay %95 CI: 2.2-4.0 ve genel sağkalım 6.4 ay %95 CI: 3.2-9.5 idi. Primer tümörün rezeksiyon durumu ve regorafenibin ≥ 4 basamak tedavi olarak kullanımı çok değişkenli analizde hem progresyonsuz sağkalım hem de genel sağkalım ile anlamlı şekilde ilişkiliydi.Sonuç: Regorafenib, bizim hastalarımızda da hem randomize kontrollü çalışmalarda hem de gerçek yaşam ortamında bildirilenlere benzer hayatta kalma süreleriyle ilişkiliydi ve genellikle iyi tolere edildi. Primer tümör rezeke edilen ve regorafenibi ≥ 4 basamak tedavi olarak kullanan hastalar istatistiksel olarak daha iyi progresyonsuz sağkalıma ve genel sağkalıma sahipti regorafenib 3. vs ≥ 4. basamak tedavi: PFS: 2.7 vs 4.6 ay, p:0.001; OS: 3.8 vs 11.4 ay, p:0.001, primeri rezeke vs rezeke olmayan: PFS: 3.8 vs 1.6 ay, p: 0.006; OS: 6.1 vs 3.1 ay, p: 0.018 . Primer tümörü rezeke edilen hastalarda regorafenib ile daha iyi sağkalım oluşunu açıklamak ve bu bilgiyi doğrulamak için başka çalışmalara ihtiyaç vardır

Anahtar Kelimeler

• Regorafenib, Metastatik kolorektal kanser, Sağkalım

Single Center Real Life Experience with Regorafenib in Patients with Metastatic Colorectal Cancer

Abstract

Objective: To evaluate the clinical benefit of regorafenib in routine clinical practice.Material and Methods: We retrospectively evaluated the data of 45 metastatic colorectal cancer mCRC patients who received regorafenib between January 2016 and November 2018.Results: The median age of all patients was 54 years, and 66.7% of the patients were male. Performance status of 20 patients 44.4% was 2, whereas in 25 patients 55.6% it was 0-1. Thirty-six patients 80% were performed primary tumor resection and KRAS mutation was detected in 53.3% of patients. Regorafenib was started at a dose of 160 mg in all patients, and a dose reduction was observed in 28.9% of patients. Line of regorafenib treatment was 3rd in 66.7% of patients, whereas in 33.3% of patients it was ≥ 4th. Best response was progressive disease 46.7% and stable disease 35.6% . The median progression free survival PFS was 3.1 months 95% CI: 2.2-4.0 and overall survival OS was 6.4 months 95% CI: 3.2-9.5 . Primary tumor resection status and using regorafenib ≥ 4 treatment line were significantly associated with both PFS and OS in multivariate analysis. Conclusion: Regorafenib was associated with survival durations similar to those reported in both randomized controlled trials and in the real-life setting, and was generally well tolerated. Patients who had primary tumor resected and using regorafenib as the ≥ 4th treatment line primary resected vs nonresected: PFS: 3.8 vs. 1.6 months, p: 0.006; OS: 6.1 vs. 3.1 months, p: 0.018, 3rd vs. 4th or more: PFS: 2.7 vs. 4.6 months, p:0.001; OS: 3.8 vs. 11.4 months, p:0.001 were associated with better PFS and OS. However, in order to explain the better survival with regorafenib in patients with primary tumor resected, this information must be confirmed with further studies

Keywords

• Regorafenib, Metastatic colorectal cancer, Survival

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