Retrospective Evaluation of Trabectedin Use in Metastatic Soft Tissue Sarcomas: A Single-Center Experience

Öz

This study aimed to evaluate the treatment responses, survival results, and drug side effects of patients treated with trabectedin for metastatic soft tissue sarcoma. The files of 16 patients who received trabectedin treatment with the diagnosis of sarcoma were reviewed retrospectively. Demographic characteristics of the patients, duration of treatment, response to treatment, and drug side effects were recorded. Of 16 patients, 9 (56.2%) were male and 7 (43.7%) were female. Median progression-free survival (PFS) for trabectedin was 2.9 months, and overall survival (OS) was 6.7 months. The only factor effective on survival was determined as trabectedin treatment line. Patients receiving trabectedin as second or third-line therapy had better PFS time (median PFS 10.3 vs 1.6 months, 95% CI: 0-21.9, p= 0.003) and OS time (median 26.7 vs 5.7 months, 95% CI: 16.9-36.5, p= 0.003). Patients with a growth modulation index (GMI) value above 1.33, which is used as an objective response evaluation metric in sarcoma studies, had statistically significantly better PFS and OS times (median PFS 19.8 months, p=0.002; median OS 26.7 months, p=0.047). Any grade side effects were observed in all patients, grade 3/4 side effects were hematological side effects in 62.5% and alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) increase in 50%. The PFS, OS, response rates and side effects detected in the study were found to be similar to other studies, and it was determined that the patients who received trabectedin as the second and third-line treatment benefited more from the drug.

Anahtar Kelimeler

• metastatic sarcoma
• trabectedin
• efficacy
• real-world data

Metastatik Yumuşak Doku Sarkomlarında Trabektedin Kullanımının Retrospektif Değerlendirilmesi: Tek Merkez Deneyimi

Öz

etkilerinin değerlendirilmesi amaçlanmıştır. Sarkom tanısıyla trabektedin tedavisi alan 16 hastanın dosyaları retrospektif olarak tarandı. Hastaların demografik özellikleri, tedavi süreleri, tedavi yanıtları, ilaç yan etkileri kaydedildi. 16 hastanın 9’u erkek (%56,2), 7’si kadındı (%43,7). Trabektedin için medyan progresyonsuz sağkalım (progression-free survival, PFS) 2,9 ay, genel sağkalım (overall survival, OS) 6,7 ay saptandı. Sağkalım üzerine etkili olan tek faktör trabektedin tedavi sırası olarak belirlendi. Trabektedini 2. ya da 3.sıra tedavi olarak alan hastalar daha iyi PFS süresine (medyan PFS 10,3 aya karşı 1,6 ay, %95 GA: 0-21.9, p= 0.003) ve OS süresine (medyan 26,7 ay’a karşı 5,7 ay, %95 GA: 16.9-36.5, p= 0.003) sahipti. Sarkom çalışmalarında objektif yanıt değerlendirme kriteri olarak kullanılan büyüme modülasyon indeksi (growth modulation index, GMI) değeri 1,33’ün üzerinde olan hastaların PFS ve OS süreleri istatiksel anlamlı olarak daha iyiydi (medyan PFS 19,8 ay, p=0.002; medyan OS 26,7 ay, p=0.047). Tüm hastalarda yan etki gözlendi, grad 3/4 yan etkiler hematolojik yan etkiler %62,5 ve alanin aminotransferaz (ALT)/ aspartat aminotransferaz (AST) artışı %50 sıklıkta oldu. Çalışmada saptanan PFS, OS, yanıt oranları ve yan etkiler diğer çalışmalar ile benzer saptanmış, trabektedini 2.ve 3.sıra tedavi olarak alan hastaların ilaçtan daha fazla fayda gördüğü belirlenmiştir.

Anahtar Kelimeler

• metastatik sarkom
• trabektedin
• etkinlik
• gerçek yaşam verisi

Kaynakça

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