Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma

Öz

Amaç: Pankreatikobilier sistem adenokarsinomları, agresif biyolojik davranışları ve yüksek metastaz potansiyeli ile prognozu kötü tümörlerdir. Bu çalışmada metastatik veya inoperabl pankreas ve bilier sistem adenokarsinomu tanılı hastalarda ikinci basamak kemoterapilerin tedavi yanıtları ve sağkalım üzerine olan etkileri ile yan etki profillerinin değerlendirilmesi amaçlanmıştır. Metod: Eskişehir Osmangazi Üniversitesi Tıp Fakültesi Medikal Onkoloji polikliniğinde 2010–2019 yılları arasında takip edilen, en az iki basamak kemoterapi almış ve dosya bilgilerine ulaşılan 74 hasta retrospektif olarak incelendi. Demografik özellikler, Eastern Cooperative Oncology Group performans skoru (ECOG-PS), operabilite, metastaz bölgeleri, serum CA 19-9 düzeyleri ile birinci ve ikinci basamak tedaviler kayıt altına alındı. Genel sağkalım (GS), progresyonsuz sağkalım (PS), tedavi yanıt oranları ve toksisite profilleri değerlendirildi. Bulgular: Tanı anında ECOG-PS durumu 0 ve operabl kabul edilen hastaların GS süreleri istatistiksel olarak anlamlı derecede daha uzundu. Tanı anındaki CA 19-9 düzeyleri ile GS arasında istatistiksel anlamlı bir ilişki saptanmadı. İkinci basamakta Kapesitabin + oksaliplatin (XELOX) kolunda GS süresinin, 5-fluorourasil + irinotekan + oksaliplatin (FOLFIRINOX) ve gemsitabin kombinasyon kollarına kıyasla daha kısa olduğu gözlemlendi. Ancak; tedavi kolları arasında PS ve yanıt oranları açısından anlamlı fark izlenmedi. Toksisite değerlendirmesinde grade 2 lökopeni ve grade 3 nötropeni oranlarının FOLFIRINOX ve gemsitabin kombinasyonlarında, XELOX’a göre istatistiksel olarak anlamlı derecede daha yüksek olduğu saptandı. Sonuç: Metastatik veya inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapi seçenekleri ile GS arasında farklılıklar saptanmış olmakla birlikte, PS ve yanıt oranları açısından belirgin bir fark tespit edilmemiştir. FOLFIRINOX ve gemsitabin kombinasyonları, hematolojik toksisite açısından daha riskli bulunmuştur. Bu tedavilerin etkinlik ve toksisite farklılıklarının değerlendirilmesinde daha geniş hasta serilerinin dahil olduğu çok merkezli çalışmalara ihtiyaç olduğunu düşünmekteyiz.

Anahtar Kelimeler

• Pankreatikobilier sistem kanserleri
• ikinci basamak tedavi
• genel sağkalım
• progresyonsuz sağkalım
• yan etki

Destekleyen Kurum

Bu araştırma için herhangi bir fon veya destek alınmamıştır.

Etik Beyan

Bu çalışma, Osmangazi Üniversitesi Tıp Fakültesi Klinik Araştırmalar Etik Kurulu tarafından onaylanmıştır(Karar No: 2020/97). Çalışma Helsinki Bildirgesi ilkelerine uygun olarak yürütülmüştür.

Efficacy and safety outcomes of second-line chemotherapies in metastatic/inoperable pancreaticobiliary system cancers: a single-center retrospective study

Öz

Background: Pancreaticobiliary system adenocarcinomas are aggressive tumors with poor prognosis due to their biological behavior and high metastatic potential. This study aimed to evaluate the impact of second-line chemotherapy regimens on treatment response, survival outcomes, and toxicity profiles in patients with metastatic or inoperable pancreatic and biliary system adenocarcinomas. Methods: A total of 74 patients who received at least two lines of chemotherapy and were followed between 2010 and 2019 at the Department of Medical Oncology, Eskişehir Osmangazi University, were retrospectively analyzed. Demographic data, Eastern Cooperative Oncology Group performance status (ECOG-PS), operability, metastatic sites, serum CA 19-9 levels, and first- and second-line treatments were recorded. Overall survival (OS), progression-free survival (PFS), response rates, and toxicity profiles were evaluated. Results: Patients with ECOG-PS 0 and operable status at diagnosis had significantly longer OS. No statistically significant association was observed between baseline CA 19-9 levels and OS. In the second-line setting, OS was shorter in the capecitabine + oxaliplatin (XELOX) group compared with the 5-fluorouracil + irinotecan + oxaliplatin (FOLFIRINOX) and gemcitabine-based combinations. However, no significant differences were found between regimens regarding PFS or response rates. Toxicity analysis revealed that grade 2 leukopenia and grade 3 neutropenia were significantly more frequent in patients treated with FOLFIRINOX and gemcitabine-based combinations compared to XELOX. Conclusion: While second-line chemotherapy regimens demonstrated differences in OS among patients with metastatic or inoperable pancreaticobiliary cancers, no significant differences were observed in PFS or response rates. FOLFIRINOX and gemcitabine-based combinations were associated with higher hematologic toxicity. Larger multicenter studies are warranted to better evaluate efficacy and toxicity differences of these regimens.

Anahtar Kelimeler

• Pancreaticobiliary system cancers
• second-line chemotherapy
• overall survival
• progression-free survival
• toxicity.

Destekleyen Kurum

This research received no external funding.

Etik Beyan

This study was approved by the Clinical Research Ethics Committee of Osmangazi University, Faculty of Medicine (Approval No: 2020/97). The study was conducted in accordance with the principles of the Declaration of Helsinki

Kaynakça

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