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

Yıl 2025, Cilt: 16 Sayı: 4, 514 - 522, 01.01.2026
https://doi.org/10.18663/tjcl.1792552

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.

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.

Destekleyen Kurum

Bu araştırma için herhangi bir fon veya destek alınmamıştır.

Kaynakça

  • Ayasun R, Saridogan T, Gaber O, Sahin IH. Systemic therapy for patients with pancreatic cancer: current approaches and opportunities for novel avenues toward precision medicine. Clin Colorectal Cancer. 2023; 22: 2-11.
  • Pajewska M, Partyka O, Czerw A, Deptała A, Cipora E, Gąska I, et al. Management of metastatic pancreatic cancer-comparison of global guidelines over the Last 5 Years. Cancers. 2023; 15: 4400.
  • Lai EC, Ung AK. Update on management of pancreatic cancer: a literature review. Chin Clin Oncol. 2024; 13: e41.
  • Amhis N, Carignan J, Tai L-H. Transforming pancreaticobiliary cancer treatment: Exploring the frontiers of adoptive cell therapy and cancer vaccines. Mol Ther Oncol. 2024;100132.
  • Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011; 364: 1817-25.
  • Wang J, Yang J, Narang A, He J, Wolfgang C, Li K, et al. Consensus, debate, and prospective on pancreatic cancer treatments. J Hematol Oncol. 2024; 17: 92.
  • Lu W, Wang L, Li X, Tang K. Efficacy and safety of FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer after gemcitabine-based therapy: A systematic review and meta-analysis. J Int Med Res. 2022; 50: 03000605221093225.
  • Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, et al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014; 32: 2423-9.
  • Gill S, Ko Y-J, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, et al. PANCREOX: a randomized phase III study of fluorouracil/leucovorin with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. J Clin Oncol. 2016; 34: 3914-20.
  • Petrelli F, Parisi A, Tomasello G, Mini E, Arru M, Russo A, et al. Comparison of different second line treatments for metastatic pancreatic cancer: a systematic review and network meta-analysis. BMC Gastroenterol. 2023; 23: 212.
  • Wang Q, Lv N, Xu D, Wu Y, Wu J, Gao W, et al. Efficacy of second-line treatment for gemcitabine-refractory unresectable pancreatic cancer in a real-world setting. BMC Cancer. 2025; 25: 1209.
  • Tempero MA, Malafa MP, Al-Hawary M, Behrman SW, Benson AB, Cardin DB, et al. Pancreatic adenocarcinoma, version 2.2021, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2021; 19: 439-57.
  • Kim CA, Lelond S, Daeninck PJ, Rabbani R, Lix L, McClement S, et al. The impact of early palliative care on the quality of life of patients with advanced pancreatic cancer: The IMPERATIVE case-crossover study. Support Care Cancer. 2023; 31: 250.
  • Park SJ, Kim H, Shin K, Hong TH, Suh JH, Lee MA. Nanoliposomal irinotecan plus fluorouracil and folinic acid as a second-line treatment option in patients with metastatic pancreatic ductal adenocarcinoma: a retrospective cohort study. BMC Cancer. 2021; 21: 1176.
  • Wang-Gillam A, Li C-P, Bodoky G, Dean A, Shan Y-S, Jameson G, et al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016; 387: 545-57.
  • Wasan H, Springett G, Chodkiewicz C, Wong R, Maurel J, Barone C, et al. CA 19-9 as a biomarker in advanced pancreatic cancer patients randomised to gemcitabine plus axitinib or gemcitabine alone. Br J Cancer. 2009; 101: 1162-7.

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

Yıl 2025, Cilt: 16 Sayı: 4, 514 - 522, 01.01.2026
https://doi.org/10.18663/tjcl.1792552

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.

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

Destekleyen Kurum

This research received no external funding.

Kaynakça

  • Ayasun R, Saridogan T, Gaber O, Sahin IH. Systemic therapy for patients with pancreatic cancer: current approaches and opportunities for novel avenues toward precision medicine. Clin Colorectal Cancer. 2023; 22: 2-11.
  • Pajewska M, Partyka O, Czerw A, Deptała A, Cipora E, Gąska I, et al. Management of metastatic pancreatic cancer-comparison of global guidelines over the Last 5 Years. Cancers. 2023; 15: 4400.
  • Lai EC, Ung AK. Update on management of pancreatic cancer: a literature review. Chin Clin Oncol. 2024; 13: e41.
  • Amhis N, Carignan J, Tai L-H. Transforming pancreaticobiliary cancer treatment: Exploring the frontiers of adoptive cell therapy and cancer vaccines. Mol Ther Oncol. 2024;100132.
  • Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011; 364: 1817-25.
  • Wang J, Yang J, Narang A, He J, Wolfgang C, Li K, et al. Consensus, debate, and prospective on pancreatic cancer treatments. J Hematol Oncol. 2024; 17: 92.
  • Lu W, Wang L, Li X, Tang K. Efficacy and safety of FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer after gemcitabine-based therapy: A systematic review and meta-analysis. J Int Med Res. 2022; 50: 03000605221093225.
  • Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, et al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014; 32: 2423-9.
  • Gill S, Ko Y-J, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, et al. PANCREOX: a randomized phase III study of fluorouracil/leucovorin with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. J Clin Oncol. 2016; 34: 3914-20.
  • Petrelli F, Parisi A, Tomasello G, Mini E, Arru M, Russo A, et al. Comparison of different second line treatments for metastatic pancreatic cancer: a systematic review and network meta-analysis. BMC Gastroenterol. 2023; 23: 212.
  • Wang Q, Lv N, Xu D, Wu Y, Wu J, Gao W, et al. Efficacy of second-line treatment for gemcitabine-refractory unresectable pancreatic cancer in a real-world setting. BMC Cancer. 2025; 25: 1209.
  • Tempero MA, Malafa MP, Al-Hawary M, Behrman SW, Benson AB, Cardin DB, et al. Pancreatic adenocarcinoma, version 2.2021, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2021; 19: 439-57.
  • Kim CA, Lelond S, Daeninck PJ, Rabbani R, Lix L, McClement S, et al. The impact of early palliative care on the quality of life of patients with advanced pancreatic cancer: The IMPERATIVE case-crossover study. Support Care Cancer. 2023; 31: 250.
  • Park SJ, Kim H, Shin K, Hong TH, Suh JH, Lee MA. Nanoliposomal irinotecan plus fluorouracil and folinic acid as a second-line treatment option in patients with metastatic pancreatic ductal adenocarcinoma: a retrospective cohort study. BMC Cancer. 2021; 21: 1176.
  • Wang-Gillam A, Li C-P, Bodoky G, Dean A, Shan Y-S, Jameson G, et al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016; 387: 545-57.
  • Wasan H, Springett G, Chodkiewicz C, Wong R, Maurel J, Barone C, et al. CA 19-9 as a biomarker in advanced pancreatic cancer patients randomised to gemcitabine plus axitinib or gemcitabine alone. Br J Cancer. 2009; 101: 1162-7.
Toplam 16 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Konular Kemoterapi
Bölüm Araştırma Makalesi
Yazarlar

Kadriye Başkurt 0000-0002-6091-730X

Bülent Yıldız 0000-0002-9111-9132

Gönderilme Tarihi 28 Eylül 2025
Kabul Tarihi 8 Ekim 2025
Yayımlanma Tarihi 1 Ocak 2026
Yayımlandığı Sayı Yıl 2025 Cilt: 16 Sayı: 4

Kaynak Göster

APA Başkurt, K., & Yıldız, B. (2026). Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma. Turkish Journal of Clinics and Laboratory, 16(4), 514-522. https://doi.org/10.18663/tjcl.1792552
AMA 1.Başkurt K, Yıldız B. Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma. TJCL. 2026;16(4):514-522. doi:10.18663/tjcl.1792552
Chicago Başkurt, Kadriye, ve Bülent Yıldız. 2026. “Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma”. Turkish Journal of Clinics and Laboratory 16 (4): 514-22. https://doi.org/10.18663/tjcl.1792552.
EndNote Başkurt K, Yıldız B (01 Ocak 2026) Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma. Turkish Journal of Clinics and Laboratory 16 4 514–522.
IEEE [1]K. Başkurt ve B. Yıldız, “Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma”, TJCL, c. 16, sy 4, ss. 514–522, Oca. 2026, doi: 10.18663/tjcl.1792552.
ISNAD Başkurt, Kadriye - Yıldız, Bülent. “Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma”. Turkish Journal of Clinics and Laboratory 16/4 (01 Ocak 2026): 514-522. https://doi.org/10.18663/tjcl.1792552.
JAMA 1.Başkurt K, Yıldız B. Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma. TJCL. 2026;16:514–522.
MLA Başkurt, Kadriye, ve Bülent Yıldız. “Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma”. Turkish Journal of Clinics and Laboratory, c. 16, sy 4, Ocak 2026, ss. 514-22, doi:10.18663/tjcl.1792552.
Vancouver 1.Başkurt K, Yıldız B. Metastatik/inoperabl pankreatikobilier sistem kanserlerinde ikinci basamak kemoterapilerin etkinlik ve güvenlilik sonuçları: tek merkez retrospektif çalışma. TJCL [Internet]. 01 Ocak 2026;16(4):514-22. Erişim adresi: https://izlik.org/JA34UM44UD


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