First-line treatment in metastatic pancreatic cancer: S comparison of the efficacy and safety of FOLFIRINOX versus gemcitabine–cisplatin regimens
Öz
Aim: FOLFIRINOX and gemcitabine–cisplatin are widely used chemotherapy regimens in the treatment of metastatic pancreatic cancer. This study aimed to compare the efficacy and safety of these two regimens as first-line treatment based on real-world data.
Materials and Methods: This retrospective, single-center study included a total of 85 patients who were diagnosed with advanced or metastatic pancreatic adenocarcinoma and received either FOLFIRINOX or gemcitabine–cisplatin as first-line therapy at the Department of Medical Oncology, Ege University Faculty of Medicine, between January 1, 2015, and December 31, 2024. Clinical and demographic data, treatment responses, and survival outcomes were retrospectively collected from patient records. Overall survival, progression-free survival, objective response rate, and treatment-related adverse events were comparatively analyzed between the two treatment groups.
Results: The median overall survival was 9,6 months in the FOLFIRINOX group and 8,1 months in the gemcitabine–cisplatin group, with a statistically significant difference (p = 0,030). Progression-free survival was also significantly longer in the FOLFIRINOX group (7,1 months vs. 5,2 months; p = 0,002). The objective response rate was 30,4% in the FOLFIRINOX group and 12,8% in the gemcitabine–cisplatin group, with a trend toward significance (p = 0,052). Adverse events were more frequently observed in the FOLFIRINOX group, particularly febrile neutropenia.
Conclusion: FOLFIRINOX demonstrated superior efficacy in terms of survival and treatment response compared to the gemcitabine–cisplatin regimen in the treatment of advanced or metastatic pancreatic cancer. However, this benefit was accompanied by increased toxicity. Given its more favorable tolerability profile, the gemcitabine–cisplatin regimen may represent an appropriate alternative, particularly in frail patients. These findings highlight the importance of personalized treatment decisions and support the need for prospective, multicenter comparative studies.
Anahtar Kelimeler
Pancreatic cancer FOLFIRINOX Gemcitabine Cisplatin Real-world data
Kaynakça
- McGuigan A, Kelly P, Turkington RC, Jones C, Coleman HG, McCain RS. Pancreatic cancer: A review of clinical diagnosis, epidemiology, treatment and outcomes. World journal of gastroenterology. 2018;24(43):4846.
- Kleeff J, Korc M, Apte M, La Vecchia C, Johnson CD, Biankin AV, et al. Pancreatic cancer. Nature reviews Disease primers. 2016;2(1):1-22.
- Ilic M, Ilic I. Epidemiology of pancreatic cancer. World journal of gastroenterology. 2016;22(44):9694.
- Luo J, Xiao L, Wu C, Zheng Y, Zhao N. The incidence and survival rate of population-based pancreatic cancer patients: Shanghai Cancer Registry 2004–2009. PloS one. 2013;8(10):e76052.
- Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. The lancet. 2011;378(9791):607-20.
- Allendorf JD, Lauerman M, Bill A, DiGiorgi M, Goetz N, Vakiani E, et al. Neoadjuvant chemotherapy and radiation for patients with locally unresectable pancreatic adenocarcinoma: feasibility, efficacy, and survival. Journal of Gastrointestinal Surgery. 2008;12(1):91-100.
- Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. New England journal of medicine. 2013;369(18):1691-703.
- Mizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. The Lancet. 2020;395(10242):2008-20.
- Barker HE, Paget JT, Khan AA, Harrington KJ. The tumour microenvironment after radiotherapy: mechanisms of resistance and recurrence. Nature Reviews Cancer. 2015;15(7):409-25.
- Eso Y, Seno H. Current status of treatment with immune checkpoint inhibitors for gastrointestinal, hepatobiliary, and pancreatic cancers. Therapeutic advances in gastroenterology. 2020;13:1756284820948773.
- Burris 3rd H, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. Journal of clinical oncology. 1997;15(6):2403-13.
- Louvet C, Labianca R, Hammel P, Lledo G, Zampino M, André T, et al. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. Journal of Clinical Oncology. 2005;23(15):3509-16.
- Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, et al. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. Journal of Clinical Oncology. 2006;24(24):3946-52.
- Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, et al. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. Journal of the National Cancer Institute. 2015;107(2):dju413.
- Wainberg ZA, Melisi D, Macarulla T, Cid RP, Chandana SR, De La Fouchardière C, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. The Lancet. 2023;402(10409):1272-81.
- Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. New England journal of medicine. 2011;364(19):1817-25.
- Colucci G, Giuliani F, Gebbia V, Biglietto M, Rabitti P, Uomo G, et al. Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: A prospective, randomized phase III study of the Gruppo Oncologico dell'Italia Meridionale. Cancer. 2002;94(4):902-10.
- Colucci G, Labianca R, Di Costanzo F, Gebbia V, Cartenì G, Massidda B, et al. Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. Journal of Clinical Oncology. 2010;28(10):1645-51.
- Chao Y, Wu C-Y, Wang JP, Lee R-C, Lee W-P, Li C-P. A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer. Cancer chemotherapy and pharmacology. 2013;72:637-42.
- Wang Y, Camateros P, Cheung WY. A real-world comparison of FOLFIRINOX, gemcitabine plus nab-paclitaxel, and gemcitabine in advanced pancreatic cancers. Journal of gastrointestinal cancer. 2019;50:62-8.
Metastatik pankreas kanserinde birinci basamak tedavi: FOLFIRINOX ile gemsitabin-sisplatin rejimlerinin etkinlik ve güvenlik açısından karşılaştırılması
Öz
Amaç: Metastatik pankreas kanseri tedavisinde FOLFIRINOX ve gemsitabin-sisplatin kombinasyonları sık kullanılan kemoterapi rejimleridir. Bu çalışmada, birinci basamak tedavi olarak uygulanan FOLFIRINOX ve gemsitabin-sisplatin rejimlerinin gerçek yaşam verileriyle etkinlik ve güvenlik açısından karşılaştırılması amaçlanmıştır.
Gereç ve Yöntem: Bu retrospektif, tek merkezli çalışmaya, 1 Ocak 2015 ile 31 Aralık 2024 tarihleri arasında Ege Üniversitesi Tıp Fakültesi Tıbbi Onkoloji Kliniği’nde ileri evre veya metastatik pankreas kanseri tanısı alarak birinci basamakta FOLFIRINOX veya gemsitabin-sisplatin tedavisi uygulanmış toplam 85 hasta dahil edilmiştir. Hastalara ait klinik ve demografik veriler ile tedavi yanıtları ve sağ kalım sonuçları hasta kayıtlarından geriye dönük olarak elde edilmiştir. Her iki tedavi grubunda genel sağ kalım, progresyonsuz sağ kalım, objektif yanıt oranı ve tedaviye bağlı advers olaylar karşılaştırmalı olarak analiz edilmiştir.
Bulgular: FOLFIRINOX grubunda medyan genel sağ kalım 9,6 ay, gemsitabin-sisplatin grubunda ise 8,1 ay olarak bulunmuştur ve bu fark istatistiksel olarak anlamlıdır (p = 0,030). Progresyonsuz sağ kalım açısından da FOLFIRINOX grubunda anlamlı üstünlük gözlenmiştir (7,1 aya karşı 5,2 ay; p = 0,002). Objektif yanıt oranı FOLFIRINOX grubunda %30,4, gemsitabin-sisplatin grubunda %12,8 olarak hesaplanmış ve bu fark istatistiksel anlamlılık sınırında kalmıştır (p = 0,052). Yan etkiler FOLFIRINOX grubunda daha sık görülmüş; özellikle nötropenik ateş oranı daha yüksek bulunmuştur.
Sonuç: FOLFIRINOX rejimi, ileri evre veya metastatik pankreas kanseri tedavisinde sağ kalım ve tedavi yanıtı açısından gemsitabin-sisplatin kombinasyonuna göre daha etkili bulunmuştur. Ancak bu etkinlik, artan toksisite oranlarıyla birlikte seyretmektedir. Gemsitabin-sisplatin tedavisi ise daha iyi tolere edilebilir olması nedeniyle özellikle kırılgan hasta gruplarında uygun bir alternatif olarak değerlendirilebilir. Bu bulgular, kişiselleştirilmiş tedavi yaklaşımlarının önemini vurgulamakta ve ileriye dönük çok merkezli prospektif çalışmalara ihtiyaç olduğunu göstermektedir.
Anahtar Kelimeler
Pankreas kanseri folfirinoks gemsitabin sisplatin gerçek yaşam verisi
Kaynakça
- McGuigan A, Kelly P, Turkington RC, Jones C, Coleman HG, McCain RS. Pancreatic cancer: A review of clinical diagnosis, epidemiology, treatment and outcomes. World journal of gastroenterology. 2018;24(43):4846.
- Kleeff J, Korc M, Apte M, La Vecchia C, Johnson CD, Biankin AV, et al. Pancreatic cancer. Nature reviews Disease primers. 2016;2(1):1-22.
- Ilic M, Ilic I. Epidemiology of pancreatic cancer. World journal of gastroenterology. 2016;22(44):9694.
- Luo J, Xiao L, Wu C, Zheng Y, Zhao N. The incidence and survival rate of population-based pancreatic cancer patients: Shanghai Cancer Registry 2004–2009. PloS one. 2013;8(10):e76052.
- Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. The lancet. 2011;378(9791):607-20.
- Allendorf JD, Lauerman M, Bill A, DiGiorgi M, Goetz N, Vakiani E, et al. Neoadjuvant chemotherapy and radiation for patients with locally unresectable pancreatic adenocarcinoma: feasibility, efficacy, and survival. Journal of Gastrointestinal Surgery. 2008;12(1):91-100.
- Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. New England journal of medicine. 2013;369(18):1691-703.
- Mizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. The Lancet. 2020;395(10242):2008-20.
- Barker HE, Paget JT, Khan AA, Harrington KJ. The tumour microenvironment after radiotherapy: mechanisms of resistance and recurrence. Nature Reviews Cancer. 2015;15(7):409-25.
- Eso Y, Seno H. Current status of treatment with immune checkpoint inhibitors for gastrointestinal, hepatobiliary, and pancreatic cancers. Therapeutic advances in gastroenterology. 2020;13:1756284820948773.
- Burris 3rd H, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. Journal of clinical oncology. 1997;15(6):2403-13.
- Louvet C, Labianca R, Hammel P, Lledo G, Zampino M, André T, et al. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. Journal of Clinical Oncology. 2005;23(15):3509-16.
- Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, et al. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. Journal of Clinical Oncology. 2006;24(24):3946-52.
- Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, et al. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. Journal of the National Cancer Institute. 2015;107(2):dju413.
- Wainberg ZA, Melisi D, Macarulla T, Cid RP, Chandana SR, De La Fouchardière C, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. The Lancet. 2023;402(10409):1272-81.
- Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. New England journal of medicine. 2011;364(19):1817-25.
- Colucci G, Giuliani F, Gebbia V, Biglietto M, Rabitti P, Uomo G, et al. Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: A prospective, randomized phase III study of the Gruppo Oncologico dell'Italia Meridionale. Cancer. 2002;94(4):902-10.
- Colucci G, Labianca R, Di Costanzo F, Gebbia V, Cartenì G, Massidda B, et al. Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. Journal of Clinical Oncology. 2010;28(10):1645-51.
- Chao Y, Wu C-Y, Wang JP, Lee R-C, Lee W-P, Li C-P. A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer. Cancer chemotherapy and pharmacology. 2013;72:637-42.
- Wang Y, Camateros P, Cheung WY. A real-world comparison of FOLFIRINOX, gemcitabine plus nab-paclitaxel, and gemcitabine in advanced pancreatic cancers. Journal of gastrointestinal cancer. 2019;50:62-8.
Ayrıntılar
| Birincil Dil | Türkçe |
|---|---|
| Konular | Klinik Onkoloji |
| Bölüm | Araştırma Makaleleri |
| Yazarlar | |
| Yayımlanma Tarihi | 8 Eylül 2025 |
| Gönderilme Tarihi | 14 Nisan 2025 |
| Kabul Tarihi | 9 Mayıs 2025 |
| Yayımlandığı Sayı | Yıl 2025 Cilt: 64 Sayı: 3 |
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