Ilkay Tugba Unek1, Ilhan Oztop1, Dogan Koca2, Tarkan Unek3, Anil Aysal Agalar4, Zeynep Gulsum Guc1, Sinan Unal1, Zumre Arican Alicikus5, Asim Leblebici6, Hulya Ellidokuz7, Ozgul Sagol4, Ugur Yilmaz8
1Department of Medical Oncology, Dokuz Eylul University School of Medicine, Izmir, Turkey.
2Department of Medical Oncology, Medical Park Hospital, Kocaeli, Turkey.
3Department of General Surgery, Dokuz Eylul University School of Medicine, Izmir, Turkey.
4Department of Pathology, Dokuz Eylul University School of Medicine, Izmir, Turkey.
5Department of Radiation Oncology, Dokuz Eylul University School of Medicine, Izmir, Turkey.
6Department of Translational Oncology, Dokuz Eylul University, Institute of Health Sciences, Izmir, Turkey.
7Department of Preventive Oncology, Dokuz Eylul University, Institute of Oncology, Izmir, Turkey.
8Department of Medical Oncology, Medical Park Hospital, Izmir, Turkey.
Summary
Purpose: There are many studies about the administration of gemcitabine and 5-fluorouracil combination regimen for advanced-stage pancreatic ductal adenocarcinoma (PDAC), but no study exists about early-stage PDAC. This study, for the first time, aimed to evaluate the efficacy and tolerability of gemcitabine and infusional 5-fluorouracil with high-dose folinic acid as adjuvant chemotherapy after curative surgery for PDAC.
Methods: Patients with curatively resected PDAC were treated with gemcitabine combined with infusional 5-fluorouracil and high-dose folinic acid (GEMFUFOL). This combination regimen was repeated every 2 weeks.
Results: A total of 62 patients who received GEMFUFOL as adjuvant chemotherapy were included in this study. At a median follow-up of 16.9 months (range, 3.6-149.2), median disease-free survival (DFS) was 11.8 months (95% CI, 7.9-15.6), with 1-year, 2-year and 3-year DFS rates of 49%, 15% and 11% identified. Median overall survival (OS) was 17.3 months (95% CI, 12.4-22.1) with 1-year, 2-year and 3-year OS rates of 72%, 37% and 17%. Severe toxicity was rarely observed. Two patients (3.2%) developed grade 4 neutropenia; however, febrile neutropenia was observed in 1 patient (1.6%). Three patients (4.8%) had grade 3 neutropenia, 2 patients (3.2%) had grade 3 anemia, 3 patients (4.8%) had grade 3 nausea, 1 patient (1.6%) had grade 3 diarrhea and 1 patient (1.6%) had grade 3 infection.
Conclusions: The GEMFUFOL regimen is an effective and tolerable regimen for adjuvant treatment of PDAC and may be an appropriate alternative for patients unsuitable for current standard treatments.
Key words: adjuvant chemotherapy, gemcitabine, 5-fluorouracil, folinic acid, pancreatic cancer.
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