Combination of gemcitabine, infusional 5-fluorouracil and high-dose folinic acid (GEMFUFOL) as adjuvant chemotherapy in resected pancreatic cancer


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ÜNEK İ. T., ÖZTOP İ., Koca D., ÜNEK T., AYSAL AĞALAR A., GÜÇ Z. G., ...More

Journal of B.U.ON., vol.26, no.6, pp.2496-2504, 2021 (SCI-Expanded, Scopus)

  • Publication Type: Article / Article
  • Volume: 26 Issue: 6
  • Publication Date: 2021
  • Journal Name: Journal of B.U.ON.
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, EMBASE, MEDLINE
  • Page Numbers: pp.2496-2504
  • Keywords: 5-fluorouracil, Adjuvant chemotherapy, Folinic acid, Gemcitabine, Pancreatic cancer
  • Open Archive Collection: AVESIS Open Access Collection
  • Dokuz Eylül University Affiliated: Yes

Abstract

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.