Final results of a prospective trial of a PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma

Michele Reni, Paolo Passoni, Elisa Bonetto, Gianpaolo Balzano, Maria Grazia Panucci, Alessandro Zerbi, Monica Ronzoni, Carlo Staudacher, Eugenio Villa, Valerio Di Carlo

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Postoperative management of patients with pancreatic adenocarcinoma (PA) is controversial. Methods: The aim of this pilot study was to assess the feasibility of postoperative combination chemotherapy followed by radiotherapy in patients aged 18-70 years with a histological diagnosis of PA, and Karnofsky performance status (KPS) ≥ 70. Cisplatin and epirubicin 40 mg/m2 on day 1, gemcitabine 600 mg/m2 on day 1 and 8, and 5-fluorouracil 200 mg/m2/day as protracted infusion (PEFG regimen) were delivered every 28 days for 4 cycles. Assuming a minimum one-year disease-free survival (DFS) of interest of 65% and a maximum of low interest of 45% (α 0.05; β 0.10), the target enrollment was 51 patients, and the strategy would be considered to deserve further analysis if more than 29 patients were DF at one-year from surgery. Results: Fifty-one patients, KPS >80: 29, median tumor size 3.5 cm, stage II/III/IVA: 2/34/13, grade 3-4: 22, positive resection margins: 26, node positive: 46, received 179 cycles of chemotherapy. Main grade 3/4 toxicity consisted of neutropenia (51%), thrombocytopenia (18%), and anemia (4%). One-year DFS was 67 ± 7%. Two-year overall survival was 53 ± 7%. Conclusion: Postoperative management of PA with this multimodality strategy was well tolerated and yielded a promising outcome.

Original languageEnglish
Pages (from-to)239-245
Number of pages7
JournalOncology
Volume68
Issue number2-3
DOIs
Publication statusPublished - Jul 2005

Keywords

  • Adjuvant chemotherapy
  • Combination chemotherapy
  • Multimodality treatment
  • Pancreatic adenocarcinoma
  • Radiotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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