AISP - 29th National Congress. Bologna (Italy). September 15-17, 2005
JOP. J Pancreas (Online) 2004; 6(5 Suppl):481-482.

Preliminary Results of a Phase II Trial of Dose-Intense PEFG (Cisplatin, Epirubicin, 5-Fluorouracil, Gemcitabine) in Advanced Pancreatic Adenocarcinoma

Cereda S, Dell'Oro S, Passoni P, Bonetto E, Vigaṇ MG, Balzano G, Zerbi A, Staudacher C, Di Carlo V, Reni M

Department of Oncology and Surgery, S. Raffaele H. Scientific Institute. Milan, Italy

ABSTRACT

Background PEFG regimen was superior to standard gemcitabine in a phase III trial in advanced pancreatic adenocarcinoma (PA) [1]. This regimen was subsequently modified by increasing dose-intensity [2].

Aim To assess activity and feasibility of dose-intense PEFG regimen.

Methods 5-fluorouracil (FU) as continuous infusion at 200 mg/m2/day for the whole duration of chemotherapy (CHT), cisplatin and epirubicin both at 30 mg/m2, and gemcitabine at 800 mg/m2 were administered every 14 days to patients with stage III or metastatic PA who were chemotherapy-naive, less than 75-year-old, performance status (PS) greater than 50, and who had normal bone marrow, renal and liver function, till progressive disease or for a maximum of 6 months.

Results Between August 2003 and April 2005, 43 (27 or 63% metastatic) consecutive patients, median age 62 years, median PS 75, were treated with dose-intense PEFG at a single institution. Accrual is ongoing. Partial response was yielded in 18 patients (42%). Among 33 patients with at least 6 months of follow-up, 18 were progression-free at 6 months from treatment start (PFS-6=54.5%) and median progression-free survival was 6.2 months. Three of 16 (18%) stage III patients became resectable after CHT. Radiotherapy concomitant to FU was administered at 10 stage III patients after the end of CHT. To date, 169 courses (range: 1-6; median: 4) of dose-intense PEFG were delivered. Main grade 3-4 toxicity consisted of: neutropenia in 9%, anaemia, stomatitis, nausea/vomiting in 3%, fatigue and diarrhoea in 2% of cycles. Dose intensity (mg/m2/week) was 13.5 for both epirubicin and cisplatin, 322 for gemcitabine and 1,053 for FU.

Conclusions Preliminary results of this study show that the outcome of PA patients treated by dose-intense PEFG regimen is at least as good as that yielded by classical PEFG in terms of PFS (PFS-6: 54.5% vs. 42%; median PFS 6.2 vs. 5.4) and response rate (42% vs. 38.5%). Dose intensity for gemcitabine was increased by 26%, for cisplatin and epirubicin by 43%. Grade 3-4 haematological toxicity (neutropenia 9% vs. 43%; thrombocytopenia 0% vs. 28.5%) was consistently reduced.

References

  1. Reni M, Cordio S, Milandri C, Passoni P, Bonetto E, Oliani C, et al. Gemcitabine versus cisplatin, epirubicin, fluorouracil, and gemcitabine in advanced pancreatic cancer: a randomised controlled multicentre phase III trial. Lancet Oncol 2005; 6:369-76. [More details]

  2. Dell'Oro S, Reni M, Bonetto E. Intensified PEFG regimen in stage III-IV pancreatic adenocarcinoma. Ann Oncol 2004; 15:242. [Abstract 919] [More details]

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