Final results of a prospective trial of a PEFG (Cisplatin, Epirubicin, 5-Fluorouracil, Gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma.

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) > or =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% (alpha 0.05; beta 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.

journal_name

Oncology

journal_title

Oncology

authors

Reni M,Passoni P,Bonetto E,Balzano G,Panucci MG,Zerbi A,Ronzoni M,Staudacher C,Villa E,Di Carlo V

doi

10.1159/000086780

subject

Has Abstract

pub_date

2005-01-01 00:00:00

pages

239-45

issue

2-3

eissn

0030-2414

issn

1423-0232

pii

86780

journal_volume

68

pub_type

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