TY - JOUR
T1 - Final results of a prospective trial of a PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma
AU - Reni, Michele
AU - Passoni, Paolo
AU - Bonetto, Elisa
AU - Balzano, Gianpaolo
AU - Panucci, Maria Grazia
AU - Zerbi, Alessandro
AU - Ronzoni, Monica
AU - Staudacher, Carlo
AU - Villa, Eugenio
AU - Di Carlo, Valerio
PY - 2005/7
Y1 - 2005/7
N2 - 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.
AB - 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.
KW - Adjuvant chemotherapy
KW - Combination chemotherapy
KW - Multimodality treatment
KW - Pancreatic adenocarcinoma
KW - Radiotherapy
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U2 - 10.1159/000086780
DO - 10.1159/000086780
M3 - Article
C2 - 16015040
AN - SCOPUS:23844495516
VL - 68
SP - 239
EP - 245
JO - Oncology
JF - Oncology
SN - 0030-2414
IS - 2-3
ER -