TY - JOUR
T1 - Adjuvant PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) or gemcitabine followed by chemoradiation in pancreatic cancer
T2 - A randomized phase II trial
AU - Reni, Michele
AU - Balzano, Gianpaolo
AU - Aprile, Giuseppe
AU - Cereda, Stefano
AU - Passoni, Paolo
AU - Zerbi, Alessandro
AU - Tronconi, Maria Chiara
AU - Milandri, Carlo
AU - Saletti, Piercarlo
AU - Rognone, Alessia
AU - Fugazza, Clara
AU - Magli, Alessandro
AU - Di Muzio, Nadia
AU - Di Carlo, Valerio
AU - Villa, Eugenio
PY - 2012/7
Y1 - 2012/7
N2 - Background. Information from randomized trials on the role of combination chemotherapy in the adjuvant treatment of pancreatic adenocarcinoma is limited. This randomized phase II trial aimed to identify the most promising regimen warranting phase III evaluation. Methods. Therapy-naive patients, age 18-75 years, Karnofsky Performance Status (KPS) >60, gross total resection of stage IB-III pancreatic adenocarcinoma, stratified for center and surgical margins, were randomly assigned to receive either gemcitabine 1 g/m 2 weekly on days 1, 8, and 15 (arm A) or the PEFG regimen (cisplatin and epirubicin 40 mg/m 2, day 1; gemcitabine 600 mg/m 2, days 1, 8; 5-fluorouracil 200 mg/m 2 daily, days 1-28) (arm B). Chemotherapy was administered every 4 weeks for 3 months and followed by irradiation concurrent to continuous infusion of 5-fluorouracil 250 mg/m 2 daily. Primary endpoint was the probability of being disease-free at 1 year from surgery. Assuming P0 = 35% and P1 = 55%, α = .05 and β = .10, the study was to enroll 51 patients per arm. Results. A total of 102 patients were randomized; 100 were eligible (arm A: 51; arm B: 49). Baseline characteristic (A/B) were: Median age was 61/60 years; 75% had KPS >80 75/76%; 36% grade 3 tumor 29/43%, 79% stage IIB/III 75/84%, 31% R1 resection 35/29%. Survival figures (A/B) were: Median disease-free survival was 11.7 and 15.2 months; 1-year disease-free survival 49.0% (95% confidence interval [95% CI] 35-63%) and 69.4% (95% CI 56-83%); median survival 24.8 and 28.9 months. Combination chemotherapy produced more hematological toxicity without relevant differences in nonhematological toxicities. Conclusions. The 4-drug regimen deserves further assessment in resectable pancreatic cancer.
AB - Background. Information from randomized trials on the role of combination chemotherapy in the adjuvant treatment of pancreatic adenocarcinoma is limited. This randomized phase II trial aimed to identify the most promising regimen warranting phase III evaluation. Methods. Therapy-naive patients, age 18-75 years, Karnofsky Performance Status (KPS) >60, gross total resection of stage IB-III pancreatic adenocarcinoma, stratified for center and surgical margins, were randomly assigned to receive either gemcitabine 1 g/m 2 weekly on days 1, 8, and 15 (arm A) or the PEFG regimen (cisplatin and epirubicin 40 mg/m 2, day 1; gemcitabine 600 mg/m 2, days 1, 8; 5-fluorouracil 200 mg/m 2 daily, days 1-28) (arm B). Chemotherapy was administered every 4 weeks for 3 months and followed by irradiation concurrent to continuous infusion of 5-fluorouracil 250 mg/m 2 daily. Primary endpoint was the probability of being disease-free at 1 year from surgery. Assuming P0 = 35% and P1 = 55%, α = .05 and β = .10, the study was to enroll 51 patients per arm. Results. A total of 102 patients were randomized; 100 were eligible (arm A: 51; arm B: 49). Baseline characteristic (A/B) were: Median age was 61/60 years; 75% had KPS >80 75/76%; 36% grade 3 tumor 29/43%, 79% stage IIB/III 75/84%, 31% R1 resection 35/29%. Survival figures (A/B) were: Median disease-free survival was 11.7 and 15.2 months; 1-year disease-free survival 49.0% (95% confidence interval [95% CI] 35-63%) and 69.4% (95% CI 56-83%); median survival 24.8 and 28.9 months. Combination chemotherapy produced more hematological toxicity without relevant differences in nonhematological toxicities. Conclusions. The 4-drug regimen deserves further assessment in resectable pancreatic cancer.
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U2 - 10.1245/s10434-011-2205-2
DO - 10.1245/s10434-011-2205-2
M3 - Article
C2 - 22237835
AN - SCOPUS:84865142675
VL - 19
SP - 2256
EP - 2263
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
SN - 1068-9265
IS - 7
ER -