Adjuvant PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) or gemcitabine followed by chemoradiation in pancreatic cancer: A randomized phase II trial

Michele Reni, Gianpaolo Balzano, Giuseppe Aprile, Stefano Cereda, Paolo Passoni, Alessandro Zerbi, Maria Chiara Tronconi, Carlo Milandri, Piercarlo Saletti, Alessia Rognone, Clara Fugazza, Alessandro Magli, Nadia Di Muzio, Valerio Di Carlo, Eugenio Villa

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)2256-2263
Number of pages8
JournalAnnals of Surgical Oncology
Volume19
Issue number7
DOIs
Publication statusPublished - Jul 2012

ASJC Scopus subject areas

  • Surgery
  • Oncology

Fingerprint Dive into the research topics of 'Adjuvant PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) or gemcitabine followed by chemoradiation in pancreatic cancer: A randomized phase II trial'. Together they form a unique fingerprint.

Cite this