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A 13-Year Single Institution Experience with 4-Drug Regimens in Patients with Advanced Pancreatic Adenocarcinoma ( PA )

Context The combination of cisplatin, epirubicin, gemcitabine and 5-fluorouracil (F; PEFG) was shown to improve the outcome of patients with stage III-IV PA in a phase III trial. In 2005, 5-FU was replaced by capecitabine (X; PEXG) in the clinical practice. Objective To report the outcome of a single institution series of 319 patients receiving either PEFG or PEXG between April 1997 and June 2010. Methods Chemonaïve patients with stage III-IV PA, age 18-75 years, Karnofsky performance status (PS) >50 received PEFG until June 2005 and PEXG thereafter for a maximum of 6 months. At the end of chemotherapy, stage III patients without systemic progressive disease (PD) received concomitant chemoradiation. Computed tomography of the abdomen and chest was made at baseline, every 8 weeks during treatment and then every 2-3 months or when PD was clinically suspected. CA 19-9 measure was done on a monthly basis. Progression-free survival (PFS) was calculated as the interval between start of treatment and PD or death, and overall survival (OS) was measured from initiation of treatment to date of death or to the last follow-up assessment. Results One-hundred and 55 patients received PEFG (group A) and 164 PEXG (group B). Patients’ characteristics were (A/B): median age 60/60 years, median PS 80/90, metastatic disease 63/60%; CA 19-9 greater than the upper limit of laboratory reference 82/88%. Disease control (complete response + partial response + stable disease) was yielded in 81% of patients in both groups. A CA 19-9 reduction >89% was observed in 30% and 26% and a reduction of 5089% in 42% and 38%. In stage III patients, median PFS was 10.9 and 9.8 months (P=0.29); 1-year OS was 66% and 69% and median OS 16.4 and 17.9 months (P=0.17). In stage IV patients, median PFS was 6.0 and 6.0 months (P=0.5); 1-year OS 32% and 43% and median OS 8.8 and 10.7 months (P=0.05). No difference was observed in grade 3-4 toxicity. Conclusions PEXG is more suitable for use in the clinical practice and yielded similar results when compared to PEFG. The present study confirmed the remarkable impact of 4-drug regimens on PA outcome and feasibility on an outpatient basis. Further investigation on PEXG regimen in the peri-operative setting is warranted.