Interferon based adjuvant chemoradiation therapy improves survival after pancreaticoduodenectomy for pancreatic adenocarcinoma

dBACKGROUND: Based on a 2-year survival of 43%, the Gastrointestinal Tumor Study Group (GITSG) recommended adjuvant 5-FU-based chemoradiation for rese cted patients with adenocarcinoma of the pancreatic heed. Here we report im proved survival over the GITSG protocol with a novel adjuvant chemoradiothe rapy based on interferon-alpha (IFN alpha). METHODS: From July 1993 to September 1998, 33 patients with adenocarcinoma of the pancreatic head underwent panereaticoduodenectomy (PD) and subsequen tly went on to adjuvant therapy (GITSG-type, n = 16) or IFN alpha-based (n = 17) typically given between 6 and 8 weeks after surgery. The latter proto col consisted of external-beam irradiation at a dose of 4,500 to 5,400 cGy (25 fractions per 5 weeks) and simultaneous three-drug chemotherapy consist ing of (1) continuous infusion 5-FU (200 mg/m(2) per day); (2) weekly intra venous bolus cisplatin (30 mg/m(2) per day); and (3) IFN alpha (3 million u nits subcutaneously every other day) during the 5 weeks of radiation. This was then followed by two 6-week courses of continuous infusion 5-FU (200 mg /m(2) per day, given weeks 9 to 14 and 17 to 22). Risk factor's for recurre nce and survival were compared for the two groups. RESULTS: A more advanced tumor stage was observed in the IFN alpha-treated patients (positive nodes and American Joint Committee on Cancer [AJCC] stag e III = 78%) than the GITSG group (positive nodes and stage III = 44%, P = 0.052). The a-year overall survival was superior in the IFN alpha cohort (8 4%) versus the GITSG group (54%). With a mean follow-up of 26 months in bot h cohorts, actuarial survival curves significantly favored the IFN alpha gr oup (P = 0.04). CONCLUSIONS: With a limited number of patients, this phase II type trial su ggests better survival in the interferon group as compared with the GITSG g roup even though the interferon group was associated with a move extensive tumor stage. The 2-year survival rate in the interferon group is the best p ublished to date for resected pancreatic cancer. The interferon/cisplatin/5 -FU-based adjuvant chemoradiation protocol appears to be a promising treatm ent for patients who have undergone PD for adenocarcinoma of the pancreatic head. (C) 2000 by Excerpta Medica, Inc.