study of pre and post chemoradiation 5-FU and gemcitabine for combined treatment of advanced unresected non metastatic pancreatic adenocarcinoma

ABSTRACT

To evaluate local effects and acute toxicities of involved field irradiation with concurrent gemcitabine [GEM], 5-flourouracil [5FU] for unresectable pancreatic carcinoma. Thirty patients with unresectable pancreatic carcinoma were treated between July 2002 and April 2004 with neoadjuvant combination chemotherapy 5FU [500 mg/m[2]] and GEM at 1000 mg/m[2] days 1, 8 and 15 [one cycle] followed by chemoradiotherapy [CCRT] using a combination of GEM 75mg/m[2] /week and bolus 5FU [500mg/m[2]] given concurrently days 1-3, at the beginning of each 20Gy of radiotherapy to a median radiation dose of 50.4 Gy in 1.8 Gy daily fractions to a standard pancreatic field. Eighteen males and 12 females were enrolled. Median age was 62.5 [range 47-74 years], ECOG PS 0/1 = 10/11 patients. As for the primary site, only five patients [16.7%] achieved a complete response at one year; however, seven additional patients attained >50% tumor reduction for an overall response rate of 40%. Grade 3 and 4 Leukopenia [33% and 6.7%], thrombocytopenia [40 and 16.7%], nausea/vomiting [20% and 0%]. Median survival time and survival at 1 year were 14 months and 62.5%, respectively, for the entire group. Involved-field irradiation with concurrent GEM/5FU was well tolerated without compromising locoregional effects. Further studies with other combinations of GEM and 5-FU are not compelling, and clinical trial resources should address other combinations and novel agents