Retrospective Analysis of Capecitabine and Radiation Therapy in the Treatment of Pancreatic Cancer.

PURPOSE

To report our clinical experience with 25 patients receiving concurrent capecitabine and irradiation in the treatment of locally advanced or resected pancreatic cancer. METHODS AND MATERIALS: We reviewed the medical records of patients with pancreatic cancer who received treatment with capecitabine and irradiation for pancreatic cancer and received capecitabine 1200 to 1600 mg/m(2) orally twice daily Monday through Friday with concurrent radiation (5040-5400 cGy, 180 cGy, 5 days/week), followed by a 4-week rest, then 6 to 8 cycles of capecitabine alone 2000 to 2500 mg/m(2) twice daily for 14 days every 3 weeks (surgically resected), and capecitabine 2000 to 2500 mg/m(2) BID for 14 days every 3 weeks until progressive disease (unresected). RESULTS: The population consisted of 14 females and 11 males, with a median age of 64 years (range 37-80 years). Histology was adenocarcinoma in 23 patients and neuroendocrine tumor in 2 patients. One patient had resected tumor, 3 patients were resected with positive margins, 1 patient was resectable with poor performance status prohibiting resection, and 20 patients had unresected locally advanced disease. Median dose of capecitabine concurrent with radiation was 1500 mg/m(2)/day (600-1600 mg/m(2)/day) given orally in two divided doses, 5 days per week on days of treatment with radiation therapy. Patients received a median total radiation dose of 5040 cGy (4500-5040 cGy) over 6 weeks. Eleven patients were continued on capecitabine cycles after treatment with concurrent capecitabine and irradiation. The median number of cycles completed was 3, with one patient completing 8 cycles. Median survival was 14 months, with 18 patients surviving through the end of the study period. Median overall primary tumor response over the study period was -2% (-100%-100%). Five patients were taken to laparotomy after treatment based on radiographic response and two patients were successfully resected. By the end of the study period, there were 4 complete remissions, 2 partial remissions, 6 stable disease, and 13 progressive disease. Grade 3 or 4 toxicity was observed mainly with gastrointestinal symptoms including nausea, vomiting, diarrhea, and anorexia. Three patients had G3 hand-foot syndrome, 1 patient had G3 peripheral neuropathy, 1 patient had G4 gastrointestinal bleed, and 1 patient had G3 radiation enteritis. There was one death directly related to treatment secondary to uncontrolled GI bleeding. CONCLUSION: In patients with locally advanced pancreatic cancer, concurrent capecitabine and radiation had good survival response in patients and good tumor response. Toxicity of oral capecitabine was well tolerated.