Capecitabine and concurrent radiation in patients with locally advanced irresectable pancreatic cancer

Background and purpose : many oncologists consider concurrent 5-Fluorouracil (5-FU) and ionizing radiation as standard treatment for patients with locally advanced, ir-resectable pancreatic cancer. Other radio-sensitizing agents coupled with radiotherapy are still under investigation. Capecitabine is an oral fluoropyrimidine which mimics continuous infusion 5-FU and has shown to be safe for outpatient treatment and to have significant anti-tumor activity in colo-rectal and breast cancer patients. In this study, we evaluated the feasibility and potential effectiveness of capecitabine and concurrent external beam radiotherapy in patients with locally advanced unresectable pancreatic cancer. Patients and methods : Twenty one patients with locally advanced irresectable pancreatic cancer were enrolled in this trial. Radiotherapy was delivered using megavoltage irradiation of 6MV photons. The daily fraction size was 1.8 Gy given 5 days a week to a prescribed dose of 54 Gy. Capecitabine dose was as follow : 825 mg / m2 twice daily, 2 hours prior to and 12 hours after radiotherapy session, 7 days a week from the beginning till the end of radiotherapy course. Toxicity and response were evaluated according to WHO criteria. Results : hematological toxicity was mainly mild to moderate (GI and II) : neutropenia 9 / 21, thrombocytopenia 7 / 21 and anemia 5 / 21. GIII neutropenia and thrombocyto-penia were encountered in 2 / 21 and 1 / 21, respectively. GIT toxicities were : GI and II diarrhea 8 / 21, GI / GII and GIII nausea and vomiting in 9 / 21 and 3 / 21, respectively, and stomatitis in 2 / 21. GII hand-foot-syndrome occurred in 2 / 21. Of the 21 patients included, 8 patients (35 %) achieved partial response (PR), whereas the tumor was rated stationary (SD) in 9 / 21 (43 %), while disease progression (DP) occurred in 4 / 21 (19 %). Total surgical excision was feasible in 3 / 8 patients who achieved PR. The median time to progression and median survival were 8 months (range 2-15 months) and 11 months (range 4-18 months), respectively. Conclusion : capecitabine in a daily dose of 2 x 825 mg / m2 and concurrent irradiation is a promising regimen in patients with locally advanced irresectable pancreatic cancer. The adverse effect of this combination is tolerable.