In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 14087-14087
Abstract:
14087 Background: The 5-year survival rate of patients with resected EBDC is less than 30%. Phase II trials demonstrated that advanced EBDC responds to both chemotherapy with gemcitabine and capecitabine and to radiotherapy. Our objective was to define a feasible and effective postoperative therapy in patients with EBDC. Methods: Patients were eligible after surgery for EBDC. Surgery included resection of lymph node positive cancer, incomplete resections and diagnostic laparotomy in unresectable tumors. Patients received a fractionated radiotherapy with 49.6 Gy accompanied by gemcitabine 100 mg/m 2 weekly × 5. After a two week rest patients were treated with gemcitabine (1000 mg/m 2 IV D1+8 q3w) and capecitabine (1500 mg/m 2 PO D1–14 q3w) on a 3-week cycle. Treatment continued for 6 cycles in nonmeasurable disease or until disease progression or intolerable toxicity. Primary endpoint was toxicity; secondary endpoints were response rate in measurable disease and overall survival. Results: 18 Patients (resectable/unresectable disease 7/11) were enrolled. Radiotherapy was completed in all patients and a total of 66 cycles of chemotherapy were applied. Anemia, fatigue, and nausea were the most common mild adverse events in 16, 14, and 16 patients, respectively. Grade 3 and 4 toxicity was rare after resection but frequent in unresectable disease and consisted of fatigue, nausea, duodenal ulcer, cachexia and cholangitis in 1, 2, 2, 4, and 4 patients, respectively. We observed a 50% disease stabilization rate in patients with measurable disease. Median overall survival was 7.9 months in patients with unresectable tumors. Median overall survival in patients after resection has not been reached after a median follow-up of 19.5 months. Conclusions: Radiochemotherapy with gemcitabine followed by gemcitabine and capecitabine is an active regimen with manageable toxicity after resection of EBDC but has significant toxicity in unresectable disease. No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2006.24.18_suppl.14087
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2006
detail.hit.zdb_id:
2005181-5
