Abstracts: Abstracts of Papers Submitted to the 36th Annual Meeting of the American Pancreatic Association, November 3-4, 2005
PHASE III RANDOMISED COMPARISON OF GEMCITABINE (GEM) WITH GEMCITABINE PLUS CAPECITABINE (GEM-CAP) IN PATIENTS WITH ADVANCED PANCREATIC CANCER
Neoptolemos, J P1; Chau, I2; Stocken, D3; Davies, C1; Dunn, J3; Valle, J4; Smith, D5; Steward, W6; Harper, P7; Cunninghamon, D2 on behalf of NCRI Upper Gastrointestinal Cancer Clinical Study Group
1University of Liverpool, 2Royal Marsden Hospital, 3University of Birmingham, 4Christie Hospital, 5Clatterbridge Centre for Oncology, 6Leicester Royal Infirmary, 7Guy's Hospital, United Kingdom
Both gemcitabine and fluoropyrimidines are valuable treatment for advanced pancreatic cancer. This study was designed to compare the survival of gemcitabine (GEM) with gemcitabine plus oral capecitabine (GEM-CAP).
Patients with histological and proven advanced carcinoma of the pancreas were randomised to GEM (1000mg/m2 weekly ×7 q8 weeks, then 1 week rest, thereafter weekly ×3 q4 weeks) or to GEM-CAP (gemcitabine 1000 mg/m2 weekly ×3 q4 weeks and capecitabine 1660 mg/m2/day for 21 days followed by 7 days' rest). Treatment continued until disease progression or intolerable toxicities. The primary outcome measure was survival.
Between May 02 and Jan 05, 533 patients were randomised to GEM (n = 266) and GEM-CAP (n = 267) arms. Baseline characteristics were well balanced (GEM/GEM-CAP) with regards to median age (62/62), stage IVB disease (71%/70%) and WHO performance status (PS) 0-1 (82%/81%). At the time of this interim analysis in May 05, 373 (70%) deaths have occurred. GEM-CAP significantly improved overall survival over GEM alone (Hazard Ratio [HR]: 0.80; 95% CI: 0.65-0.98; p = 0.026). The median survival for GEM and GEM-CAP was 6 months and 7.4 months respectively and 1-year survival rates were 19% and 26% respectively. After adjusting for baseline stratification factors (disease extent and PS), the survival advantage for GEM-CAP remains (HR: 0.77; 95% CI: 0.63-0.95; p = 0.014). The objective response rates were 7% (0CR, 19PRs) and 14% (3CRs, 35 PRs) in GEM and GEM-CAP respectively (p = 0.008).
There was a significant improvement in overall survival by the addition of capecitabine to gemcitabine and is the new standard of treatment.© 2005 Lippincott Williams & Wilkins, Inc.