Data presented at the 13th European Conference (ECCO) revealed that using the combination of gemcitabine and capecitabine increased overall survival in some patients.
Between May 2003 and January 2005, 533 patients
with previously untreated or cytological proven locally advanced metastatic carcinoma
of the pancreas were randomized to receive either gemcitabine treatment alone, or gemcitabine and capecitabine treatment. Treatment continued until the disease progressed or the side effects/toxicity effects became intolerable. The primary outcome was survival.
At the time of the interim analysis in May 2005, the median survival for gemcitabine alone and gemcitabine and capecitabine was 6 months and 7.4 months respectively but 1-year survival rates were 19% and 26% respectively. The investigators concluded there was a significant improvement in overall survival by the addition of capecitabine to gemcitabine over gemcitabine alone in advanced pancreatic cancer with acceptable levels of toxicity.
However another study, presented at the 41 st American Society of Cincal Oncology Meeting did not have the same result. The addition of capecitabine (Xeloda) to gemcitabine (Gemzar) failed to produce a significant survival advantage compared with gemcitabine alone in patients with advanced pancreatic cancer, according to results of a phase III study by the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative Oncology Group (CECOG). However, the combination did produce a significant improvement in those patients who had a good performance status at baseline. The NCCN has added this regimen to its recommended list.
J. J. Knox, D. Hedley, A. Oza, R. Feld, L. L. Siu, E. Chen, M. Nematollahi, G. R. Pond, J. Zhang, and M. J. MooreCombining Gemcitabine and Capecitabine in Patients With Advanced Biliary Cancer: A Phase II TrialJ. Clin. Oncol., April 1, 2005; 23(10): 2332 – 2338.
G. P. Stathopoulos, K. Syrigos, A. Polyzos, G. Fountzilas, S. K. Rigatos, N. Ziras, A. Potamiannou, I. Tsiakopoulos, N. Androulakis, G. Aravantinos, A. Athanasiadis, P. Papakotoulas, and V. GeorgouliasFront-line treatment of inoperable or metastatic pancreatic cancer with gemcitabine and capecitabine: an intergroup, multicenter, phase II studyAnn. Onc., February 1, 2004; 15(2): 224 – 229.