Lay Summary: Gemcitine is FDA approved by itself or with erlotinib for pancreatic cancer. Xeloda and gemcitabine is a promising new regimen but is still being debated.
In 2005 at ASCO there was a phase 3 trial that compared the combination of gemcitabine and capecitabine vs single-agent gemcitabine. This study, like so many other trials of cytotoxic doublets, failed to show an improvement in median survival with the combination. However, as in prior randomized phase 3 studies, they observed that patients who had a good performance status who received the cytotoxic doublet appeared to have a better survival. In a 2007 update, GemCap failed to improve OS at a statistically significant level compared with standard Gem treatment. The safety of GemCap and Gem was similar. In the subgroup of patients with good performance status, median OS was improved significantly. GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status.
In another study in 2002, patients with advanced pancreatic cancer treated with the combination had a median survival of 7.4 months, compared with six months for Gemzar alone.
There remains a significant debate on the utility of this regimen. However, with two non-inferior and somewhat effective randomized trials, it can resonably be expected to provide safety, effectiveness and a net benefical outcome. Please note that this conclusion applies only to the combination of gemcitabine and Xeloda and not to the different GTC regimen that aso icludes docetaxel.
Herrmann R, Bodoky G, Ruhstaller T, et al. Gemcitabine (G) plus capecitabine (C) versus G alone in locally advanced or metastatic pancreatic cancer. A randomized phase III study of the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative Oncology Group (CECOG). Proc Am Soc Clin Oncol. 2005;23:310s. Abstract LBA4010.
Cunningham D et al. Phase III randomised comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. ECCO 13, Abstract PS11, presented Nov. 2, 2005.
Richard Herrmann, György Bodoky, Thomas Ruhstaller, Bengt Glimelius, Emilio Bajetta, Johannes Schüller, Piercarlo Saletti, Jean Bauer, Arie Figer, Bernhard Pestalozzi, Claus-Henning Köhne, Walter Mingrone, Salomon M. Stemmer, Karin Tàmas, Gabriela V. Kornek, Dieter Koeberle, Susanne Cina, Jürg Bernhard, Daniel Dietrich, Werner Scheithauer
Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group Journal of Clinical Oncology, Vol 25, No 16 (June 1), 2007: pp. 2212-2217
S. Boeck and V. Heinemann
Second-Line Therapy in Gemcitabine-Pretreated Patients With Advanced Pancreatic Cancer
J. Clin. Oncol., March 1, 2008; 26(7): 1178 – 1179.