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Gemcitabine is used as standard therapy for the treatment of advanced pancreatic cancer. Compared to 5-FU gemcitabine offers certain advantages, especially with regard to symptom control and quality of life. As to objective response the superiority of gemcitabine is rather small, suggesting that a combination therapy might be
the strategy of choice in order to enhance efficacy. Based on preclinical studies it seems promising to combine gemcitabine with the oral 5-FU prodrug capecitabine, thus taking advantage of different mechanisms of action. A clinical trial of R. Herrmann et al. (ASCO 2000, A 1038) has shown that this concept could lead to exciting results. In a phase I study 26 chemonaive patients with metastatic pancreatic cancer have been included. Gemcitabine was used in a fixed dose of 1.000 mg/m² (days 1 and 8) while capecitabine was administered in escalating dosages starting with 1.000 mg/m² (14 days) and increasing it to 1.300 (level 2) and 1.600 mg/m² (level 3). Dose limiting toxicities have been observed in 1/9 patients on level 1, 1/11 patients on level 2 and 2/6 patients on level 3. The most important side effects were myelotoxicity and stomatitis. 
Although the number of patients included so far is rather small, the
response rate of 33% (6/18 evaluable patients with at least 2 cycles) suggests that this combination therapy is very effective and deserves
further investigation in a larger population.

ASCO meeting, May 2000, New Orleans, USA