Palliative treatment for advanced gastrointestinal cancer: is response a suitable end-point?

Treatment results of standard chemotherapy in advanced gastrointestinal tract cancer are disappointing. 5-Fluorouracil (FU) is the therapeutic mainstay since its discovery more than 35 years ago. Response rates of single agent FU treatment range between 5 and 20% dependent on dose and schedule. The efforts of the last two decades have been focused on the improvement of objective response rates using several combinations of chemotherapy regimens including doxorubicin, cisplatin, mitomycin and etoposide. Most of the phase l/II studies have reported encouraging treatment results initially with respect to response rates. Subsequent randomized trials, however, revealed a high rate of World Healt…