FU chemoradiotherapy continues to play an important role in the management of many cancer sites. During the last four decades, optimal dosing schedules have produced a therapeutic gain. The introduction of oral prodrug analogs will likely further improve the results of FU therapy in several organ systems, such as the rectum, head and neck, and esophagus.
Cancers of the esophagus, stomach, and pancreas have been successfully treated recently with combinations of radiosensitizing chemotherapy and irradiation. New approaches building onto 5-fluorouracil chemoradiation include capecitabine (Xeloda) and irradiation. Capecitabine is an oral 5-fluorouracil (5-FU) prodrug that is more convenient than using infusional 5-FU, appears to have a similar therapeutic profile, and can be combined with daily irradiation. The addition of a cyclooxygenase-2 (COX-2) inhibitor is being investigated in upper gastrointestinal cancer sites because there is a high degree of overexpression of COX-2 in these cancers.
Background: Responses have been observed in several studies of docetaxel as treatment for advanced pancreatic carcinoma. This trial was designed to determine if the addition of docetaxel to gemcitabine therapy produced responses in ≧25% of patients with chemonaive advanced pancreatic cancer. Patients and Methods: This trial involved patients with biopsy-proven, advanced carcinoma of the pancreas not amenable to surgical resection. Patients received docetaxel 75 mg/m2 i.v. over 1 h followed by gemcitabine 2,000 mg/m2 biweekly until progression or intolerable toxicity. The primary endpoint of the trial was to determine the objective response rate with secondary endpoints of progression-free survival and overall survival. Results: Out of the 32 eligible patients, 2 patients had a complete response and 2 patients had a partial response for an observed objective response rate of 12.5% (90% CI: 4.4, 26.4%). Median survival was 4.7 months. Most toxicities were hematologic, with 48% of patients experiencing grade 4 toxicity. Conclusions: The confirmed complete response rate of 6% and partial response rate of 6% is encouraging, but the toxicity of this regimen appears significant. Based upon these results, this combination of gemcitabine and docetaxel is not worthy of further study. Different schedules and dosages may be more promising.
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