Many head and neck and esophageal cancers are diagnosed in patients over 65 years old, but limited data are available on the tolerance of elderly patients to chemotherapy protocols designed for adults. We therefore retrospectively evaluated tolerance of cisplatin (100 mg/m(2) day 1) plus fluorouracil (1,000 mg/m(2)/day as a 120 h infusion) in a group of patients over 65 years of age with squamous cell carcinoma (n=20, group A) and compared it with a second group of younger patients (n=20, group B). Baseline patient characteristics were well balanced between the 2 groups. The median age was 69 years (range, 66-76) in group A and 47 years (range, 19-61) in group B. A total of 54 cycles (range, 1-6) and 65 cycles (range, 1-7) were delivered respectively in group A and B. Dose reductions were required in 9% (group A) and in 10% (group B) of the cycles. No toxic death was recorded in either group. No statistical difference in hematological toxicity was observed between the 2 groups of patients. Although the incidence of grade 1-2 renal toxicity was higher in elderly patients (5 vs 1), the difference was not significant (p=0.09). A similar incidence of mucositis (25%), nausea/vomiting (40%) and diarrhea (5%) was observed for each group. In conclusion, selected elderly patients with good performance status and adequate organ function can be safely treated with CDDP and FU without significantly increased toxicity.

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