Gemcitabine, a novel anticancer agent, was demonstrated to be well tolerated in both elderly and younger patients. Safety data were collected from 18 completed clinical studies (790 patients) in a variety of solid tumor types. All studies used a starting dose of 800-1250 mg/m2 administered once a week for 3 weeks followed by a week of rest. Patients were initially divided using a cut-off age of 65 years, and subsequently using a cut-off age of 70 years. Gemcitabine was well tolerated by patients of all ages, with few clinically meaningful differences between the age groups. Gemcitabine was also found to be as efficacious in older patients as in younger ones. Efficacy data was collected from four studies (329 evaluable patients) in non-small cell lung cancer with consistent response rates of 20%. When patients were divided into two groups, those aged below 70 years and those 70 years and above, the response rates were 19.0% (95% C.I., 14.6-23.4) and 25.0% (95% C.I., 10.0-40.0) respectively. In conclusion, elderly patients should benefit from gemcitabine treatment.