Advanced non-small cell lung cancer in the elderly: effective and well tolerated weekly gemcitabine and cisplatin regimen. A pilot study.

BACKGROUND: The frequency of advanced non-small cell lung cancer (NSCLC) increases with age and more effective and less toxic chemotherapy schedules are needed in elderly patients. Cisplatin-based regimens are considered the best treatment for advanced NSCLC, although they produce only a modest advantage in overall survival with considerable toxicity.METHODS: In the present study the activity and toxicity of a weekly gemcitabine and cisplatin schedule was evaluated in a small group of advanced NSCLC patients aged 68 years or more. Treatment consisted of gemcitabine 1000 mg/m2 i.v. and cisplatin 35 mg/m2 i.v., both given weekly on days 1, 8, 15 followed by 1 week of rest.RESULTS: Fifteen previously untreated patients entered the study; their median age was 72 years (range 68-76). One hundred and sixteen weekly administrations were delivered. The median dose-intensity was 614.5 mg/m2 per week for gemcitabine (82%) and 21 mg/m2 per week for cisplatin (80%). All the 15 patients were evaluable for response and toxicity. The overall response rate was 40% [95% CI = 16-68%]. The main toxicity was WHO grade III-IV thrombocytopenia that was recorded in 6 patients (40%). Other major toxicities were very low and no treatment-related deaths were reported.CONCLUSIONS: This schedule appears to be active, to have a favourable toxicity profile and can be considered in advanced NSCLC elderly patients. Of interest, the patients enrolled received high dose intensities of both drugs