Clinical benefit of gemcitabine-cisplatin in advanced non-small cell lung cancer elderly patients.

Background: Cisplatin-based chemotherapy seems to improve the control of non-small cell lung cancer (NSCLC)-related symptoms, but assessment of symptomatic gain in these patients is often difficult. This study was designed to test a method for the assessment of clinical benefit in elderly advanced NSCLC patients, after weekly cisplatin-gemcitabine chemotherapy. Patients and Methods: Evaluation of clinical benefit was the primary end-point. Clinical benefit derived from the evaluation of eight parameters: PS, cough, dyspnea, pain and hemoptysis were considered primary parameters. Weight loss, asthenia and anorexia were secondary parameters. Results: Twenty-nine patients aged > 65 years, symptomatic at study entry, were enrolled. Responses were calculated according to the intent-to treat principle. Fifteen patients were considered as clinical benefit responders for an overall clinical benefit response rate of 52% (95% C.I. = 33.5% to 70%). The median duration of clinical benefit was 9 months (range 2-36). Tumour objective responses, according to WHO criteria, were 14, for an overall response rate of 48% (95% C.I = 3 1% to 65%). Ten patients (34%) obtained both clinical benefit and tumour response. The median survival-time was 10 months (range 1-36). Chemotherapy was well-tolerated with low incidence of WHO grade III-IV toxicities. Conclusion: Evaluation of clinical benefit in advanced, symptomatic, elderly NSCLC patients is feasible and could be used together with tumor response and quality of life questionnaires to assess the efficacy of chemotherapy. It could reasonably be extended to non-elderly NSCLC patients. Our results suggest that weekly cisplatin-gemcitabine seems to be able to improve the principal NSCLC-related symptoms in elderly patients.