Vinorelbine in elderly patients with inoperable nonsmall cell lung carcinoma - A Phase II study

BACKGROUND. Cancer in the elderly is becoming a complex and frequent issue. At least 30% of lung carcinomas are expected to arise each year in elderly patients, who often have significant comorbidity. The most appropriate tre atment for this large portion of cancer patients remains unknown. The purpo se of this Phase II trial was to make a comprehensive evaluation of the act ivity, toxicity, and tolerability of single-agent vinorelbine in elderly an d relatively poorly performing patients with inoperable nonsmall cell lung carcinoma (NSCLC). METHODS. Patients age 70 years or older were eligible to participate in thi s trial if they had a pathologic diagnosis, a performance status lower than 4 (Eastern Cooperative Oncology Group [ECOG] scale), and gave informed con sent. Vinorelbine was given intravenously (i.v.) at a dose of 25 mg/m(2) ev ery week until progression, persistent toxicity, or refusal. RESULTS. Forty-six patients entered the study; their median age was 75 year s (range, 70-83 years). Five patients never started on vinorelbine; 27 othe rs had early treatment suspensions. The median number of weekly infusions w as 5 (range, 0-28); the median dose intensity was 70% of projected. Toxicit y was generally mild, mainly hematologic, and never life-threatening. ECOG performance status, body weight, and almost all the scores from the quality -of-life questionnaires remained constant during the first 6 weeks of treat ment. Two patients obtained partial response, 10 patients had some tumor re gression, and 26 had tumor stabilization. The estimated median time to prog ression was 19 weeks (quartile range, 11-23 weeks), and the median survival 34 weeks (quartile range, 16-63 weeks). CONCLUSIONS. In our group of patients who had poor prognoses, vinorelbine w as well tolerated, moderately active, and capable of ensuring relatively lo ng survival. It may represent a valuable therapeutic option for the treatme nt of nonresectable NSCLC in elderly patients. (C) 2000 American Cancer Soc iety.