A phase II randomized trial of docetaxel weekly or every 3 weeks in elderly and/or poor performance status (PS) patients (pts) with advanced non-small cell lung cancer (NSCLC)

7057 Background: Docetaxel has been used in elderly and PS 2 pts with advanced NSCLC with acceptable toxicity. However, myelosuppression can be severe on the every 3-week schedule. Docetaxel weekly appears to have similar efficacy and less hematologic toxicity. Practice varies widely and no comparative study has yet been completed in the US. Methods: Randomized phase II trial of docetaxel 75mg/m2 d1 q.3 wks (arm A) versus docetaxel 30 mg/m2 d1,8,15 q. 28 days (arm B) in chemo-naive, elderly (=70) and/or PS 2 patients with advanced NSCLC. Overall toxicity is the primary endpoint; response, survival, and quality of life are also evaluated. Results: 96 patients have been enrolled; 54 elderly and 42 PS 2; 30 pts are both elderly and PS 2; 22% are =80; M/F: 54/42; 85% stage IV. 65 pts are evaluable for toxicity and 55 for response and survival. Gr 3–4 ANC was 30% in arm A and 3% in arm B. One episode of febrile neutropenia was observed in arm A. Gr 3–4 non-heme toxicities (arm A vs. B): fatigue (12% vs 6%), N/...