Introduction: The poor prognosis of non small cell lung cancer (NSCLC), as well as the significant toxicity from many conventional cytotoxic regimens warrants the investigation of combinations of new active agents for treatment. This is a phase I-II (dose-finding, efficacy, and toxicity) study of docetaxel + gemcitabine in patients with stage IIIB-IV NSCLC without prior systemic therapy. Patients were treated in cohorts of 3 with alternating increasing doses of docetaxel and gemcitabine at each level. Patients: Fifty patients were entered, of which 49 were eligible including 28 males and 21 females; 15 stage IIIB and 34 stage IV; median age 57 yrs (35-74). Results: The Maximum Tolerated Dose (MTD) was docetaxel 60 mg/m(2) day 1 and gemcitabine 750 mg/m(2) d1 & 8, every 21 days. The overall response rate is 20%. Eight patients are not formally assessable for response due to early discontinuation or loss to follow-up and are considered to have progressive disease. The median time to progression (TTP) is 3.5 months (1-25), with 11 pts with at least 7 months TTP. There were 10 pts ( 20%) with a partial response (PR); 18 (37%) maintained stable disease; 21 (43%) had progressive disease (PD) or were not assessable. Toxicity: Forty-nine patients are evaluable for assessment for toxicity: Grade (Gr) 3/4 toxicity was documented thus: 14 with neutropenia, 1 with anemia, 1 with nausea, 2 liver function, 2 dyspnea, 2 fatigue, 1 allergy, 1 neurologic. Conclusion: This regimen is well tolerated and results in phase I-II testing in this patient population warrant further consideration of the study of docetaxel + gemcitabine for advanced NSCLC.
