A phase II trial of weekly chemotherapy with paclitaxel plus gemcitabine as a first-line treatment in advanced non-small-cell lung cancer

The efficacy and toxicity of combined paclitaxel (PTX) and gemcitabine (GEM) was evaluated as a protocol for first-line chemotherapy in 40 patients with advanced non-small-cell lung cancer (NSCLC). Paclitaxel, 100 mg/m(2), was administered intravenously (IV) as a 1-h infusion, followed by GEM, 1,000 mg/m(2), IV over 30 min on days 1 and 8 of a 21-day cycle. The median age of patients was 66 years with a range of 33-75 years. Nearly all patients (39/40) had an ECOG performance status of 0 or 1. Thirteen patients (32%) had initial stage IIIB disease and 27 patients (68%) had stage IV disease. Histological subtypes were adenocarcinoma (73%) and squamous cell carcinoma (25%). Twenty-two patients (55%) achieved a partial response and none achieved a complete response, giving an overall response rate of 55% (95% confidence interval: 38.2-71.8%). Disease stability was achieved in 14 patients (35%), and 4 patients (10%) had progressive disease. The median survival time was 11.9 months (95% CI: 10.3-14 months), with a 1-year survival rate of 47.5%. Grade 3 or 4 hematological toxicities observed included neutropenia in 37.5%, anemia in 2.5%, and thrombocytopenia in 5.0% of these patients. Non-hematologic toxicities were mild, with the exception of grade 3 and 4 pneumonitis. There were no deaths due to toxicity. Weekly chemotherapy with PTX plus GEM is effective and is acceptable for the first line treatment of advanced NSCLC.