Pulmonary toxicity in patients treated with gemcitabine plus vinorelbine or docetaxel for advanced non-small cell lung cancer: outcome data on a randomized phase II study

Studies with the gemcitabine/vinorelbine (GV) or the gemcitabine/docetaxel (GD) combinations have shown similar efficacy and less toxicity compared to platinum-based chemotherapies, in patients with advanced non-small-cell lung cancer (NSCLC). The present trial was designed to test the efficacy and safety of both, GV and GD, combinations. Chemotherapy-naïve patients (n = 39) ≤75 years of age, KPS ≥ 60% and adequate hematological, renal and hepatic function were randomly assigned to receive G 1,000 mg/m² + either V 25 mg/m² or D 35 mg/m² (all of which were administered i.v.) on days 1 and 8 every 21 days. Baseline characteristics were comparable in GV (n = 20) and GD (n = 19) groups. Results indicated objective response of 7 (35%) vs 6 (31%) patients and median time-to-treatment failure of 120 versus 90 days in the GV and GD arms, respectively. The most common non-hematological toxicities were (GV vs GD): grade 2–4 pulmonary toxicity in 1 (5%) vs 7 (37%); grade 2–3 diarrhea 0 versus 4 (21%) and edema 1 (5%) vs 3 (16%); grade 3–4 hematological toxicities occurred in 3 (15%) vs 1 (5%) patients. Our results indicate that the combination of gemcitabine/docetaxel does not have a favorable safety profile with this schedule of administration, particularly in terms of pulmonary toxicity.