Docetaxel plus fractionated cisplatin is a safe and active schedule as first-line treatment of patients with advanced non-small cell lung cancer: Results of a phase II study

Byline: Jose Luis Firvida (1), Margarita Amenedo (2), Ruben Rodriguez (1), Ana Gonzalez (2), Mercedes Salgado (1), Manuel Ramos (2), Gustavo Losada (2) Keywords: docetaxel; fractionated cisplatin; non-small cell lung cancer Abstract: This phase II trial evaluated the efficacy and safety of docetaxel 85 mg/m.sup.2 (day 1) and cisplatin 80 mg/m.sup.2 (administered as 40 mg/m.sup.2 doses each on days 1 and 2) every 3 weeks as first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). Forty-two NSCLC patients were enrolled, most of them with stage IV disease (74%). A total of 195 chemotherapy cycles were administered (median 6, range 1--6). All patients were considered evaluable for efficacy and toxicity in an intention-to-treat (ITT) analysis. The overall response rate was 48% (95% CI, 33--64), including one CR (3%) and 19 PRs (45%). Stable disease was found in 6 patients (14%). The median time to disease progression was 4.9 months (95% CI, 4.0--5.7) and the median overall survival was 10.5 months (95% CI, 5.1--16.0). The survival rates at 1 and 2 years were 36.0% (95% CI, 19.9--52.0) and 18.0% (95% CI, 3.9--32.1), respectively. Overall, the combination showed an excellent safety profile. Severe hematological toxicities were uncommon: neutropenia (5% of patients, 1% of cycles) and febrile neutropenia (2% of patients, 0.5% of cycles). Asthenia (12%) was the only grade 3/4 non-hematological toxicity that affected more than 10% of patients. There were no toxic deaths. In conclusion, docetaxel plus fractionated cisplatin as first-line treatment of advanced NSCLC patients showed similar efficacy as the same combination with higher doses of docetaxel but where cisplatin was administered in a single dose. This new schedule shows promise in its excellent hematological and non-hematological toxicity profile. A randomized phase III trial is needed to confirm these results. Author Affiliation: (1) Complejo Hospitalario de Ourense, Ourense, Spain (2) Centro Oncologico de Galicia, A Coruna, Spain Article History: Registration Date: 02/10/2004