Paclitaxel and vinorelbine combination in advanced inoperable adenocarcinoma of the lung: a phase II study.

Background: The purpose of this study was to determine the efficacy of paclitaxel (PCT) combined with vinorelbine (VRL) in adenocarcinoma of the lung.

Patients And Methods: Untreated inoperable patients with metastatic disease were enrolled and underwent front-line treatment with a new combination as follows: a 30-minute infusion of VRL at a dose of 25 mg/m2 followed by a 3-hour infusion of PCT 135 mg/m2. Chemotherapy was repeated every 2 weeks with the intention of administering 9 cycles.

Results: Fifty-four out of 58 enrolled patients were assessable; the median age was 63 years (range 48-81). All patients were chemotherapy-naïve and all had histologically- or cytologically- confirmed adenocarcinoma. Twenty-seven patients (50%) responded: 5 with complete response (9.3%) and 22 with partial response (40.7%); 17 patients had stable disease (31.5%) and 10 showed disease progression (18.5%). Median response duration was 6 months (range 2-14.5) and median survival was 10 months (range 2-35+). The main adverse reaction was myelotoxicity in 87% of the patients, of whom only 8 (14.8%) had grade 4 neutropenia which in 4 cases (7.4%) was febrile. No patient required dose reduction, but treatment was postponed by one week in 4 patients a total of nine times. Patients received 98.6% of the planned dose.

Conclusion: The PCT and VRL combination is an active first-line treatment for lung adenocarcinoma. These two cytotoxic drugs produce acceptable toxicity when repeated every 2 weeks.