<p>Objective Vinorelbine combined with carboplatin is one of the recommended first-line chemotherapy regimens in advanced non-small cell lung cancer (NSCLC). Vinorelbine, traditionally administered intravenously, is also available for oral administration. However, more information regarding the efficacy of oral versus intravenous therapy is desirable. The Norwegian Lung Cancer Study Group (NLCG) conducted three first-line NSCLC trials between 2000 and 2009, which included 590 patients who received three cycles of carboplatin and vinorelbine. Two trials administered intravenous vinorelbine, and one trial administered oral vinorelbine. The aim of the current study was to compare outcomes between oral and intravenous vinorelbine in combination with carboplatin as the first-line treatment in advanced NSCLC. Materials and methods We retrospectively compared the survival, HRQoL and haematological toxicity between oral and intravenous vinorelbine using individual data from three trials. Eligible patients received a maximum of three 21-day cycles with intravenous carboplatin on day 1 and vinorelbine on day 1 and day 8, at doses of either 60 mg/m
² orally or 25 mg/m
² intravenously. Results and conclusion In total, 222 and 368 patients received oral or intravenous vinorelbine, respectively. The overall survival (7.0 vs. 6.9 months), chemotherapy compliance, HRQoL outcomes and toxicity were similar, although oral patients reported less worsening of constipation and had fewer adverse events of grade III–IV leukopenia and anaemia. Oral 60 mg/m² vinorelbine and intravenous 25 mg/m² provided similar survival outcomes. HRQoL outcomes were similar or in favour of oral vinorelbine. Oral vinorelbine caused less haematological toxicity. Microabstract The study compares the effects of oral to intravenous vinorelbine both combined with carboplatin in advanced NSCLC. We used data from 590 patients in three previous randomized controlled trials. Survival and overall HRQoL were similar. Use of oral vinorelbine was associated with less haematological toxicity and patient reported constipation.
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