Mitomycin plus vinorelbine salvage chemotherapy in non-small cell lung cancer: A prospective study

SummaryWe aimed to evaluate, in a phase II study, the efficacy of the mitomycin–vinorelbine combination in non-small cell lung cancer (NSCLC) patients, relapsing after taxane-based regimens, a situation in which no standard chemotherapy is currently available. Patients with NSCLC progressing or relapsing after taxane therapy, with a Karnofsky performance status 50–100, and without clinical or biological contra-indications, were given mitomycin (8 mg/m2 day 1) plus vinorelbine (25 mg/m2 days 1 and 8) every 3 weeks. Responses were assessed every three cycles. Sixty-five eligible patients were registered between December 2000 and December 2005. Taxanes and cisplatin were previously administered in 100% and 88% of the patients, respectively. All but four received at least two previous chemotherapy regimens. Two hundred and twenty-two cycles of chemotherapy were administered. The main grade 3–4 toxicity was leucopenia, in 47% of the patients. Among 60 assessable patients, response rate was 10% (95% confidence interval [CI]: 4–21). Median progression-free survival (PFS) was 9.7 weeks (95% CI: 8.4–11.1) and median survival (MST) was 28.4 weeks (95% CI: 23.0–34.8). Patients always progressing on all chemotherapy regimens administered before mitomycin–vinorelbine (primary failures) had shorter median PFS (8.1 weeks) than those having at least once partial response (PR) or no change (NC) (secondary failures) (10.4 weeks) (p = 0.02). Respective MST were 23.7 weeks and 29.3 weeks (p = 0.16). In conclusion, mitomycin–vinorelbine combination is a moderately active regimen in heavily pre-treated patients with NSCLC relapsing or progressing after taxanes and platinum-based chemotherapy. Its toxicity is limited.