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

Lung Cancer. 2008 Sep;61(3):378-84. doi: 10.1016/j.lungcan.2008.01.011. Epub 2008 Mar 3.


We 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/m(2) day 1) plus vinorelbine (25mg/m(2) 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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Disease Progression
  • Disease-Free Survival
  • Female
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Mitomycin / administration & dosage
  • Prospective Studies
  • Salvage Therapy
  • Taxoids / administration & dosage
  • Treatment Outcome
  • Vinblastine / administration & dosage
  • Vinblastine / analogs & derivatives
  • Vinorelbine


  • Taxoids
  • Mitomycin
  • Vinblastine
  • Vinorelbine