title: Mitomycin plus vinorelbine salvage chemotherapy in non-small cell lung cancer: a prospective study.
abstract: 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.
authors.affiliation: Department of Intensive Care Unit and Thoracic Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Berghmans
authors.forename: Delphine
authors.initials: D
authors.lastname: Gourcerol
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Lafitte
authors.forename: Katerina
authors.initials: K
authors.lastname: Kotsori
authors.forename: Marianne
authors.initials: M
authors.lastname: Paesmans
authors.forename: Arnaud
authors.initials: A
authors.lastname: Scherpereel
authors.forename: Nathalie
authors.initials: N
authors.lastname: Leclercq
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Sculier
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D011446:Prospective Studies; D016879:Salvage Therapy; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D016685:Mitomycin; D014747:Vinblastine; D000077235:Vinorelbine