title: Phase II study of IV vinflunine in patients with chemotherapy naive metastatic malignant melanoma.
abstract: This phase II study evaluated vinflunine in chemotherapy naive patients with metastatic melanoma. Vinflunine was administered at 350 mg/m(2) every 3 weeks, but after 9 patients this was reduced to 320 mg/m(2) based on interim analyses of all phase II trials. A partial response was observed in 1 of the first 9 patients (11.1%) treated at 350 mg/m(2), which gives a 3.0% [95% confidence interval (CI): 0.08-15.8] response rate in 33 patients. No change was the best response in 13 patients (39.4%) with progressive disease in 16 (48.5%) and 3 were not evaluable for response. The time to response was 1.4 months and duration was 6 months. At 350 mg/m(2) grade 4 neutropaenia occurred in 3 patients (33.3%) and grade 3 in 2 patients (22.2%) while at 320 mg/m(2) grade 4 neutropaenia occurred in 6 patients (25%) and grade 3 in 3 patients (12.5%) with 2 episodes of grade 3 febrile neutropaenia. Two patients (8.3%) had grade 3 anaemia. These results do not show activity at this dose and schedule for vinflunine in patients with chemotherapy naive metastatic melanoma.
authors.affiliation: Royal Adelaide Hospital Cancer Centre, North Terrace, Adelaide, South Australia 5000, Australia. ian.olver@cancer.org.au
authors.forename: I N
authors.initials: IN
authors.lastname: Olver
authors.forename: M J
authors.initials: MJ
authors.lastname: Byrne
authors.forename: E
authors.initials: E
authors.lastname: Walpole
authors.forename: D
authors.initials: D
authors.lastname: Vorobiof
authors.forename: C
authors.initials: C
authors.lastname: Jacobs
authors.forename: K
authors.initials: K
authors.lastname: Maart
authors.forename: S
authors.initials: S
authors.lastname: Hewitt
authors.forename: G
authors.initials: G
authors.lastname: McAdam
authors.forename: J C
authors.initials: JC
authors.lastname: Pouget
authors.forename: M C
authors.initials: MC
authors.lastname: Pinel
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; C111217:vinflunine; D014747:Vinblastine