title: Phase II trial of dolastatin-10 in patients with advanced breast cancer.
abstract: OBJECTIVE
  Phase II multicenter cooperative group study investigated the efficacy and toxicity of the novel anti-microtubule agent dolastatin-10 in patients with advanced breast cancer.
  
  
  METHODS
  Twenty-one patients with measurable metastatic breast cancer were treated with dolastatin-10 at a dose of 400 mcg/m2 by intravenous bolus once every 3 weeks. Patients must have received a total of 1 or 2 prior chemotherapy regimens and have an Eastern Cooperative Oncology Group performance status of 0-2. Patients received this treatment as either a first (n = 11) or second-line (n = 10) chemotherapy for metastatic disease. Eighteen patients (86%) had received a prior anthracycline. The National Cancer Institute provided the dolastatin-10.
  
  
  RESULTS
  One out of 21 patients (5%; 95% CI: 0-24%) achieved a partial remission for a duration of 113 days. Four patients maintained stable disease for a median of 87 days. A total of 58 courses of dolastatin-10 were administered. Patients received a median of two cycles of dolastatin-10. Hematologic toxicity was moderate, with 8 patients developing grade 4 neutropenia, and 5 with grade 3 neutropenia; one grade 3 febrile neutropenia was observed. These episodes of grade 3 and 4 neutropenia were experienced on 36% of the treatment cycles. Non-hematologic toxicity was uncommon.
  
  
  CONCLUSIONS
  While the toxicity profile of dolastatin-10 was acceptable, it had minimal activity in this advanced breast cancer study. We are not pursuing further clinical trials of this agent in the setting of advanced breast cancer.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. perez.edith@mayo.edu
authors.forename: Edith A
authors.initials: EA
authors.lastname: Perez
authors.forename: David W
authors.initials: DW
authors.lastname: Hillman
authors.forename: Paul A
authors.initials: PA
authors.lastname: Fishkin
authors.forename: James E
authors.initials: JE
authors.lastname: Krook
authors.forename: Winston W
authors.initials: WW
authors.lastname: Tan
authors.forename: Phillip A
authors.initials: PA
authors.lastname: Kuriakose
authors.forename: Steven R
authors.initials: SR
authors.lastname: Alberts
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D047630:Depsipeptides; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D047630:Depsipeptides; D009842:Oligopeptides; C064570:dolastatin 10