title: Late phase II clinical study of vinorelbine monotherapy in advanced or recurrent breast cancer previously treated with anthracyclines and taxanes.
abstract: BACKGROUND
  At present, it is one of the most important issues for the treatment of breast cancer to develop the standard therapy for patients previously treated with anthracyclines and taxanes. With the objective of determining the usefulness of vinorelbine monotherapy in patients with advanced or recurrent breast cancer after standard therapy, we evaluated the efficacy and safety of vinorelbine in patients previously treated with anthracyclines and taxanes.
  
  
  METHODS
  Vinorelbine was administered at a dose level of 25 mg/m(2) intravenously on days 1 and 8 of a 3 week cycle. Patients were given three or more cycles in the absence of tumor progression. A maximum of nine cycles were administered.
  
  
  RESULTS
  The response rate in 50 evaluable patients was 20.0% (10 out of 50; 95% confidence interval, 10.0-33.7%). Responders plus those who had minor response (MR) or no change (NC) accounted for 58.0% [10 partial responses (PRs) + one MR + 18 NCs out of 50]. The Kaplan-Meier estimate (50% point) of time to progression (TTP) was 115.0 days. The response rate in the visceral organs was 17.3% (nine PRs out of 52). The major toxicity was myelosuppression, which was reversible and did not require discontinuation of treatment.
  
  
  CONCLUSIONS
  The results of this study show that vinorelbine monotherapy is useful in patients with advanced or recurrent breast cancer previously exposed to both anthracyclines and taxanes.
authors.affiliation: Department of Clinical Trials and Research, Tokyo Metropolitan Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8687 Japan. maktoi77@wa2.so-net.ne.jp
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Saeki
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
authors.forename: Muneaki
authors.initials: M
authors.lastname: Sano
authors.forename: Kiyohiko
authors.initials: K
authors.lastname: Hatake
authors.forename: Taro
authors.initials: T
authors.lastname: Asaga
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.forename: Shoshu
authors.initials: S
authors.lastname: Mitsuyama
authors.forename: Morihiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Motoshi
authors.initials: M
authors.lastname: Tamura
authors.forename: Toshio
authors.initials: T
authors.lastname: Tabei
authors.forename: Eisei
authors.initials: E
authors.lastname: Shin
authors.forename: Reiki
authors.initials: R
authors.lastname: Nishimura
authors.forename: Shinji
authors.initials: S
authors.lastname: Ohno
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000556:secondary; D008207:Lymphatic Metastasis; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D012074:Remission Induction; D043823:Taxoids / Q000008:administration & dosage; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D018943:Anthracyclines; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D014747:Vinblastine; D000077235:Vinorelbine