Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer.

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  • Additional Information
    • Source:
      Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print Cited Medium: Print ISSN: 0732-183X (Print) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE
    • Publication Information:
      Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology
      Original Publication: New York, N.Y. : Grune & Stratton, c1983-
    • Subject Terms:
      Breast Neoplasms/*drug therapy ; Bridged-Ring Compounds/*therapeutic use ; Doxorubicin/*therapeutic use ; Mitomycin/*therapeutic use ; Taxoids/*therapeutic use ; Vinblastine/*analogs & derivatives ; Vinblastine/*therapeutic use; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; Breast Neoplasms/pathology ; Doxorubicin/adverse effects ; Drug Resistance, Neoplasm ; Female ; Humans ; Liposomes ; Middle Aged ; Mitomycin/adverse effects ; Neoplasm Metastasis ; Salvage Therapy ; Vinblastine/adverse effects ; Vinorelbine
    • Abstract:
      Purpose: To compare the efficacy of pegylated liposomal doxorubicin (PLD) with that of a common salvage regimen (comparator) in patients with taxane-refractory advanced breast cancer.
      Patients and Methods: Following failure of a first- or second-line taxane-containing regimen for metastatic disease, 301 women were randomly assigned to receive PLD (50 mg/m(2) every 28 days); or comparator-vinorelbine (30 mg/m(2) weekly) or mitomycin C (10 mg/m(2) day 1 and every 28 days) plus vinblastine (5 mg/m(2) day 1, day 14, day 28, and day 42) every 6 to 8 weeks. Patients were stratified before random assignment based on number of previous chemotherapy regimens for metastatic disease and presence of bone metastases only.
      Results: Progression-free survival (PFS) and overall survival (OS) were similar for PLD and comparator (PFS: hazard ratio [HR], 1.26; 95% CI, 0.98 to 1.62; P =.11; median, 2.9 months [PLD] and 2.5 months [comparator]; OS: HR, 1.05; 95% CI, 0.82 to 1.33; P =.71; median, 11.0 months [PLD] and 9.0 months [comparator]). In anthracycline-naïve patients, PFS was somewhat longer with PLD, relative to the comparator (n = 44; median PFS, 5.8 v 2.1 months; HR, 2.40; 95% CI, 1.16 to 4.95; P =.01). Most frequently reported adverse events were nausea (23% to 31%), vomiting (17% to 20%), and fatigue (9% to 20%) and were similar among treatment groups. PLD-treated patients experienced more palmar-plantar erythrodysesthesia (37%; 18% grade 3, 1 patient grade 4) and stomatitis (22%; 5% grades 3/4). Neuropathy (11%), constipation (16%), and neutropenia (14%) were more common with vinorelbine. Alopecia was low in both the PLD and vinorelbine groups (3% and 5%).
      Conclusion: PLD has efficacy comparable to that of common salvage regimens in patients with taxane-refractory metastatic breast cancer, thereby representing a useful therapeutic option.
    • Comments:
      Comment in: J Clin Oncol. 2005 Sep 1;23(25):6260; author reply 6261. (PMID: 16135495)
    • Accession Number:
      0 (Bridged-Ring Compounds)
      0 (Liposomes)
      0 (Taxoids)
      1605-68-1 (taxane)
      50SG953SK6 (Mitomycin)
      5V9KLZ54CY (Vinblastine)
      80168379AG (Doxorubicin)
      Q6C979R91Y (Vinorelbine)
    • Publication Date:
      Date Created: 20041002 Date Completed: 20041022 Latest Revision: 20231024
    • Publication Date:
      20240829
    • Accession Number:
      10.1200/JCO.2004.08.157
    • Accession Number:
      15459210