European Journal of Cancer
Volume 39, Issue 13 , Pages 1866-1871, September 2003

Phase II trial of pegylated-liposomal doxorubicin in the treatment of locally advanced unresectable or metastatic transitional cell carcinoma of the urothelial tract

  • E. Winquist

      Affiliations

    • Division of Medical Oncology, 790 Commissioners Road East, London, Ontario, Canada N6A 4L6
    • Corresponding Author InformationCorresponding author. Tel.: +1-519-685-8600; fax: +1-519-685-8624
    • ,
  • D.S. Ernst

      Affiliations

    • Department of Medical Oncology, Tom Baker Cancer Centre, Calgary, Alberta, Canada
    • ,
  • D. Jonker

      Affiliations

    • Division of Medical Oncology, 790 Commissioners Road East, London, Ontario, Canada N6A 4L6
    • ,
  • M.J. Moore

      Affiliations

    • Department of Medical Oncology, Princess Margaret Hospital, Toronto, Canada
    • ,
  • R. Segal

      Affiliations

    • Department of Medical Oncology, Ottawa Regional Cancer Centre, Ottawa, Canada
    • ,
  • G. Lockwood

      Affiliations

    • Department of Biostatistics, Princess Margaret Hospital, Toronto, Canada
    • ,
  • A. Rodgers

      Affiliations

    • Schering Canada Inc, Pointe-Claire, Quebec, Canada

Received 12 December 2002; received in revised form 31 January 2003; accepted 4 April 2003.

Abstract 

34 patients with advanced unresectable or metastatic urothelial carcinoma who had not received prior chemotherapy for metastatic disease were treated with pegylated-liposomal doxorubicin (PLD) 50 mg/m2 by a 1-h intravenous infusion (i.v.) every 4 weeks in a multi-institutional phase II trial. 6 of 30 evaluable patients had a partial response to treatment (20%; 95% Confidence Interval (CI), 8–39%) and seven patients had stable disease. Toxicities were primarily non-haematological, but severe palmar-plantar erythrodysesthesia (PPE), lethargy and anorexia were infrequent. Despite a high proportion of patients with poor prognostic features, PLD had clinically significant activity in urothelial cancer in this study. The activity and unique toxicity profile of this drug make it of interest for further study in advanced urothelials cancers in combination with other active agents.

Keywords:  Bladder neoplasms, Urological neoplasms, Doxorubicin, Liposomes, Drug therapy

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PII: S0959-8049(03)00358-7

doi:10.1016/S0959-8049(03)00358-7

European Journal of Cancer
Volume 39, Issue 13 , Pages 1866-1871, September 2003

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