Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer

Mary E R O'Brien, N. Wigler, M. Inbar, R. Rosso, E. Grischke, A. Santoro, R. Catane, D. G. Kieback, P. Tomczak, S. P. Ackland, F. Orlandi, L. Mellars, L. Alland, C. Tendler

Research output: Contribution to journalArticle

Abstract

Background: This study was designed to demonstrate that efficacy [progression-free survival (PFS)] of CAELYX™ [pegylated liposomal doxorubicin HCl (PLD)] is non-inferior to doxorubicin with significantly less cardiotoxicity in first-line treatment of women with metastatic breast cancer (MBC). Patients and methods: Women (n = 509) with MBC and normal cardiac function were randomized to receive either PLD 50 mg/m2 (every 4 weeks) or doxorubicin 60 mg/m2 (every 3 weeks). Cardiac event rates were based on reductions in left ventricular ejection fraction as a function of cumulative anthracycline dose. Results: PLD and doxorubicin were comparable with respect to PFS [6.9 versus 7.8 months, respectively; hazard ratio (HR) = 1.00; 95% confidence interval (CI) 0.82-1.22]. Subgroup results were consistent. Overall risk of cardiotoxicity was significantly higher with doxorubicin than PLD (HR = 3.16; 95%CI 1.58-6.31; P

Original languageEnglish
Pages (from-to)440-449
Number of pages10
JournalAnnals of Oncology
Volume15
Issue number3
DOIs
Publication statusPublished - Mar 2004

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Doxorubicin
Breast Neoplasms
Disease-Free Survival
Confidence Intervals
Anthracyclines
Therapeutics
Stroke Volume
liposomal doxorubicin
Cardiotoxicity

Keywords

  • Cardiotoxicity
  • Pegylated liposomal doxorubicin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. / O'Brien, Mary E R; Wigler, N.; Inbar, M.; Rosso, R.; Grischke, E.; Santoro, A.; Catane, R.; Kieback, D. G.; Tomczak, P.; Ackland, S. P.; Orlandi, F.; Mellars, L.; Alland, L.; Tendler, C.

In: Annals of Oncology, Vol. 15, No. 3, 03.2004, p. 440-449.

Research output: Contribution to journalArticle

O'Brien, MER, Wigler, N, Inbar, M, Rosso, R, Grischke, E, Santoro, A, Catane, R, Kieback, DG, Tomczak, P, Ackland, SP, Orlandi, F, Mellars, L, Alland, L & Tendler, C 2004, 'Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer', Annals of Oncology, vol. 15, no. 3, pp. 440-449. https://doi.org/10.1093/annonc/mdh097
O'Brien, Mary E R ; Wigler, N. ; Inbar, M. ; Rosso, R. ; Grischke, E. ; Santoro, A. ; Catane, R. ; Kieback, D. G. ; Tomczak, P. ; Ackland, S. P. ; Orlandi, F. ; Mellars, L. ; Alland, L. ; Tendler, C. / Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. In: Annals of Oncology. 2004 ; Vol. 15, No. 3. pp. 440-449.
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