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

doi:10.1093/annonc/mdh097

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

Istituto Clinico Humanitas

Research output: Contribution to journal › Article › peer-review

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 language	English
Pages (from-to)	440-449
Number of pages	10
Journal	Annals of Oncology
Volume	15
Issue number	3
DOIs	https://doi.org/10.1093/annonc/mdh097
Publication status	Published - Mar 2004

Keywords

Cardiotoxicity
Pegylated liposomal doxorubicin

ASJC Scopus subject areas

Oncology
Cancer Research

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O'Brien, M. 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. (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, 15(3), 440-449. https://doi.org/10.1093/annonc/mdh097

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. et al.

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

Research output: Contribution to journal › Article › peer-review

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

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abstract = "Background: This study was designed to demonstrate that efficacy [progression-free survival (PFS)] of CAELYX{\texttrademark} [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 ",

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AU - Tomczak, P.

AU - Ackland, S. P.

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AU - Mellars, L.

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AU - Tendler, C.

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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

Abstract

Keywords

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