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 | |
| Publication status | Published - Mar 2004 |
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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 journal › Article
}
TY - JOUR
T1 - 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
AU - O'Brien, Mary E R
AU - Wigler, N.
AU - Inbar, M.
AU - Rosso, R.
AU - Grischke, E.
AU - Santoro, A.
AU - Catane, R.
AU - Kieback, D. G.
AU - Tomczak, P.
AU - Ackland, S. P.
AU - Orlandi, F.
AU - Mellars, L.
AU - Alland, L.
AU - Tendler, C.
PY - 2004/3
Y1 - 2004/3
N2 - 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
AB - 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
KW - Cardiotoxicity
KW - Pegylated liposomal doxorubicin
UR - http://www.scopus.com/inward/record.url?scp=11144357506&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=11144357506&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdh097
DO - 10.1093/annonc/mdh097
M3 - Article
C2 - 14998846
AN - SCOPUS:11144357506
VL - 15
SP - 440
EP - 449
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 3
ER -