Elsevier

Annals of Oncology

Volume 15, Issue 3, March 2004, Pages 440-449
Annals of Oncology

Original articles
Breast cancer
Reduced cardiotoxicity and comparable efficacy in a phase IIItrial of pegylated liposomal doxorubicin HCl(CAELYX™/Doxil®) versus conventional doxorubicin forfirst-line treatment of metastatic breast cancer

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ABSTRACT

Background

This study was designed todemonstrate that efficacy [progression-free survival (PFS)] ofCAELYX™ [pegylated liposomal doxorubicin HCl (PLD)] isnon-inferior to doxorubicin with significantly less cardiotoxicity infirst-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 eitherPLD 50 mg/m2 (every 4 weeks) or doxorubicin 60 mg/m2(every 3 weeks). Cardiac event rates were based on reductions in leftventricular ejection fraction as a function of cumulative anthracyclinedose.

Results

PLD and doxorubicin were comparable withrespect 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 wassignificantly higher with doxorubicin than PLD (HR = 3.16;95%CI 1.58–6.31; P <0.001). Overallsurvival was similar (21 and 22 months for PLD and doxorubicin,respectively; HR = 0.94; 95%CI 0.74–1.19). Alopecia(overall, 66% versus 20%; pronounced, 54% versus7%), nausea (53% versus 37%), vomiting (31%versus 19%) and neutropenia (10% versus 4%) were moreoften associated with doxorubicin than PLD. Palmar-plantarerythrodysesthesia (48% versus 2%), stomatitis (22%versus 15%) and mucositis (23% versus 13%) were moreoften associated with PLD thandoxorubicin.

Conclusions

In first-line therapy for MBC,PLD provides comparable efficacy to doxorubicin, with significantly reducedcardiotoxicity, myelosuppression, vomiting andalopecia.

Keywords

cardiotoxicity
pegylated liposomal doxorubicin

Cited by (0)

M. E. R. O’Brien and N. Wigler contributed equally to this work