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document
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 . 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 < 0.001 ) . Overall survival 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 % versus 7 % ) , nausea ( 53 % versus 37 % ) , vomiting ( 31 % versus 19 % ) and neutropenia ( 10 % versus 4 % ) were more often associated with doxorubicin than PLD . Palmar-plantar erythrodysesthesia ( 48 % versus 2 % ) , stomatitis ( 22 % versus 15 % ) and mucositis ( 23 % versus 13 % ) were more often associated with PLD than doxorubicin . CONCLUSIONS In first-line therapy for MBC , PLD provides comparable efficacy to doxorubicin , with significantly reduced cardiotoxicity , myelosuppression , vomiting and alopecia .
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Intervention_Pharmacological
pegylated liposomal doxorubicin HCl ( CAELYX/Doxil )
16432
Intervention_Pharmacological
conventional doxorubicin
16433
Intervention_Pharmacological
CAELYX [ pegylated liposomal doxorubicin HCl ( PLD )
16434
Intervention_Pharmacological
doxorubicin
16435
Intervention_Pharmacological
PLD
16436
Intervention_Pharmacological
doxorubicin 60 mg/m2
16437
Intervention_Pharmacological
anthracycline
16438
Intervention_Pharmacological
PLD
16439
Intervention_Pharmacological
doxorubicin
16440
Intervention_Pharmacological
doxorubicin
16441
Intervention_Pharmacological
PLD
16442
Intervention_Pharmacological
PLD
16443
Intervention_Pharmacological
doxorubicin
16444
Intervention_Pharmacological
doxorubicin
16445
Intervention_Pharmacological
PLD
16446
Intervention_Pharmacological
PLD
16447
Intervention_Pharmacological
doxorubicin
16448
Intervention_Pharmacological
PLD
16449
Intervention_Pharmacological
doxorubicin
16450
Outcome_Mortality
progression-free survival ( PFS )
16451
Outcome_Adverse-effects
Cardiac event rates
16452
Outcome_Mortality
PFS
16453
Outcome_Adverse-effects
Overall risk of cardiotoxicity
16454
Outcome_Mortality
Overall survival
16455
Outcome_Adverse-effects
Alopecia
16456
Outcome_Adverse-effects
nausea
16457
Outcome_Adverse-effects
vomiting
16458
Outcome_Adverse-effects
neutropenia
16459
Outcome_Adverse-effects
Palmar-plantar erythrodysesthesia
16460
Outcome_Adverse-effects
stomatitis
16461
Outcome_Adverse-effects
mucositis
16462
Outcome_Adverse-effects
cardiotoxicity
16463
Outcome_Physical
myelosuppression
16464
Outcome_Adverse-effects
vomiting
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Outcome_Adverse-effects
alopecia
16466
Participant_Condition
metastatic breast cancer
16467
Participant_Condition
first-line treatment of women with metastatic breast cancer ( MBC ) .
16468
Participant_Sex
Women
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Participant_Condition
MBC and normal cardiac function