64770
document
Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer . Three hundred twenty-five women with metastatic adenocarcinoma of the breast who had failed one prior chemotherapeutic regimen for advanced disease were randomized to receive 14 mg/m2 of mitoxantrone or 75 mg/m2 of doxorubicin intravenously ( IV ) every 3 weeks . Enrollment was closed on October 31 , 1984 , after 165 patients were randomized to mitoxantrone and 160 patients to doxorubicin . Patients randomized to the two treatment groups were compared for response rate , duration of response , time to progression or death , time to treatment failure ( TTF ) , and survival . The response rate to mitoxantrone was 20.6 % , to doxorubicin 29.3 % ( P = .07 ) . The median response duration was 151 days for the mitoxantrone group and 126 days for the doxorubicin group ( P = .16 ) . The median TTF was 70 days in the mitoxantrone group and 104 days in the doxorubicin group ( P = .36 ) . The median survival of patients initially randomized to receive mitoxantrone was 273 days ; for doxorubicin 268 days ( P = .40 ) . There were three responses among 77 patients crossed over to mitoxantrone after initial treatment with doxorubicin . The major dose-limiting toxicity for both drugs was leukopenia . There was significantly less severe and less frequent toxicity with mitoxantrone administration . Severe nausea and vomiting occurred in 9.5 % of mitoxantrone patients and 25.3 % of doxorubicin patients ( P less than .001 ) . The incidence of severe stomatitis and mucositis was 0.6 % in the mitoxantrone group and 8.4 % in the doxorubicin group ( P = .001 ) . Severe alopecia occurred in 5.1 % of mitoxantrone patients and 61.0 % of doxorubicin patients ( P less than .001 ) . A life-table comparison of the cumulative dose to the development of a cardiac event showed that mitoxantrone had significantly less cardiotoxicity than doxorubicin ( P = .0005 ) . This study demonstrates that mitoxantrone is active as a single agent in the treatment of metastatic breast cancer . Compared with doxorubicin it appears to be marginally less active and significantly less toxic . We conclude that mitoxantrone can be used alone or with other standard drugs to palliate the symptoms of metastatic breast cancer , especially in settings where drug toxicity is an important consideration .
64771
Intervention_Pharmacological
mitoxantrone
64772
Intervention_Pharmacological
doxorubicin
64773
Intervention_Pharmacological
mitoxantrone
64774
Intervention_Pharmacological
doxorubicin
64775
Intervention_Pharmacological
mitoxantrone
64776
Intervention_Pharmacological
doxorubicin
64777
Intervention_Pharmacological
mitoxantrone
64778
Intervention_Pharmacological
doxorubicin
64779
Intervention_Pharmacological
mitoxantrone
64780
Intervention_Pharmacological
doxorubicin
64781
Intervention_Pharmacological
mitoxantrone
64782
Intervention_Pharmacological
doxorubicin
64783
Intervention_Pharmacological
mitoxantrone
64784
Intervention_Pharmacological
doxorubicin
64785
Intervention_Pharmacological
mitoxantrone
64786
Intervention_Pharmacological
doxorubicin
64787
Intervention_Pharmacological
mitoxantrone
64788
Intervention_Pharmacological
mitoxantrone
64789
Intervention_Pharmacological
doxorubicin
64790
Intervention_Pharmacological
mitoxantrone
64791
Intervention_Pharmacological
doxorubicin
64792
Intervention_Pharmacological
mitoxantrone
64793
Intervention_Pharmacological
doxorubicin
64794
Intervention_Pharmacological
mitoxantrone
64795
Intervention_Pharmacological
doxorubicin
64796
Intervention_Pharmacological
mitoxantrone
64797
Intervention_Pharmacological
doxorubicin
64798
Intervention_Pharmacological
mitoxantrone
64799
Outcome_Other
response rate , duration of response , time to progression
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Outcome_Physical
or
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Outcome_Mortality
death
64802
Outcome_Physical
,
64803
Outcome_Other
time to treatment failure ( TTF )
64804
Outcome_Physical
, and
64805
Outcome_Mortality
survival
64806
Outcome_Physical
.
64807
Outcome_Other
response rate
64808
Outcome_Other
median response duration
64809
Outcome_Other
median TTF
64810
Outcome_Mortality
median survival
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Outcome_Other
The major dose-limiting toxicity
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Outcome_Adverse-effects
leukopenia .
64813
Outcome_Other
less severe and less frequent toxicity
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Outcome_Adverse-effects
Severe nausea and vomiting
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Outcome_Adverse-effects
severe stomatitis and mucositis
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Outcome_Adverse-effects
alopecia
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Outcome_Physical
cardiotoxicity
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Outcome_Physical
metastatic breast cancer .
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Outcome_Other
marginally less active and significantly less toxic .
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Outcome_Other
drug toxicity
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Participant_Condition
previously treated patients with metastatic breast cancer .