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document
Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer : final analysis of overall survival . BACKGROUND A randomized phase II study in first-line MBC demonstrated superior efficacy and safety of weekly nab-paclitaxel compared with docetaxel . Final survival analyses and updated safety results are reported . PATIENTS AND METHODS Three hundred two patients with no previous chemotherapy for MBC were randomized to receive nab-paclitaxel 300 mg/m ( 2 ) q3w , nab-paclitaxel 100 mg/m ( 2 ) or 150 mg/m ( 2 ) the first 3 of 4 weeks ( qw 3/4 ) , or docetaxel 100 mg/m ( 2 ) q3w . The trial was powered for analyses of antitumor activity and safety . RESULTS Treatment with nab-paclitaxel 150 mg/m ( 2 ) qw 3/4 resulted in a median overall survival ( OS ) of 33.8 months compared with 22.2 , 27.7 , and 26.6 months for nab-paclitaxel 100 mg/m ( 2 ) qw 3/4 , nab-paclitaxel 300 mg/m ( 2 ) q3w , and docetaxel , respectively ( overall P = .047 ) . Patients receiving 150 mg/m ( 2 ) nab-paclitaxel had prolonged median OS compared with those in the 100 mg/m ( 2 ) nab-paclitaxel arm ( hazard ratio , 0.575 ; P = .008 ) . A trend toward a longer OS was noted in the 150 mg/m ( 2 ) nab-paclitaxel arm versus docetaxel arm ( hazard ratio , 0.688 ) . Grade 3 or 4 fatigue , neutropenia , and febrile neutropenia were less frequent in all nab-paclitaxel arms compared with docetaxel . CONCLUSIONS Consistent with previously published efficacy results , these data suggest that 150 mg/m ( 2 ) qw 3/4 may represent the most clinically efficacious nab-paclitaxel dosing regimen for patients with no previous chemotherapy for MBC . A phase III trial confirming these results would be necessary and prudent before widespread adoption of the 150 mg/m ( 2 ) dose in clinical practice .
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
docetaxel
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Intervention_Physical
.
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Intervention_Pharmacological
nab-paclitaxel 300 mg/m ( 2 )
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Intervention_Pharmacological
nab-paclitaxel 100 mg/m ( 2 )
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Intervention_Pharmacological
150 mg/m ( 2 )
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Intervention_Pharmacological
docetaxel 100 mg/m ( 2 )
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
docetaxel
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Mortality
survival
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Outcome_Other
safety
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Outcome_Other
antitumor activity
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Outcome_Other
safety
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Outcome_Mortality
survival
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Outcome_Mortality
median OS
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Outcome_Mortality
OS
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Outcome_Physical
Grade 3 or 4 fatigue
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Outcome_Physical
neutropenia ,
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Outcome_Physical
febrile neutropenia
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Participant_Condition
metastatic breast cancer
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Participant_Sample-size
Three hundred two
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Participant_Condition
with no previous chemotherapy
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Participant_Condition
MBC