TY - JOUR
T1 - Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer
T2 - Final analysis of overall survival
AU - Gradishar, William J.
AU - Krasnojon, Dimitry
AU - Cheporov, Sergey
AU - Makhson, Anatoly N.
AU - Manikhas, Georgiy M.
AU - Clawson, Alicia
AU - Bhar, Paul
AU - McGuire, John R.
AU - Iglesias, Jose
N1 - Funding Information:
Dimitry Krasnojon, Sergey Cheporov, Anatoly N. Makhson, and Georgiy M. Manikhas have received research funding from Abraxis . Alicia Clawson, Paul Bhar, and Jose Iglesias are Celgene employees and own stock in the company. John McGuire is employed by MediTech, Media, Ltd. William J. Gradishar has no conflicts of interest.
PY - 2012/10
Y1 - 2012/10
N2 - 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/m2 q3w, nab-paclitaxel 100 mg/m2 or 150 mg/m2 the first 3 of 4 weeks (qw 3/4), or docetaxel 100 mg/m2 q3w. The trial was powered for analyses of antitumor activity and safety. Results: Treatment with nab-paclitaxel 150 mg/m2 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/m2 qw 3/4, nab-paclitaxel 300 mg/m2 q3w, and docetaxel, respectively (overall P =.047). Patients receiving 150 mg/m2 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/m2 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/m2 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/m2 dose in clinical practice.
AB - 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/m2 q3w, nab-paclitaxel 100 mg/m2 or 150 mg/m2 the first 3 of 4 weeks (qw 3/4), or docetaxel 100 mg/m2 q3w. The trial was powered for analyses of antitumor activity and safety. Results: Treatment with nab-paclitaxel 150 mg/m2 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/m2 qw 3/4, nab-paclitaxel 300 mg/m2 q3w, and docetaxel, respectively (overall P =.047). Patients receiving 150 mg/m2 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/m2 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/m2 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/m2 dose in clinical practice.
KW - Dose
KW - Schedule
KW - Solvent
KW - Taxane
KW - Treatment-naive
UR - http://www.scopus.com/inward/record.url?scp=84867058051&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84867058051&partnerID=8YFLogxK
U2 - 10.1016/j.clbc.2012.05.001
DO - 10.1016/j.clbc.2012.05.001
M3 - Article
C2 - 22728026
AN - SCOPUS:84867058051
SN - 1526-8209
VL - 12
SP - 313
EP - 321
JO - Clinical breast cancer
JF - Clinical breast cancer
IS - 5
ER -
