Nab-paclitaxel: 1L trials
•
Phase II RCT: Nab-paclitaxel
300q3w
vs Nab-paclitaxel
100qw 3/4
vs Nab-paclitaxel
150qw3/4
vs
docetaxel
100q3w
•
Total N=302 (all 1L)
•
84% visceral mtx & 42% EBC systemic therapy
•
Primary endpoint: ORR (secondary: DCR, PFS, DoR, OS)
Gradishar et al JCO 2009 / CBC2012
* 100 mg/m
2
nab-paclitaxel vs docetaxel
P
=0.002
nab
-paclitaxel
docetaxel
150 & 100 mg/m
2
> RR vs
Doce (NS)
150 & 100 mg/m
2
> RR vs
Doce (p=SGVO)*
P
=0.024
P
<0.001
P
=0.002
n=302
*