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Issue 1 - San Antonio Breast Cancer Symposium

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Abstract 41<br />

PL + D<br />

(n=241)<br />

BV 7.5 mg/kg + D<br />

(n=248)<br />

BV 15 mg/kg + D<br />

(n=247)<br />

Deaths, % 44.8 47.6 47.0<br />

OS<br />

HR 1.05 1.03<br />

95% CI 0.81–1.36 0.79–1.33<br />

P value<br />

P value<br />

P value<br />

0.7198 0.8528<br />

Median 31.9 30.8 30.2<br />

Stratified PFS*<br />

HR 0.80 0.67<br />

95% CI 0.65–1.00 0.54–0.83<br />

P value † 0.0450 0.0002<br />

Median 8.1 9.0 10.0<br />

ORR ‡ , % 46.4 55.2 64.1<br />

0.0739 0.0003<br />

1-y survival, % 76 81 84<br />

PL + D<br />

(n=231)<br />

0.198 0.02<br />

BV 7.5 mg/kg + D<br />

(n=252)<br />

BV 15 mg/kg + D<br />

(n=247)<br />

SAEs, % 32.5 37.3 42.9<br />

Pts discontinuing<br />

treatment due to<br />

AE, %<br />

BV/PL 11.7 8.7 13.8<br />

D 24.7 20.6 24.3<br />

AEs leading to<br />

death, %<br />

2.6 1.6 1.6<br />

*Pts were censored if they had started non-protocol therapy before disease progression.<br />

† Exploratory.<br />

‡ Pts with measurable disease at baseline.<br />

NR, not reached.

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