WHEN RESPONSE RATES MATTER,

CHOOSE ABRAXANE FOR YOUR PATIENTS WITH MBC

CHOOSE ABRAXANE FOR YOUR PATIENTS WITH MBC

THE MAJORITY OF PATIENTS IN BOTH ARMS HAD POOR PROGNOSTIC FACTORS
  • 79%
    had visceral metastases
  • 76%
    >3 sites of metastases
  • 79% had visceral metastases
  • 76% >3 sites of metastases
ABRAXANE ALMOST DOUBLED THE RESPONSE RATE (recTLRR) VS PACLITAXEL IN THE ITT POPULATION
21.5% ABRAXANE® (95% CI: 16.19%-26.73%) vs 11.1% paclitaxel (95% CI: 6.94%-15.09%) reconciled target lesion response rates in metastatic breast cancer (MBC) phase III trial - chart
  • Indication population:
    15.5% (n=20/129 [95% CI: 9.26%-21.75%]) vs
    8.4% (n=12/143 [95% CI: 3.85%-12.94%])

    • ABRAXANE
    • Paclitaxel Injection
  • aFrom Cochran-Mantel-Haenszel test stratified by first-line vs >first-line therapy.
MEDIAN OVERALL SURVIVAL21
ITT: No significant difference in OS between treatments
ITT: No significant difference in OS between treatments

ABRAXANE® for metastatic breast cancer (MBC) median overall survival in ITT population from phase III clinical trial: ABRAXANE® (14.9 months) vs paclitaxel (12.8 months) - chart

HR=0.90 (95% CI: 0.73-1.11); P=NS

≥ One prior therapy: Post-hoc exploratory analysisb
≥ One prior therapy: Post-hoc exploratory analysisb

ABRAXANE® for metastatic breast cancer (MBC) median overall survival post-hoc analysis from phase III clinical trial: ABRAXANE® (12.9 months) vs paclitaxel (10.7 months) - chart

HR=0.73 (95% CI: 0.56-0.96); P=NS

bAnalysis Limitations: A post-hoc exploratory analysis should not be interpreted to determine a treatment difference between arms in this selected subgroup because of potential selection bias, insufficient sample size, and a higher probability of making a false positive finding.
  • c Median overall survival was measured in weeks and converted to months (assuming 4.348125 weeks in 1 Gregorian month).
MOST COMMON AEs (≥20%)
  • Alopecia
  • Neutropenia
  • Sensory Neuropathy
  • Abnormal ECG
  • Fatigue/Asthenia
  • Myalgia/Arthralgia
  • AST Elevations
  • Alkaline Phosphatase Elevations
  • Anemia
  • Nausea
  • Infections
  • Diarrhea
  • Alopecia
  • Neutropenia
  • Sensory Neuropathy
  • Abnormal ECG
  • Fatigue/Asthenia
  • Myalgia/Arthralgia
  • AST Elevations
  • Alkaline Phosphatase Elevations
  • Anemia
  • Nausea
  • Infections
  • Diarrhea
Study design

Multicenter, 1:1 randomized, phase III study comparing ABRAXANE 260 mg/m2 IV q3w with paclitaxel injection 175 mg/m2 IV q3w in 460 patients with MBC. The primary efficacy endpoint was recTLRR. recTLRR was based on independent radiologic assessment of target lesions reconciled with investigator-reported responses for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy. The secondary endpoints were time to disease progression and overall survival.

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Additional Information for Readers Provided by Celgene Corporation

The clinical trial described in this article served as the
basis for the approval for ABRXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.

Please see Important Safety Information and Prescribing Information, including Boxed WARNING.

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