GRADE 3 NEUROPATHY: MEDIAN TIME TO IMPROVEMENT WITHIN
1 MONTH AFTER DOSE MODIFICATION11

48% of patients who received ABRAXANE + carboplatin developed any grade peripheral neuropathy compared with 64% of patients in the paclitaxel + carboplatin arm
Grade 3 peripheral neuropathy in the ABRAXANE + carboplatin arm vs paclitaxel + carboplatin
Grade 3 peripheral neuropathy in the ABRAXANE + carboplatin arm vs paclitaxel + carboplatin
In the Phase III study, 3% of patients in the ABRAXANE + carboplatin arm (17/514) experienced Grade 3 peripheral neuropathy vs 12% of patients in the paclitaxel injection + carboplatin arm (63/524). 59% (10/17) of patients in the ABRAXANE + carboplatin arm with Grade 3 neuropathy improved to Grade 1 or resolved following interruption or discontinuation of ABRAXANE. 24 days was the median time to improvement in the majority of patients with ≥ Grade 3 peripheral neuropathy by at least 1 Grade or more.In the Phase III study, 3% of patients in the ABRAXANE + carboplatin arm (17/514) experienced Grade 3 peripheral neuropathy vs 12% of patients in the paclitaxel injection + carboplatin arm (63/524). 59% (10/17) of patients in the ABRAXANE + carboplatin arm with Grade 3 neuropathy improved to Grade 1 or resolved following interruption or discontinuation of ABRAXANE. 24 days was the median time to improvement in the majority of patients with ≥ Grade 3 peripheral neuropathy by at least 1 Grade or more.
  • 1% of patients discontinued ABRAXANE due to peripheral neuropathy
  • No patients in the ABRAXANE + carboplatin arm developed Grade 4 peripheral neuropathy
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The clinical trial described in this article served as the
basis for the approval for ABRAXANE for Injectable Suspension.
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