BASELINE PATIENT CHARACTERISTICS IN THE ABRAXANE PHASE III STUDY

BASELINE PATIENT CHARACTERISTICS IN THE ABRAXANE PHASE III STUDY

MBC patients in phase III clinical trial in both arms had poor prognosis factors: 79% had visceral metastases, 76% had more than 3 metastatic sites - chart

*Most common dominant sites of metastasis.

Patient characteristics in MBC phase III trial: ECOG 0 (35%) ECOG1 (59%) ECOG 2/3 (6%), mean age (53.1), prior anthracycline exposure (77%) - chart
MBC patients in phase III clinical trial in both arms had poor prognosis factors: 79% had visceral metastases, 76% had more than 3 metastatic sites - chart
  • *Most common dominant sites of metastasis.
MBC patients in phase III clinical trial in both arms had poor prognosis factors: 79% had visceral metastases, 76% had more than 3 metastatic sites - chart
MBC patients in phase III clinical trial in both arms had poor prognosis factors: 79% had visceral metastases, 76% had more than 3 metastatic sites - chart

59% of MBC patients received ABX after at least one prior chemotherapy

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.

  • IV=intravenously; PS=performance status; Q3W=every 3 weeks; recTLRR=reconciled target lesion response rate.
  • A Rigorous Primary Efficacy Endpoint

    PHASE III RIGOROUS TUMOR RESPONSE ENDPOINT: recTLRR

    PHASE III RIGOROUS TUMOR RESPONSE ENDPOINT: recTLRR

    • The primary efficacy endpoint: reconciled target lesion response rate (recTLRR)
      – recTLRR was based on independent radiologic assessment of tumor responses
      – recTLRR was reconciled with investigator-reported responses for the first 6 cycles of therapy
      The primary efficacy endpoint: reconciled target lesion response rate (recTLRR)
      • recTLRR was based on independent radiologic assessment of tumor responses
      • recTLRR was reconciled with investigator-reported responses for the first 6 cycles of therapy
    • Secondary efficacy endpoints included time to disease progression and overall survival, among other measures24
    • An exploratory analysis was conducted for overall survival to evaluate the subgroup of patients receiving ABRAXANE as second-line or later therapy

    Patients who completed 6 cycles of ABRAXANE therapy and did not progress were able to continue treatment at the investigator's discretion.24

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  • NCCN Recommendation

    RECOMMENDATIONS FOR METASTATIC BREAST CANCER PATIENTS WITH VISCERAL METASTASES

    The predominance of visceral metastases in the Phase III study is consistent with the National Comprehensive Cancer Network® (NCCN®) recommended* patient population for albumin-bound paclitaxel (ABRAXANE)3

    *NCCN Guidelines® (V.6.2020) recommend albumin-bound paclitaxel as Category 2A.

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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 ABRAXANE 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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