SELECT ADJUVANT DOSING AND ADMINISTRATION


Patient selection

Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency.1

Adjuvant eligibility

To begin PERJETA and Herceptin® (trastuzumab)-based therapy in the adjuvant setting, patients must have HER2+ early breast cancer at high risk of recurrence.1

Please see the full Prescribing Information for complete dosing and administration, including dose considerations, dose modifications, preparation, storage, and handling. You can also download the PERJETA Dosing & Administration Guide.

LEARN ABOUT STARTING PERJETA

IN THE NEOADJUVANT SETTING

Patients who begin PERJETA and Herceptin in the neoadjuvant setting should continue to receive PERJETA and Herceptin every 3 weeks for a total of 1 year (up to 18 cycles), or until disease recurrence or unmanageable toxicity, whichever occurs first.

Starting treatment in the adjuvant setting1

*Or until disease recurrence or unmanageable toxicity, whichever occurs first.

Recommended dosing

PERJETA and Herceptin are administered every 3 weeks starting on Day 1 of the first taxane-containing cycle1
PERJETA is a fixed dose, regardless of body weight. Administer 840 mg loading dose, 420 mg for subsequent cycles; Herceptin dosing: 8 mg/kg loading dose, 6 mg/kg for subsequent cycles.

Dosing considerations

Dose sequencing1

  • PERJETA, Herceptin, and taxanes should be administered sequentially
    • PERJETA and Herceptin can be given in any order, and taxane should be administered after PERJETA and Herceptin
  • In patients receiving an anthracycline-based regimen, PERJETA and Herceptin should be administered following completion of the anthracycline
  • An observation period of 30 to 60 minutes is recommended after each PERJETA infusion and before commencement of any subsequent infusion of Herceptin or chemotherapy

If a delayed or missed dose of PERJETA occurs1

Dose interruption or discontinuation of treatment1

  • PERJETA should be discontinued if Herceptin treatment is discontinued
  • Dose reductions are not recommended for PERJETA
  • For chemotherapy dose modifications, see their respective prescribing information
  • If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies
    • The infusion should be discontinued immediately if the patient experiences a serious hypersensitivity reaction

Adjuvant chemotherapy regimens, as given in the APHINITY trial1

Non–anthracycline-based chemotherapy regimen

  • 6 cycles of docetaxel + carboplatin

Anthracycline-based regimens

  • 3 or 4 cycles of FEC§ or FAC, followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
  • 4 cycles of AC# or EC,** followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel

AC=doxorubicin and cyclophosphamide; EC=epirubicin and cyclophosphamide; FAC=5-fluorouracil, doxorubicin, cyclophosphamide; FEC=5-fluorouracil, epirubicin, and cyclophosphamide; GCSF=granulocyte colony–stimulating factor.
Docetaxel dosing: 75 mg/m2, which could be escalated to 100 mg/m2 if initial dose was well-tolerated (not escalated in non–anthracycline-based regimens); docetaxel dosing following AC or EC administration: 100 mg/m2 for 3 cycles or 75 mg/m2 for first cycle and 100 mg/m2 for subsequent 3 cycles, or 75 mg/m2 for 4 cycles.
Carboplatin dosing: AUC 6.
§FEC dosing: 5-fluorouracil (500-600 mg/m2), epirubicin (90-120 mg/m2), and cyclophosphamide (500-600 mg/m2).
FAC dosing: 5-fluorouracil (500-600 mg/m2), doxorubicin (50 mg/m2), and cyclophosphamide (500-600 mg/m2).
Paclitaxel dosing: 80 mg/m2.
#AC dosing: doxorubicin (60 mg/m2) and cyclophosphamide (500-600 mg/m2) every 3 weeks or 2 weeks with GCSF support.
**EC dosing: epirubicin (90-120 mg/m2) and cyclophosphamide (500-600 mg/m2) every 3 weeks or 2 weeks with GCSF support.

Patient monitoring1

Left ventricular ejection fraction (LVEF)
Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits, as indicated below. If LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered.

Dose modifications for left ventricular dysfunction in EBC

††For patients receiving anthracycline-based chemotherapy, an LVEF ≥50% is required after completion of anthracyclines, before starting PERJETA and Herceptin.

Cardiac monitoring

Please see the full Prescribing Information for complete dosing and administration, including dose considerations, dose modifications, preparation, storage, and handling. You can also download the PERJETA Dosing & Administration Guide.

Reference