TRASTUZUMAB mgKg Loading Dose Day Only mgKg Maintenance Dose asthenia

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					                                            BREAST CANCER REGIMENS
Chemotherapy                                    BR-VINOR-TRAST

                           First Cycle - INTERMEDIATE LEVEL REGIMEN-
                         Regional Hospital with Dedicated Cancer Treatment Unit
                        Other Cycles (if no reaction) - BASIC LEVEL REGIMEN-
                             Community Hospital with Oncology Nurses
   (Treatment of Advanced Breast Cancer in Women whose Tumours Overexpress the HER2 Protein)

        VINORELBINE 30mg/m2 IV Day 1 & Day 8 (or Day 15) (Round to nearest 1mg)
         May reduce dose to 25mg/m2 IV (for frail, elderly or heavily-pretreted patients)
           • Slow push through sidearm of free flowing IV (Normal Saline 250mL); Infuse over 6-10
             minutes; infuse balance of IV bag
           • If extravasation occurs during administration, discontinue immediately and infuse the
             remaining dose through another IV site (into another vein)
           REPEAT EVERY 21 DAYS - May give Days 1, 8 & 15 every 28 days,
             or weekly until blood counts below threshold

        TRASTUZUMAB 4mg/Kg Loading Dose Day 1 Only
           • Mix in 250mL solution (Normal Saline, do NOT mix in 5% Dextrose)
           • Infuse IV over 90 minutes, then observe for 60 minutes
        2mg/Kg Maintenance Dose Weekly from Day 8
           • Infuse IV over 30 minutes (longer, if hypersensitivity reaction), then observe for 30 minutes
           • Mix in 250mL solution (Normal Saline, do NOT mix in 5% Dextrose)
           REPEAT EVERY 7 DAYS - Until Disease Progression

                   SUPPORTIVE CARE                                                    GUIDELINE
 ANTIEMETIC REGIMEN:                                             See the CCNS Website for the
 Vinorelbine Days- LOW RISK                                      guideline on Trastuzumab for advanced breast cancer
 • May give Dopamine Receptor Antagonist PO before
   chemotherapy (Prochlorperazine 10mg PO or
   Metoclopramide 10-20mg PO)
 • After chemotherapy, use Prochlorperazine 10 mg PO
   q4-6h PRN, or Metoclopramide 10 mg PO q4h PRN
 Trastuzumab ONLY Days-                                          STANDING ORDERS AVAILABLE FOR THIS REGIMEN
                                                                                    PATIENT VISIT
 • Follow hypersensitivity management protocol
                                                                 Chemotherapy Patient Visit:
 • Give Diphenhydramine 50mg IV push & Hydrocortisone            First Trastuzumab Treatment Visit- Approx. 6 hours
   100mg IV push                                                 CHEMO APP’T TYPE F
                                                                 Other Trastuzumab ONLY Treatment Visits-
                   DOSE MODIFICATION                             Approximately 1 hour     CHEMO APPOINTMENT
                                                                 TYPE C
 Vinorelbine Treatments:                                         Trastuzumab/Vinorelbine Treatment Visits:
 • If ANC < 1.5 x 109/L, notify physician and HOLD dose          Approximately 1 1/2 hours      CHEMO
                                                                 APPOINTMENT TYPE D
                                                                                                              [Rev 05/02]
                                        (continued on page 59)

BR-58                   For more information on drug interactions, dosing, pharmacology and other, see the Appendix section
                                               BREAST CANCER REGIMENS
                                                                                                         (continued from page 58)
                                                          Vinor elbine-Trastuzumab Chemotherapy

            CLINICAL MONITORING                                          DOSING CALCULATION TABLE
  Trastuzumab Criteria                                 Loading Dose & Maintenance Dose in mg/mL
  • Close observation for infusion-related symp-
    toms, including fever, chills, pain (including     Weight (Kg)     40-45            46-50       51-55       56-60
    pain in tumour), asthenia, and other flu-like
    symptoms. If treatment is well-tolerated           Loading Dose 170/8.1             189/9.0     210/10.0    231/11.0
    during loading dose and early maintenance          Maintenance     84/4.0       94.5/4.5        105/5.0     115.5/5.5
    doses, observation times may be reduced.
  • Baseline and periodic cardiac tests for all
    patients with cardiac risk factors or suspected    Weight (Kg)     61-65            66-70       71-75       76-80
    cardiac toxicity                                   Loading Dose 250/11.9        271/12.9        290/13.8    311/14.8
  0. None                                              Maintenance     126/6.0          134.4/6.4   145/6.9     155.4/7.4
  2. Asymptomatic, resting ejection fraction
                                                       Weight (Kg)     81-85            86-90       91-95       96-100
    decline by >10% baseline; or abnormal
    cardiac function tests (LVEF >50) with no          Loading Dose 330/15.7        351/16.7        370/17.6    391/18.6
    baseline for comparison                            Maintenance     166/7.9          174.3/8.3   185/8.8     195.3/9.3
  3. Mild Congestive Heart Failure, responds to
  4. Severe/refractory Congestive Heart Failure        Weight (Kg)     101-105          106-110     111-115     116-120
                                                       Loading Dose 409.5/19.5 430.5/20.5 449.4/21.4 470.4/22.4
  Vinorelbine Criteria
  • Complete blood count including differen-           Maintenance     206/9.8          214.2/10.2 225/10.7     235.2/11.2
    tial, platelets and hemoglobin (CBC) and
    serum uric acid levels before each cycle of
  • Baseline liver function tests [serum alkaline
                                                                                ADVERSE EFFECTS
    phosphatase, GGT, ALT, AST & Bilirubin
    levels]                                                                   Trastuzumab
  • Neurologic toxicity ratings (Sensory, Consti-      IMMEDIATE ONSET            (hours to days)
    pation) at each visit                                infusion-related reactions: chills, fever, pain, rigor,
  • Watch for symptoms of fever or infection             headache, dizziness, dyspnea, hypotension,
  CONSTIPATION                                           wheezing, bronchospasm, reduced oxygen saturation,
  0. No change                                           respiratory distress, rash, asthenia
  2. Mild                                                nausea/vomiting
  3. Moderate                                          EARLY ONSET                (days to weeks)
  4. Severe                                            * Cardiac Adverse Events: dyspnea, edema
  4. Ileus >96 hours                                     -->increased incidence observed in combination
  SENSORY                                                   with chemotherapy (esp. anthracycline or
  0. No change                                              cyclophosphamide)
  1. Mild paraesthesia; no deep tendon reflex            Pulmonary effects- increased cough
  2. Mild/moderate sensory loss; moderate                                          Vinorelbine
    paraesthesia                                      IMMEDIATE ONSET            (hours to days)
  3. Sensory loss interferes with function            * myelosuppression, increased susceptibility to infection
   Rated at each clinic visit                           nausea, vomiting (44%)
                                                        injection site reaction (28%)
                                                      EARLY ONSET                (days to weeks)
                                                        anemia (83%)
                                                        pulmonary reactions
                                                        alopecia (12%)
                                                        jaw pain
                                                        stomatitis, constipation (35%)
                                                            * may be life-threatening     bold, italic side effects are common

See Drug Monographs for further details on treatment and supportive care drugs                                               BR-59

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