ELIGIBILITY FORM (for the 1st 3 courses)
Transcription
ELIGIBILITY FORM (for the 1st 3 courses)
Evidence Building Program Eligibility Form Adjuvant Trastuzumab with Chemotherapy for HER2/neu-Overexpressing Breast Cancer Tumours Less than or Equal to 1 cm in Diameter 1. Patient Profile Surname: ________________________________ Given Name: __________________________________ OHIN: ________________________________ Chart Number: __________________________________ Postal Code: ________________________________ Height (cm): __________ Weight (kg): ____________ Date of Birth: _____ •______•_______ 2 BSA (m ): ________________ Gender (M, F or O): Day ____________ Month Year Facility: ________________________________ Physician: Physician’s Fax #: ________________________________ Physician’s Email: __________________________________ 2. __________________________________ Eligibility Criteria a. For breast cancer patients with node negative HER2-positive tumours ≥ 1mm and ≤ 1cm; HER2-positive defined as either IHC3+ or FISH/SISH ratio of ≥ 2 b. The patient is a candidate for trastuzumab-based chemotherapy; If age ≤ 50 years, LVEF ≥ 50% based on MUGA or ECHO If age > 50 years, LVEF ≥ 55% based on MUGA or ECHO No clinically significant cardiac disease Adequate marrow, renal and hepatic function c. 3. Trastuzumab will be used in combination with, or sequentially after, adjuvant chemotherapy Baseline Information a. Date of pathological diagnosis: _____ •______•_______ Day 1 Month Year b. Tumour size _________cm unreported c. 1 2 3 d. Histology Ductal Lobular Other e. Multifocality Yes No f. ER status If positive, ER _____% Positive Negative g. PR status If positive, PR _____% Positive Negative Tumour grade h. Lymphovascular invasion Yes No i. IHC3+ FISH/SISH ≥ 2 Test(s) to confirm HER2 positivity: unreported j. LVEF baseline ________% k. Cardiac Testing Method l. Adjuvant endocrine therapy (please select all that apply): Tamoxifen Aromatase Inhibitor Other: ________________ Not applicable MUGA ECHO m. Adjuvant chemotherapy: CEF AC CMF FEC-T FEC AC-Docetaxel dd-AC-Taxol AC-Taxol weekly paclitaxel Other(please specify):__________________ TC (see note) AC-Taxol-weekly n. Patient has undergone Breast Conservation Surgery Mastectomy Not Applicable o. Adjuvant radiotherapy (please select one) Local Regional Local & Regional Not applicable p. Has the patient received prior trastuzumab treatments? Yes No Number of prior trastuzumab treatments (equivalent of q3 weeks): _________ q. Date of first trastuzumab treatment _____ •______•_______ Day 5. Month Year Notes a. Prior approval by CCO is required. The completed eligibility form along with a copy of the baseline pathology report (with the date of the biopsy, staging and other information [e.g. tumour size, tumour grade, node status, histology, hormone receptor status, HER2 status, HER2 testing information, multifocalilty, etc.), and the left ventricular ejection fraction (LVEF) results (MUGA or echocardiography [ECHO]) can be uploaded through CCO’s secure link https://ebp.cancercare.on.ca. b. LVEF results using MUGA or ECHO must be completed before the start of trastuzumab (and after an anthracycline-based chemotherapy), every three months while on trastuzumab and then at twelve months after completion of trastuzumab. Should cardiac symptoms or greater than 10% absolute asymptomatic decline in LVEF occur within twelve months after completion of trastuzumab, then annual cardiac assessments following trastuzumab completion may be considered. c. Cardiac function tests demonstrating normal LVEF must be provided to CCO every three months from the start of trastuzumab therapy to ensure continued reimbursement. Should the patient experience cardiac symptoms requiring discontinuation of trastuzumab, a cardiologic assessment documenting the ability to continue therapy must also be provided to CCO when treatment is resumed. The documents can be uploaded using CCO’s secure link https://ebp.cancercare.on.ca d. Trastuzumab dosing is q3 weeks (loading dose 8mg/kg IV x1, followed by 6mg/kg q3 weeks). The total treatment duration is one year (or the equivalent of eighteen q3 week treatments) or until limited by cardiotoxicity. Trastuzumab may be administered once weekly (or q2 weeks) for eight weeks (during the paclitaxel component), then q3 weeks for patients receiving the dose-dense AC-Taxol regimen (weekly dosing would involve a loading dose of 4mg/kg IV x1, followed by 2mg/kg IV weekly; the dose for q2 weeks is the same as the q3 week dosing). e. Trastuzumab may be used with any chemotherapy that is considered standard of care for breast cancer tumours >1cm. If the drug used in the regimen of choice is currently funded by the NDFP, the corresponding NDFP eligibility form would also need to be submitted to CCO (NDFP funding policies will apply). If TC is the regimen of choice, then completion of this form will automatically enroll the patient for the docetaxel component of the TC, which will also be funded as part of the Evidence Building Program. f. If trastuzumab is discontinued for more than five weeks, prior approval must be obtained before resuming treatment (as per the HERA trial). The patient named above, or relevant substitute decision-maker where applicable, has been informed of the process for submission of the patient’s reimbursement claim to the EBP program and has provided their consent for the collection, use and disclosure of the patient’s personal health information, as detailed in the Evidence Building Program eligibility form, by Cancer Care Ontario for the purposes of administering the EBP program. ________________________________________ Signature of Prescribing Physician Trastuzumab – Breast – 81.2 2 _____ •______•_______ Day Month Year