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AC-PACL(DD)+PERT+TRAS

Cancer Type: Breast  Intent: Curative, Adjuvant
Regimen Category: Evidence-informed
Funding:
New Drug Funding Program
    Paclitaxel - Adjuvant Treatment for Breast Cancer
New Drug Funding Program
    Trastuzumab - Adjuvant Treatment for HER2_neu-Overexpressing Primary Breast Cancer
A - Regimen Name

AC-PACL(DD)+PERT+TRAS Regimen
ADRIAMYCIN ® (DOXOrubicin)-Cyclophosphamide then PACLitaxel (Dose Dense) and Pertuzumab, Trastuzumab


Disease Site
Breast

Intent
Curative
Adjuvant

Regimen Category
Evidence-informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully  improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.


Rationale and Uses

Treatment in patients with early HER2-positive breast cancer who have a high risk of recurrence

 


Supplementary Public Funding

PACLitaxel
New Drug Funding Program (Paclitaxel - Adjuvant Treatment for Breast Cancer)

trastuzumab
New Drug Funding Program (Trastuzumab - Adjuvant Treatment for HER2_neu-Overexpressing Primary Breast Cancer)

 
B - Drug Regimen

AC: (x 4 cycles)

DOXOrubicin
60 mg /m² IV Day 1
cyclophosphamide
600 mg /m² IV Day 1

THEN

PACLITAXEL (Taxol®): (x 4 cycles)

PACLitaxel
175 mg /m² IV Day 1


Pertuzumab and Trastuzumab to be given every 21 Days for one year, starting concurrently with Paclitaxel:

PERTuzumab
840 mg IV loading dose Day 1
(This drug is not currently publicly funded for this regimen and intent)
trastuzumab
8 mg /kg IV loading dose Day 1

THEN,

PERTuzumab
420 mg IV maintenance dose (Every 21 days)
(This drug is not currently publicly funded for this regimen and intent)
trastuzumab
6 mg /kg IV maintenance dose (Every 21 days)

 

 

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C - Cycle Frequency

REPEAT EVERY 14 DAYS:  AC X 4 cycles then Paclitaxel (Taxol®) X 4 cycles.

Pertuzumab and trastuzumab to start concurrently with paclitaxel and continue q21 days .

Refer to PERT+TRAS for cycles after the chemotherapy is completed.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (AC)
Low (Paclitaxel)


Febrile Neutropenia Risk:

High

Give filgrastim* 5 mcg/kg/day SC on days 3 to 10, in AC and PACL cycles.

* or alternative

Also see G-CSF recommendations.


Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

Pre-medications* (prophylaxis for infusion reaction):

To be given 30-60 minutes prior to paclitaxel infusion.

  • Dexamethasone 10 mg IV, starting in cycle 1
  • Diphenhydramine 25-50 mg IV/PO
  • Ranitidine 50 mg IV OR Famotidine 20 mg IV

* Consider discontinuing pre-medications for paclitaxel if there was no IR in the first 2 doses.

 
J - Administrative Information

Approximate Patient Visit
AC: 1 to 1.5 hours; Paclitaxel: 3 to 5 hours; PERT+TRAS: 3 hours (first cycle); 1-1.5 hours (subsequent cycles)
Pharmacy Workload (average time per visit)
29.158 minutes
Nursing Workload (average time per visit)
65.75 minutes
 
K - References

Citron M, Berry D, Cirrincione C, et al. Randomized trial of dose dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: First Report of Intergroup Trial C9741/Cancer and Leukemia Group B trial 9741. J Clin Oncol; 2003 Apr 15. 21(8): 1431-1439.

doxorubicin, cyclophosphamide, paclitaxel drug monographs, Cancer Care Ontario.

von Minckwitz G, Proctor M, de Azambuja E, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. 2017;377(2):122-131.


PEBC Advice Documents or Guidelines

November 2019 New ST-QBP regimen


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.