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A - Regimen Name

AC Regimen
ADRIAMYCIN ® (DOXOrubicin)-Cyclophosphamide


Disease Site
Breast

Intent
Palliative

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.


Rationale and Uses

Treatment of advanced breast cancer

 
B - Drug Regimen

DOXOrubicin
60 mg /m² IV Day 1
cyclophosphamide
600 mg /m² IV Day 1
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Until evidence of non-response, disease progression or limited by cardiotoxicity risk

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High


Febrile Neutropenia Risk:

Low

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

Dosage with toxicity

Hematologic Toxicities:  See Appendix 6 for general recommendations.
 
Worst Toxicity Type /
Counts (x 109/L) in Previous Cycle
Doxorubicin
(% previous dose)
 
Cyclophosphamide
(% previous dose)
Febrile Neutropenia
Thrombocytopenic bleeding
Grade 4 ANC ≥ 7 d
 
 
75%*
 
Cardiotoxicity **
Discontinue
Caution
 
Grade 3 related non-hematologic / organ 
 
75% for suspect drug(s) *
Grade 4 related non-hematologic / organ 
 
Discontinue

 * Retreat when toxicities have recovered to ≤ grade 2, platelets ≥ 100 x 109/L, and ANC ≥ 1.5 x 109/L.
** including any signs and symptoms of heart failure, greater than 10% decline in LVEF to below the lower limit of normal, a greater than 20% decline in LVEF from any level, or LVEF ≤ 45%. 



Hepatic Impairment

Bilirubin
 
AST/ALT
Cyclophosphamide
Doxorubicin
(% of previous dose)
1-2 x ULN
AND
 
< 2 x ULN
100%
50%
2-4 x ULN
OR
2-4x ULN
Caution
25%
>4 x ULN
OR
>4 x ULN
Caution
Discontinue

 

 

 

 


Renal Impairment

 

Creatinine Clearance (mL/min)

Cyclophosphamide
Doxorubicin
(% of previous dose)
>30-50 100% 100%
10-30 50-75% 100%
<10 50% or OMIT 100%

 
F - Adverse Effects

Refer to DOXOrubicin, cyclophosphamide drug monograph(s) for additional details of adverse effects


Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Myelosuppression ± infection
  • Nausea and vomiting
  • Alopecia
  • Mucositis
  • Diarrhea
  • Cystitis
  • ↑ LFTs
  • Anorexia
  • Reproductive risks
  • Cardiotoxicity
  • Thromboembolism, DIC, VOD
  • Secondary leukemia or malignancies
  • SIADH
  • Pneumonitis
  • Pancreatitis
  • Rhabdomyolysis
  • Photosensitivity
  • Vesicant
 
G - Interactions
Refer to DOXOrubicin, cyclophosphamide drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions

Refer to DOXOrubicin, cyclophosphamide drug monograph(s) for additional details

 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • Clinical toxicity assessment (including GI, cardiotoxicity, local toxicity, cystitis, infection); at each visit
  • CBC; baseline and before each cycle
  • Baseline and regular liver function tests
  • Baseline and regular renal function tests and urinalysis
  • Cardiac examination especially with risk factors (including prior therapy with epirubicin, mitoxantrone, or other cardiotoxic drug), or a cumulative doxorubicin dose of > 450 mg/m2
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
1 to 1.5 hours
Pharmacy Workload (average time per visit)
30.564 minutes
Nursing Workload (average time per visit)
56.667 minutes
 
K - References

Fisher B, Brown AM, Dimitrov NV, et al. Two months of doxorubicin/cyclophosphamide with and without interval reinduction therapy compared with six months of Cyclophosphamide, Methotrexate and 5-Fluorouracil in node-positive breast cancer patients with tamoxifen non-responsive tumors: results from the NSABP B-15. J. Clin Oncol 1990 Sep; 8(9): 1483-96.

Nabholtz JM, Falkson C, Campos D, et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicentre, phase III trial. J Clin Oncol 2003; 21: 968-75.

 

January 2018 removed dose rounding factor


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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.