Is it safe to use Procrit (Epoetin alfa) in a patient with a history of breast cancer?

Use of Procrit (Epoetin Alfa) in Patients with History of Breast Cancer

Procrit (epoetin alfa) should not be used in patients with a history of breast cancer when the treatment intent is curative, and should be used with extreme caution even in metastatic breast cancer settings due to increased risks of mortality and tumor progression. 1

Risk Assessment for ESA Use in Breast Cancer

The decision to use Procrit in patients with breast cancer history must carefully consider:

• Treatment Intent:

  • Absolutely contraindicated when treatment is curative in intent 1, 2
  • May be considered with extreme caution only in advanced metastatic settings 1

• Evidence of Harm:

  • Meta-analyses have shown increased risk of death in breast cancer patients using ESAs (odds ratio 1.20; 95% CI, 1.03-1.40) 1
  • A 2016 non-inferiority trial in metastatic breast cancer patients failed to demonstrate that epoetin alfa was non-inferior to best supportive care 1

• FDA Boxed Warning:

  • ESAs shorten overall survival and/or increase risk of tumor progression or recurrence in patients with breast cancer 2
  • FDA label explicitly states Procrit is not indicated "in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure" 2

Limited Scenarios Where ESA Use Might Be Considered

If all the following conditions are met, Procrit might be considered with extreme caution:

1. Patient has metastatic breast cancer (non-curative setting) 1
2. Patient is currently receiving myelosuppressive chemotherapy expected to continue for at least 2 additional months 2
3. Hemoglobin has fallen below 10 g/dL 3
4. Anemia cannot be adequately managed by transfusion alone 2
5. Patient understands and accepts the risks after thorough discussion 1

Alternative Approaches

• Blood transfusion is the preferred approach for managing anemia in breast cancer patients, especially during first or second-line chemotherapy for metastatic disease 1
• For severe anemia (Hb < 8 g/dL), transfusion provides immediate correction while ESAs take 2-6 weeks to significantly increase hemoglobin levels 3

Patient Communication Requirements

If ESA use is being considered despite the risks, providers must:

1. Discuss that ESAs have been found to shorten overall survival and/or speed tumor growth in breast cancer patients 1
2. Explain increased risk of thromboembolism 1
3. Clarify that the primary goal is reducing transfusion requirements, not improving quality of life 1
4. Have patient sign an acknowledgment form confirming discussion of risks 1
5. Provide the FDA-required medication guide 1
6. Enroll in the APPRISE Oncology Program as required by FDA 1

Monitoring if ESA is Used

If ESA therapy is initiated despite the risks:

• Monitor hemoglobin after 4 weeks of therapy 1
• If hemoglobin increase is <1 g/dL after 4 weeks, consider discontinuation 1
• Stop therapy when normal hemoglobin is reached 1
• Consider parenteral iron supplementation in iron-deficient patients 1

Common Pitfalls to Avoid

1. Ignoring treatment intent: Never use ESAs when treatment is potentially curative
2. Targeting high hemoglobin: Attempts to increase Hb >12 g/dL may be harmful 1
3. Overlooking alternatives: Blood transfusion should be considered the preferred approach 1
4. Continuing too long: Discontinue following completion of chemotherapy course 2
5. Inadequate patient counseling: Thorough discussion of risks is legally and ethically required 1