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1. For questions 1-6, please use the following Patient CASE:
AG is a 43-year-old female with newly diagnosed triple-negative breast cancer (TNBC) (i.e., estrogen receptor [ER]-, progesterone receptor [PR]-, and human epidermal growth factor receptor 2 [HER2]- negative) with metastases to the skin and bones. She presents to clinic for consideration of systemic therapy for the treatment of her cancer, and she asks about immunotherapy.

In order for AG to be considered for an immune checkpoint inhibitor (ICI) combination therapeutic regimen for the treatment of her breast cancer, what marker/alteration must her tumor express?

A. BRCA1 deletion B. BRCA2 deletion C. Programmed death-ligand 1 (PD-L1) positive D. Epidermal growth factor receptor (EGFR) positive E. Unsure

2. What FDA-approved companion diagnostic should be used to evaluate AG's tumor to assess her eligibility for atezolizumab?

A. BRACAnalysis CDx B. IHC 22C3 pharmDx C. Guardant360 D. VENTANA SP142 assay E. Unsure

3. As the pharmacist, you order the appropriate companion diagnostic for ICI therapy for AG and the result was positive. What ICI combination is FDA-approved for the first-line treatment of AG's cancer?

A. Durvalumab + olaparib B. Pembrolizumab + eribulin C. Atezolizumab + nab-paclitaxel D. Avelumab + doxorubicin E. Unsure

4. AG was treated with 3 cycles of ICI plus chemotherapy when she developed severe colitis (grade 3: 7 bowel movements per day above her “normal”) that was deemed to be an immune-mediated adverse event (imAE). What is the appropriate action regarding her ICI?

A. Reduce the dose of the ICI B. Increase the dose of the ICI C. Hold the ICI D. Continue the current schedule and dose of the ICI E. Unsure

5. What measures should be initiated for AG to treat and manage her immune-mediated colitis?

A. Supportive care, including loperamide, and encouraging adequate oral intake of fluids B. Systemic corticosteroids C. Increase in monitoring D. All of the above E. Unsure

6. AG returned to clinic after 2 weeks on systemic corticosteroids. Her symptoms persisted, so her corticosteroid dose was increased. After another 2 weeks, she is seen back in clinic and reports only 3 stools per day above her baseline (grade 1). What is the appropriate action at this time?

A. Begin to taper corticosteroids slowly over 4 to 6 weeks B. Add antimicrobial prophylaxis C. Add stress ulcer prophylaxis and calcium and vitamin D supplementation D. All of the above E. Unsure

7. For questions 7-10, please use the following CASE:
MA is a 49-year-old premenopausal Caucasian woman who presents to the outpatient oncology clinic for her newly diagnosed breast cancer found through screening mammogram. She had undergone an ultrasound, which confirmed a mass of 1.3 cm x 2.0 cm and negative axillary lymph nodes. A core biopsy of the mass indicated an invasive ductal carcinoma with nuclear grade of 3 and a Ki-67 of 58%; the tumor was estrogen and progesterone receptor negative, and the human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) score was +1. Her other work up showed no metastatic disease. The disease at this time is considered stage II (T2, N0, M0) triple-negative breast cancer (TNBC).

Which of the following choices would not be appropriate therapy for MA at this point?

A. Adjuvant chemotherapy with dose-dense AC-T (doxorubicin plus cyclophosphamide followed by paclitaxel) B. Adjuvant chemotherapy with dose-dense CMF (cyclophosphamide, methotrexate, and fluorouracil) C. Adjuvant chemotherapy with TC (docetaxel plus cyclophosphamide) every 3 weeks D. Neoadjuvant chemotherapy with AC-T (doxorubicin plus cyclophosphamide followed by paclitaxel) E. Unsure

8. MA is interested in neoadjuvant therapy with an immunotherapy agent. Which of the following is the most accurate information to provide to the patient?

A. Pembrolizumab is being studied in 2 clinical trials (I-SPY-2 and Keynote-522) as a neoadjuvant approach and, so far, the data is promising when pembrolizumab is combined with chemotherapy B. Pembrolizumab is approved in combination with paclitaxel as a new neoadjuvant treatment C. Immunotherapy agents did not show any promising data in the adjuvant setting D. Pembrolizumab is approved in combination with nab-paclitaxel as a new neoadjuvant treatment E. Unsure

9. MA would like to know, in detail, her chances of achieving pathologic complete response (pCR) if she receives standard neoadjuvant chemotherapy alone. What do you advise her?

A. Less than 10% of patients achieve pCR B. 10% to 20% of patients achieve pCR C. 30% to 40% of patients achieve pCR D. 50% of patients achieve pCR E. Unsure

10. Upon further testing, MA's tumor is noted to have BRCA1 and BRCA2 mutations and is programmed death-ligand 1 (PD-L1) positive. Which of the following is true, according to the IMpassion130 study?

A. Progression-free survival (PFS) is better in patients who have BRCA1/2 mutations and are PD-L1 negative B. PFS is better in patients who have BRCA1/2 mutations and are PD-L1 positive C. PFS is better in patients with wild-type BRCA1/2 and are PD-L1 negative D. PFS is better in patients with wild-type BRCA1/2 and an unknown PD-L1 status E. Unsure

Maintenance is scheduled for 8/7/2023 7:00 AM EST - 8:00 AM EST.

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2. What FDA-approved companion diagnostic should be used to evaluate AG's tumor to assess her eligibility for atezolizumab?

3. As the pharmacist, you order the appropriate companion diagnostic for ICI therapy for AG and the result was positive. What ICI combination is FDA-approved for the first-line treatment of AG's cancer?

4. AG was treated with 3 cycles of ICI plus chemotherapy when she developed severe colitis (grade 3: 7 bowel movements per day above her “normal”) that was deemed to be an immune-mediated adverse event (imAE). What is the appropriate action regarding her ICI?

5. What measures should be initiated for AG to treat and manage her immune-mediated colitis?

6. AG returned to clinic after 2 weeks on systemic corticosteroids. Her symptoms persisted, so her corticosteroid dose was increased. After another 2 weeks, she is seen back in clinic and reports only 3 stools per day above her baseline (grade 1). What is the appropriate action at this time?

8. MA is interested in neoadjuvant therapy with an immunotherapy agent. Which of the following is the most accurate information to provide to the patient?

9. MA would like to know, in detail, her chances of achieving pathologic complete response (pCR) if she receives standard neoadjuvant chemotherapy alone. What do you advise her?

10. Upon further testing, MA's tumor is noted to have BRCA1 and BRCA2 mutations and is programmed death-ligand 1 (PD-L1) positive. Which of the following is true, according to the IMpassion130 study?

Evaluation Questions

11. How confident are in your treatment choices for AG in above questions:

12. How confident are in your treatment choices for MA in above questions:

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Maintenance is scheduled for 8/7/2023 7:00 AM EST - 8:00 AM EST.

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2. What FDA-approved companion diagnostic should be used to evaluate AG's tumor to assess her eligibility for atezolizumab?

3. As the pharmacist, you order the appropriate companion diagnostic for ICI therapy for AG and the result was positive. What ICI combination is FDA-approved for the first-line treatment of AG's cancer?

4. AG was treated with 3 cycles of ICI plus chemotherapy when she developed severe colitis (grade 3: 7 bowel movements per day above her “normal”) that was deemed to be an immune-mediated adverse event (imAE). What is the appropriate action regarding her ICI?

5. What measures should be initiated for AG to treat and manage her immune-mediated colitis?

6. AG returned to clinic after 2 weeks on systemic corticosteroids. Her symptoms persisted, so her corticosteroid dose was increased. After another 2 weeks, she is seen back in clinic and reports only 3 stools per day above her baseline (grade 1). What is the appropriate action at this time?

8. MA is interested in neoadjuvant therapy with an immunotherapy agent. Which of the following is the most accurate information to provide to the patient?

9. MA would like to know, in detail, her chances of achieving pathologic complete response (pCR) if she receives standard neoadjuvant chemotherapy alone. What do you advise her?

10. Upon further testing, MA's tumor is noted to have BRCA1 and BRCA2 mutations and is programmed death-ligand 1 (PD-L1) positive. Which of the following is true, according to the IMpassion130 study?

Evaluation Questions

11. How confident are in your treatment choices for AG in above questions:

12. How confident are in your treatment choices for MA in above questions:

« Return to Activity

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