Case Study 10

For each question, choose the answer you think is correct. See the end of this page for the answers.

L.A. is a 77-year-old male diagnosed with stage IV non-small cell lung cancer. Biopsy testing demonstrates an EGFR-mutation positive adenocarcinoma. ALK and PD-L1 mutation testing are negative. His performance status is ECOG 1. He was deemed as an appropriate candidate for the LUAVAFAT protocol.

Lab results taken 24 hours prior to first treatment:

Lab value	Patient's labs	Normal range
WBC	7.3	4 – 10 x 10⁹/L
ANC	5.1	2 – 7.5 x 10⁹/L
Hgb	126	115 – 155 g/L
Plt	331	150 – 400 x 10⁹/L
SCr	59	45 – 90 umol/L
eGFR	86	≥ 60 mL/min/1.73m²
Albumin	37	35 – 50 g/L
GGT	32	<49 U/L
AST	26	<36 U/L
ALT	17	<36 U/L
ALP	96	35 – 120 U/L
Total bilirubin	4	<17 umol/L
LD	410	<225 U/L
CRP	56	<4.8 mg/L

Weight = 65.2 kg, Height = 165 cm

1. Which of the following are acceptable patient identifiers to confirm that the prescription you received was written for L.A.?

Patient's name
Patient's name and date of birth
Patient's name and PHN
Options 2 and 3 are correct
Any of the above

2. Which of the following best describes the BC Cancer benefit status of AFAtinib?

It is a Class I drug and does not require special approval prior to treatment
It is a Class I drug and special approval must be obtained prior to treatment
It is a restricted drug but does not require special approval prior to treatment
It is a restricted drug and case-by-case Compassionate Access Program (CAP) approval must be obtained prior to treatment

3. What type of drug therapy is AFAtinib classified as?

Chemotherapy
Targeted therapy using PD-1 immune checkpoint inhibition
Targeted therapy using tyrosine kinase inhibition
Targeted therapy using CDK4/6 inhibition

4. What is the standard dosing regimen of AFAtinib?

one 40 mg tablet PO once daily on an empty stomach
one 40 mg tablet PO once daily for 2 weeks, then 2 weeks off
one 40 mg tablet PO once daily for 3 weeks, then 1 week off
one 40 mg tablet PO once daily with a high-fat meal

5. L.A. is concerned about developing diarrhea and asks for your advice on management so he can best prepare himself. All of the following recommendations would be appropriate EXCEPT:

Keep an adequate supply of loperamide 2 mg tablets at home so diarrhea can be treated at the first sign of loose or more frequent stools than usual
Follow the loperamide package instructions for treatment of diarrhea at the first sign of loose or more frequent stools than usual
To help with diarrhea: drink plenty of fluids, eat and drink often in small amounts, and avoid high-fibre foods
If you are lactose-intolerant, you may need to take LACTAID® tablets before each AFAtinib dose
Call your doctor if diarrhea does not improve 24 hours after starting loperamide

6. After 3 weeks of continuous therapy, L.A. develops a mild acneiform rash on his face and upper chest and calls the physician for help. Which of the following would NOT be an appropriate management option?

Treat the affected area with a topical steroid cream. Counsel to avoid sun exposure and to wear appropriate sun protection
Treat with oral diphenhydramine. Counsel to avoid sun exposure and to wear appropriate sun protection
Treat with oral pantoprazole. Counsel to avoid sun exposure and to wear appropriate sun protection
Treat with oral minocycline. Counsel to avoid sun exposure and to wear appropriate sun protection

7. Upon disease progression on AFAtinib, which of the following second-line treatment options would L.A. be eligible for?

gefitinib 250 mg PO once daily
erlotinib 150 mg PO once daily
Immunotherapy with nivolumab 6 mg/kg every 4 weeks
Platinum-based doublet with CISplatin/CARBOplatin and DOCEtaxel/PACLitaxel
All of the above

Answer 1

The correct answer is 4.

Rationale: According to the BC Cancer Clinical Pharmacy Guide module 2, a minimum of two patient identifiers are required to confirm patient identity. These identifiers include two of the following: name, date of birth, identification number (BC Cancer/hospital/PHN).

Answer 2

The correct answer is 1.

Rationale: According to the BC Cancer Benefit Drug List, AFAtinib is a class I drug. This means that as long as the patient meets the eligibility criteria specified in the protocol, they may receive AFAtinib at no charge from BC Cancer.

Answer 3

The correct answer is 3.

Rationale: As mentioned in the BC Cancer drug monograph for AFAtinib, it is a second generation tyrosine kinase inhibitor that irreversibly binds to the kinase domains of EGFR, HER2 and HER4.

Answer 4

The correct answer is 1.

Rationale: As mentioned in the LUAVAFAT protocol, AFAtinib is taken orally once daily on an empty stomach (at least 1 hour before or 3 hours after a meal). The standard starting dose is 40 mg daily.

Answer 5

The correct answer is 2.

Rationale: Diarrhea is managed with a dose that is much higher than the package instructions for loperamide. Patients are instructed to use 4mg immediately, followed by 2mg with every loose bowel movement, up to a maximum of 20mg daily. Loperamide should be continued until 12 hours after the last loose bowel movement.

Answer 6

The correct answer is 3.

Rationale: According to the BC Cancer drug monograph for AFAtinib, dependent on severity, management of acneiform rash includes topical or systemic steroids, anti-infectives or antihistamines.

Answer 7

The correct answer is 4.

Rationale: As mentioned in the LUAVAFAT eligibility criteria, use of first-line AFAtinib to progression precludes the use of both gefitinib and erlotinib as any subsequent line of therapy in the same patient. Therefore, consideration should be given to a standard platinum-based doublet as second-line therapy. L.A. does not yet meet the eligibility criteria to receive immunotherapy.