Case Study 11

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

A.P. is a 50-year-old female diagnosed with metastatic breast cancer with a primary lesion in the left breast and disease involving bones, lungs and liver. Tumour is ER-positive, PR-positive, and HER2-negative. She has pain in her right upper quadrant radiating towards the left scapula. She is also on pamidronate. She will be starting treatment with BRAVPALAI.

Lab results taken 24 hours prior to first treatment:

Lab value	Patient's labs	Normal range
WBC	3.3	4 – 10 x 109/L
ANC	1.7	2 – 7.5 x 109/L
Hgb	142	115 – 155 g/L
Plt	190	150 – 400 x 109/L
SCr	54	45 – 90 umol/L
eGFR	93	≥ 60 mL/min/1.73m2
GGT	34	<49 U/L
AST	26	<36 U/L
ALT	32	<36 U/L
ALP	128	35 – 120 U/L
Total bilirubin	7	<17 umol/L
LD	156	<225 U/L

Weight = 53.8 kg, Height = 160 cm

1. Which of the following patient populations would be eligible to receive palbociclib?

Post-menopausal women with ER-negative, HER-2 positive advanced breast cancer with no prior systemic treatment for metastatic disease
Women receiving concurrent ovarian suppression with no prior treatment for metastatic disease
Post-menopausal women with ER-positive, HER-2 positive advanced breast cancer with prior systemic chemotherapy for metastatic disease
Post-menopausal women with ER-positive, HER-2 negative advanced breast cancer with no prior systemic treatment for metastatic disease
Options 1 and 2 are correct
Options 2 and 4 are correct

2. What is the standard dosing regimen of palbociclib?

One tablet PO once daily continuously until disease progression or unacceptable toxicity
One tablet PO once daily for 3 weeks, then 1 week off until disease progression, unacceptable toxicity, or a maximum of 2 years of treatment
One tablet PO once daily for 3 weeks, then 1 week off until disease progression or unacceptable toxicity
One injection given subcutaneously every 3 months until disease progression or unacceptable toxicity

3. On day 15 of Cycle 1, A.P's bloodwork reveals the following: ANC = 0.8 x 10⁹/L, Platelets = 100 x 10⁹/L. Per protocol, she continues treatment at the same dose. Hematology is repeated on day 22: ANC = 0.7 x 10⁹/L, Platelets = 105 x 10⁹/L. Per protocol, which of the following would be the most appropriate treatment plan?

Nothing; there are no dose modifications based on Cycle 1 Day 22 bloodwork
Delay the start of Cycle 2 by 1 week; provided ANC recovers to ≥ 1 x 10⁹/L, resume treatment at the same dose
Delay the start of Cycle 2 by 1 week; provided ANC recovers to ≥ 1 x 10⁹/L, resume treatment at the next lower dose
Keep treatment as scheduled (without delay); provided ANC recovers to ≥ 1 x 10⁹/L prior to Cycle 2, resume treatment at the same dose
Keep treatment as scheduled (without delay); provided ANC recovers ≥ 1 x 10⁹/L prior to Cycle 2, resume treatment at the next lower dose

4. A.P. returned to clinic in anticipation of Cycle 2 with Day 1 blood work reporting: ANC = 0.4 x 10⁹/L, Platelets = 100 x 10⁹/L. Her treatment was delayed for 1 week. Repeat bloodwork now reports: ANC = 1.1 x 10⁹/L, Platelets = 153 x 10⁹/L. Per protocol, which of the following would be the most appropriate treatment plan?

Resume treatment at the same dose as previous, 125 mg/day
Resume treatment at the next lower dose, 100 mg/day
Delay treatment for 1 more week, then resume at the same dose as previous, 125 mg/day
Resume treatment at the next lower dose of 75 mg/day

5. Which of the following would best explain why A.P. is also receiving pamidronate (Protocol code: BRAVPAM)?

She has symptomatic hypocalcemia
She has a history of atypical femoral fracture
She is experiencing acute bone pain
She has a diagnosis of osteopenia

6. A.P. now returns to clinic in anticipation of Cycle 8, but without any bloodwork. Based on the protocol, would it be okay for her to proceed with treatment today without current labs?

Yes; after cycle 7, CBC monitoring is no longer required
Yes; results from Cycle 7 are available and CBC won't be repeated again until Cycle 10
No; CBC should be monitored with each subsequent cycle
Yes; results from Cycle 7 are available and CBC won't be repeated again until Cycle 9

Answer 1

The correct answer is 6.

Rationale: As per the revised eligibility of BRAVPALAI after PALMOA-3 trial results were published, women who are on concurrent ovarian suppression (with LHRH agonists) are also eligible to receive treatment.

Answer 2

The correct answer is 3.

Rationale: According to the BRAVPALAI protocol, palbociclib is taken orally once daily for 21 days on, 7 days off with one cycle being 28 days long until disease progression or unacceptable toxicity.

Answer 3

The correct answer is 4.

Rationale: Based on the BRAVPALAI dose modification table, if ANC is between 0.5 to less than 1 x 10⁹/L on days 15 and 22, treatment can be resumed at the same dose level.

Answer 4

The correct answer is 2.

Rationale: Based on the BRAVPALAI dose modification table, if the patient experiences grade 4 neutropenia (ANC < 0.5 x 10⁹/L), hold treatment until ANC ≥ 1 x 10⁹/L, and resume treatment at next lower dose.

Answer 5

The correct answer is 3.

Rationale: The BRAVPAM protocol indicates that patients with acute pain secondary to metastatic breast cancer are eligible for treatment.

Answer 6

The correct answer is 3.

Rationale: As per the tests section of the protocol, CBC monitoring requirements for Cycle 7 onwards are based on ANC values from Cycles 1-6, with the ANC threshold being 1 x10⁹/L. During the first 6 cycles of treatment, A.P.'s ANC dropped below 1 x10⁹/L, and therefore, per protocol, CBC should continue to be monitored with each cycle of treatment.