How HCPs Can Support Informed Treatment Discussions About Calquence and Brukinsa
Targeted therapies are among the treatment options for Chronic Lymphocytic Leukemia. Healthcare Professionals (HCPs) are expected to educate their patients on the various treatment options available, including the benefits and risks of said treatments as well as the monitoring and management of any adverse effects that may occur. BTK inhibitors such as Calquence (acalabrutinib) and Brukinsa (zanubrutinib) are approved for the treatment of adults with CLL or SLL (small lymphocytic lymphoma).
Informed treatment discussions not only include the choice of the right medicine for a patient. Patients also need to be informed about the reasons for choosing a specific treatment, the expected outcomes of the chosen treatment, how the treatment is given, what kind of side effects need to be monitored, and how a patient’s specific characteristics could affect a choice of treatment for his/her leukemia.
Establishing the Clinical Context
The clinical context of the patient’s disease needs to be explained to the patient before any discussion of individual treatments. Treatment of CLL can progress in different ways and not all patients with CLL might need treatment for their disease. However, when a patient does need treatment for their CLL, there are a number of factors that can influence the choice of treatment. These factors include the patient’s disease, previous treatment, molecular characteristics, co-morbidities and overall health.
Additional consideration should be made for a patient’s prior CLL treatment. There are different approaches to treat a patient newly diagnosed with CLL compared to a patient with relapsed or refractory CLL. Furthermore, prior treatment with targeted therapies, including other BTK inhibitors, can influence the choice of a subsequent BTK inhibitor, as resistance may have developed.
Explaining the Role of BTK Inhibition
HCPs need to explain to patients and their families about how BTK inhibitors work. By explaining that BTK is part of the signaling pathway of the B-cell receptor and that, by inhibiting BTK, acalabrutinib and zanubrutinib interfere with the activation, proliferation and survival of malignant B cells, they can give them an idea of what kind of medicine they are taking and how it works.
HCPs need to explain to patients the difference between Calquence and Brukinsa. Even though they are in the same class of targeted therapy for CLL/SLL, HCPs and their patients need to understand the key differences. Calquence is an oral targeted therapy for the treatment of adults with CLL/SLL. It is taken approximately every 12 hours with 100 mg per dose, as stated in the U.S. prescribing information. Brukinsa (Zanubrutinib) is also an oral targeted therapy, for the treatment of adults with CLL/SLL. The U.S. prescribing information for Brukinsa lists 160 mg taken twice daily or 320 mg taken once daily.
Discussing Efficacy Without Overpromising
Efficacy of CLL Treatment: When discussing the different treatment options with patients, the HCPs should use the most relevant clinically meaningful endpoints and provide evidence from the most relevant clinical trial(s) conducted in similar patient populations in similar clinical settings. For example, the progression-free survival (PFS), overall response rate (ORR), and duration of response (DOR) for patients with previously untreated CLL in clinical trials of acalabrutinib and zanubrutinib should be provided to patients. It should be explained to patients that clinical trial results are based on a group of patients who participated in a clinical trial and that individual results may vary.
Direct comparison data versus indirect comparison data: When reviewing data from studies that compare different treatment options, including studies that compare the different BTK inhibitors, it is very important to note the patient population under study as well as the comparison therapy(s) and the study duration. Additionally, the inclusion and exclusion criteria for the patient populations studied in each of the individual trials can affect the results in very significant ways. Thus, one should be very cautious in using the results of individual trials to make conclusions regarding the relative efficacy of the different BTK inhibitors.
The health care provider should acknowledge the uncertainty in selecting a treatment for a patient’s condition when there is limited amount of evidence to support the treatment of patients with similar clinical presentations. The health care provider and patient can then discuss the limited amount of evidence that supports the selection of a particular treatment for the patient’s condition and avoid unrealistic treatment outcomes.
Reviewing Safety and Monitoring
Calquence Brukinsa come with important warnings and precautions, including risks of serious and potentially life-threatening adverse reactions. The warnings and precautions for Brukinsa include embryo-fetal toxicity. Healthcare professionals may monitor patients for certain treatment-related adverse reactions through evaluation of hemoglobin, platelet count, absolute neutrophil count, cardiac function, liver function, and others.
Blood tests to check for other cytopenias (in addition to low white blood cells) need to be done when a patient is on a treatment that can cause a decrease in white blood cells. These test results can then be reviewed by the HCP to assess whether the treatment is still appropriate for that patient.
Reviewing Drug Interactions and Practical Considerations
It is also very important to review with patients all of the prescription medicines, as well as over-the-counter medicines and supplements that the patient is currently taking before starting any oral targeted therapies. In addition, all of the new medicines that are going to be added to their current list of medicines as well as all of the current medicines that are going to be discontinued from their current list of medicines need to be reviewed with patients beforehand.
Both Calquence and Brukinsa have been reviewed for their clinical drug interaction considerations as CYP3A inhibitors and inducers with some key differences between the two drugs.
Review the information with the patient on how to take the medication, what to do if a dose is missed, how to store the medication, and when to contact the HCPs. This is particularly important for patients on long-term oral targeted therapy who will be taking their medication outside of the hospital or infusion center setting.
Considering Patient-Specific Factors
Patient specific factors that may affect treatment choices for a patient with CLL would include age, co-morbid CVD, risk of bleeding, history of infections, liver function, current medications, previous treatments for CLL and patient preferences.
There are many other factors related to the disease that are important to discuss in the treatment discussion with patients. These factors include the molecular characteristics of their CLL, such as the presence of TP53 mutations and del(17p). These factors can affect the prognosis and help to determine the appropriate treatment.
Encouraging Shared Decision-Making
Shared decision-making that involves the patient in the treatment decision making process is important. Healthcare professionals may discuss the reasons for a proposed treatment option and address patients’ priorities and concerns.
Questions from patients and families can help understand the rationale behind the timing and selection of treatment, as well as treatment goals. Topics of discussion may include the recognition and management of treatment-related adverse reactions, the expected course of treatment, alternative treatment approaches, and the eligibility for clinical trials.
It may be helpful to provide patients with written copies of the key points from their consultation and to encourage them to bring a family member or caregiver with them to the consultation as well, in order that all relevant individuals can gain an understanding of the patient’s treatment.
Maintaining Ongoing Communication
An informed discussion about the treatment of CLL must continue throughout the course of the disease, as the status of the CLL, the patient’s ability to tolerate treatment, the changes in the laboratory values for the patient, the introduction of new medicines for the treatment of CLL and the changing priorities and concerns of the patient must all be discussed.
Patients need to inform their health care providers in case of any adverse effects or other problems that might occur, and health care providers may address those problems and even modify treatment as necessary.
Patient-centred care aims to support the patients and their families in making appropriate treatment decisions. In addition to explaining the treatment options that are available for CLL, including clinical trials, the healthcare professional must keep the patient informed of the positive and negative aspects of each of the treatments for the duration of time that the patient is on each treatment.
Medical Disclaimer: The information provided in this article is intended for educational purposes only and should not be interpreted as medical advice, clinical guidelines, or a recommendation for any specific treatment.
