Patients who take a more active role in their treatment are more likely to follow physician direction and take their medication as prescribed, which ultimately can lead to better outcomes.1,2 Brochures such as Reaching Your New Ph+ CML Treatment Goals may be available (depending on local legal and regulatory specifications) to help patients better understand their treatment and encourage them to take a more active role. Contact your local Novartis representative for more information.
Here are some answers to commonly asked questions that you may hear from your patients:
What is an RQ-PCR test?
An RQ-PCR test is a simple blood test that measures the number of Ph+ CML cells in your blood.3 It is an important test to perform because it is very sensitive. It can detect 1 Ph+ CML cell out of 100,000 cells, so it can detect very low numbers of remaining Ph+ CML cells.3 Remember, the lower the amount of Ph+ CML cells left in the blood, the less chance there is for Ph+ CML to relapse and progress.4-6 Therefore, this test will help us know how well your treatment is working and help us make better decisions about your care.
What is a log drop?
An RQ-PCR test measures the number of Ph+ CML cells in your blood. The way it counts the decrease of cells is in terms of a log drop or log reduction.4 Each log reduction means you have 10 times fewer BCR-ABL genes than you had at diagnosis.7 For example, a 1 log reduction is the same as dividing the number of Ph+ cells you have at diagnosis by 10. Ultimately, what is most important is that the trend of your log reductions continues to decrease over time until you reach a major molecular response, which is equivalent to a 3-log reduction (or 0.1% BCR-ABL to control gene ratio on the international scale).4 Results from 2 landmark studies show that patients who have a major molecular response have a much better chance of remaining free from disease progression, or relapse.8,9 This means their Ph+ CML cells didn’t increase for a long period of time.
When should I get a RQ-PCR test?
RQ-PCR tests are recommended at diagnosis and every 3 months until you achieve a major molecular response.10 After that, we will give you an RQ-PCR test every 6 months.10 These are simple blood tests that we will do when we regularly take blood to monitor your progress.
When should I expect to reach MMR?
Experts recommend certain response goals at different time points: a CHR at 3 months, a CCyR at 12 months, and an MMR within 18 months. We will continue to monitor your blood frequently to ensure the trend of Ph+ CML disease is continuing to go down and evaluate you according to response.10 It’s important to remember that you still need to take your medication every day as directed to keep Ph+ CML cells from coming back.
What happens if a result shows an increase?
You may receive a test result that doesn’t show a continued reduction of Ph+ CML cells. It’s not a cause for alarm. Results may vary from time to time for a number of reasons. For example, if you have missed doses, or if a different lab was used, the test results could vary. This doesn’t necessarily mean your Ph+ CML is relapsing and getting worse. We will simply schedule an extra test to make sure you are still on track.10
Why is it important for me to take my medicine as directed?
If you don’t take your medicine exactly as directed, it increases the chance that your Ph+ CML will relapse and get worse.1,2 Clinical studies have shown that patients who take their CML medicine every day have significantly higher chances of reaching a major molecular response, which is linked to a significantly lower risk of their Ph+ CML relapsing and getting worse.1,2,8
If your medication makes you feel bad, don’t skip a dose! I can help you manage most side effects by giving you over-the-counter medicines that may help you feel better. If you feel great and want to forget your disease, don’t skip a dose! Remember that you must take your medication as prescribed to achieve and maintain an optimal response.
How can I keep from forgetting to take my medicine?
There are a number of ways to help remind you take your medicine. These may include trying to link taking your medication to a daily ritual, setting a cell phone alarm, scheduling a meeting or appointment reminder to take your medicine, or enlisting a treatment buddy to help remind you. Remember that you must take your medication as prescribed to achieve and maintain an optimal response.1,2
Why is a major molecular response an important treatment goal?
The optimal goal of therapy is to achieve and maintain a major molecular response, which greatly reduces the risk of Ph+ CML relapsing and getting worse. Results from 2 landmark studies show that patients who have a major molecular response have a much better chance of remaining free from disease progression, or relapse. This means their Ph+ CML cells didn’t increase for a long period of time.8,9
What is a complete molecular response?
A complete molecular response is the absence of any detectable Ph+ CML cells in your body. Taking your medication as prescribed once you achieve a major molecular response may further reduce the number of Ph+ CML cells remaining in your body to a level so low they are no longer detectable.7
Next: Maximizing Adherence
Note: Before prescribing, please read full European Summary of Product Characteristics.
References
- Marin D, Bazeos A, Mahon FX, et al. Adherence is the critical factor for achieving molecular responses in chronic myeloid leukemia patients treated with imatinib for at least two years. J Clin Oncol. 2010;28(14):2381-2388.
- Noens L, van Lierde MA, De Bock R, et al. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood. 2009;113:5401-5411.
- Radich JP. How I monitor residual disease in chronic myeloid leukemia. Blood. 2009;114(16):3376-3381.
- Hughes T, Deininger M, Hochhaus A, et al. Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood. 2006;108(1):28-37.
- Palandri F, Iacobucci I, Soverini S, et al. Treatment of Philadelphia-positive chronic myeloid leukemia with imatinib: importance of a stable molecular response. Clin Cancer Res. 2009;15(3):1059-1063.
- Hughes TP, Hochhaus A, Branford S, et al. Reduction of BCR-ABL transcript levels at 6, 12, and 18 months (mo) correlates with long-term outcomes on imatinib (IM) at 72 mo: an analysis from the International Randomized Study of Interferon versus STI571 (IRIS) in patients (pts) with chronic phase chronic myeloid leukemia (CML-CP). Blood. 2008;112(11):Abstract 334.
- Baccarani M, Pane F, Saglio G. Monitoring treatment of chronic myeloid leukemia. Haematologica. 2008;93(2):161-166.
- Deininger M, O’Brien SG, Guilhot F, et al. International randomized study of interferon and STI571 (IRIS) 8-year follow-up: Sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase treated with imatinib. Poster presented at: 51st American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2009; New Orleans, LA.
- Saglio G, Kim D-W, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010;362(24):2251-2259.
- Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol. 2009;27(35):6041-6051.