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New and Emerging Developments in the Management of Chronic Lymphocytic Leukemia: Role of the Pharmacist

JHOP - December 2016 Vol 6, No 4
Patrick J. Medina, PharmD, BCOP
Medical Science Liaison
Medical Affairs, GlaxoSmithKline
Collegeville, PA
Adjunct Professor of Pharmacy
University of Oklahoma College of Pharmacy
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An estimated 19,000 new cases of chronic lymphocytic leukemia (CLL) will be diagnosed this year in the United States, with more than 4600 deaths resulting from this hematologic malignancy.1 Historically, the management of patients with CLL with nucleoside analogue-based chemotherapy could have been avoided until the patient became symptomatic, or until a rapid progression of the disease was displayed. However, with the recent approval of new targeted agents by the US Food and Drug Administration (FDA), treating patients earlier in the disease course or for longer periods of time with maintenance therapy have started to become more common.

This issue of the Journal of Hematology Oncology Pharmacy includes the third and final part of the 3-part series on the recent developments and a variety of treatment issues related to the management of CLL by Combest and colleagues.2

The first part in the series appeared in this journal in June 2016 and focused on the changing clinical trial and financial landscape regarding the treatment of CLL.3 Dr Combest and colleagues discussed the rapid expansion of clinical trials for CLL, as well as the 4 new agents that have been approved since late 2013. Not surprisingly, they noted that these new therapies come at an annual cost of more than $100,000.3

The continued increase in oral chemotherapy agents receiving FDA approval, and their expanded use in the first-line setting or their incorporation with intravenous agents continue to affect oncology practice. Approximately 25% or more of all cancer drugs recently approved by the FDA are oral agents, and this trend is expected to continue or even increase in the coming years.

In part 2 of this article series, the authors focused on the increased use of cytogenetics to determine the best therapies for patients with CLL, specifically for those with deletion of chromosomes 11q and 17p, as well as look for more active and tolerable regimens for older patients.4 The authors conducted a thorough review of the role of the new agents for the treatment of CLL with regard to tailoring chemotherapy choices to the patient's age, comorbidities, and cytogenetic results, as well as the new developments associated with these new treatment options. For example, the use of ibrutinib in the first-line setting for patients with CLL associated with deletion 17p is now listed by the National Comprehensive Cancer Network as a preferred option over traditional chemotherapy.5

As noted above, the current issue includes the final part of the series.2 In this third and final portion of the series, Combest and colleagues try to predict the future of CLL with regard to the rapidly changing landscape of managing patients with this hematologic malignancy. The authors provide a review of current and planned clinical trials that include FDA-approved and emerging investigational agents for the treatment of patients with CLL. In addition to new agents that target B-cell signaling, such as next-generation Bruton's tyrosine kinase and phosphoinositide 3-kinase inhibitors, new targeted agents, including spleen tyrosine kinase inhibitors and checkpoint inhibitors, are being discussed.

With more than 100 clinical trials related to CLL management accumulating worldwide, the treatment landscape of this disease is expected to continue to evolve rapidly, as long as the barriers to patient accrual to clinical trials can be overcome.

The use of fludarabine-based chemotherapy with rituximab is no longer the only option for treating patients with symptomatic CLL. Drugs that target new pathways in this malignancy have allowed us to choose therapies based on a variety of clinical- and disease-based factors.

Pharmacists can assist in many aspects of care for patients with CLL, especially regarding drug procurement, patient counseling for oral medications that are being taken at home, as well as the management of adverse events, as long as pharmacists remain up to date on the rapidly changing treatment options outlined by Combest and colleagues in this 3-part series.

1. National Cancer Institute Surveillance, Epidemiology, and End Results Program. SEER stat fact sheets: chronic lymphocytic leukemia (CLL). 2016. Accessed November 14, 2016.
2. Combest AJ, Danford RC, Andrews ER, et al. Overview of the current development landscape in chronic lymphocytic leukemia, part 3. J Hematol Oncol Pharm. 2016;6(4):137-144.
3. Combest AJ, Danford RC, Andrews ER, et al. Overview of the recent developments in chronic lymphocytic leukemia, part 1. J Hematol Oncol Pharm. 2016;6(2):54-56.
4. Combest AJ, Danford RC, Andrews ER, et al. Overview of the current treatment paradigm in chronic lymphocytic leukemia, part 2. J Hematol Oncol Pharm. 2016;6(3):89-94.
5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia. Version 1.2017. September 28, 2016. Accessed November 9, 2016.

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