In Treating Older CLL Patients, Cost Considerations Are a Factor

New therapies to treat chronic lymphocytic leukemia (CLL) will receive plenty of attention this week at the 55thAmerican Society of Hematology Annual Meeting and Exposition in New Orleans. At an education session that opened the meeting Saturday, a physician with the Mayo Clinic made it clear that cost considerations are a reality for many older patients.

Tait Shanafelt, MD, who discussed management of elderly patients with CLL, said after appearing on the panel, “Chronic Lymphocytic Leukemia: A New Era is Born,” that for all the excitement surrounding targeted therapies, it is important to understand that many of the older chemotherapies remain quite effective and may remain a viable option in older patients whose disease is moving slowly.

CLL is a blood cancer that occurs when abnormal white blood cells called lymphocytes accumulate in the blood, bone marrow, and lymph nodes or other organs, causing these organs to enlarge. Approximately 15,000 Americans are diagnosed with CLL every year, and nearly 70 percent of those affected are 65 or older. For some patients with a slower progressing disease, many physicians employ “watch and wait” strategies to minimize unnecessary toxic treatments. However, patients with high-risk features or a more rapidly progressing disease require prompt treatment.

The nature of the difference between the profile of older and younger CLL patients — not just in disease progression, but also in resources on hand to combat it – came through in Dr Shanafelt’s talk. He pointed to the example of the ibrutinib, which just won accelerated approval from the US Food and Drug Administration to treat mantle cell lymphoma (MCL). Some estimates peg the drug’s cost at $125,000 a year; Shanafelt asked whether it is realistic to think patients who are all on Medicare will spend “$500,000 or $600,000” on the drug.

Dr Shanafelt’s talk discussed the unique nature of CLL, specifically that it is a leukemia of advanced age, with most of its patients suffering at least 1 comorbidity. He reviewed how the classification of the “fitness” of CLL patients is important and not always obvious, what criteria should be used to classify patient fitness, when elderly patients should be treated, how therapy should be selected for elderly patients, and which therapy is best for each individual patient.

Classifying a patient’s fitness level is extremely important in determining that person’s life expectancy outside of the CLL diagnosis, from which all treatment decisions flow. “Fitness” is not determined by a single variable, but by an examination of age, overall health and organ condition. “There’s no standard criteria,” for what constitutes, 'elderly,' ” he said.

Dr Shanafelt appeared with Michael Hallek, MD, of the University of Cologne, who addressed how to treat patients who exhibit fitness with new therapies. Hallek, whose work has focused on younger, fitter patients with CLL, is a driving force behind the studies that led to the recent approval of obinutuzumab, which on November 1, 2013, received FDA’s green light for use in combination with chlorambucil for the treatment of patients with previously untreated CLL.

Also appearing was John Gribben, MD, of Barts Cancer Institute in London, who gave a clinical overview including features of immunosuppression, which causes increased susceptibility to infections and failure of an anti-tumor immune response. Gribben discussed the status of allogeneic stem cell transplantation (SCT) and other immunotherapeutic approaches such as CLL vaccines, and stated that transplantation should not be occurring outside a clinical trial.

Advances in targeted therapies for CLL were the focus of today’s major press announcement at ASH, where researchers presented data to highlight progress in developing treatments to precisely aim at proteins known to trigger CLL, while leaving normal cells unharmed. Three studies presented today revealed data on the performance of several new CLL therapies that demonstrate potent effects on key regulators of cancer cell behavior.

“These exciting developments in CLL therapy represent a shift toward treatments that hone in on specific regulators of cancer, ultimately providing a safer and more effective treatment regimen,” said Jennifer R. Brown, MD, PhD, director of the Chronic Lymphocytic Leukemia Center at Dana-Farber Cancer Institute in Boston. “These data give us even more reason to believe that the future outlook for CLL patients is bright.”