Javier Pinilla-Ibarz, MD, PhD: Phase III Data to Support Usage of Bruton's TKIs
Relapsed and Refractory CLL with Javier Pinilla-lbarz, MD, PhD and Paul Barr, MD: Case 2
What phase III data support the use of a Bruton’s tyrosine kinase inhibitor in this patient?
In terms of a BTK inhibitor, one must look at the Resonate trial. The use of a monoclonal antibody should be compared to the antigen CD20 and ibrutinib as a comparator arm. This shows once again that the benefit of this drug, ibrutinib, is independent of the cytogenetic group of patients.
Case 2: Relapsed and Refractory CLL
James S. is a 67-year-old college professor from Ithaca, New York; he is a Vietnam veteran with a history of treatment for Agent Orange exposure; his history is also notable for prior smoking (15-pack year) and mild COPD.
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In November 2013, he presented to his PCP for a routine physical; his examination showed mild lymphadenopathy and his CBC showed evidence of lymphocytosis (lymphocytes 6 x 109/L); he was referred to an oncologist for further diagnostic evaluation.
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Differential diagnosis showed B-cell CLL, with absolute lymphocytosis (19,000/mm3) and flow cytometry positive for CD5 and CD23.
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Interphase cytogenetic analysis showed no deletion of 17p.
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The oncologist initiates treatment with bendamustine/rituximab (BR) and James shows improvement in hematologic parameters after 6 cycles.
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James was out of the country at a meeting, and he failed to return for a scheduled follow-up appointment in January 2015.
In March 2015, he presented to his oncologist with symptoms of unintentional weight loss over the past 2 months (>10%), severe fatigue (interfering with work), and dyspnea; his CBC is consistent with worsening anemia and thrombocytopenia.
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CT scan shows evidence of extensive abdominal lymph node recurrence.
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At the time of his recurrence, James’s ECOG performance status was 2, and liver and kidney functioning were within normal limits.
