Javier Pinilla-Ibarz, MD, PhD: Dose Intensity

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What is the importance of achieving good dose intensity in this patient?

The clinical trial has shown that the use of three pills, in this case, 460 mg/day of ibrutinib, is the optimal dosing to achieve the best response. However, there is no doubt that some patients may [experience] side effects, acute or chronic, [which] may decrease quality of life. Patients may ask, or doctors may consider, dose reduction when these side effects negatively affect quality of life of CLL patients that relapse.


Case 1: Relapsed and Refractory CLL

Robert is a 63-year-old retired civil engineer from Houston, Texas. His medical history is notable for mild hypertension and for an acute appendicitis and appendectomy in 2010. He presented to his PCP in September 2012 with symptoms of intermittent fatigue and abdominal discomfort.

On physical examination, Robert showed moderate splenomegaly (12 cm), lymphadenopathy, and CBC showed elevated WBC count of 98 x 109/L, with 80% lymphocytes, and anemia (Hb 11 g/dL).

He was referred to an oncologist for further evaluation and was subsequently diagnosed with (CLL); peripheral blood flow cytometry showed mature B lymphocytes CD5+/CD23+.

Interphase cytogenetic analysis showed 17p13.1 deletion

He was initiated on chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR) in October 2012

After 5 cycles he displayed a complete response, with disappearance of palpable disease, normalization of blood counts, and no evidence of disease on bone marrow biopsy and CT scans.

In January 2015, he presented to his oncologist with symptoms of worsening fatigue and abdominal distension.

  • On relapse he shows bulky disease 5.5 cm; Hb 12 g/dL, platelets 120,000 cells/mm3, lymphocytes 39,000/mm3, and beta 2 microglobulin of 4.1 mg/L
  • His ECOG performance status at the time of recurrence was 1, and liver and kidney function were within normal limits
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