Background and Importance Ibrutinib has revolutionised the treatment of chronic lymphocytic leukaemia (CLL). Clinical trial data showed similar survival between patients randomised to ibrutinib or chemoimmunotherapy with crossover to ibrutinib at progression.
Aim and Objectives Outcome analysis of the real-life use of ibrutinib after relapse to conventional chemotherapy in patients with chronic lymphocytic leukaemia.
Material and Methods Observational retrospective study of patients treated with ibrutinib as second line from 2017 to the present at a tertiary level hospital. Clinical variables: sex, age, diagnosis date, comorbidities, Eastern Cooperative Oncology Group scale (ECOG), Binet Staging System, cytogenetics (mutation TP53, immunoglobulin heavy-chain variable region gene (IGHV), chromosome delection (11, 13, 12 and 17), treatment, duration, response (complete, partial) and relapse, progression-free survival (PFS), adverse effects, dose modification or discontinuation. Data was obtained from electronic prescription with the application Prisma® and electronic health records with Diraya®.
Results 31 patients were treated with ibrutinib (18 patients as second line and 13 as third). Median age 71 years (IQR 65-78), 51.6% male. Median age of diagnosis 2012 (IQR 2008-2014). 29.5% of patients had previous hypertension, 23.6% kidney disease, 17.3% diabetes mellitus, 11.8% cardiac diseases and 5.5% respiratory pathologies. 41% of patients had Binet Staging A, 28.4% B and 5.8% C. All patients had ECOG 0. TP53 mutated in 16 patients, 15 with unmutated IGHV, 24 with 11q negative and 18 with 13q and 17q negative. Treatments used as first line were chlorambucil (9), fludarabine, cyclophosphamide and rituximab (7), bendamustine and rituximab (5). 14 patients achieved complete response, 4 partial and 7 discontinued due to toxicity. PFS 19.17 months. As second line in patients without ibrutinib, the most frequent treatment was bendamustine with rituximab (50%). All except one started with 420 mg dose. Median duration of treatment was 32 months. 11 patients reduced dose due to toxicity (66.6% diarrhoea, 16.6% renal failure and skin toxicity), 7 suspended indefinitely due to cardiac toxicity and 4 temporarily due to cardiac and gastrointestinal toxicity. 4 patients died from causes other than the disease. No patient lost response to treatment.
Conclusion and Relevance Treatment with ibrutinib proved effectiveness as second or third line in CLL. However, adverse effects require dose adjustments and sometimes discontinuation.
Conflict of Interest No conflict of interest
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