Long term follow up of treatment with ibrutinib and rituximab (IR) in patients with high-risk Chronic Lymphocytic Leukemia (CLL)
Mené sur 40 patients atteints d'une leucémie lymphoïde chronique à haut risque (âge médian : 65 ans, durée médiane de suivi : 47 mois), cet essai analyse l'efficacité, du point de vue du le taux de réponse globale et de la survie sans progression, d'un traitement de première ligne combinant ibrutinib et rituximab
Background: Ibrutinib is an active therapy with acceptable safety profile for patients with CLL, including high-risk patients with del17p or with TP53 mutations. Ibrutinib is broadly indicated for the treatment of patients with chronic lymphocytic leukemia and specifically including those with 17p deletion. The optimal use of ibrutinib in combination with other agents, remains controversial. Methods: We report the long term outcome [median follow up of 47 months (range 36-51 months)] of 40 patients with high risk CLL, treated on the first ibrutinib combination trial with rituximab (IR). The majority of patients (36/40) were previously treated. Results: Median age was 65 years and 21 patients (52%) had 17p deletion. Median duration on treatment was 41 months (range 2-51 months) and median number of treatment cycles was 42 (range 2-49). Overall response rate (ORR) was 95% and 9 patients (23%) attained a complete remission (CR). 21 patients discontinued treatment, 10 due to disease progression, 9 for other causes, and 2 due to stem cell transplantation, the remaining 19 patients continue on ibrutinib. Median progression free survival (PFS) for all patients was 45 months, which was significantly shorter in the subgroup of patients with del17p (n=21, 32.3 months, p=0.02). Fourteen patients (35%) died, 5 from progressive disease, 5 from infections, and 4 from other causes. Median overall survival (OS) has not been reached. Conclusions: IR combination therapy leads to durable remissions in high risk CLL; the possible benefit from the addition of rituximab is currently explored in a randomized trial.%U http://clincancerres.aacrjournals.org/content/clincanres/early/2016/11/19/1078-0432.CCR-16-1948.full.pdf