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CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2017; 38(04): 508-515
DOI: 10.4103/ijmpo.ijmpo_43_17
Original Article

Efficacy and Safety of Ibrutinib in Indian Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma: Cases from a Named Patient Program

Mohan B Agarwal
Department of Haematology, Bombay Hospital and Medical Research Centre, Mumbai, India
,
Dinesh Bhurani
Department of Hemato-Oncology and Bone Marrow Transplant, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Chirag Shah
Department of Medical Oncology and Haematology, Apollo Hospitals International, Ahmedabad, Gujarat, India
,
Nitin Sood
Department of Medical Oncology and Haematology, Medanta-The Medicity, Gurgaon, Haryana, India
,
Manish Singhal
Departmemt of Medical Oncology, Indraprastha Apollo Hospitals, New Delhi, India
,
Anil Kamat
Departmemt of Oncology and Haematology, Jupiter Hospital, Thane, Maharashtra, India
,
Subash Chezhian
Department of Haematology, Haemato-oncology and Bone Marrow Transplant, MIOT Hospitals, Chennai, Tamil Nadu, India
,
Suryaprakash Mishra
Medical Affairs, Janssen , Mumbai, India
,
Dinesh Nagrale
Medical Affairs, Janssen , Mumbai, India
› Author Affiliations Financial support and sponsorship Nil.
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Abstract

Context: This named patient program evaluated the safety and efficacy of ibrutinib, a selective inhibitor of Bruton's tyrosine kinase in Indian patients with relapsed/refractory chronic lymphocytic leukemia (CLL, with/without chromosome 17 deletion [del17p]) and mantle cell lymphoma (MCL). Subjects and Methods: The eight enrolled patients (relapsed/refractory CLL: n = 6 [4/6 patients with del17p] and relapsed/refractory MCL: n = 2) had median age of 55 years (range, 52–60) and had received a median of 3 (CLL patients) and 4 (MCL patients) prior therapies. Patients received once-daily dose of ibrutinib (420 mg: CLL, 560 mg: MCL). Results: In CLL patients, the median time to response was 3 months (range, 0.5–7) and five of six patients had partial response (PR) whereas one achievedcomplete response (CR). Median time on treatment was 11.5 months (range, 8–14); five patients continued treatment and one was recommended stem cell transplantation (SCT). Of the two MCL patients, one achieved PR and one showed CR and advanced to SCT. In CLL patients, the median (range) hemoglobin level improved from 9.8 g/dL (7.2–11) at baseline to 12.0 g/dL (9.5–13.2) and median (range) platelet count improved from 150,000 cells/μL (21,000–195,000) at baseline to 190,350 cells/μL (130,000–394,000) at the time of analysis (July 2016). Most adverse events (AEs) reported were infections (n = 2). No Grade 3-4 or serious AEs, dose reductions, or treatment discontinuation due to AEs were reported. Conclusions: In this first real-world experience in Indian patients, ibrutinib demonstrated therapeutic efficacy in relapsed/refractory CLL (with/without del17p) and MCL. Safety results were consistent with the current known profile of ibrutinib.

Keywords

B-cell malignancies - Bruton's tyrosine kinase inhibitor - efficacy - ibrutinib - Indian - safety


Publication History

Article published online:
04 July 2021

© 2017. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used forcommercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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