PMID- 29333021
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220311
IS  - 0971-5851 (Print)
IS  - 0975-2129 (Electronic)
IS  - 0971-5851 (Linking)
VI  - 38
IP  - 4
DP  - 2017 Oct-Dec
TI  - 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.
PG  - 508-515
LID - 10.4103/ijmpo.ijmpo_43_17 [doi]
AB  - 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 achieved complete 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/muL (21,000-195,000) at 
      baseline to 190,350 cells/muL (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.
FAU - Agarwal, Mohan B
AU  - Agarwal MB
AD  - Department of Haematology, Bombay Hospital and Medical Research Centre, Mumbai, 
      India.
FAU - Bhurani, Dinesh
AU  - Bhurani D
AD  - Department of Hemato-Oncology and Bone Marrow Transplant, Rajiv Gandhi Cancer 
      Institute and Research Center, New Delhi, India.
FAU - Shah, Chirag
AU  - Shah C
AD  - Department of Medical Oncology and Haematology, Apollo Hospitals International, 
      Ahmedabad, Gujarat, India.
FAU - Sood, Nitin
AU  - Sood N
AD  - Department of Medical Oncology and Haematology, Medanta-The Medicity, Gurgaon, 
      Haryana, India.
FAU - Singhal, Manish
AU  - Singhal M
AD  - Departmemt of Medical Oncology, Indraprastha Apollo Hospitals, New Delhi, India.
FAU - Kamat, Anil
AU  - Kamat A
AD  - Departmemt of Oncology and Haematology, Jupiter Hospital, Thane, Maharashtra, 
      India.
FAU - Chezhian, Subash
AU  - Chezhian S
AD  - Department of Haematology, Haemato-oncology and Bone Marrow Transplant, MIOT 
      Hospitals, Chennai, Tamil Nadu, India.
FAU - Mishra, Suryaprakash
AU  - Mishra S
AD  - Medical Affairs, Janssen India, Mumbai, India.
FAU - Nagrale, Dinesh
AU  - Nagrale D
AD  - Medical Affairs, Janssen India, Mumbai, India.
LA  - eng
PT  - Journal Article
PL  - Germany
TA  - Indian J Med Paediatr Oncol
JT  - Indian journal of medical and paediatric oncology : official journal of Indian 
      Society of Medical & Paediatric Oncology
JID - 9604571
PMC - PMC5759073
OTO - NOTNLM
OT  - B-cell malignancies
OT  - Bruton's tyrosine kinase inhibitor
OT  - Indian
OT  - efficacy
OT  - ibrutinib
OT  - safety
COIS- Drs. Mishra and Nagrale are full-time employees of Janssen India (a Johnson & 
      Johnson company). Drs. Agarwal, Bhurani, Shah, Sood, Singhal, Kamat, and Chezhian 
      were the prescribing physicians who provided patient data for this study.
EDAT- 2018/01/16 06:00
MHDA- 2018/01/16 06:01
PMCR- 2017/10/01
CRDT- 2018/01/16 06:00
PHST- 2018/01/16 06:00 [entrez]
PHST- 2018/01/16 06:00 [pubmed]
PHST- 2018/01/16 06:01 [medline]
PHST- 2017/10/01 00:00 [pmc-release]
AID - IJMPO-38-508 [pii]
AID - 10.4103/ijmpo.ijmpo_43_17 [doi]
PST - ppublish
SO  - Indian J Med Paediatr Oncol. 2017 Oct-Dec;38(4):508-515. doi: 
      10.4103/ijmpo.ijmpo_43_17.