The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma Journal Article


Authors: Fowler, N. H.; Nastoupil, L.; De Vos, S.; Knapp, M.; Flinn, I. W.; Chen, R.; Advani, R. H.; Bhatia, S.; Martin, P.; Mena, R.; Davis, R. E.; Neelapu, S. S.; Eckert, K.; Ping, J.; Co, M.; Beaupre, D. M.; Neuenburg, J. K.; Palomba, M. L.
Article Title: The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma
Abstract: This phase 2 study evaluated the activity and safety of ibrutinib, a Bruton’s tyrosine kinase inhibitor, plus rituximab in adults with previously untreated follicular lymphoma. Patients received once-daily ibrutinib 560 mg continuously plus once-weekly rituximab 375 mg/m2 for 4 weeks beginning Week 1 (Arm 1, n = 60) or Week 9 (following an 8-week ibrutinib lead-in) to explore biomarkers (Arm 2, n = 20). The primary endpoint was the best overall response rate (ORR). The median age was 58 years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84%). At a median study follow-up of 34 months in Arm 1 and 29 months in Arm 2, ORRs were 85% [95% confidence interval (CI) 73–93] and 75% (95% CI 51–91), respectively, with complete responses in 40% and 50%. The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2). The most common adverse events were fatigue, diarrhoea and nausea. Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events occurred infrequently. Ibrutinib plus rituximab was active and tolerable in first-line follicular lymphoma. © 2020 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd
Keywords: adult; cancer survival; controlled study; aged; survival rate; major clinical study; drug tolerability; fatigue; cancer combination chemotherapy; diarrhea; drug safety; treatment duration; rituximab; cancer staging; follow up; biological marker; progression free survival; controlled clinical trial; phase 2 clinical trial; anemia; bleeding; heart disease; nausea; thrombocytopenia; bradycardia; continuous infusion; febrile neutropenia; heart palpitation; survival time; drug response; follicular lymphoma; heart ventricle tachycardia; tachycardia; hematologic disease; sinus tachycardia; rectum hemorrhage; sinus bradycardia; adverse event; heart atrium flutter; faintness; ibrutinib; human; male; female; priority journal; article; paroxysmal tachycardia; ear hemorrhage
Journal Title: British Journal of Haematology
Volume: 189
Issue: 4
ISSN: 0007-1048
Publisher: John Wiley & Sons  
Date Published: 2020-05-01
Start Page: 650
End Page: 660
Language: English
DOI: 10.1111/bjh.16424
PUBMED: 32180219
PROVIDER: scopus
DOI/URL:
Notes: Article -- Source: Scopus
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MSK Authors
  1. Maria Lia Palomba
    169 Palomba