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 |
| PMCID: | PMC7317728 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
