Ian W Flinn1, Richard van der Jagt2, Brad Kahl3, Peter Wood4, Tim Hawkins5, David MacDonald6, David Simpson7, Kathryn Kolibaba8, Samar Issa9, Julie Chang10, Judith Trotman11, Doreen Hallman12, Ling Chen13, John M Burke14. 1. 1 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN. 2. 2 Ottawa Hospital, Ottawa, Ontario, Canada. 3. 3 Washington University School of Medicine, St Louis, MO. 4. 4 Princess Alexandra Hospital, Woolloongabba, Queensland, Australia. 5. 5 Auckland City Hospital, Auckland, New Zealand. 6. 6 Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada. 7. 7 North Shore Hospital, Auckland, New Zealand. 8. 8 US Oncology Research, Vancouver, WA. 9. 9 Middlemore Hospital, Auckland, New Zealand. 10. 10 University of Wisconsin Hospitals and Clinics, Madison, WI. 11. 11 Concord Repatriation General Hospital, University of Sydney, Concord, New South Wales, Australia. 12. 12 Teva Global Clinical Operations, Malvern, PA. 13. 13 Teva Biometrics Operations, Malvern, PA. 14. 14 US Oncology Research, The Woodlands, TX.
Abstract
PURPOSE: The BRIGHT study ( ClinicalTrials.gov identifier: NCT00877006) was initiated to compare the efficacy and safety of bendamustine plus rituximab (BR) with either rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP) for treatment-naive patients with indolent non-Hodgkin lymphoma or mantle-cell lymphoma. This publication provides long-term follow-up data. PATIENTS AND METHODS: Patients were monitored for a minimum of 5 years after completion of study treatment for the time-to-event end points of progression-free survival (PFS), event-free survival, duration of response, and overall survival per investigator assessment. Data on the number of patients who received second-line anticancer treatment and the occurrence of other malignancies were also collected. RESULTS: The medians were not reached for any of the time-to event end points for either the BR or R-CHOP/R-CVP study treatment groups by study completion. PFS rates at 5 years were 65.5% in the BR treatment group and 55.8% in the R-CHOP/R-CVP group. The difference in PFS was considered significant with a hazard ratio of 0.61 (95% CI, 0.45 to 0.85; P = .0025). The hazard ratio for event-free survival and duration of response (P = .0020 and .0134, respectively) also favored the BR regimen over R-CHOP/R-CVP. However, no significant difference in overall survival was observed. The overall safety profiles of BR, R-CHOP, and R-CVP were as expected; no new safety data were collected during long-term follow-up. A higher number of secondary malignancies was noted in the BR treatment group. CONCLUSION: Overall, BR demonstrated better long-term disease control than R-CHOP/R-CVP and should be considered as a first-line treatment option for patients with indolent and mantle-cell lymphoma.
RCT Entities:
PURPOSE: The BRIGHT study ( ClinicalTrials.gov identifier: NCT00877006) was initiated to compare the efficacy and safety of bendamustine plus rituximab (BR) with either rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP) for treatment-naive patients with indolent non-Hodgkin lymphoma or mantle-cell lymphoma. This publication provides long-term follow-up data. PATIENTS AND METHODS: Patients were monitored for a minimum of 5 years after completion of study treatment for the time-to-event end points of progression-free survival (PFS), event-free survival, duration of response, and overall survival per investigator assessment. Data on the number of patients who received second-line anticancer treatment and the occurrence of other malignancies were also collected. RESULTS: The medians were not reached for any of the time-to event end points for either the BR or R-CHOP/R-CVP study treatment groups by study completion. PFS rates at 5 years were 65.5% in the BR treatment group and 55.8% in the R-CHOP/R-CVP group. The difference in PFS was considered significant with a hazard ratio of 0.61 (95% CI, 0.45 to 0.85; P = .0025). The hazard ratio for event-free survival and duration of response (P = .0020 and .0134, respectively) also favored the BR regimen over R-CHOP/R-CVP. However, no significant difference in overall survival was observed. The overall safety profiles of BR, R-CHOP, and R-CVP were as expected; no new safety data were collected during long-term follow-up. A higher number of secondary malignancies was noted in the BR treatment group. CONCLUSION: Overall, BR demonstrated better long-term disease control than R-CHOP/R-CVP and should be considered as a first-line treatment option for patients with indolent and mantle-cell lymphoma.
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