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Randomized Controlled Trial
. 2019 Apr 20;37(12):984-991.
doi: 10.1200/JCO.18.00605. Epub 2019 Feb 27.

First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study

Ian W Flinn  1 , Richard van der Jagt  2 , Brad Kahl  3 , Peter Wood  4 , Tim Hawkins  5 , David MacDonald  6 , David Simpson  7 , Kathryn Kolibaba  8 , Samar Issa  9 , Julie Chang  10 , Judith Trotman  11 , Doreen Hallman  12 , Ling Chen  13 , John M Burke  14
Affiliations
Randomized Controlled Trial

First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study

Ian W Flinn et al. J Clin Oncol. .

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.

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Figures

FIG 1.
FIG 1.
Progression-free survival (PFS) by treatment group for (A) all patients, (B) patients with indolent non-Hodgkin lymphoma, and (C) patients with mantle-cell lymphoma. Note: Censored values are represented by a vertical bar. BR, bendamustine plus rituximab; R-CHOP, rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CVP, rituximab plus cyclophosphamide, vincristine, and prednisone.
FIG 2.
FIG 2.
Overall survival (OS) by treatment group for (A) all patients, (B) patients with indolent non-Hodgkin lymphoma, and (C) patients with mantle-cell lymphoma. Note: Censored values are represented by a vertical bar. BR, bendamustine plus rituximab; R-CHOP, rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CVP, rituximab plus cyclophosphamide, vincristine, and prednisone.
FIG 3.
FIG 3.
Time to first new lymphoma treatment (TTNT) by treatment group. Note: Censored values are represented by a vertical bar. BR, bendamustine plus rituximab; R-CHOP, rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CVP, rituximab plus cyclophosphamide, vincristine, and prednisone.
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References

    1. Flinn IW, van der Jagt R, Kahl BS, et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: The BRIGHT study. Blood. 2014;123:2944–2952. - PMC - PubMed
    1. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): B-Cell Lymphoma, Version 2.2018. https://www.nccn.org/professionals/physician_gls/default.aspx.
    1. Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: An open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013;381:1203–1210. - PubMed
    1. Flinn I. First-line treatment of iNHL or MCL patients with BR or R-CHOP/R-CVP: Results of the BRIGHT 5-year follow-up study. J Clin Oncol. 2017;35(suppl 15; abstr 7500) - PMC - PubMed
    1. Rummel M, Maschmeyer G, Ganser A, et al. Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent lymphomas: Nine-year updated results from the StiL NHL1 study. J Clin Oncol. 2017;35(suppl 15; abstr 7501)

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