FIRST‐LINE TREATMENT OF INHL OR MCL PATIENTS WITH BR OR R‐CHOP/R‐CVP: RESULTS OF THE BRIGHT 5‐YEAR FOLLOW‐UP STUDY
Bibliographic record
Abstract
Introduction: BRIGHT, a phase 3, open-label, noninferiority study comparing efficacy and safety of bendamustine plus rituximab (BR) vs rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or rituximab with cyclophosphamide, vincristine, and prednisone (R-CVP) in treatment-naive patients with indolent non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL), showed that the complete response rate for first-line BR was statistically noninferior to R-CHOP/R-CVP (Blood 2014;123:2944-52). Patients were monitored for ≥5 years to assess the overall effect of BR or R-CHOP/R-CVP in a controlled clinical setting. This analysis reports the time-to-event variables of the 5-year follow-up study. Methods: Patients with iNHL or MCL randomized to 6-8 cycles of BR or R-CHOP/R-CVP underwent complete assessments at end of treatment, then were monitored regularly. Progression-free survival (PFS), event-free survival (EFS), duration of response (DOR), and overall survival (OS) were compared using a stratified log-rank test. Results: Of 447 randomized patients, 224 received BR, 104 R-CHOP, and 119 R-CVP; 419 entered the follow-up study. The median follow-up time was 65.0 and 64.1 months for BR and R-CHOP/R-CVP, respectively. The 5-year PFS rate was 65.5% (95% confidence interval [CI]: 58.5-71.6) and 55.8% (48.4-62.5), and OS was 81.7% (75.7-86.3) and 85% (79.3-89.3) for BR and R-CHOP/R-CVP, respectively. The hazard ratio (95% CI) for PFS was 0.61 (0.45-0.85; P = .0025), EFS 0.63 (0.46-0.84; P = .0020), DOR 0.66 (0.47-0.92; P = .0134), and OS 1.15 (0.72-1.84; P = .5461) comparing BR vs R-CHOP/R-CVP. Similar results were found in iNHL [PFS 0.70 (0.49-1.01; P = .0582)] and MCL [PFS 0.40 (0.21-0.75; P = .0035)], with the strongest treatment effect in MCL (Figure). Use of rituximab maintenance was similar, 43% in BR and 45% in R-CHOP/R-CVP. Bendamustine was included as second-line in 27 (36%) of the 75 patients requiring therapy who originally received R-CHOP/R-CVP. Comparable safety profiles with expected adverse events were observed in the follow-up study in BR vs R-CHOP/R-CVP. Conclusions: The long-term follow-up of the BRIGHT study has confirmed that PFS, EFS, and DOR were significantly better for BR, and OS was not statistically different between BR and R-CHOP/R-CVP. The safety profile was as previously reported. Keywords: bendamustine; mantle cell lymphoma (MCL); non-Hodgkin lymphoma (NHL).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".