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Bending the Curve Trial by Trial
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StiL NHL1

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

Phase 3N = 549NCT00991211

Population
Newly diagnosed stage III or IV indolent or mantle-cell lymphoma (the abstract does not give the follicular subset); 274 assigned to bendamustine plus rituximab (261 assessed) and 275 to R-CHOP (253 assessed).
Design
Prospective, multicentre, randomised, open-label, non-inferiority trial at 81 centres in Germany (1 September 2003 to 31 August 2008). Adults with newly diagnosed stage III or IV indolent or mantle-cell lymphoma, stratified by histological subtype, received bendamustine 90 mg/m2 on days 1 and 2 of a 4-week cycle or CHOP every 3 weeks, for a maximum of six cycles, each with rituximab 375 mg/m2 on day 1 of each cycle. Primary endpoint: progression-free survival, non-inferiority margin 10%. Analysis was per protocol. 549 patients were assigned.
Primary endpoint
PFS
Arms
  • R-CHOP (control, n = 275): CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, prednisone 100 mg/day for 5 days) every 3 weeks plus rituximab 375 mg/m2, up to six cycles
  • Bendamustine plus rituximab (experimental, n = 274): Bendamustine 90 mg/m2 on days 1 and 2 of a 4-week cycle plus rituximab 375 mg/m2, up to six cycles
People
Rummel MJ
PFSHR 0.58 (95% CI 0.44–0.74)Δ median PFS+38.3 months
Show the numbers
Results reported for StiL NHL1
EndpointAnalysisBendamustine plus rituximabR-CHOPEffect
PFSPer protocol (261 bendamustine-rituximab, 253 R-CHOP)primarymedian follow-up 45 monthsRummel 2013median 69.5 monthsmedian 31.2 monthsHR 0.58 (95% CI 0.44–0.74)P<0.0001The bracketed ranges in the abstract (26.1 to not yet reached months, and 15.2 to 65.7 months) are not labelled as confidence intervals. Median follow-up 45 months (interquartile range 25 to 57).
Results reported for StiL NHL1
EndpointAnalysisBendamustine plus rituximabR-CHOPEffect
PFSPer protocol (261 bendamustine-rituximab, 253 R-CHOP)primarymedian follow-up 45 monthsRummel 2013median 69.5 monthsmedian 31.2 monthsHR 0.58 (95% CI 0.44–0.74)P<0.0001The bracketed ranges in the abstract (26.1 to not yet reached months, and 15.2 to 65.7 months) are not labelled as confidence intervals. Median follow-up 45 months (interquartile range 25 to 57).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.580.44–0.74
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%050100150Months (modelled)
  • Bendamustine plus rituximab (experimental)
  • R-CHOP (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsBendamustine plus rituximabR-CHOP
0100.0%100.0%
4365.1%38.5%
8742.0%14.5%
13027.3%5.6%
17417.6%2.1%
Primary publication: Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, 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(9873):1203-10. PubMedDOI

Appears in

Sources

  1. Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, 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(9873):1203-10.

    PubMedDOI