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LNH03-6B

Dose-dense rituximab-CHOP compared with standard rituximab-CHOP in elderly patients with diffuse large B-cell lymphoma (the LNH03-6B study): a randomised phase 3 trial

Phase 3N = 602NCT00144755

Population
Untreated diffuse large B-cell lymphoma, aged 60 to 80 years, with at least one adverse prognostic factor (age-adjusted IPI of 1 or more).
Design
Randomised phase 3 trial at 83 centres in four countries; permuted-block randomisation 1:1 stratified by centre and number of adverse prognostic factors; eight cycles of R-CHOP every 14 days or every 21 days. Primary endpoint event-free survival; final analysis of the intention-to-treat population after exclusion of two ineligible patients allocated R-CHOP21. ClinicalTrials.gov lists 600 actual enrolment (title also covers a darbepoetin question); the paper reports 602 eligible for randomisation.
Primary endpoint
EFS
Arms
  • R-CHOP-21 (control, n = 298): Eight cycles of R-CHOP given every 21 days
  • R-CHOP-14 (experimental, n = 304): Eight cycles of R-CHOP given every 14 days
People
Delarue R, senior author Bosly A, Groupe d'Etude des Lymphomes de l'Adulte (GELA); ClinicalTrials.gov lists the Lymphoma Study Association as sponsor
EFSHR 1.04 (95% CI 0.82–1.31)Δ 36-month EFS−4 pointsΔ Red-blood-cell transfusion+16 points
Show the numbers
Results reported for LNH03-6B
EndpointAnalysisR-CHOP-14R-CHOP-21Effect
EFSIntention-to-treat population (two ineligible patients allocated R-CHOP21 excluded)finalmedian follow-up 56 monthsDelarue 201356% at 3 y (50–62%)60% at 3 y (55–66%)HR 1.04 (95% CI 0.82–1.31)P=0.7614Hazard ratio for R-CHOP14 relative to R-CHOP21 as reported. Median follow-up IQR 27 to 60 months.
Red-blood-cell transfusionThe abstract does not label the population; the counts (143 of 304 allocated R-CHOP14 and 93 of 296 assigned R-CHOP21) are consistent with the analysed patientsfinalDelarue 201347%31%P=0.0001At least one red-blood-cell transfusion. Grade 3-4 neutropenia occurred in 74% with R-CHOP14 and 64% with R-CHOP21 despite more G-CSF use with R-CHOP14.
Results reported for LNH03-6B
EndpointAnalysisR-CHOP-14R-CHOP-21Effect
EFSIntention-to-treat population (two ineligible patients allocated R-CHOP21 excluded)finalmedian follow-up 56 monthsDelarue 201356% at 3 y (50–62%)60% at 3 y (55–66%)HR 1.04 (95% CI 0.82–1.31)P=0.7614Hazard ratio for R-CHOP14 relative to R-CHOP21 as reported. Median follow-up IQR 27 to 60 months.
Red-blood-cell transfusionThe abstract does not label the population; the counts (143 of 304 allocated R-CHOP14 and 93 of 296 assigned R-CHOP21) are consistent with the analysed patientsfinalDelarue 201347%31%P=0.0001At least one red-blood-cell transfusion. Grade 3-4 neutropenia occurred in 74% with R-CHOP14 and 64% with R-CHOP21 despite more G-CSF use with R-CHOP14.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS1.040.82–1.31
Primary publication: Delarue R, Tilly H, Mounier N, Petrella T, Salles G, Thieblemont C, et al. Dose-dense rituximab-CHOP compared with standard rituximab-CHOP in elderly patients with diffuse large B-cell lymphoma (the LNH03-6B study): a randomised phase 3 trial. Lancet Oncol. 2013;14(6):525-33. PubMedDOI

Appears in

Sources

  1. Delarue R, Tilly H, Mounier N, Petrella T, Salles G, Thieblemont C, et al. Dose-dense rituximab-CHOP compared with standard rituximab-CHOP in elderly patients with diffuse large B-cell lymphoma (the LNH03-6B study): a randomised phase 3 trial. Lancet Oncol. 2013;14(6):525-33.

    PubMedDOI