Background
MInT: phase III RCT in 824 young (<60yo) good-prognosis patients with DLBCL, stage II-IV or stage I with bulk (>7.5cm), evaluating addition of rituximab to CHOP-like chemotherapy.
Interventions and follow up
Arm A: CHOP-like chemo (413 pts) + rituximab 375 mg/m2 D1,22,43,64,85,106
Arm B: CHOP-like chemo alone (411 pts)
Primary endpoint: EFS
mFollow up: 34mo (primary); 72mo (2011 update)
Arm B: CHOP-like chemo alone (411 pts)
Primary endpoint: EFS
mFollow up: 34mo (primary); 72mo (2011 update)
Results
3yr EFS: 79% vs 59% (P<.0001)
3yr OS: 93% vs 84% (P=.0001)
6yr OS: 90.1% vs 80% (P=.0004)
6yr EFS (2011 update): 74.3% vs 55.8% (P<.0001)
Second cancers: 16 vs 18 (P=.730)
3yr OS: 93% vs 84% (P=.0001)
6yr OS: 90.1% vs 80% (P=.0004)
6yr EFS (2011 update): 74.3% vs 55.8% (P<.0001)
Second cancers: 16 vs 18 (P=.730)
Adverse events
Grade 3-4 (Arm A vs B): infection 7% vs 8%; cardiotoxicity 2% vs 1%; neurotoxicity 3% vs 3%
Treatment-related deaths: no significant difference between arms (P=.123)
Treatment-related deaths: no significant difference between arms (P=.123)
Conclusions
Landmark practice-changing trial establishing chemoimmunotherapy (R-CHOP) as standard of care in young good-prognosis DLBCL, with EFS and OS benefit sustained at long-term follow-up and no excess toxicity.
Key Limitations
Restricted to young (<60yo) good-prognosis patients (0-1 IPI factors), limiting generalizability to older or higher-risk DLBCL. CHOP-like backbone varied by country (CHOP21, CHOEP21, MACOPB, PMitCEBO).
Clinical Context
Together with the GELA LNH98-5 trial in elderly patients, MInT cemented R-CHOP as the global standard frontline regimen for DLBCL, endorsed by ESMO and ASCO. Long-term update: Pfreundschuh M, Lancet Oncol 2011, PMID 21940214.