MInT: trial | Bending the Curve: Trial by Trial

MInT

CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group

N = 824NCT00064116 NCT00400907

Population

Previously untreated diffuse large-B-cell lymphoma, aged 18 to 60 years, with no or one risk factor on the age-adjusted International Prognostic Index, stage II-IV disease, or stage I disease with bulk.

Design

Randomised controlled trial from 18 countries: six cycles of CHOP-like chemotherapy with or without rituximab; bulky and extranodal sites received additional radiotherapy. NCT00064116 is the trial; NCT00400907 is the registered observational follow-up study used for the 6-year report. ClinicalTrials.gov lists 824 actual enrolment for NCT00064116.

Primary endpoint

EFS

Arms

CHOP-like chemotherapy (control, n = 411): Six cycles of CHOP-like chemotherapy alone
CHOP-like chemotherapy plus rituximab (experimental, n = 413): Six cycles of CHOP-like chemotherapy plus rituximab

People

Pfreundschuh M, senior author Loeffler M, MabThera International Trial (MInT) Group

Δ 36-month EFS+20 pointsΔ 36-month OS+9 pointsΔ 72-month EFS+18.5 points

Show the numbers

Results reported for MInT
Endpoint	Analysis	CHOP-like chemotherapy plus rituximab	CHOP-like chemotherapy	Effect
EFSRandomised patients (824); the abstract states analyses were done by intention to treat and per protocol without saying which produced these figures	primarymedian follow-up 34 monthsPfreundschuh 2006	79% at 3 y (75–83%)	59% at 3 y (54–64%)	P<0.0001 (log-rank)Difference between groups 20% (95% CI 13 to 27). Median follow-up range 0.03 to 61 months.
OSRandomised patients (824); the abstract states analyses were done by intention to treat and per protocol without saying which produced these figures	primarymedian follow-up 34 monthsPfreundschuh 2006	93% at 3 y (90–95%)	84% at 3 y (80–88%)	P=0.0001 (log-rank)Difference between groups 9% (95% CI 3 to 13).
EFSIntention-to-treat population (410 chemotherapy alone, 413 chemotherapy plus rituximab)	long term-updatemedian follow-up 72 monthsPfreundschuh 2011	74.3% at 6 y (69.3–78.6%)	55.8% at 6 y (50.4–60.9%)	P<0.0001 (log-rank)Difference between groups 18.5% (95% CI 11.5 to 25.4). 166 events with chemotherapy alone and 98 with chemotherapy plus rituximab. The 6-year report counts 410 patients in the chemotherapy-alone group, the primary paper 411.

Results reported for MInT
Endpoint	Analysis	CHOP-like chemotherapy plus rituximab	CHOP-like chemotherapy	Effect
EFSRandomised patients (824); the abstract states analyses were done by intention to treat and per protocol without saying which produced these figures	primarymedian follow-up 34 monthsPfreundschuh 2006	79% at 3 y (75–83%)	59% at 3 y (54–64%)	P<0.0001 (log-rank)Difference between groups 20% (95% CI 13 to 27). Median follow-up range 0.03 to 61 months.
OSRandomised patients (824); the abstract states analyses were done by intention to treat and per protocol without saying which produced these figures	primarymedian follow-up 34 monthsPfreundschuh 2006	93% at 3 y (90–95%)	84% at 3 y (80–88%)	P=0.0001 (log-rank)Difference between groups 9% (95% CI 3 to 13).
EFSIntention-to-treat population (410 chemotherapy alone, 413 chemotherapy plus rituximab)	long term-updatemedian follow-up 72 monthsPfreundschuh 2011	74.3% at 6 y (69.3–78.6%)	55.8% at 6 y (50.4–60.9%)	P<0.0001 (log-rank)Difference between groups 18.5% (95% CI 11.5 to 25.4). 166 events with chemotherapy alone and 98 with chemotherapy plus rituximab. The 6-year report counts 410 patients in the chemotherapy-alone group, the primary paper 411.

Appears in

2006 MInT: rituximab with CHOP-like therapy, young low-risk DLBCL (2006)

Sources

Pfreundschuh M, Trümper L, Osterborg A, Pettengell R, Trneny M, Imrie K, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006;7(5):379-91.
PubMed DOI
Pfreundschuh M, Kuhnt E, Trümper L, Osterborg A, Trneny M, Shepherd L, et al. CHOP-like chemotherapy with or without rituximab in young patients with good-prognosis diffuse large-B-cell lymphoma: 6-year results of an open-label randomised study of the MabThera International Trial (MInT) Group. Lancet Oncol. 2011;12(11):1013-22.
PubMed DOI