Pfreundschuh M et al. – Rituximab decreased the adverse prognostic effect of maximum tumor diameter (MTD) in pts age 18–60 yr with good-prognosis diffuse large-B-cell lymphoma (DLBCL); cut-off points for bulky disease can be 5-10 cm, based on clinical considerations Methods
Study of MTD effect in 802 MInT study subjects with good-prognosis DLBCL, who had CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)-like chemotherapy with/without rituximab
Analysis of event-free (EFS) and overall survival (OS) after CHOP-like chemotherapy with/without rituximab
Martingale residual analyses and Cox regression models
Radiotherapy to primary bulky disease sites based on national standards and to primary extranodal disease at physician discretion
Primary endpoint: EFS; secondary endpoint: OS; intention to treat analyses
Results
Martingale residual analysis: MTD adverse prognostic effect on EFS and OS, with linear increase
Multivariable analysis with MTD as linear regression variable: MTD effect significant after CHOP-like treatment alone for EFS and OS and after CHOP-like/rituximab for OS
For CHOP-like treatment, 3-yr EFS: 78.2% (MTD <5 cm) to 41.3% (MTD >=10 cm)
For CHOP-like/rituximab, 3-yr EFS 83.2% (MTD <5 cm) to 72.7% (MTD >=10 cm)
For CHOP-like, 3-yr OS decreased from 92.9% (MTD <5 cm) to 73.5% (MTD >=10 cm)
For CHOP-like/rituximab, 3-yr OS decreased from 98% (MTD <5 cm) to 85.2% (MTD >=10 cm)
For CHOP-like, any cut-off point between 5-10 cm separated two populations with significant EFS and OS difference
For CHOP-like/rituximab, only a cut-off point of 10 cm separated two populations with a significant EFS difference; any cut-off point of >=6 cm separated two populations with a significant OS difference