Abstract
Introduction: Rituximab plus chemotherapy has been proved to be the standard in treating advanced follicular lymphoma. However in mantle cell lymphoma (MCL) the results are still controversial.
Methods: In a prospective randomised trial (OSHO#39) we compared the efficacy and toxicity of MCP chemotherapy(mitoxantrone 8 mg/m2 d 1+2, chlormabucil 3x3 mg/m2 d 1–5 and prednisolone 25 mg/m2 d q 4 weeks)versus MCP plus rituximab (375 mg/m2 d -1) in advanced indolent lymphoma and mantle cell lymphoma. Here we present the results of the MCL subgroup (n=90) among the 358 randomised patients (FL, MCL, LPL). Study endpoints included overall and complete response rate (RR + CR), progression free survival (PFS), event free survival (EFS), overall survival (OS) and toxicities.
Results: with a median follow-up of 43 months for the MCL subgroup we can provide relatively mature data. Concerning toxicities there was no striking difference between the treatment groups. The treatment results for the MCL patients are as follows:
Conclusions: Concerning all end-points R-MCP is not superior to MCP chemotherapy alone in advanced mantle cell lymphoma. Immunochemotherapy is obviously not the solution for this poor prognosis lymphoma entity.
. | R-MCP n=44 . | MCP n=46 . | p-value . |
---|---|---|---|
Response Rate | 70,5% | 63% | .5074 |
Complete Responses | 31,8% | 15,2% | .0822 |
PFS median | 20,5 months | 19 months | .2482 |
PFS 42 months | 31% | 14% | |
EFS median | 19 months | 14 months | .1369 |
EFS 42 months | 27% | 11,5% | |
OS median | 56 months | 50 months | .4862 |
OS 42 months | 60% | 61% |
. | R-MCP n=44 . | MCP n=46 . | p-value . |
---|---|---|---|
Response Rate | 70,5% | 63% | .5074 |
Complete Responses | 31,8% | 15,2% | .0822 |
PFS median | 20,5 months | 19 months | .2482 |
PFS 42 months | 31% | 14% | |
EFS median | 19 months | 14 months | .1369 |
EFS 42 months | 27% | 11,5% | |
OS median | 56 months | 50 months | .4862 |
OS 42 months | 60% | 61% |
Author notes
Disclosure:Research Funding: Roche Pharma AG, Germany. Honoraria Information: Roche Pharma AG, Germany. Membership Information: Member of Roche speaker’s bureau and advisory board. Off Label Use: Rituximab is not licensed for MCL in Germany.
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