Nordic MCL3 study: 90Y-ibritumomab-tiuxetan added to BEAM/C in non-CR patients before transplant in mantle cell lymphoma
Arne Kolstad, Anna Laurell, Mats Jerkeman, Kirsten Grønbæk, Erkki Elonen, Riikka Räty, Lone Bredo Pedersen, Annika Loft, Trond Velde Bogsrud, Eva Kimby, Per Boye Hansen, Unn-Merete Fagerli, Herman Nilsson-Ehle, Grete Fossum Lauritzsen, Anne Kristine Lehmann, Christer Sundstrom, Marja-Liisa Karjalainen-Lindsberg, Elisabeth Ralfkiaer, Mats Ehinger, Jan Delabie, Hans Bentzen, Jukka Schildt, Kamelia Kostova-Aherdan, Henrik Frederiksen, Peter de Nully Brown, Christian H Geisler, Nordic Lymphoma Group, Peter Meyer, Martin Maisenholder, Bjørn Østenstad, Ulf-Henrik Mellqvist, Jaan Vaart, Ingemar Lagerlof, Martin Erlanson, Kristina Arnljots, Lars Andreasson, Sven Erdal, Eva Mrazek, Ilse Christiansen, Esa Jantunen, Outi Kuittinen, Arne Kolstad, Anna Laurell, Mats Jerkeman, Kirsten Grønbæk, Erkki Elonen, Riikka Räty, Lone Bredo Pedersen, Annika Loft, Trond Velde Bogsrud, Eva Kimby, Per Boye Hansen, Unn-Merete Fagerli, Herman Nilsson-Ehle, Grete Fossum Lauritzsen, Anne Kristine Lehmann, Christer Sundstrom, Marja-Liisa Karjalainen-Lindsberg, Elisabeth Ralfkiaer, Mats Ehinger, Jan Delabie, Hans Bentzen, Jukka Schildt, Kamelia Kostova-Aherdan, Henrik Frederiksen, Peter de Nully Brown, Christian H Geisler, Nordic Lymphoma Group, Peter Meyer, Martin Maisenholder, Bjørn Østenstad, Ulf-Henrik Mellqvist, Jaan Vaart, Ingemar Lagerlof, Martin Erlanson, Kristina Arnljots, Lars Andreasson, Sven Erdal, Eva Mrazek, Ilse Christiansen, Esa Jantunen, Outi Kuittinen
Abstract
The main objective of the MCL3 study was to improve outcome for patients not in complete remission (CR) before transplant by adding (90)Y-ibritumomab-tiuxetan (Zevalin) to the high-dose regimen. One hundred sixty untreated, stage II-IV mantle cell lymphoma patients <66 years received rituximab (R)-maxi-CHOP (cyclophosphamide, hydroxydaunorubicin, vincristine, and prednisone) alternating with R-high-dose cytarabine (6 cycles total), followed by high-dose BEAM/C (bis-chloroethylnitrosourea, etoposide, cytarabine, and melphalan or cyclophosphamide) and autologous stem cell transplantation from 2005 to 2009. Zevalin (0.4 mCi/kg) was given to responders not in CR before transplant. Overall response rate pretransplant was 97%. The outcome did not differ from that of the historic control: the MCL2 trial with similar treatment except for Zevalin. Overall survival (OS), event-free survival (EFS), and progression-free survival (PFS) at 4 years were 78%, 62%, and 71%, respectively. For responding non-CR patients who received Zevalin, duration of response was shorter than for the CR group. Inferior PFS, EFS, and OS were predicted by positron emission tomography (PET) positivity pretransplant and detectable minimal residual disease (MRD) after transplant. In conclusion, positive PET and MRD were strong predictors of outcome. Intensification with Zevalin may be too late to improve the outcome of patients not in CR before transplant. This trial was registered at www.clinicaltrials.gov as #NCT00514475.
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Source: PubMed