title: Nordic MCL3 study: 90Y-ibritumomab-tiuxetan added to BEAM/C in non-CR patients before transplant in mantle cell lymphoma.
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.
authors.affiliation: Oncology, Oslo University Hospital, Oslo, Norway;
authors.forename: Arne
authors.initials: A
authors.lastname: Kolstad
authors.forename: Anna
authors.initials: A
authors.lastname: Laurell
authors.forename: Mats
authors.initials: M
authors.lastname: Jerkeman
authors.forename: Kirsten
authors.initials: K
authors.lastname: Grønbæk
authors.forename: Erkki
authors.initials: E
authors.lastname: Elonen
authors.forename: Riikka
authors.initials: R
authors.lastname: Räty
authors.forename: Lone Bredo
authors.initials: LB
authors.lastname: Pedersen
authors.forename: Annika
authors.initials: A
authors.lastname: Loft
authors.forename: Trond Velde
authors.initials: TV
authors.lastname: Bogsrud
authors.forename: Eva
authors.initials: E
authors.lastname: Kimby
authors.forename: Per Boye
authors.initials: PB
authors.lastname: Hansen
authors.forename: Unn-Merete
authors.initials: UM
authors.lastname: Fagerli
authors.forename: Herman
authors.initials: H
authors.lastname: Nilsson-Ehle
authors.forename: Grete Fossum
authors.initials: GF
authors.lastname: Lauritzsen
authors.forename: Anne Kristine
authors.initials: AK
authors.lastname: Lehmann
authors.forename: Christer
authors.initials: C
authors.lastname: Sundstrom
authors.forename: Marja-Liisa
authors.initials: ML
authors.lastname: Karjalainen-Lindsberg
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Ralfkiaer
authors.forename: Mats
authors.initials: M
authors.lastname: Ehinger
authors.forename: Jan
authors.initials: J
authors.lastname: Delabie
authors.forename: Hans
authors.initials: H
authors.lastname: Bentzen
authors.forename: Jukka
authors.initials: J
authors.lastname: Schildt
authors.forename: Kamelia
authors.initials: K
authors.lastname: Kostova-Aherdan
authors.forename: Henrik
authors.initials: H
authors.lastname: Frederiksen
authors.forename: Peter de Nully
authors.initials: Pde N
authors.lastname: Brown
authors.forename: Christian H
authors.initials: CH
authors.lastname: Geisler
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D020522:Lymphoma, Mantle-Cell / Q000628:therapy*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D015999:Multivariate Analysis; D018365:Neoplasm, Residual / Q000175:diagnosis; D011379:Prognosis; D016499:Radioimmunotherapy; D033581:Stem Cell Transplantation / Q000379:methods*; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D003561:Cytarabine; C422802:ibritumomab tiuxetan; D005047:Etoposide; D003520:Cyclophosphamide; D008558:Melphalan; D002330:Carmustine