title: Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG).
abstract: OBJECTIVE
  Mantle cell lymphoma (MCL) is characterized by a poor prognosis with a low to moderate sensitivity to chemotherapy and a median survival of only 3 to 4 years. In an attempt to improve outcome, the German Low Grade Lymphoma Study Group (GLSG) initiated a randomized trial comparing the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) and rituximab (R-CHOP) with CHOP alone as first-line therapy for advanced-stage MCL.
  
  
  METHODS
  One hundred twenty-two previously untreated patients with advanced-stage MCL were randomly assigned to six cycles of CHOP (n = 60) or R-CHOP (n = 62). Patients up to 65 years of age achieving a partial or complete remission underwent a second randomization to either myeloablative radiochemotherapy followed by autologous stem-cell transplantation or interferon alfa maintenance (IFNalpha). All patients older than 65 years received IFNalpha maintenance.
  
  
  RESULTS
  R-CHOP was significantly superior to CHOP in terms of overall response rate (94% v 75%; P = .0054), complete remission rate (34% v 7%; P = .00024), and time to treatment failure (TTF; median, 21 v 14 months; P = .0131). No differences were observed for progression-free survival. Toxicity was acceptable, with no major differences between the two therapeutic groups.
  
  
  CONCLUSIONS
  The combined immunochemotherapy with R-CHOP resulted in a significantly higher response rate and a prolongation of the TTF as compared with chemotherapy alone. Hence, R-CHOP may serve as a new baseline regimen for advanced stage MCL, but needs to be further improved by novel strategies in remission.
authors.affiliation: Department of Internal Medicine III of the Ludwig-Maximilians University, Marchioninistrasse 15, 81377 Munich, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Lenz
authors.forename: Martin
authors.initials: M
authors.lastname: Dreyling
authors.forename: Eva
authors.initials: E
authors.lastname: Hoster
authors.forename: Bernhard
authors.initials: B
authors.lastname: Wörmann
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dührsen
authors.forename: Bernd
authors.initials: B
authors.lastname: Metzner
authors.forename: Hartmut
authors.initials: H
authors.lastname: Eimermacher
authors.forename: Andreas
authors.initials: A
authors.lastname: Neubauer
authors.forename: Hannes
authors.initials: H
authors.lastname: Wandt
authors.forename: Hjalmar
authors.initials: H
authors.lastname: Steinhauer
authors.forename: Sonja
authors.initials: S
authors.lastname: Martin
authors.forename: Else
authors.initials: E
authors.lastname: Heidemann
authors.forename: Ali
authors.initials: A
authors.lastname: Aldaoud
authors.forename: Reza
authors.initials: R
authors.lastname: Parwaresch
authors.forename: Joerg
authors.initials: J
authors.lastname: Hasford
authors.forename: Michael
authors.initials: M
authors.lastname: Unterhalt
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hiddemann
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use*; D004317:Doxorubicin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D000069283:Rituximab; D033581:Stem Cell Transplantation; D017211:Treatment Failure; D014750:Vincristine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D016898:Interferon-alpha; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone