title: Rituximab added to first-line mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma: an East German Study Group Hematology and Oncology Study.
abstract: OBJECTIVE
  Rituximab has been shown to be active in follicular lymphoma (FL), both as monotherapy and in combination with chemotherapy. We conducted a randomized trial comparing mitoxantrone, chlorambucil, and prednisolone (MCP) chemotherapy plus rituximab with MCP alone.
  
  
  METHODS
  Previously untreated patients with stage III or IV CD20+ indolent or mantle cell lymphoma were randomly assigned to either eight 28-day cycles of MCP plus rituximab (R-MCP; n = 181) or eight cycles of MCP alone (n = 177). All patients who achieved a complete or partial remission were treated with interferon maintenance until relapse. Herein, we report the results from the primary analysis population of patients with FL, who constituted the majority of patients (56%) recruited to the trial (n = 201; R-MCP, n = 105; MCP, n = 96).
  
  
  RESULTS
  Rates of overall and complete response were significantly higher in the R-MCP arm than the MCP arm (overall response, 92% v 75%, respectively; P = .0009; complete response, 50% v 25%, respectively; P = .004). With a median follow-up time of 47 months, median event-free survival (EFS) and progression-free survival (PFS) times were significantly prolonged with R-MCP compared with MCP (EFS, not reached v 26 months, respectively; P < .0001; PFS, not reached v 28.8 months, respectively; P < .0001), and overall survival (OS) was significantly improved with R-MCP compared with MCP (4-year OS rate, 87% v 74%, respectively; P = .0096).
  
  
  CONCLUSIONS
  The R-MCP regimen significantly improves complete and overall response rates, EFS, PFS, and OS in patients with previously untreated advanced FL, without a clinically significant increase in toxicity.
authors.affiliation: HELIOS Klinikum Erfurt GmbH, 2 Medizinische Klinik, Bereich Hamatologie/Onkologie, Erfurt, Germany. miherold@erfurt.helios-kliniken.de
authors.forename: Michael
authors.initials: M
authors.lastname: Herold
authors.forename: Antje
authors.initials: A
authors.lastname: Haas
authors.forename: Stefanie
authors.initials: S
authors.lastname: Srock
authors.forename: Sabine
authors.initials: S
authors.lastname: Neser
authors.forename: Kathrin Haifa
authors.initials: KH
authors.lastname: Al-Ali
authors.forename: Andreas
authors.initials: A
authors.lastname: Neubauer
authors.forename: Gottfried
authors.initials: G
authors.lastname: Dölken
authors.forename: Ralph
authors.initials: R
authors.lastname: Naumann
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Knauf
authors.forename: Mathias
authors.initials: M
authors.lastname: Freund
authors.forename: Robert
authors.initials: R
authors.lastname: Rohrberg
authors.forename: Klaus
authors.initials: K
authors.lastname: Höffken
authors.forename: Astrid
authors.initials: A
authors.lastname: Franke
authors.forename: Thomas
authors.initials: T
authors.lastname: Ittel
authors.forename: Erika
authors.initials: E
authors.lastname: Kettner
authors.forename: Ursula
authors.initials: U
authors.lastname: Haak
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mey
authors.forename: Christian
authors.initials: C
authors.lastname: Klinkenstein
authors.forename: Michael
authors.initials: M
authors.lastname: Assmann
authors.forename: Ullrich
authors.initials: U
authors.lastname: von Grünhagen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002699:Chlorambucil / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D011239:Prednisolone / Q000008:administration & dosage; D011379:Prognosis; D011994:Recombinant Proteins; D000069283:Rituximab; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002699:Chlorambucil; D000069283:Rituximab; D011239:Prednisolone; D008942:Mitoxantrone