title: Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group.
abstract: Phase 2 studies suggest that the monoclonal antibody rituximab may improve the prognosis of patients with follicular lymphoma (FL) when it is added to chemotherapy. In the current study, 428 patients with untreated, advanced-stage FL were randomly assigned for therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) alone (n = 205) or CHOP combined with rituximab (R-CHOP) (n = 223). R-CHOP reduced the relative risk for treatment failure by 60% and significantly prolonged the time to treatment failure (P < .001). In addition, a significantly higher overall response rate (96% vs 90%; P = .011) and a prolonged duration of remission (P = .001) were achieved. In spite of a relatively short observation time, these beneficial effects even translated to superior overall survival (P = .016), with 6 deaths in the R-CHOP group compared with 17 deaths in the CHOP group within the first 3 years. The predominant treatment-related adverse effect was myelosuppression. Severe granulocytopenia was more frequently observed after R-CHOP (63% vs 53%; P = .01). However, severe infections were rare and of similar frequency after R-CHOP and CHOP (5% and 7%). Hence, adding rituximab to CHOP significantly improves the outcome for patients with previously untreated advanced-stage FL and does not induce major adverse effects.
authors.affiliation: Department of Internal Medicine III, University of Munich, Grosshadern Marchioninistr 15, 81377 München, Germany. sekrmed3@med.uni-muenchen.de
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hiddemann
authors.forename: Michael
authors.initials: M
authors.lastname: Kneba
authors.forename: Martin
authors.initials: M
authors.lastname: Dreyling
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
authors.forename: Eva
authors.initials: E
authors.lastname: Lengfelder
authors.forename: Rudolf
authors.initials: R
authors.lastname: Schmits
authors.forename: Marcel
authors.initials: M
authors.lastname: Reiser
authors.forename: Bernd
authors.initials: B
authors.lastname: Metzner
authors.forename: Harriet
authors.initials: H
authors.lastname: Harder
authors.forename: Susanna
authors.initials: S
authors.lastname: Hegewisch-Becker
authors.forename: Thomas
authors.initials: T
authors.lastname: Fischer
authors.forename: Martin
authors.initials: M
authors.lastname: Kropff
authors.forename: Hans-Edgar
authors.initials: HE
authors.lastname: Reis
authors.forename: Mathias
authors.initials: M
authors.lastname: Freund
authors.forename: Bernhard
authors.initials: B
authors.lastname: Wörmann
authors.forename: Roland
authors.initials: R
authors.lastname: Fuchs
authors.forename: Manfred
authors.initials: M
authors.lastname: Planker
authors.forename: Jörg
authors.initials: J
authors.lastname: Schimke
authors.forename: Hartmut
authors.initials: H
authors.lastname: Eimermacher
authors.forename: Lorenz
authors.initials: L
authors.lastname: Trümper
authors.forename: Ali
authors.initials: A
authors.lastname: Aldaoud
authors.forename: Reza
authors.initials: R
authors.lastname: Parwaresch
authors.forename: Michael
authors.initials: M
authors.lastname: Unterhalt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D000069283:Rituximab; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011239:Prednisolone