title: Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19).
abstract: OBJECTIVE
  The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine + prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine + prednisone (COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma.
  
  
  METHODS
  A total of 164 patients with follicular lymphoma (grade 1/2), mantle cell lymphoma or lymphoplasmacytic lymphoma (immunocytoma) was randomised to treatment with vincristine 2 mg (day 1) and prednisone 100 mg/m2 (days 1-5) + bendamustine 60 mg/m2 (days 1-5) or + cyclophosphamide 400 mg/m2 (days 1-5) for a total of eight 21-day cycles.
  
  
  RESULTS
  The rate of complete remission was 22% with BOP and 20% with COP. The projected 5-year survival rate was 61% with BOP and 46% with COP. The BOP-associated 5-year survival advantage almost reached significance in the subgroup of patients who responded to therapy (74% vs. 56%; P = 0.05), and did reach significance in responders who did not receive interferon maintenance therapy (70% vs. 47%; P = 0.03). Toxicity was acceptable in both treatment groups, although alopecia and leucopenia were more severe with COP.
  
  
  CONCLUSIONS
  Bendamustine can efficaciously and safely replace cyclophosphamide, as used in standard COP therapy, for the treatment of patients with indolent NHL and mantle cell lymphoma. Long-term survival data suggest a clinically significant benefit for patients treated with BOP.
authors.affiliation: HELIOS Klinikum Erfurt GmbH, 2. Medizinische Klinik, Bereich Hämatologie/Onkologie, Nordhäuserstr. 74, 99089, Erfurt, Germany, miherold@erfurt.helios-kliniken.de.
authors.forename: M
authors.initials: M
authors.lastname: Herold
authors.forename: A
authors.initials: A
authors.lastname: Schulze
authors.forename: D
authors.initials: D
authors.lastname: Niederwieser
authors.forename: A
authors.initials: A
authors.lastname: Franke
authors.forename: H J
authors.initials: HJ
authors.lastname: Fricke
authors.forename: P
authors.initials: P
authors.lastname: Richter
authors.forename: M
authors.initials: M
authors.lastname: Freund
authors.forename: B
authors.initials: B
authors.lastname: Ismer
authors.forename: K
authors.initials: K
authors.lastname: Dachselt
authors.forename: C
authors.initials: C
authors.lastname: Boewer
authors.forename: V
authors.initials: V
authors.lastname: Schirmer
authors.forename: J
authors.initials: J
authors.lastname: Weniger
authors.forename: R
authors.initials: R
authors.lastname: Pasold
authors.forename: C
authors.initials: C
authors.lastname: Winkelmann
authors.forename: C
authors.initials: C
authors.lastname: Klinkenstein
authors.forename: M
authors.initials: M
authors.lastname: Schulze
authors.forename: H
authors.initials: H
authors.lastname: Arzberger
authors.forename: K
authors.initials: K
authors.lastname: Bremer
authors.forename: S
authors.initials: S
authors.lastname: Hahnfeld
authors.forename: A
authors.initials: A
authors.lastname: Schwarzer
authors.forename: C
authors.initials: C
authors.lastname: Müller
authors.forename: Chr
authors.initials: C
authors.lastname: Müller
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000401:mortality; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D009588:Nitrogen Mustard Compounds; D014750:Vincristine; D003520:Cyclophosphamide; D000069461:Bendamustine Hydrochloride; D011241:Prednisone