title: Differences in Quality of Life Between Bendamustine-Rituximab and R-CHOP/R-CVP in Patients With Previously Untreated Advanced Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma.
abstract: BACKGROUND
  We previously reported results of the phase III, randomized, noninferiority trial comparing bendamustine-rituximab (BR) with standard R-CHOP (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone)/R-CVP (rituximab/cyclophosphamide/vincristine/prednisone) in previously untreated advanced indolent non-Hodgkin and mantle cell lymphomas. Here we report health-related quality of life (HRQOL) results from the trial.
  
  
  METHODS
  HRQOL, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), was a secondary end point. Differences between group means in global health status (GHS), 5-item functioning, and 9 symptoms/single-item measures at week 1 of cycle 1 and end-of- cycles 3 and 6 were examined using the screening (baseline) score as a covariate in analysis of covariance.
  
  
  RESULTS
  Overall EORTC QLQ-C30 compliance was 75.2%, 89.5%, and 89.9% at week 1 of cycle 1 and end-of-cycles 3 and 6, respectively. Patients treated with BR reported improvements in Cognitive Functioning, Physical Functioning, Social Functioning, Emotional Functioning, and GHS as well as reduction in dyspnea, constipation, and fatigue at some, but not all, time points. Patients treated with standard therapy reported less nausea/vomiting at one time point.
  
  
  CONCLUSIONS
  Compared with patients treated with standard therapy, patients treated with BR reported better quality of life in several areas.
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands, TX; Medical Oncology, Rocky Mountain Cancer Centers, Aurora, CO. Electronic address: john.burke@usoncology.com.
authors.forename: John M
authors.initials: JM
authors.lastname: Burke
authors.affiliation: Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
authors.forename: Richard H C
authors.initials: RH
authors.lastname: van der Jagt
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, University of Wisconsin, Carbone Cancer Center, Madison, WI.
authors.forename: Brad S
authors.initials: BS
authors.lastname: Kahl
authors.affiliation: Department of Haematology, Princess Alexandra Hospital, Queensland, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Wood
authors.affiliation: Department of Haematology, Auckland Hospital, Auckland, New Zealand.
authors.forename: Tim E
authors.initials: TE
authors.lastname: Hawkins
authors.affiliation: Division of Hematology, Department of Medicine, Dalhousie University, Halifax, NS, Canada.
authors.forename: David
authors.initials: D
authors.lastname: MacDonald
authors.affiliation: Department of Haematology, Westmead Hospital, New South Wales, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Hertzberg
authors.affiliation: Department of Haematology, North Shore Hospital, Takapuna, New Zealand.
authors.forename: David
authors.initials: D
authors.lastname: Simpson
authors.affiliation: Department of Medicine, Section of Hematology/Oncology, West Virginia University, Morgantown, WV.
authors.forename: Michael
authors.initials: M
authors.lastname: Craig
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands, TX; Medical Oncology/Hematology Specialty, Compass Oncology, Vancouver, WA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Kolibaba
authors.affiliation: Department of Haematology, Middlemore Hospital, Auckland, New Zealand.
authors.forename: Samar
authors.initials: S
authors.lastname: Issa
authors.affiliation: New Therapeutic Entity, Clinical Research and Development, Teva Branded Pharmaceutical Products R&D, Inc, Frazer, PA.
authors.forename: Mihaela
authors.initials: M
authors.lastname: Munteanu
authors.affiliation: Science and Strategy, Kantar Health, Princeton, NJ; Department Biostatistics and Epidemiology, University of Pennsylvania, Graduate School of Education, Philadelphia, PA.
authors.forename: Timothy W
authors.initials: TW
authors.lastname: Victor
authors.affiliation: Blood Cancer Research Program, Sarah Cannon Research Institute, Nashville, TN.
authors.forename: Ian W
authors.initials: IW
authors.lastname: Flinn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use; D011788:Quality of Life; D000069283:Rituximab / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D014750:Vincristine / Q000627:therapeutic use
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; C571759:R-CHOP protocol; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069461:Bendamustine Hydrochloride; D011241:Prednisone
keywords: BRIGHT trial; EORTC QLQ-C30; First-line therapy; Patient-reported outcomes; Phase 3