title: Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab).
abstract: The aim of this study was to evaluate patient preference and satisfaction for the subcutaneous (s.c.) versus intravenous (i.v.) formulation of rituximab given with chemotherapy in previously untreated patients with CD20+ diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).
  
  
  
  Patients received eight cycles of rituximab according to 2 schedules: Arm A received 1 cycle rituximab i.v. (375 mg/m2) and 3 cycles rituximab s.c. (1400 mg) then 4 cycles rituximab i.v.; Arm B received 4 cycles rituximab i.v. (375 mg/m2) then 4 cycles rituximab s.c. (1400 mg). Alongside rituximab, both arms received 6-8 cycles of chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), cyclophosphamide, vincristine, prednisone (CVP), or bendamustine as per standard local practice). Preference for s.c. or i.v. administration was evaluated using the Patient Preference Questionnaire (PPQ) at cycles 6 and 8. Patient satisfaction and convenience were assessed using the Cancer Therapy Satisfaction Questionnaire (CTSQ), and Rituximab Administration Satisfaction Questionnaire (RASQ) at cycles 4 and 8.
  
  
  
  At the primary data cut-off (19 January 2015), the intent-to-treat population comprised 743 patients. The majority had DLBCL (63%) and baseline characteristics were balanced between arms. At cycle 8, 81% of patients completing the PPQ preferred rituximab s.c. Preference was not impacted by treatment sequence or disease type. Patient satisfaction as measured by RASQ was higher for s.c. versus i.v. CTSQ scores were similar between arms. Adverse events were generally balanced between administration routes and no new safety signals were detected.
  
  
  
  Most previously untreated patients with CD20+ DLBCL or FL preferred s.c. to i.v. rituximab administration. Patient satisfaction with rituximab treatment was generally greater with s.c. administration.
  
  
  
  NCT01724021 (ClinicalTrials.gov).
authors.affiliation: Department of Hematology & Oncology, University Hospital Giessen, Giessen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Rummel
authors.affiliation: Division of Hematology & Medical Oncology, Seoul National University Hospital, Seoul, South Korea.
authors.forename: T M
authors.initials: TM
authors.lastname: Kim
authors.affiliation: University of Parma, Parma, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Aversa
authors.affiliation: Schwarzwald-Baar Clinic Villingen-Schwenningen, Academic Teaching Hospital, University of Freiburg, Freiburg, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Brugger
authors.affiliation: Center for Hematology, Livorno, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Capochiani
authors.affiliation: University of Parma, Parma, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Plenteda
authors.affiliation: University Hospital Parma, Parma, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Re
authors.affiliation: Genentech Inc., South San Francisco, USA.
authors.forename: P
authors.initials: P
authors.lastname: Trask
authors.affiliation: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: S
authors.initials: S
authors.lastname: Osborne
authors.affiliation: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Smith
authors.affiliation: Department of Clinical Haematology, Austin Hospital, Heidelberg, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Grigg
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D055104:Infusions, Subcutaneous; D008224:Lymphoma, Follicular / Q000188:drug therapy*; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D011446:Prospective Studies; D000069283:Rituximab / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D000069283:Rituximab
keywords: DLBCL; FL; chemotherapy; rituximab; subcutaneous