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

BACKGROUND: To evaluate patient preference and satisfaction for the subcutaneous (SC) versus intravenous (IV) formulation of rituximab given with chemotherapy in previously untreated patients with CD20+ diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). PATIENTS AND METHODS: Patients received 8 cycles of rituximab according to 2 schedules: Arm A received 1 cycle rituximab IV (375 mg/m2) and 3 cycles rituximab SC (1400 mg) then 4 cycles rituximab IV; Arm B received 4 cycles rituximab IV (375 mg/m2) then 4 cycles rituximab SC (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 SC or IV 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. RESULTS: 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 SC. Preference was not impacted by treatment sequence or disease type. Patient satisfaction as measured by RASQ was higher for SC versus IV. CTSQ scores were similar between arms. Adverse events were generally balanced between administration routes and no new safety signals were detected. CONCLUSION: Most previously untreated patients with CD20+ DLBCL or FL preferred SC to IV rituximab administration. Patient satisfaction with rituximab treatment was generally greater with SC administration.