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)
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)
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DOI：
10.1093/annonc/mdw685
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发表时间：
2017-04-01
影响因子：
50.5
通讯作者：
Grigg, A.
中科院分区：
文献类型：
--
作者：
Rummel, M.;Kim, T. M.;Grigg, A.
背景：本研究的目的是评估患者对皮下（s.c.）与静脉内（i. v.）患者和方法：患者根据2个时间表接受8个周期的利妥昔单抗：A组接受1个周期的利妥昔单抗i. v.（375 mg/m2）和3个周期的利妥昔单抗s.c. (1400 mg），然后4个周期利妥昔单抗静脉内; B组接受4个周期的利妥昔单抗静脉注射（375 mg/m2），然后接受4个周期的利妥昔单抗皮下注射。(1400 mg）。除利妥昔单抗外，两组均接受6-8个周期的化疗（环磷酰胺、多柔比星、长春新碱、泼尼松（CHOP）、环磷酰胺、长春新碱、泼尼松（CVP）或苯达莫司汀，根据当地标准实践）。偏好s.c.在第6和第8周期使用患者偏好问卷（PPQ）评价静脉或静脉内给药。在第4周期和第8周期使用癌症治疗满意度问卷（CTSQ）和利妥昔单抗给药满意度问卷（RASQ）评估患者满意度和便利性。结果：在主要数据截止日期（2015年1月19日），意向治疗人群包括743例患者。大多数患者患有DLBCL（63%），两组之间的基线特征平衡。在第8周期，81%完成PPQ的患者首选利妥昔单抗s.c.偏好不受治疗顺序或疾病类型的影响。通过RASQ测量的患者满意度高于s.c.组间CTSQ评分相似。不良事件之间的管理途径，并没有新的安全性signals.Conclusion：大多数以前未经治疗的患者CD 20 + DLBCL或FL首选s.c.静脉注射利妥昔单抗。患者对利妥昔单抗治疗的满意度通常高于皮下注射。局
Background: 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 and methods: Patients received eight cycles of rituximab according to 2 schedules: Arm A received 1 cycle rituximab i.v. (375 mg/m(2)) and 3 cycles rituximab s.c. (1400 mg) then 4 cycles rituximab i.v.; Arm B received 4 cycles rituximab i.v. (375 mg/m(2)) 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.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 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.Conclusion: 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.