Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study.
Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study.
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DOI：
10.3324/haematol.2017.173583
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发表时间：
2017-11
期刊：
影响因子：
10.1
通讯作者：
Pfreundschuh M
中科院分区：
文献类型：
--
作者：
Lugtenburg P;Avivi I;Berenschot H;Ilhan O;Marolleau JP;Nagler A;Rueda A;Tani M;Turgut M;Osborne S;Smith R;Pfreundschuh M
静脉注射利妥昔单抗加化疗是弥漫性大B细胞淋巴瘤的标准治疗。利妥昔单抗的皮下制剂预计将简化和缩短药物制备和给药时间，并减轻治疗负担。MabEase（clinicaltrials.gov标识符：01649856）检查了皮下利妥昔单抗联合化疗在弥漫性大B细胞淋巴瘤初治患者中的疗效、安全性和患者满意度。患者以2：1的比例随机接受皮下利妥昔单抗（静脉注射375 mg/m2，第1周期;皮下注射1,400 mg，第2-8周期）或静脉利妥昔单抗（375 mg/m2，第1-8周期）联合环磷酰胺、多柔比星、长春新碱和泼尼松，每14或21天一次。主要终点是评估者评估的完全缓解/未经证实的完全缓解。次要终点包括安全性、治疗满意度（癌症治疗满意度问卷和利妥昔单抗给药满意度问卷）、节省时间和生存率。在576例随机化患者中，572例（378例皮下注射; 194例静脉注射）接受了治疗。诱导结束时完全缓解/未证实的完全缓解率分别为50.6%（皮下注射）和42.4%（静脉注射）。中位35个月后，未达到中位总体、无事件和无进展生存期。两组之间≥3级不良事件（皮下注射58.3%;静脉注射54.3%）和给药相关不良事件（两组均为21%）相似。皮下注射的注射部位反应更常见（分别为5.7%和0%）。皮下注射与静脉注射相比，利妥昔单抗给药满意度问卷中“对日常生活活动的影响”、“依从性”和“满意度”评分均有所改善;两组之间的癌症治疗满意度问卷评分相似。与静脉注射利妥昔单抗相比，皮下注射利妥昔单抗的中位给药时间（6分钟vs. 2.6 - 3.0小时）、椅子/床和总体住院时间更短。总体而言，皮下注射和静脉注射利妥昔单抗具有相似的疗效和安全性，提高了患者满意度并节省了时间。
Intravenous rituximab plus chemotherapy is standard treatment for diffuse large B-cell lymphoma. A subcutaneous formulation of rituximab is expected to simplify and shorten drug preparation and administration, and to reduce treatment burden. MabEase (clinicaltrials.gov Identifier: 01649856) examined efficacy, safety and patient satisfaction with subcutaneous rituximab plus chemotherapy in treatment-naïve patients with diffuse large B-cell lymphoma. Patients were randomized 2:1 to subcutaneous rituximab (intravenous 375 mg/m2 cycle 1; subcutaneous 1,400 mg cycles 2–8) or intravenous rituximab (375 mg/m2 cycles 1–8) plus cyclophosphamide, doxorubicin, vincristine, and prednisone every 14 or 21 days. The primary endpoint was investigator-assessed complete response/unconfirmed complete response. Secondary endpoints included safety, treatment satisfaction (Cancer Treatment Satisfaction Questionnaire and Rituximab Administration Satisfaction Questionnaire), time savings, and survival. Of 576 randomized patients, 572 (378 subcutaneous; 194 intravenous) received treatment. End of induction complete response/unconfirmed complete response rates were 50.6% (subcutaneous) and 42.4% (intravenous). After a median 35 months, median overall, event-free and progression-free survivals were not reached. Grade ≥3 adverse events (subcutaneous 58.3%; intravenous 54.3%) and administration-related adverse events (both groups 21%) were similar between arms. Injection-site reactions were more common with subcutaneous injections (5.7% versus 0%, respectively). Rituximab Administration Satisfaction Questionnaire scores for ‘impact on activities of daily living’, ‘convenience’, and ‘satisfaction’ were improved with subcutaneous versus intravenous injections; Cancer Therapy Satisfaction Questionnaire scores were similar between arms. Median administration time (6 minutes vs. 2.6 to 3.0 hours), chair/bed and overall hospital times were shorter with subcutaneous versus intravenous rituximab. Overall, subcutaneous and intravenous rituximab had similar efficacy and safety, with improved patient satisfaction and time savings.
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影响因子：
51.1
作者：
Pfreundschuh, Michael;Schubert, Joerg;Loeffler, Markus
通讯作者：
Loeffler, Markus
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20.3
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作者：
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