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Haematologica. 2017 Nov;102(11):1913-1922. doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.
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Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial.皮下注射利妥昔单抗与静脉注射利妥昔单抗一线治疗滤泡性淋巴瘤的疗效和安全性(SABRINA):一项随机、开放标签的3期试验
Lancet Haematol. 2017 Jun;4(6):e272-e282. doi: 10.1016/S2352-3026(17)30078-9. Epub 2017 May 2.
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A Canadian perspective on the subcutaneous administration of rituximab in non-Hodgkin lymphoma.加拿大对利妥昔单抗皮下注射治疗非霍奇金淋巴瘤的观点。
Curr Oncol. 2017 Feb;24(1):33-39. doi: 10.3747/co.24.3470. Epub 2017 Feb 27.
4
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).未接受治疗的 CD20+弥漫性大 B 细胞淋巴瘤或滤泡性淋巴瘤患者对利妥昔单抗皮下或静脉给药的偏好:来自一项前瞻性、随机、开放标签、交叉研究(PrefMab)的结果。
Ann Oncol. 2017 Apr 1;28(4):836-842. doi: 10.1093/annonc/mdw685.
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Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries.与利妥昔单抗静脉输注相比,利妥昔单抗皮下注射节省的时间:八个国家的时间与动作研究
PLoS One. 2016 Jun 30;11(6):e0157957. doi: 10.1371/journal.pone.0157957. eCollection 2016.
6
Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study.利妥昔单抗皮下与静脉给药作为滤泡性淋巴瘤维持治疗的比较:来自两阶段、Ib 期研究的结果。
J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12.
7
Subcutaneous vs intravenous rituximab in patients with non-Hodgkin lymphoma: a time and motion study in the United Kingdom.皮下注射与静脉注射利妥昔单抗治疗非霍奇金淋巴瘤患者的对比:英国的一项时间与动作研究
J Med Econ. 2014 Jul;17(7):459-68. doi: 10.3111/13696998.2014.914033. Epub 2014 May 7.
8
Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study.滤泡淋巴瘤患者皮下注射利妥昔单抗的药代动力学和安全性(SABRINA):一项随机 3 期研究的 1 期分析。
Lancet Oncol. 2014 Mar;15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1. Epub 2014 Feb 10.
9
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10
Advances in the management of follicular lymphoma.滤泡性淋巴瘤的治疗进展。
Curr Opin Oncol. 2012 Nov;24(6):742-7. doi: 10.1097/CCO.0b013e328358f602.

皮下注射利妥昔单抗在加拿大全身治疗套房中的应用评估。

Evaluation of subcutaneous rituximab administration on Canadian systemic therapy suites.

作者信息

Stewart D A, Boudreault J S, Maturi B, Boras D, Foley R

机构信息

Tom Baker Cancer Centre and University of Calgary, Calgary, AB.

Hôpital du Sacré-Coeur de Montréal, Montreal, QC.

出版信息

Curr Oncol. 2018 Oct;25(5):300-306. doi: 10.3747/co.25.4231. Epub 2018 Oct 31.

DOI:10.3747/co.25.4231
PMID:30464679
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6209563/
Abstract

BACKGROUND

Non-Hodgkin lymphoma (nhl) is the most common hematologic malignancy. Diffuse large B-cell lymphoma (dlbcl) and follicular lymphoma (fl) constitute 55% of new nhl cases and are initially treated with rituximab-based chemoimmunotherapy. Relative to intravenous (IV) rituximab, a subcutaneous (sc) formulation approved in 2016 has comparable pharmacokinetics, efficacy, and safety, and a greatly reduced administration time; it is also preferred by patients. The objective of the present study was to estimate the effect (on systemic therapy suite time and on the costs of drug acquisition and administration) of implementing sc rituximab in the initial chemoimmunotherapy for fl and dlbcl over 3 years in the Canadian market.

METHODS

An Excel (Microsoft Corporation, Redmond, WA, U.S.A.)-based model was created with a population size based on epidemiologic data and current rituximab use, duration of use considering initial therapy, time savings for sc rituximab administration from published studies, costs from standard Canadian sources, and assumed uptake in implementing provinces of 65%, 75%, and 80% over 3 years. Key parameters and sensitivity analysis values were validated by clinical experts located in various Canadian jurisdictions. Costs are reported in 2017 Canadian dollars from the perspective of the health care system.

RESULTS

More than 3 years after implementation of sc rituximab, we estimated that 5762 Canadians would be receiving sc rituximab, resulting in savings of 128,715 hours in systemic therapy suite time and approximately $40 million in drug and administration costs. Sensitivity analyses suggest that the model is most sensitive to sc market uptake, number of induction therapy cycles, and eligible patients.

CONCLUSIONS

Subcutaneous administration of rituximab can significantly reduce systemic therapy suite time and achieve substantial savings in drug and administration costs.

摘要

背景

非霍奇金淋巴瘤(NHL)是最常见的血液系统恶性肿瘤。弥漫性大B细胞淋巴瘤(DLBCL)和滤泡性淋巴瘤(FL)占新诊断NHL病例的55%,初始治疗采用基于利妥昔单抗的化疗免疫疗法。相对于静脉注射(IV)利妥昔单抗,2016年获批的皮下(SC)制剂具有相似的药代动力学、疗效和安全性,且给药时间大幅缩短;患者也更倾向于选择。本研究的目的是评估在加拿大市场3年内将SC利妥昔单抗用于FL和DLBCL初始化疗免疫治疗对全身治疗时间以及药物采购和给药成本的影响。

方法

基于美国华盛顿州雷德蒙德微软公司的Excel软件创建了一个模型,其人口规模基于流行病学数据和当前利妥昔单抗的使用情况,使用时长考虑初始治疗,根据已发表研究得出SC利妥昔单抗给药节省的时间,成本来自加拿大标准来源,并假设实施省份在3年内的采用率分别为65%、75%和80%。关键参数和敏感性分析值由加拿大不同司法管辖区的临床专家进行验证。成本以2017年加拿大元为单位,从医疗保健系统的角度报告。

结果

在实施SC利妥昔单抗3年多后,我们估计有5762名加拿大人将接受SC利妥昔单抗治疗,这将使全身治疗时间节省128,715小时,药物和给药成本节省约4000万美元。敏感性分析表明,该模型对SC市场采用率、诱导治疗周期数和符合条件的患者最为敏感。

结论

皮下注射利妥昔单抗可显著减少全身治疗时间,并在药物和给药成本方面实现大幅节省。