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Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study.随机、III 期临床试验:帕尼单抗联合氟尿嘧啶、亚叶酸钙和奥沙利铂(FOLFOX4)对比 FOLFOX4 一线治疗未经治疗的转移性结直肠癌患者:PRIME 研究。
J Clin Oncol. 2010 Nov 1;28(31):4697-705. doi: 10.1200/JCO.2009.27.4860. Epub 2010 Oct 4.
2
Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer.一项比较帕尼单抗联合氟尿嘧啶、亚叶酸钙和伊立替康(FOLFIRI)与单独 FOLFIRI 二线治疗转移性结直肠癌患者的随机 III 期研究。
J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4.
3
Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: CECOG trial.西妥昔单抗联合 FOLFOX6 或 FOLFIRI 方案治疗转移性结直肠癌:CECOG 试验。
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4
Managing cetuximab hypersensitivity-infusion reactions: incidence, risk factors, prevention, and retreatment.管理西妥昔单抗超敏反应性输注反应:发生率、危险因素、预防及再次治疗
J Support Oncol. 2010 Mar-Apr;8(2):72-7.
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Clin Colorectal Cancer. 2010 Apr;9(2):102-7. doi: 10.3816/CCC.2010.n.014.
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Clin J Oncol Nurs. 2010 Apr;14(2):E10-21. doi: 10.1188/10.CJON.E10-E21.
7
Clinical and economic impact of infusion reactions in patients with colorectal cancer treated with cetuximab.在接受西妥昔单抗治疗的结直肠癌患者中输注反应的临床和经济影响。
Ann Oncol. 2010 Jul;21(7):1455-1461. doi: 10.1093/annonc/mdp535. Epub 2010 Jan 25.
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Oxaliplatin-induced allergic reaction in patients with colorectal cancer in Japan.日本结直肠癌患者奥沙利铂诱导的过敏反应。
Int J Clin Oncol. 2009 Oct;14(5):397-401. doi: 10.1007/s10147-009-0883-6. Epub 2009 Oct 25.
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A phase II, multicenter study of cetuximab monotherapy in patients with refractory, metastatic colorectal carcinoma with absent epidermal growth factor receptor immunostaining.一项评估西妥昔单抗单药治疗表皮生长因子受体免疫组化阴性的转移性结直肠癌患者的 II 期、多中心研究。
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转移性结直肠癌化疗和单克隆抗体相关输注反应的系统评价

Systematic review on infusion reactions associated with chemotherapies and monoclonal antibodies for metastatic colorectal cancer.

作者信息

Song Xue, Long Stacey R, Barber Beth, Kassed Cheryl A, Healey Marcus, Jones Clare, Zhao Zhongyun

机构信息

Thomson Reuters, Cambridge, MA 02140, USA.

出版信息

Curr Clin Pharmacol. 2012 Feb 1;7(1):56-65. doi: 10.2174/157488412799218806.

DOI:10.2174/157488412799218806
PMID:22299770
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3363055/
Abstract

OBJECTIVE

The objective of this systematic review is to summarize the literature to date on the rates of infusion reactions (IR) associated with chemotherapies and monoclonal antibody (mAb) drug therapies used for the treatment of metastatic colorectal cancer (mCRC) and the associated clinical and economic impact.

METHODS

This study searched Medline, Medline (R) In-Process, Embase and Cochrane Library databases for studies on IRs associated with chemotherapy and mAbs in mCRC patients from 2000-2011.

RESULTS

For chemotherapy, the incidence of IRs ranged from 0-71% for all grades and 0-15% for grade 3-4. Rates of all grade IRs associated with cetuximab ranged from 7.6-33% and grade 3-4 IR rates were 0-22%. Rates of all grade IRs associated with panitumumab ranged from 0-4% and rates of grade 3-4 IRs ranged from 0-1%. The overall rate of IRs associated with bevacizumab ranged from 1.6-11%, with a rate of 0-4% for grade 3-4 IRs. A range of 50-100% of patients with grade 3-4 IRs terminated chemotherapy, and 34-100% of cetuximab patients with grade 3-4 IRs discontinued cetuximab therapy. No data were reported for bevacizumab or panitumumab. Only one study evaluated the economic impact of IRs. The study compared cetuximab administrations without an IR to those with an IR requiring resource utilization and found that mean costs were $9308 and $1725 higher for those with an IR requiring an emergency room visit or hospitalization and for those with an IR requiring outpatient treatment, respectively.

CONCLUSIONS

The incidence of IRs varies among different mAbs; and IRs may cause treatment disruption and require costly medical interventions.

摘要

目的

本系统评价的目的是总结迄今为止关于用于治疗转移性结直肠癌(mCRC)的化疗和单克隆抗体(mAb)药物治疗相关的输注反应(IR)发生率以及相关的临床和经济影响的文献。

方法

本研究在Medline、Medline(R)在研数据库、Embase和Cochrane图书馆数据库中检索2000 - 2011年mCRC患者中与化疗和mAb相关的IR研究。

结果

对于化疗,所有级别的IR发生率为0 - 71%,3 - 4级为0 - 15%。与西妥昔单抗相关的所有级别的IR发生率为7.6 - 33%,3 - 4级IR发生率为0 - 22%。与帕尼单抗相关的所有级别的IR发生率为0 - 4%,3 - 4级IR发生率为0 - 1%。与贝伐单抗相关的IR总体发生率为1.6 - 11%,3 - 4级IR发生率为0 - 4%。50 - 100%的3 - 4级IR患者终止化疗,34 - 100%的3 - 4级IR西妥昔单抗患者停止西妥昔单抗治疗。未报告贝伐单抗或帕尼单抗的数据。仅有一项研究评估了IR的经济影响。该研究比较了无IR的西妥昔单抗给药与需要资源利用的有IR的给药情况,发现对于需要急诊就诊或住院的有IR患者以及需要门诊治疗的有IR患者,平均成本分别高出9308美元和1725美元。

结论

不同mAb的IR发生率各不相同;IR可能导致治疗中断并需要昂贵的医疗干预。