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本文引用的文献

1
A critical review of the role of Fc gamma receptor polymorphisms in the response to monoclonal antibodies in cancer.Fcγ 受体多态性在癌症中对单克隆抗体反应的作用的批判性评价。
J Hematol Oncol. 2013 Jan 4;6:1. doi: 10.1186/1756-8722-6-1.
2
Cetuximab hypersensitivity infusion reactions: Incidence and risk factors.西妥昔单抗超敏输注反应:发生率及危险因素
J Oncol Pharm Pract. 2013 Sep;19(3):222-7. doi: 10.1177/1078155212462440. Epub 2012 Nov 7.
3
Bevacizumab-based therapies in the first-line treatment of metastatic colorectal cancer.贝伐珠单抗为基础的治疗方案在转移性结直肠癌的一线治疗中的应用。
Oncologist. 2012;17(4):513-24. doi: 10.1634/theoncologist.2012-0003. Epub 2012 Apr 3.
4
Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study.在转移性结直肠癌一线治疗中,西妥昔单抗联合连续或间断氟尿嘧啶、亚叶酸钙和奥沙利铂(北欧 FLOX)与 FLOX 单药治疗的 III 期临床试验:NORDIC-VII 研究。
J Clin Oncol. 2012 May 20;30(15):1755-62. doi: 10.1200/JCO.2011.38.0915. Epub 2012 Apr 2.
5
Cancer statistics, 2012.癌症统计数据,2012 年。
CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
6
First-line XELOX plus bevacizumab followed by XELOX plus bevacizumab or single-agent bevacizumab as maintenance therapy in patients with metastatic colorectal cancer: the phase III MACRO TTD study.XELOX 联合贝伐珠单抗一线治疗后,XELOX 联合贝伐珠单抗或贝伐珠单抗单药维持治疗转移性结直肠癌患者:III 期 MACRO TTD 研究。
Oncologist. 2012;17(1):15-25. doi: 10.1634/theoncologist.2011-0249. Epub 2012 Jan 10.
7
Phase II study of irinotecan and cetuximab given every 2 weeks as second-line therapy for advanced colorectal cancer.替伊立替康和西妥昔单抗每 2 周 1 次给药作为二线治疗晚期结直肠癌的 II 期研究。
Clin Colorectal Cancer. 2012 Mar;11(1):53-9. doi: 10.1016/j.clcc.2011.05.003. Epub 2011 Aug 2.
8
Biweekly cetuximab plus irinotecan as second-line chemotherapy for patients with irinotecan-refractory and KRAS wild-type metastatic colorectal cancer according to epidermal growth factor receptor expression status.根据表皮生长因子受体表达状态,对伊立替康耐药且 KRAS 野生型转移性结直肠癌患者进行每两周一次的西妥昔单抗联合伊立替康二线化疗。
Invest New Drugs. 2012 Aug;30(4):1607-13. doi: 10.1007/s10637-011-9703-8. Epub 2011 Jun 25.
9
Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial.西妥昔单抗联合奥沙利铂一线治疗晚期结直肠癌的随机 3 期 MRC COIN 试验结果。
Lancet. 2011 Jun 18;377(9783):2103-14. doi: 10.1016/S0140-6736(11)60613-2. Epub 2011 Jun 5.
10
Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status.西妥昔单抗联合伊立替康、氟尿嘧啶和亚叶酸钙作为转移性结直肠癌的一线治疗:根据肿瘤 KRAS 和 BRAF 突变状态更新的总生存分析。
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西妥昔单抗用于转移性结直肠癌患者的交替给药方案。

Alternate dosing of cetuximab for patients with metastatic colorectal cancer.

作者信息

Hubbard Joleen M, Alberts Steven R

机构信息

Department of Oncology Mayo Clinic Rochester, MN.

出版信息

Gastrointest Cancer Res. 2013 Mar;6(2):47-55.

PMID:23745159
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3674463/
Abstract

BACKGROUND

Many chemotherapeutic regimens used to treat colorectal cancer (CRC), including 5-fluorouracil plus leucovorin in combination with irinotecan (FOLFIRI) or oxaliplatin (FOLFOX), are administered on an every-other-week (q2w) dosing schedule. Chemotherapy in combination with a monoclonal antibody (mAb) directed toward the epidermal growth factor receptor (EGFR) has emerged as an effective treatment option. There are currently 2 anti-EGFR mAbs approved by the United States Food and Drug Administration: cetuximab and panitumumab. Mutations of KRAS, a downstream protein in the EGFR pathway, predict resistance to EGFR mAbs. Thus, cetuximab and panitumumab are indicated for patients without a KRAS mutation (KRAS wild-type). Whereas panitumumab is approved on a q2w dosing schedule, cetuximab is approved as a weekly dose. However, only cetuximab is approved with FOLFIRI for frontline metastatic CRC, whereas panitumumab is approved for third-line. Because concomitant therapies are often administered q2w, the weekly dosing of cetuximab results in additional medical office visits.

DESIGN

Several studies have assessed the safety and efficacy of cetuximab q2w. For this review, a comprehensive literature search of studies evaluating cetuximab q2w dosing was conducted. Safety and efficacy results of these trials and retrospective analyses were summarized and reviewed.

RESULTS

In general, results with cetuximab q2w were comparable to those obtained with the weekly regimen.

CONCLUSION

These data suggest that for patients for whom weekly treatment with cetuximab presents a substantial burden to their quality of life, q2w dosing of cetuximab is a viable treatment option with a benefit:risk profile similar to that of the weekly regimen.

摘要

背景

许多用于治疗结直肠癌(CRC)的化疗方案,包括5-氟尿嘧啶加亚叶酸联合伊立替康(FOLFIRI)或奥沙利铂(FOLFOX),均采用每两周一次(q2w)的给药方案。化疗联合针对表皮生长因子受体(EGFR)的单克隆抗体(mAb)已成为一种有效的治疗选择。目前,美国食品药品监督管理局批准了2种抗EGFR mAb:西妥昔单抗和帕尼单抗。EGFR通路中的下游蛋白KRAS的突变预示着对EGFR mAb耐药。因此,西妥昔单抗和帕尼单抗适用于无KRAS突变(KRAS野生型)的患者。帕尼单抗获批采用q2w给药方案,而西妥昔单抗获批为每周给药一次。然而,仅西妥昔单抗获批与FOLFIRI联合用于一线转移性CRC,而帕尼单抗获批用于三线治疗。由于伴随疗法通常每两周给药一次,西妥昔单抗每周给药会导致额外的门诊就诊。

设计

多项研究评估了西妥昔单抗q2w的安全性和疗效。对于本综述,对评估西妥昔单抗q2w给药的研究进行了全面的文献检索。总结并回顾了这些试验和回顾性分析的安全性和疗效结果。

结果

总体而言,西妥昔单抗q2w的结果与每周给药方案获得的结果相当。

结论

这些数据表明,对于那些每周接受西妥昔单抗治疗会对其生活质量造成重大负担的患者,西妥昔单抗q2w给药是一种可行的治疗选择,其获益风险比与每周给药方案相似。