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妇科恶性肿瘤抗瘤药物监管审批试验中的合理研究终点

Rational study endpoints in anti-neoplastic agent regulatory approval trials in the gynecologic malignancies.

作者信息

Markman Maurie

机构信息

Cancer Treatment Centers of America, Philadelphia, PA, USA Drexel University College of Medicine, Philadelphia, PA, USA

出版信息

Womens Health (Lond). 2016 Jul;12(4):396-9. doi: 10.1177/1745505716655555.

DOI:10.1177/1745505716655555
PMID:27638892
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5373277/
Abstract

A discussion of rational endpoints in clinical trials seeking regulatory approval for new anti-neoplastic agents involving the three major gynecologic malignancies, cancers of the ovary, cervix, and endometrial, is particularly interesting as (in the opinion of this commentator) the conclusion will be different in the individual cancers.

摘要

对于寻求监管批准用于治疗三大妇科恶性肿瘤(卵巢癌、宫颈癌和子宫内膜癌)的新型抗肿瘤药物的临床试验中的合理终点进行讨论,特别有意思,因为(在本评论员看来)每种癌症的结论会有所不同。

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本文引用的文献

1
Characteristics of Long-Term Survivors of Epithelial Ovarian Cancer.上皮性卵巢癌长期存活者的特征
Obstet Gynecol. 2015 Sep;126(3):491-497. doi: 10.1097/AOG.0000000000000981.
2
Second-Line Therapy for Endometrial Cancer: The Need for Better Options.子宫内膜癌的二线治疗:对更好治疗方案的需求。
J Clin Oncol. 2015 Nov 1;33(31):3535-40. doi: 10.1200/JCO.2015.61.7225. Epub 2015 Jul 20.
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Improved survival with bevacizumab in advanced cervical cancer.贝伐珠单抗治疗晚期宫颈癌可提高生存率。
N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa1309748.
4
OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer.OCEANS:一项在铂敏感复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌患者中进行的化疗联合或不联合贝伐珠单抗的随机、双盲、安慰剂对照 III 期试验。
J Clin Oncol. 2012 Jun 10;30(17):2039-45. doi: 10.1200/JCO.2012.42.0505. Epub 2012 Apr 23.
5
Medical therapy of endometrial cancer: current status and promising novel treatments.子宫内膜癌的医学治疗:现状和有前途的新治疗方法。
Drugs. 2012 Mar 26;72(5):705-13. doi: 10.2165/11631840-000000000-00000.
6
Detecting an overall survival benefit that is derived from progression-free survival.检测从无进展生存中获得的总生存获益。
J Natl Cancer Inst. 2009 Dec 2;101(23):1642-9. doi: 10.1093/jnci/djp369. Epub 2009 Nov 9.
7
Ovarian cancer.卵巢癌
Lancet. 2009 Oct 17;374(9698):1371-82. doi: 10.1016/S0140-6736(09)61338-6. Epub 2009 Sep 28.
8
Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study.含顺铂的四种双联方案用于IVB期、复发性或持续性宫颈癌的III期试验:一项妇科肿瘤学组研究
J Clin Oncol. 2009 Oct 1;27(28):4649-55. doi: 10.1200/JCO.2009.21.8909. Epub 2009 Aug 31.
9
Chemotherapy for advanced, recurrent, and metastatic cervical cancer.晚期、复发性和转移性宫颈癌的化疗。
J Natl Compr Canc Netw. 2008 Jan;6(1):53-7. doi: 10.6004/jnccn.2008.0006.
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J Clin Oncol. 2006 Oct 10;24(29):4699-707. doi: 10.1200/JCO.2006.06.0913. Epub 2006 Sep 11.