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奥林匹亚德试验:谁赢得了金牌?

The OlympiAD trial: who won the gold?

作者信息

Gyawali Bishal

机构信息

Institute of Cancer Policy, King's College London, Guy's Hospital Campus, Great Maze Pond Road, London SE1 9RT, UK.

出版信息

Ecancermedicalscience. 2017 Dec 6;11:ed75. doi: 10.3332/ecancer.2017.ed75. eCollection 2017.

DOI:10.3332/ecancer.2017.ed75
PMID:29290761
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5739869/
Abstract

OlympiAD was a phase 3 randomized controlled trial of a PARP inhibitor olaparib for metastatic HER2 negative breast cancer patients harboring a BRCA mutation. Although the OlympiAD trial met its primary endpoint, there are concerns regarding whether olaparib truly improves meaningful outcomes for these patients. In this editorial, I examine these issues in detail. An exploration of these issues will provide important educational insights for oncologists and cancer policy makers. I conclude that although olaparib seems to have won the Gold with OlympiAD, the patients probably have not. We need to stop celebrating a gold-plated bronze as a true gold so that one day our patients can finally get the gold they deserve.

摘要

OlympiAD是一项针对携带BRCA突变的转移性HER2阴性乳腺癌患者的PARP抑制剂奥拉帕利的3期随机对照试验。尽管OlympiAD试验达到了其主要终点,但对于奥拉帕利是否真的能改善这些患者的有意义结局仍存在担忧。在这篇社论中,我将详细探讨这些问题。对这些问题的探讨将为肿瘤学家和癌症政策制定者提供重要的教育启示。我的结论是,尽管奥拉帕利似乎凭借OlympiAD试验获得了金牌,但患者可能并未受益。我们需要停止将镀金的铜牌当作真正的金牌来庆祝,以便有朝一日我们的患者最终能够获得他们应得的金牌。

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本文引用的文献

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Targeting DNA repair and replication stress in the treatment of ovarian cancer.靶向DNA修复和复制应激在卵巢癌治疗中的应用
Int J Clin Oncol. 2017 Aug;22(4):619-628. doi: 10.1007/s10147-017-1145-7. Epub 2017 Jun 22.
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Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation.奥拉帕利治疗携种系 BRCA 突变的转移性乳腺癌患者。
N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4.
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Economics of Cancer Medicines: For Whose Benefit?癌症药物经济学:造福于谁?
New Bioeth. 2017 Apr;23(1):95-104. doi: 10.1080/20502877.2017.1314885.
4
The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses.肿瘤学中替代终点与生存之间关联强度的系统评价:试验水平荟萃分析。
JAMA Intern Med. 2015 Aug;175(8):1389-98. doi: 10.1001/jamainternmed.2015.2829.
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Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer.在转移性三阴性乳腺癌患者中,尼拉帕尼联合吉西他滨和卡铂与吉西他滨和卡铂的 III 期研究。
J Clin Oncol. 2014 Dec 1;32(34):3840-7. doi: 10.1200/JCO.2014.55.2984. Epub 2014 Oct 27.
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Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial.新辅助卡铂治疗三阴性和 HER2 阳性早期乳腺癌患者(GeparSixto;GBG 66):一项随机 2 期试验。
Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.