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NALIRIFOX在转移性胰腺癌癌症一线的应用:NAPOLI3之外的证据

NALIRIFOX in the frontline for metastatic pancreatic cancer: evidence beyond NAPOLI 3

Nature 等信源发布 2024-10-25 00:09

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We read with interest the News & Views article by Nevala-Plagemann and Garrido-Laguna (Nevala-Plagemann, C. & Garrido-Laguna, I. NALIRIFOX for metastatic pancreatic adenocarcinoma: hope or hype? Nat. Rev. Clin. Oncol. 21, 567–568 (2024))1. In this article, the authors question whether the addition of nanoliposomal irinotecan, 5-fluorouracil, leucovorin and oxaliplatin (NALIRIFOX) to therapeutic options constitutes true progress for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).The authors perform a cross-trial comparison of data from NAPOLI 3 (ref.

我们饶有兴趣地阅读了Nevala Plagemann和Garrido Laguna的新闻和观点文章(Nevala Plagemann,C。&Garrido Laguna,I。转移性胰腺癌的Narifox:希望还是炒作?Nat。Rev。Clin。Oncol。21567-568(2024))1。在本文中,作者质疑纳米脂质体伊立替康,5-氟尿嘧啶,亚叶酸钙和奥沙利铂(纳利福)在治疗选择中的添加是否构成了转移性胰腺导管腺癌(mPDAC)患者的真正进展。作者对那不勒斯3号的数据进行了交叉试验比较(参考文献)。

2) and PRODIGE 4 (ref. 3) and state that “in the context of prior results from the PRODIGE 4 trial testing 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (modified FOLFIRINOX), NALIRIFOX does not seem to raise the bar, but rather exposes patients and health-care systems to financial toxicities”.

2) 。

As the principal investigators on the NAPOLI 3 study, we would like to raise several points that challenge these assertions.First, nanoliposomal irinotecan-based regimens have improved overall survival (OS) in pancreas cancer in several randomized trials. These include NAPOLI-1 (which tested the addition of liposomal irinotecan to second-line 5-fluorouracil–leucovorin and showed improved OS4) and, more recently, NAPOLI 3 (ref.

作为那不勒斯3号研究的主要调查人员,我们想提出几点挑战这些断言的观点。。其中包括NAPOLI-1(它测试了在二线5-氟尿嘧啶-亚叶酸钙中添加脂质体伊立替康,并显示出改善的OS4)和最近的NAPOLI 3(参考文献)。

2) (which showed improved progression-free survival, OS and objective response rate), which demonstrates consistent benefit with this agent.Second, given the major differences between the NAPOLI 3 (ref. 2) and PRODIGE 4 (ref. 3) trials, cross-trial comparisons of efficacy and safety data are fraught with bias and, in our opinion, not scientifically valid: NAPOLI 3 compared NALIRIFOX to gemcitabine–nab-paclitaxel whereas PRODIGE 4 compared FOLFIRINOX to gemcitabine monotherapy, both in.

2) (显示出改善的无进展生存期,OS和客观缓解率),这表明该药物具有一致的益处。其次,鉴于那不勒斯3号试验(参考文献2)和PRODIGE 4号试验(参考文献3)之间的主要差异,疗效和安全性数据的交叉试验比较充满了偏见,我们认为这在科学上是不正确的:那不勒斯3号比较了那利福和吉西他滨-纳布紫杉醇,而PRODIGE 4比较了FOLFIRINOX和吉西他滨单药治疗。

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Download referencesAcknowledgementsE.M.O’R. has received grants from the National Institute of Health/National Cancer Institute and Parker Institute; has had leadership or fiduciary role in board, society, committee or advocacy groups with the Avner Foundation, National Pancreas Foundation and Pancreas Cancer Action Network; and has had other interactions from the American Association of Cancer Research and ASCO.Author informationAuthors and AffiliationsDavid Geffen School of Medicine, University of California, Los Angeles, CA, USAZev A.

下载referencesAcknowledgementsE。M、 O'R。;曾在Avner基金会、国家胰腺基金会和胰腺癌行动网络的董事会、社会、委员会或倡导团体中担任领导或受托人角色;并与美国癌症研究协会和ASCO进行了其他互动。作者信息作者和附属机构美国加利福尼亚大学洛杉矶分校维德·格芬医学院。

WainbergDavid M. Rubenstein Center for Pancreatic Cancer Research, Memorial Sloan Kettering Cancer Center, New York, NY, USAEileen M. O’ReillyAuthorsZev A. WainbergView author publicationsYou can also search for this author in.

WainbergDavid M.Rubenstein胰腺癌研究中心,纪念斯隆·凯特琳癌症中心,纽约,纽约,USAileen M.O'ReillyAuthorsZev A.WainbergView作者出版物您也可以在中搜索这位作者。

PubMed Google ScholarEileen M. O’ReillyView author publicationsYou can also search for this author in

PubMed Google ScholarEileen M.O'ReillyView作者出版物您也可以在

PubMed Google ScholarCorresponding authorCorrespondence to

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Zev A. Wainberg.Ethics declarations

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Competing interests

相互竞争的利益

Z.A.W. is a NAPOLI 3 study investigator; has received grants or contracts from Arcus and Bristol Myers Squibb; consulting fees from Amgen, Arcus, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Gilead, Ipsen, Merck Sharp & Dohme and Seagen; travel support from Amgen, Bayer and Merck Sharp & Dohme; and has participated on data safety monitoring or advisory boards for Mirati and Pfizer.

Z、 A.W.是那不勒斯3号研究调查员;已获得Arcus和百时美施贵宝的赠款或合同;安进(Amgen)、阿库斯(Arcus)、阿斯特拉斯(Astellas)、阿斯利康(AstraZeneca)、拜耳(Bayer)、百时美施贵宝(Bristol-Myers Squibb)、第一三共(Daiichi Sankyo)、吉利德(Gilead)、益普生(Ipsen)、默克夏普(Merck Sharp&Dohme)和希;安进(Amgen)、拜耳(Bayer)和默克(Merck Sharp&Dohme)的旅行支持;并参加了米拉蒂和辉瑞的数据安全监测或咨询委员会。

E.M.O’R. is a NAPOLI 3 study investigator; has received grants or contracts from AstraZeneca, Arcus, BioNTech, Elicio, Genentech–Roche, and Pertzye; personal consulting fees from Astellas, AstraZeneca, Autem, BioNTech, Bristol Myers Squibb, Fibrogen, Ipsen, Merck, Sharp & Dohme, Merus, Novartis, Revolution Medicine and Tempus; and their spouse has received grants or contracts from Agios, Eisai and Genentech–Roche..

E、 。是那不勒斯3号研究调查员;已获得阿斯利康、Arcus、BioNTech、Elicio、Genentech–Roche和Pertzye的赠款或合同;Astellas,AstraZeneca,Autem,BioNTech,百时美施贵宝,Fibrogen,Ipsen,Merck,Sharp&Dohme,Merus,Novartis,Revolution Medicine和Tempus的个人咨询费;他们的配偶已经从Agios、Eisai和Genentech–Roche获得了赠款或合同。。

Rights and permissionsReprints and permissionsAbout this articleCite this articleWainberg, Z.A., M. O’Reilly, E. NALIRIFOX in the frontline for metastatic pancreatic cancer: evidence beyond NAPOLI 3.

权利和许可本文引用本文Wainberg,Z.A.,M。O'Reilly,E。Narifox在转移性胰腺癌的前线:那不勒斯以外的证据3。

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