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FOLFIRINOX或吉西他滨作为胰腺癌的辅助治疗
FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer


Thierry Conroy ... 肿瘤 • 2018.12.20
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• 奥拉帕利用于生殖细胞系BRCA突变转移性胰腺癌的维持治疗 • FOLFIRINOX和吉西他滨用于胰腺癌辅助治疗的比较 • FOLFIRINOX与吉西他滨治疗转移性胰腺癌的比较 • 吉西他滨加卡培他滨用于胰腺癌切除术后患者 • ASCO 2017报告——胃肠道癌症

摘要


背景

在转移性胰腺癌患者中,与吉西他滨治疗相比,氟尿嘧啶、亚叶酸、伊立替康和奥沙利铂(FOLFIRINOX)联合化疗获得了较长的总生存期。我们比较了改良FOLFIRINOX方案和吉西他滨作为胰腺癌患者切除术后辅助治疗的疗效和安全性。

 

方法

我们将493例胰腺导管腺癌切除术后的患者随机分组,分别接受改良FOLFIRINOX方案(每次给予奥沙利铂[85 mg/m2]、伊立替康[180 mg/m2,在方案规定的安全性分析之后降低至150 mg/m2]、亚叶酸[400 mg/m2]和氟尿嘧啶[2,400 mg/m2],每2周重复1次)或吉西他滨(每周期在第1日、第8日和第15日给予1,000 mg/m2,每4周重复1次)治疗24周。主要终点为无病生存期。次要终点包括总生存期和安全性。

 

结果

中位随访33.6个月时,在改良FOLFIRINOX组和吉西他滨组中,中位无病生存期分别为21.6个月和12.8个月(癌症相关事件、第二癌症或死亡的分层风险比,0.58;95%置信区间[CI],0.46~0.73;P<0.001)。改良FOLFIRINOX组和吉西他滨组的3年无病生存率分别为39.7%和21.4%。改良FOLFIRINOX组和吉西他滨组的中位总生存期分别为54.4个月和35.0个月(死亡的分层风险比,0.64;95% CI,0.48~0.86;P=0.003)。改良FOLFIRINOX组和吉西他滨组的3年总生存率分别为63.4%和48.6%。在改良FOLFIRINOX组和吉西他滨组中,3级或4级不良事件的发生率分别为75.9%和52.9%。吉西他滨组1例患者死于毒性作用(间质性肺炎)。

 

结论

在胰腺癌切除术后患者中,与吉西他滨相比,改良FOLFIRINOX方案辅助治疗获得了显著较长的生存期,但毒性作用的发生率较高(由R&D Unicancer等资助;在ClinicalTrials.gov注册号为NCT01526135;在EudraCT注册号为2011-002026-52)。





作者信息

Thierry Conroy, M.D., Pascal Hammel, M.D., Ph.D., Mohamed Hebbar, M.D., Ph.D., Meher Ben Abdelghani, M.D., Alice C. Wei, M.D., C.M., Jean-Luc Raoul, M.D., Ph.D., Laurence Choné, M.D., Eric Francois, M.D., Pascal Artru, M.D., James J. Biagi, M.D., Thierry Lecomte, M.D., Ph.D., Eric Assenat, M.D., Ph.D., Roger Faroux, M.D., Marc Ychou, M.D., Ph.D., Julien Volet, M.D., Alain Sauvanet, M.D., Gilles Breysacher, M.D., Frédéric Di Fiore, M.D., Ph.D., Christine Cripps, M.D., Petr Kavan, M.D., Ph.D., Patrick Texereau, M.D., Karine Bouhier-Leporrier, M.D., Faiza Khemissa-Akouz, M.D., Jean-Louis Legoux, M.D., Béata Juzyna, Eng., Sophie Gourgou, M.Sc., Christopher J. O’Callaghan, D.V.M., Ph.D., Claire Jouffroy-Zeller, Pharm.D., Patrick Rat, M.D., David Malka, M.D., Ph.D., Florence Castan, M.Sc., and Jean-Baptiste Bachet, M.D., Ph.D. for the Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group*
From the Institut de Cancérologie de Lorraine and Université de Lorraine (T.C.) and Centre Hospitalier Universitaire (L.C.), Nancy, Hôpital Beaujon and University Paris VII, Clichy (P.H., A.S.), Hôpital Huriez, Lille (M.H.), Centre Paul Strauss, Strasbourg (M.B.A.), Institut Paoli-Calmettes, Marseille (J.-L.R.), Centre Antoine-Lacassagne, Nice (E.F.), Hôpital Jean-Mermoz, Lyon (P.A.), Hôpital Trousseau, Tours (T.L.), Centre Hospitalier Universitaire de Saint-Eloi (E.A.) and Institut du Cancer de Montpellier–Val d’Aurelle, Université de Montpellier (M.Y., S.G., F.C.), Montpellier, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon (R.F.), Centre Hospitalier Universitaire Robert Debré, Reims (J.V.), Hôpital Louis Pasteur, Colmar (G.B.), Normandie University, Rouen University Hospital, Rouen (F.D.F.), Hôpital Layné, Mont-de-Marsan (P.T.), Centre Hospitalier Universitaire Côte de Nacre, Caen (K.B.-L.), Hôpital Saint-Jean, Perpignan (F.K.-A.), Centre Hospitalier Régional, Orléans (J.-L.L.), R&D Unicancer (B.J., C.J.-Z.) and Sorbonne Université, Hôpitaux Universitaires Pitié–Salpétrière, Assistance Publique–Hôpitaux de Paris (J.-B.B.), Paris, Gustave Roussy, Université Paris-Saclay, Villejuif (D.M.), and Centre Hospitalier Universitaire, Dijon (P.R.) — all in France; and the Princess Margaret Cancer Centre, Toronto (A.C.W.), Kingston General Hospital (J.J.B.) and the Canadian Cancer Trials Group, Queen’s University (C.J.O.), Kingston, ON, the Ottawa Health Research Institute, Ottawa (C.C.), and Segal Cancer Centre, Jewish General Hospital, Montreal (P.K.) — all in Canada. Address reprint requests to Dr. Conroy at the Department of Medical Oncology, Institut de Cancérologie de Lorraine, 6 Ave. de Bourgogne, CS 30519, 54519 Vandoeuvre-lès-Nancy CEDEX, France, or at t.conroy@nancy.unicancer.fr. *A complete list of the investigators in the Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group is provided in the Supplementary Appendix, available at NEJM.org.

 

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