摘要
背景
目前尚缺乏由奥沙利铂、伊立替康、氟尿嘧啶和亚叶酸钙联合用药方案（FOLFIRINOX）与吉西他滨单药作为转移性胰腺癌患者一线治疗方案的有效性和安全性评估的相关数据。
方法
我们将342例美国东部肿瘤协作组（Eastern Cooperative Oncology Group）体能状况评分为0或1分（在0～5分的范围内，评分越高预示病情越重）的患者随机分成2组，一组接受FOLFIRINOX（奥沙利铂，85 mg/m2体表面积；伊立替康，180 mg/m2；亚叶酸钙，400 mg/m2；氟尿嘧啶，400 mg/m2首剂和随后2,400 mg/m2持续46小时静脉注射，每2周重复1次）治疗；另一组接受吉西他滨1,000 mg/m2每周1次，持续7～8周后再维持3～4周。对于2组中肿瘤缓解的患者，建议持续化疗6个月。主要研究终点为总体生存期。
结果
FOLFIRINOX组的中位生存期为11.1个月，吉西他滨组为6.8个月（死亡风险比，0.57；95%可信区间[CI]，0.45～0.73；P<0.001）。FOLFIRINOX组的中位疾病无进展生存期为6.4个月，吉西他滨组为3.3个月（疾病进展风险比，0.47；95% CI，0.37～0.59；P<0.001）。FOLFIRINOX组的客观缓解率为31.6%，吉西他滨组为9.4%（P<0.001）。FOLFIRINOX组有更多的不良事件，该组5.4%的患者出现粒细胞减少性发热。在6个月时，FOLFIRINOX组中有31%的患者出现明确的生活质量下降，而吉西他滨组为66%（风险比，0.47；95% CI，0.30～0.70；P<0.001）。
结论
与吉西他滨相比，FOLFIRINOX方案治疗更具有生存优势，但会增加毒性。对于体能状况良好的转移性胰腺癌患者，FOLFIRINOX可作为一种治疗选择（由法国政府等资助；ClinicalTrials.gov注册号为NCT00112658）。
Thierry Conroy, M.D., Françoise Desseigne, M.D., Marc Ychou, M.D., Ph.D., Olivier Bouché, M.D., Ph.D., Rosine Guimbaud, M.D., Ph.D., Yves Bécouarn, M.D., Antoine Adenis, M.D., Ph.D., Jean-Luc Raoul, M.D., Ph.D., Sophie Gourgou-Bourgade, M.Sc., Christelle de la Fouchardière, M.D., Jaafar Bennouna, M.D., Ph.D., Jean-Baptiste Bachet, M.D., Faiza Khemissa-Akouz, M.D., Denis Péré-Vergé, M.D., Catherine Delbaldo, M.D., Eric Assenat, M.D., Ph.D., Bruno Chauffert, M.D., Ph.D., Pierre Michel, M.D., Ph.D., Christine Montoto-Grillot, M.Chem., and Michel Ducreux, M.D., Ph.D., for the Groupe Tumeurs Digestives of Unicancer and the PRODIGE Intergroup*
From Nancy University and Centre Alexis Vautrin, Nancy (T.C.); Centre Léon Bérard, Lyon (F.D., C.F.); Centre Val d'Aurelle (M.Y., S.G.-B.) and Centre Hospitalo-Universitaire Saint-Eloi (E.A.), Montpellier; Centre Hospitalier Universitaire Robert Debré, Reims (O.B.); Institut Claudius Regaud, Toulouse (R.G.); Institut Bergonié, Bordeaux (Y.B.); Centre Oscar Lambret, Lille (A.A.); Centre Eugène Marquis, Rennes (J.-L.R.); Centre René Gauducheau, Nantes (J.B.); Hôpital Ambroise Paré, Boulogne-Billancourt (J.-B.B.); Centre Hospitalier, Perpignan (F.K.-A.); Hôpital de la Croix Rousse, Lyon (D.P.-V.); Centre Hospitalier Henri Mondor, Créteil (C.D.); Centre Georges-François Leclerc, Dijon (B.C.); Rouen University Hospital and University of Rouen, Rouen (P.M.); Unicancer–Bureau d'Etudes Cliniques et Thérapeutiques, Paris (C.M.-G.); Institut Gustave Roussy, Villejuif (M.D.); and Paris-Sud 11 University, Le Kremlin-Bicêtre (M.D.) — all in France.Address reprint requests to Dr. Conroy at the Department of Medical Oncology, Centre Alexis Vautrin, 54511 Vandoeuvre-lès-Nancy CEDEX, France, or at t.conroy@nancy.fnclcc.fr.*Additional investigators are listed in the Supplementary Appendix, available at NEJM.org.
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