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| 1 | 帕博利珠单抗联合以铂类为基础的化疗治疗非小细胞肺癌合并稳定性脑转移患者的结局:KEYNOTE-021、-189和-407研究的汇总分析显示文摘背景与目的此项探索性分析回顾评价了晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的结局,旨在确定基线时合并脑转移是否会影响一线应用帕博利珠单抗联合化疗(pembrolizumab plus chemotherapy,PC)比对单用化疗的疗效。患者和方法对KEYNOTE-021队列G(非鳞癌)、KEYNOTE-189(非鳞癌)和KEYNOTE-407(鳞癌)三项研究晚期NSCLC患者的数据进行汇总分析。患者接受含铂两药化疗和/或35个周期帕博利珠单抗治疗(每3周200 mg)。所有研究均纳入了经治或初治的稳定性脑转移患者(KEYNOTE-189与KEYNOTE-407研究纳入初治脑转移患者)。经治的脑转移患者已处于病情稳定的状态≥2周(KEYNOTE-021队列G患者≥4周),无新发或脑转移病灶扩大的证据且入组前至少3天以上未使用激素。初治的无症状脑转移患者需定期接受脑部影像学检查。结果共纳入1298例患者,其中171例有基线脑转移,1127例无脑转移。两组的中位随访时间(范围)在数据截止时分别为10.9(0.1-35.1)个月和11.0(0.1-34.9)个月。合并脑转移和无脑转移患者的总生存期[0.48(95%CI:0.32-0.70)和0.63(95%CI:0.53-0.75)]和无进展生存期[0.44(95%CI:0.31-0.62)和0.55(95%CI:0.48-0.63)]的风险比(PC/化疗)相似。合并脑转移的患者中,PC组和单用化疗组患者的中位总生存期分别为18.8个月和7.6个月,中位无进展生存期分别为6.9个月和4.1个月。无论是否合并脑转移,PC组患者的客观缓解率都高于单用化疗组,且缓解持续时间有显著延长。合并脑转移的患者中,PC组与单用化疗组的治疗相关不良事件发生率分别为88.2%和82.8%;而无脑转移的患者中,两组治疗相关不良事件的发生率分别为94.5%和90.6%。结论无论是否合并脑转移,与单用化疗相比,帕博利珠单抗联合以铂类为基础的组织学特异性化疗可改善所有PD-L1亚组的临床结局,其中包括PD-L1肿瘤比例评分<1%的患者,并且在晚期NSCLC患者中安全性良好。该方案是晚期NSCLC初治患者的标准方案,并可用于合并稳定性脑转移的患者。 | 周清(翻译校对) Steven F Powell Delvys Rodríguez-Abreu Corey J Langer Ali Tafreshi Luis Paz-Ares Hans-Georg Kopp Jeronimo Rodríguez-Cid Dariusz M Kowalski Ying Cheng Takayasu Kurata Mark M Awad Jinaxin Lin Bin Zhao M Catherine Pietanza Bilal Piperdi Marina C Garassino | 2022 | 中国肺癌杂志2022，25，1： | 6 |
| 2 | Inducible inactivation of Notchl causes nodular regenerative hyperplasia in mice显示文摘 | Croquelois A Blindenbacher A Terracciano L Wang X Langer I Radtke F | 2005 | Hepatology2005，41，： | 1 |
| 3 | Studies Instabilities and pattern formation in crystal growth显示文摘 | Langer R F | 1980 | Rev Mod Phys1980，52，1： | 1 |
| 4 | Increase in Global Atmospheric Concentrations of Mercury Inferred from Measurements Over the Atlantic Ocean显示文摘 | Langer E | 1992 | Nature1992，，355： | 1 |
| 5 | Valve -sparing aortic root replacement in bicuspid aortic valves: a reasonable option? 显示文摘 | AICHER D LANGER F KISSINGER A | 2004 | J Thorac Cardiovasc Surg2004，128，5： | 1 |
| 6 | Nanoparticle technologies for cancer therapy显示文摘 | Alexisr F Pridgen EM Langer R | 2010 | Handb Exp Pharmacol2010，，197： | 1 |
| 7 | Modeling and Managing Student Loyalty An Ap- proach Based on the Concept of Relationship Quali- ty显示文摘 | Hennig-Thurau T Langer M F and Hansen U | 2001 | Journal of Service Research2001，3，4： | 1 |
| 8 | Cytokine response to pulmonary thromboendarterectomy 显示文摘 | Langer F Schramm R Bauer M | 2004 | Chest2004，126，1： | 1 |
| 9 | Cusp repair in aortic valve reconstruction: does the technique affect stability? 显示文摘 | AICHER D LANGER F ADAM O | 2007 | J Thorac Cardiovasc Surg2007，134，6： | 1 |
| 10 | Reliability of lymphoma classification in bone marrow trephines显示文摘 | Buhr T Langer F Schlu6 J | 2002 | Br J Haematol2002，118，2： | 1 |
| 11 | Alterations in left ventricular torsion and diastolic recoil after myocardial infarction with and without chronic ischemic mitral regurgitation显示文摘 | TIBAYAN F A RODRIGUEZ F LANGER F | 2004 | Circulation2004，110，11： | 1 |
| 12 | Quantitative assessment of promoter hypermethylation during breast cancer development显示文摘 | Lehmann U Langer F Feist H | 2002 | Am J Pathol2002，160，2： | 1 |
| 13 | Sleeve Gastrectomy and Gastric Banding: Effects on Plasma Ghrelin Levels显示文摘 | F B Langer M A Reza Hoda A Bohdjalian F X Felberbauer J Zacherl E Wenzl K Schindler A Luger B Ludvik G Prager | 2005 | Obesity Surgery2005，，7： | 1 |
| 14 | Modelling and managing studenl loyalty:An approach based on the concept of relationship quality显示文摘 | Hennig-Thurau T Langer M F Hansen U | 2001 | Journal of Service Research2001，3，4： | 1 |
| 15 | A new class of small molecule RNA polymerase inhibitors with activity against Rifampicin-resistant Staphylococcus auerus显示文摘 | ARHIN F B(E)LANGER O CIBLAT S | 2006 | Bioorg Med Chem2006，14，17： | 1 |
| 16 | Trust and Risk in E-government Adoption显示文摘 | Bélanger F Carter L | 2008 | The Journal of Strategic Information Systems2008，17，2： | 1 |
| 17 | Aortic root remodeling: ten-year experience with 274 patients 显示文摘 | Aicher D Langer F Lausberg H | 2007 | J Thorac Cardiovasc Surg2007，134，4： | 1 |
| 18 | PVRC Interpretive Report of Pressure Vessel Research, Section 1 - Design Consideration 显示文摘 | Langer B F | 1964 | Welding Research Council Bulletin1964，86，： | 1 |
| 19 | Microbial biomass,enzyme activities and microbial community structure in two European long-term fieldexperiments显示文摘 | Bhme L Langer U Bhme F | 2005 | Agriculture Ecosystems and Environment2005，109，： | 1 |
| 20 | Multiconter study on the clinical valne of fetal pulse oximetry显示文摘 | Carbonne B Langer B Goffinet F | 1997 | Am J Obstet Gynecol1997，177，3： | 1 |
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