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| 1 | 帕博利珠单抗治疗伴脑转移NSCLC患者的一项非随机、开放Ⅱ期试验的长期随访结果和生物标志物分析显示文摘背景与目的我们开展了一项帕博利珠单抗用于伴未治疗脑转移的非小细胞肺癌(non-small cell lung cancer,NSCLC)或黑色素瘤患者的疗效和安全性的II期试验,旨在评估程序性死亡受体1(programmed cell death 1,PD-1)抑制剂在中枢神经系统(central nervous system,CNS)中的疗效。中期结果已发表,现报道对NSCLC队列的更新分析结果。方法这是一项开放性、单中心、II期试验。纳入标准:年龄≥18岁,诊断为晚期NSCLC并伴有≥1个5 mm-20 mm脑转移病灶,既往从未治疗或之前放疗后进展,无神经系统症状,不需要激素治疗且美国东部肿瘤协作组(Eastern Cooperative Oncology Group,ECOG)<2分。患者每2周接受一次帕博利珠单抗(10 mg/kg)治疗。队列1为程序性死亡配体1(programmed cell death ligand 1,PD-L1)≥1%的患者,队列2为PD-L1<1%或未评估的患者。主要终点是脑转移患者缓解比例。所有经治患者均纳入疗效与安全性终点的分析。该研究已结束入组,并于Clinicaltrials.gov登记注册,注册号为NCT02085070。结果2014年3月31日-2018年5月21日,共42例患者接受治疗。中位随访时间为8.3个月(IQR:4.5个月-26.2个月)。队列1的37例患者中11例有脑转移缓解[29.7%(95%CI:15.9%-47.0%)]。队列2未观察到缓解。治疗相关的3级-4级不良事件(adverse events,AEs)包括2例肺炎、1例全身症状、1例结肠炎、1例肾上腺皮质功能不全、1例高血糖症和1例低钾血症。6例(14%)患者发生了治疗相关的严重不良事件,包括肺炎、急性肾损伤、低钾血症和肾上腺皮质功能不全。没有观察到治疗相关死亡病例。结论帕博利珠单抗治疗PD-L1≥1%的NSCLC伴脑转移患者有效,且对所有纳入的未经治疗的脑转移患者安全。需要进一步探索免疫治疗用于NSCLC合并CNS转移。 | Sarah B GOLDBERG Kurt A SCHALPER Scott N GETTINGER Amit MAHAJAN Roy S HERBST Anne C CHANG Rogerio LILENBAUM Frederick H WILSON Sacit Bulent OMAY James B YU Lucia JILAVEANU Thuy TRAN Kira PAVLIK Elin ROWEN Heather GERRSH Annette KOMLO Richa GUPTA Hailey WYATT Matthew RIBEIRO Yuval KLUGER Geyu ZHOU Wei WEI Veronica L CHANG Harriet M KLUGER 董晓荣(翻译/校对) | 2021 | 中国肺癌杂志2021，24，9： | 34 |
| 2 | Transfusion practice in the criticallyill显示文摘 | Corwin HL Surgenor SD Gettinger A | 2003 | Crit Care Med2003，31，12： | 1 |
| 3 | Nivolumab (Anti- PD-1 ; BMS-936558, ONO-4538) and Ipilimumab in First-Line Non-Small Cell Lung Cancer (NSCLC) : Interim Phase 1 Re- suits显示文摘 | Antonia S J Gettinger S Chow L Q | 2014 | J Clin Oncol2014，32，： | 1 |
| 4 | Efficacy and safety of epoetin alfa in critically ill patients 显示文摘 | Corwin H L Gettinger A Fabian T C | 2007 | N Engl J Med2007，357，： | 1 |
| 5 | RBC transfusion in the ICU: is there a reason显示文摘 | Corwin HL Parsonnet KC Gettinger A | 1995 | Chest1995，108，3： | 1 |
| 6 | Targeted therapy in advanced non-small-cell lung cancer 显示文摘 | Gettinger S | 2008 | Semin Respir Crit Care Med2008，29，3： | 1 |
| 7 | Nivolumab (anti-PD- 1; BMS-936558, ONO-4538) and ipilimumab in first-lineNSCLC: Interim phase I results显示文摘 | Antonia SJ Gettinger SN Chow LO~ | 2014 | J Clin Oncol2014，32，5： | 1 |
| 8 | Management of patients with advanced non-small cell lung cancer:current and emerging options显示文摘 | Triano LR Deshpande H Gettinger SN | 2010 | Drugs2010，70，2： | 1 |
| 9 | The CRIT Study: Anemia and blood transfusion in the critically ill-cmTent clinical practice in the United States 显示文摘 | Corwin HL Gettinger A Pearl RG | 2004 | Crit Care Med2004，32，： | 1 |
| 10 | Efficacy of recombinant human erythropoietin in critically ill patients显示文摘 | Corwin HL Gettinger A Pearl R | 2002 | JAMA2002，288，： | 1 |
| 11 | Management of patients with advanced non-small cell lung cancer:current and emerging options显示文摘 | TRIANO L R DESHPANDE H GETTINGER S N | 2010 | Drugs2010，70，2： | 1 |
| 12 | Transfusion practice in the critically ill patients显示文摘 | Corwin HL Surgenor SD Gettinger A | 2003 | Crit Care Med2003，31，： | 1 |
| 13 | Efficacy of recombinant human erythropoietin in the critically ill patients显示文摘 | Corwin HL Gettinger A Rodriguez RM | 2002 | JAMA2002，288，22： | 1 |
| 14 | The CRIT study:Anemia and blood transfusion in the critically ill:Current clinical practice in the United States显示文摘 | Corwin HL Gettinger A Pearl RG | 2004 | Crit Care Med2004，32，： | 1 |
| 15 | The CRIT study:anemia and blood transfusion in the critically ill--current clinical practice in the United States显示文摘 | Corwin HL Gettinger A Pearl RG | 2004 | Crit Care Med2004，32，1： | 1 |
| 16 | Novel chemotherapy options for advanced thyroid tumors:small molecules offer great hope显示文摘 | Deshpande HA Gettinger SN Sosa JA | 2008 | Curr Opin Oncol2008，20，1： | 1 |
| 17 | Overall Survival and Long-Term Safety of Nivolumab (Anti-Programmed Death 1 Antibody, BMS-936558, ONO-4538) in Patients With Previous- ly Treated Advanced Non-Small--Cell Lung Cancer显示文摘 | Gettinger SN Horn L Gandhi L | 2015 | J Clin Oncol2015，33，18： | 1 |
| 18 | Efficacy of recombi- nant human erythropoietin in critically ill patients: a randomized controlled trial 显示文摘 | Corwin HL Gettinger A Pearl RG | 2002 | JAMA2002，288，22： | 1 |
| 19 | Activity of IPI-504, a novel heat-shock protein 90 inhibitor, in patients with molecularly defined non-small-cell lung cancer显示文摘 | Sequist LV Gettinger S Senzer NN | 2010 | J Clin Oncol2010，28，33： | 1 |
| 20 | Efficacy of recombinant human erythropoietin in the critically ill patients: a randomized, doubleblind, placebo-eontrolled trial显示文摘 | Corwin HL Gettinger A Rodriguez RM | 1999 | Crit Care Med1999，27，11： | 1 |
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