SCI

19March

NivolumabandIpilimumabasMaintenanceTherapyinExtensive-DiseaseSmall-CellLungCancer:CheckMate

OwonikokoTaofeekK,ParkKeunchil,GovindanRamaswamyetal.NivolumabandIpilimumabasMaintenanceTherapyinExtensive-DiseaseSmall-CellLungCancer:CheckMate.[J].JClinOncol,,undefined:JCO.

Inextensive-diseasesmall-celllungcancer(ED-SCLC),responseratestofirst-lineplatinum-basedchemotherapyarerobust,butresponseslackdurability.CheckMate,adouble-blindphaseIIItrial,evaluatednivolumabplusipilimumabandnivolumabmonotherapyasmaintenancetherapyfollowingfirst-linechemotherapyforED-SCLC.

在广泛期小细胞肺癌(ED-SCLC)中，一线铂类化疗的应答率是强劲的，但应答缺乏持久性。CheckMate是一项双盲III期试验，评估了纳武单抗+伊匹单抗和纳武单抗单药治疗作为ED-SCLC一线化疗后的维持治疗。

PatientswithED-SCLC,EasternCooperativeOncologyGroupperformancestatus0-1,andnoprogressionafter≤4cyclesoffirst-linechemotherapywererandomlyassigned(1:1:1)tonivolumab1mg/kgplusipilimumab3mg/kgonceevery3weeksfor12weeksfollowedbynivolumabmgonceevery2weeks,nivolumabmgonceevery2weeks,orplacebofor≤2yearsoruntilprogressionorunacceptabletoxicity.Primaryendpointwasoverallsurvival(OS)withnivolumabplusipilimumabversusplacebo.Secondaryendpointswerehierarchicallytested.

ED-SCLC患者PS评分0-1,一线化疗4周期后,没有进展，被随机分配(1:1：1)纳武单抗1毫克/公斤+伊匹单抗3毫克/公斤每隔3周,12周之后纳武单抗毫克每隔2周,纳武单抗毫克每隔2周,或安慰剂，持续至少2年或直到进展或不可接受的*性。主要终点为纳武单抗+伊匹单抗组与安慰剂组的总生存期(OS)。次要终点进行了分级测试。

Overall,patientswererandomlyassigned.Theminimumfollow-upwas8.9months.OSwasnotsignificantlyprolongedwithnivolumabplusipilimumabversusplacebo(hazardratio[HR],0.92;95%CI,0.75to1.12;=.37;median,9.29.6months).TheHRforOSwithnivolumabversusplacebowas0.84(95%CI,0.69to1.02);themedianOSfornivolumabwas10.4months.Progression-freesurvivalHRsversusplacebowere0.72fornivolumabplusipilimumab(95%CI,0.60to0.87)and0.67fornivolumab(95%CI,0.56to0.81).AtrendtowardOSbenefitwithnivolumabplusipilimumabwasobservedinpatientswithtumormutationalburden≥13mutationspermegabase.Ratesofgrade3-4treatment-relatedadverseeventswerenivolumabplusipilimumab(52.2%),nivolumab(11.5%),andplacebo(8.4%).

总的来说，名患者被随机分配。最小随访时间为8.9个月。纳武单抗联合伊匹单抗与安慰剂相比，OS没有显著延长(风险比[HR]，0.92;95%CI,0.75~1.12;P=0.37;中位数9.2个月vs9.6个月)。纳武单抗与安慰剂的风险比为0.84(95%CI,0.69-1.02);纳武单抗的中位总生存期为10.4个月。与安慰剂相比，纳武单抗联合伊匹单抗的无进展生存HRs为0.72(95%CI,0.60-0.87)，纳武单抗为0.67(95%CI,0.56-0.81)。纳武单抗联合伊匹单抗治疗每兆酶突变值≥13的肿瘤患者的OS获益趋势已被观察到。3-4级治疗相关不良事件发生率为纳武单抗+伊匹单抗(52.2%)、纳武单抗(11.5%)和安慰剂(8.4%)。

MaintenancetherapywithnivolumabplusipilimumabdidnotprolongOSforpatientswithED-SCLCwhodidnotprogressonfirst-linechemotherapy.Therewerenonewsafetysignals.

纳武单抗联合伊匹单抗的维持治疗对一线化疗没有进展的ED-SCLC患者的生存期没有延长。没有新的安全信号。

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