CAJ | 학술논문

目的探索尼妥珠单抗与同期放化疗联合应用在Ⅲ期NSCLC的可行性与耐受性.方法选取18～ 74岁ⅢA、ⅢB期NSCLC初治患者.尼妥珠单抗分为100、200、400 mg组,每组3～6例.前3例如出现1例剂量限制性毒性(DLT)则再增加3例,半数出现DLT则停止爬坡.放疗总剂量60～ 66 Gy分30～33次.采用顺铂、依托泊苷联合化疗.同步结束后继续尼妥珠单抗至16周或进展,加或不加同方案化疗2周期.评价不良反应、近期疗效、最佳肿瘤体积退缩情况及生存情况.结果共入组9例,7例可检测EGFR表达.3个剂量组均能良好耐受,未有DLT发生.最常见不良反应为血液系统,3级白细胞减少、粒细胞减少、血红蛋白降低及血小板减少分别为66％、66％、11％、22％;其次为食管炎,1级44％、2级22％;1级恶心呕吐44％;1级放射性肺炎44％.未发现皮疹或皮肤过敏反应.最佳总体积退缩平均为88％.中位随访时间和中位生存时间26.4个月,1年和2年OS、DFS、PFS分别为78％和67％、56％和44％、78％和56％.结论尼妥珠单抗100、200、400 mg每周方案与同期放化疗应用在局部晚期NSCLC可被良好耐受.
목적 탐색니타주단항여동기방화료연합응용재Ⅲ기NSCLC적가행성여내수성.방법 선취18～ 74세ⅢA、ⅢB기NSCLC초치환자.니타주단항분위100、200、400 mg조,매조3～6례.전3례여출현1례제량한제성독성(DLT)칙재증가3례,반수출현DLT칙정지파파.방료총제량60～ 66 Gy분30～33차.채용순박、의탁박감연합화료.동보결속후계속니타주단항지16주혹진전,가혹불가동방안화료2주기.평개불량반응、근기료효、최가종류체적퇴축정황급생존정황.결과 공입조9례,7례가검측EGFR표체.3개제량조균능량호내수,미유DLT발생.최상견불량반응위혈액계통,3급백세포감소、립세포감소、혈홍단백강저급혈소판감소분별위66％、66％、11％、22％;기차위식관염,1급44％、2급22％;1급악심구토44％;1급방사성폐염44％.미발현피진혹피부과민반응.최가총체적퇴축평균위88％.중위수방시간화중위생존시간26.4개월,1년화2년OS、DFS、PFS분별위78％화67％、56％화44％、78％화56％.결론 니타주단항100、200、400 mg매주방안여동기방화료응용재국부만기NSCLC가피량호내수.
Objective To observe the feasibility of nimotuzumab in combination with concurrent chemo-radiotherapy in locally-advanced non-small cell lung cancer (NSCLC).Methods From 2011 to 2012,Untreated stage ⅢA/ⅢB NSCLC patients were chosen and divided into three weekly dose level of nimotuzumab:100 mg,200 mg and 400 mg,3-6 cases per group.If one of the first three patients experienced DLT,three additional patients were recruited to that dose level.If DLTs were observed in 50％ patients in any cohort,dose escalation was stopped and that dose was designated the maximum tolerated dose.Intensity-modulated radiotherapy (IMRT) was taken,with total dose of 60-66 Gy in 30-33 fractions.Concurrent cisplantin and etoposide chemotherapy were performed.After concurrent treatment,consolidation weekly nimotuzumab treatment was performed until 16 weeks or disease progression observed.Assessment of efficacy and safety were performed via RECIST and CTC AE V3.0,respectively,maximum change in tumor volume and survival were calculated.Results Totally 9 cases enrolled.All three dose level were well tolerated,no dose-limiting toxicity observed.The most commonly reported severe adverse events were grade 3 hematological,including leucopenia (66％),neutropenia (66％),anemia (11％),and thrombocytopenia (22％).Most common non-hematological toxicity are esophagitis,grade 1 (44％) or 2(22％),grade 1 radiation pneumonitis (44％),and grade 1 nausea/vomiting (44％).Mean total tumor volume decrease was 88％.With median survival of 26.4 months,the total 1 year and 2 year overall survival,disease free survival and progression free survival were 78％ and 67％,56％ and 44％,78％ and 56％,respectively.Conclusion Weekly 100 mg,200 mg and 400 mg nimotuzumab in combination with concurrent chemoradiotherapy can be well tolerated in locally advanced non-small cell lung cancer.