CAJ | 학술논문

目的比较曲妥珠单抗联合化疗与单纯化疗,一线治疗人表皮生长因子受体2 (HER-2)阳性、无法手术的局部进展期、转移性胃或胃食管结合部腺癌的有效性和安全性.方法中国15家研究中心参与BO18255 (ToGA)试验.患胃或胃食管结合部腺癌且肿瘤HER-2表达阳性的患者入选试验,ToGA试验按照随机区组设计,以1∶1的比例随机接受单纯化疗(卡培他滨或氟尿嘧啶+顺铂,对照组)或化疗联合曲妥珠单抗(试验组),中国地区入组84例患者,试验组患者36例,对照组48例.结果试验组患者的中位生存时间为12.6个月,对照组为9.7个月(HR=0.72,95％ CI为0.40～1.29).试验组患者≥3级不良反应的发生率(63.9％)高于对照组(47.9％),主要为中性粒细胞减少、呕吐、恶心.只有试验组出现2例轻度心脏不良反应.试验组和对照组中分别有3例患者发生了严重不良反应,其中试验组患者因血小板减少导致死亡1例.结论 HER-2阳性、无法手术的局部进展期或转移性中国胃癌患者接受曲妥珠单抗联合化疗治疗后,疗效和安全性与ToGA研究总体人群的分析结果一致,疗效较好,且患者耐受性良好.曲妥珠单抗联合化疗可做为HER-2阳性、无法手术的局部进展期或转移性胃或胃食管结合部腺癌新的治疗选择.
목적 비교곡타주단항연합화료여단순화료,일선치료인표피생장인자수체2 (HER-2)양성、무법수술적국부진전기、전이성위혹위식관결합부선암적유효성화안전성.방법 중국15가연구중심삼여BO18255 (ToGA)시험.환위혹위식관결합부선암차종류HER-2표체양성적환자입선시험,ToGA시험안조수궤구조설계,이1∶1적비례수궤접수단순화료(잡배타빈혹불뇨밀정+순박,대조조)혹화료연합곡타주단항(시험조),중국지구입조84례환자,시험조환자36례,대조조48례.결과 시험조환자적중위생존시간위12.6개월,대조조위9.7개월(HR=0.72,95％ CI위0.40～1.29).시험조환자≥3급불량반응적발생솔(63.9％)고우대조조(47.9％),주요위중성립세포감소、구토、악심.지유시험조출현2례경도심장불량반응.시험조화대조조중분별유3례환자발생료엄중불량반응,기중시험조환자인혈소판감소도치사망1례.결론 HER-2양성、무법수술적국부진전기혹전이성중국위암환자접수곡타주단항연합화료치료후,료효화안전성여ToGA연구총체인군적분석결과일치,료효교호,차환자내수성량호.곡타주단항연합화료가주위HER-2양성、무법수술적국부진전기혹전이성위혹위식관결합부선암신적치료선택.
Objective To evaluate the efficacy and safety of trastuzumab in combination with chemotherapy versus chemotherapy alone in the first-line treatment of HER-2-positive advanced gastric or gastro-oesophageal junction cancer.Methods Fifteen Chinese research centers are involved in the BO18255 (ToGA) study.Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumor showed overexpression of HER-2 protein by immunohistochemistry + + + or FISH-positive.Patients were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine or 5-FU plus cisplatin or chemotherapy in combination with intravenous trastuzumab.The primary endpoint was overall survival.Results Eighty-five Chinese patients were enrolled in this study,of whom 84 were included in the primary analysis:trastuzumab plus chemotherapy (FP/H) (n =36) and chemotherapy alone (FP)(n =48).The median follow-up was 15.2 months in the FP/H group and 14.2 months in the FP group.The median survival time was 12.6 months in the FP/H group compared with 9.7 months in the FP group [hazard ratio 0.72,95％ CI (0.40; 1.29)].Grade 3/4 adverse events were higher in the FP/H(63.9％)than FP (47.9％) groups,including neutropenia,vomiting and nausea.Two mild cardiac adverse events occurred in the FP/H group.Severe adverse events occurred in 3 cases of both two groups,respectively.Conclusions Addition of trastuzumab to chemotherapy is well tolerated and shows improved survival in Chinese patients with advanced gastric or gastro-oesophageal junction cancer.These results are consistent with the results of ToGA whole population trial.Trastuzumab in combination with chemotherapy can be considered as a new option for patients with HER-2-positive advanced gastric or gastrooesophageal junction cancer.