CAJ | 학술논문

目的评价曲妥珠单抗与蒽环类药物同步应用于乳腺癌辅助治疗的安全性和疗效.方法采用前瞻性、随机、对照方法,对符合入组标准的乳腺癌患者按照1:1随机方法分为试验组和对照组.试验组采用曲妥珠单抗和蒽环类药物同步治疗,对照组采用曲妥珠单抗和蒽环类序贯治疗.研究的主要终点为心脏安全性,次要终点为无病生存时间(DFS)和总生存时间(OS).结果共109例乳腺癌患者入组,其中试验组55例,对照组54例.共出现心脏不良事件12例(11.0％),均表现为无症状的左室射血分数(LVEF)下降,其中试验组5例(9.1％),对照组7例(13.0％),差异无统计学意义(P =0.556).试验组和对照组患者在入组前和治疗后3、6、9、12个月的LVEF差异也无统计学意义(P＞0.05).109例患者中,有10例(9.2％)患者出现复发转移,其中试验组4例(7.3％),对照组6例(11.1％),两组患者的DFS差异无统计学意义(P =0.724).两组患者均未出现死亡病例.结论在乳腺癌辅助治疗中,曲妥珠单抗与蒽环类药物同步治疗并不增加患者心脏不良事件的风险,安全性良好,其疗效还有待于进一步随访.
목적 평개곡타주단항여은배류약물동보응용우유선암보조치료적안전성화료효.방법 채용전첨성、수궤、대조방법,대부합입조표준적유선암환자안조1:1수궤방법분위시험조화대조조.시험조채용곡타주단항화은배류약물동보치료,대조조채용곡타주단항화은배류서관치료.연구적주요종점위심장안전성,차요종점위무병생존시간(DFS)화총생존시간(OS).결과 공109례유선암환자입조,기중시험조55례,대조조54례.공출현심장불량사건12례(11.0％),균표현위무증상적좌실사혈분수(LVEF)하강,기중시험조5례(9.1％),대조조7례(13.0％),차이무통계학의의(P =0.556).시험조화대조조환자재입조전화치료후3、6、9、12개월적LVEF차이야무통계학의의(P＞0.05).109례환자중,유10례(9.2％)환자출현복발전이,기중시험조4례(7.3％),대조조6례(11.1％),량조환자적DFS차이무통계학의의(P =0.724).량조환자균미출현사망병례.결론 재유선암보조치료중,곡타주단항여은배류약물동보치료병불증가환자심장불량사건적풍험,안전성량호,기료효환유대우진일보수방.
Objective To investigate the safety and efficacy of trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer.Methods It is a prospective,randomized and controlled trial.Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen.The primary endpoint was cardiac safety.The second endpoints were disease-free survival (DFS) and overall survival (OS).Results One hundred and nine breast cancer patients were enrolled and randomized in this trial.Fifty-five participants received trastuzumab administered concurrently with anthracycline-containing adjuvant regimen and 54 patients received trastuzumab administered sequentially with anthracycline.The primary cardiac event was asymptomatic decrease in the left ventricular ejection fraction (LVEF).There was no significant difference between concurrent and sequential groups in cardiac event rates (9.1％ vsl3.0％,P =0.556),neither of LVEF values at basline or at 3,6,9 and 12 months during trastuzumab treatment (P ＞ 0.05).Four patients (7.3％) in the concurrent group suffered local recurrences or distant metastases,and 6 participants (11.1％) in the sequential group had distant metastases.There was no significant difference between the two groups in DFS (P =0.724).There was no death in both groups.Conclusions Trastuzumab administered concurrently with anthracycline is a safe adjuvant regimen for breast cancer and does not increase cardiac events.Further research is needed to determine the efficacy of this treatment regimen.