Adjuvant trastuzumab: A milestone in the treatment of HER-2-positive early breast cancer
Adjuvant trastuzumab: A milestone in the treatment of HER-2-positive early breast cancer
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DOI：
10.1634/theoncologist.11-90001-4
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发表时间：
2006-01-01
期刊：
影响因子：
5.8
通讯作者：
Bell, Richard
中科院分区：
文献类型：
--
作者：
Baselga, Jose;Perez, Edith A.;Bell, Richard
在被诊断为早期乳腺癌(EBC)的女性中，多达四分之一的肿瘤是人类表皮生长因子受体2(HER-2)阳性。这与复发和死于转移性疾病的高风险有关。曲妥珠单抗是一种针对HER-2胞外区的单抗，可以改善接受化疗的HER-2阳性转移性乳腺癌患者的存活率和生活质量。四项主要的辅助试验--赫赛汀(注册商标)佐剂(HERA)、国家外科手术辅助乳肠计划(NSABP)B-31、北中央癌症治疗组(NCCTG)N9831和乳腺癌国际研究小组(BCIRG)006--包括它们和GT之间；13,000名HER-2阳性的EBC患者已经研究了曲妥珠单抗的不同辅助治疗方法。这些试验表明，曲妥珠单抗在该人群中将3年复发风险降低了约一半。尽管患者群体、化疗方案和治疗顺序不同，但所有试验的益处都是相似的。在两年的随访中，对NSABP B-31和NCCTG N9831试验的联合分析的中期结果显示，曲妥珠单抗的死亡率降低了三分之一，HERA和BCIRG试验的总体存活率有提高的趋势。芬兰的一项小型试验FinHer正在调查另一种曲妥珠单抗方案，也显示出类似的积极结果。对主要辅助试验的进一步跟踪将阐明接受曲妥珠单抗治疗的妇女的生存益处，以及最佳治疗时间(1或2年)。值得注意的是，这些试验中含有曲妥珠单抗的患者的心脏事件一直保持在可接受的水平，充血性心力衰竭的发生率略高(0.6%-3.3%)，大多数对治疗有反应。进一步的随访将提供有关心脏长期安全性的信息。总体而言，临床试验的结果足以令人信服，根据这些研究中显示的风险：收益比，可以考虑对HER-2阳性的EBC妇女进行1年的曲妥珠单抗辅助治疗。
Up to one fourth of women diagnosed with early breast cancer (EBC) have tumors that are human epidermal growth factor receptor 2 (HER-2) positive. This is associated with a high risk of relapse and death from metastatic disease. Trastuzumab, a monoclonal antibody directed against the extracellular domain of HER-2, improves survival and quality of life in women with HER-2-positive metastatic breast cancer receiving chemotherapy. Four major adjuvant trials-Herceptin (R) Adjuvant (HERA), National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31, North Central Cancer Treatment Group (NCCTG) N9831, and Breast Cancer International Research Group (BCIRG) 006-including between them > 13,000 women with HER-2-positive EBC, have investigated different adjuvant treatment approaches with trastuzumab. These trials have shown that trastuzumab reduces the 3-year risk of recurrence by about half in this population. The benefit was similar across the trials despite differences in patient populations, chemotherapy regimens, and sequencing of treatment. At a 2-year follow-up, interim results from the combined analysis of the NSABP B-31 and NCCTG N9831 trials showed a one third lower mortality for trastuzumab, and there was a trend toward an overall survival benefit in the HERA and BCIRG trials. A small Finnish trial, FinHer, investigating another regimen of trastuzumab, has also shown similarly positive results. Further follow-up of the major adjuvant trials will clarify the survival benefit for women receiving trastuzumab, as well as the optimal treatment duration (1 or 2 years). Notably, cardiac events in the trastuzumab-containing arms of these trials have remained within acceptable levels, with a slightly higher (0.6%-3.3%) incidence of congestive heart failure that mostly responded to treatment. Further follow-up will provide information on long-term cardiac safety. Overall, results from clinical trials are sufficiently compelling to consider 1 year of adjuvant trastuzumab treatment for women with HER-2-positive EBC based on the risk:benefit ratio demonstrated in these studies.