Cancer Research UK Laboratories, Division of Cancer, Imperial College London, UK.
Clin Breast Cancer. 2011 Apr;11(2):93-102. doi: 10.1016/j.clbc.2011.03.001. Epub 2011 Apr 11.
Adjuvant trastuzumab (AT) is known to significantly improve survival of women with HER2(+) early breast cancer. This study explores the use and nonuse of AT in early breast cancer, as well as the efficacy in a neoadjuvant and adjuvant population, within a routine clinical setting.
Histopathology reports of invasive breast cancer resected at Imperial College Healthcare NHS Trust (ICHT) between January 2006 and December 2008 were reviewed. HER2(+) patients were identified and their case notes reviewed. In addition, patients who received AT at our center but underwent surgery elsewhere were included in the efficacy and safety analyses.
The local HER2(+) rate was 13.1%, with 54.5% of these patients receiving AT. A total of 128 patients received AT (85 local and 43 referrals from elsewhere). Neoadjuvant chemotherapy (CT) followed by postoperative AT was associated with a significantly increased risk of recurrence compared with adjuvant CT and then AT (hazard ratio [HR] 18.6 [95% CI, 1.8-152.2]; P = .013). The proportion of patients who were disease free at 3 years from primary therapy was 96.4% (95% CI, 89.8%-100%) for adjuvant therapy, compared with 72.0% (95% CI, 56.5%-91.6%) for neoadjuvant therapy. AT was omitted in 49 HER2(+) patients; the main reason for AT omission was clinical judgment that the breast cancer was low risk. Patients treated with AT had a significantly decreased risk of recurrence (HR 0.27 [95% CI, 0.08-0.97]; P = .04) compared with the untreated patients. The majority of untreated relapses were in patients in whom there was an original intent to use AT. The proportion alive at 3 years for adjuvant CT, neoadjuvant CT, and untreated AT was 100%, 74.5%, and 92.7% respectively.
The overall efficacy and safety of AT in our routine clinical setting is comparable to the large randomized trials. HER2(+) patients who underwent neoadjuvant CT had a significantly increased risk of disease recurrence compared with patients treated with adjuvant CT followed by trastuzumab. Untreated patients had an increased risk of recurrence.
曲妥珠单抗（AT）辅助治疗可显著改善 HER2（+）早期乳腺癌患者的生存。本研究旨在探讨在常规临床环境下，曲妥珠单抗在早期乳腺癌中的使用和未使用情况，以及新辅助和辅助人群中的疗效。
回顾 2006 年 1 月至 2008 年 12 月期间在帝国理工学院保健 NHS 信托基金会（ICHT）接受手术的浸润性乳腺癌患者的组织病理学报告。确定 HER2（+）患者，并对其病历进行回顾。此外，在我院接受曲妥珠单抗治疗但在其他地方接受手术的患者也纳入疗效和安全性分析。
本地 HER2（+）率为 13.1%，其中 54.5%的患者接受了 AT 治疗。共 128 例患者接受 AT 治疗（局部 85 例，外地转诊 43 例）。与辅助 CT 后序贯 AT 相比，新辅助 CT 后序贯 AT 与复发风险显著增加（风险比 [HR]18.6 [95%CI，1.8-152.2]；P=0.013）。从原发治疗开始，辅助治疗的 3 年无病生存率为 96.4%（95%CI，89.8%-100%），新辅助治疗为 72.0%（95%CI，56.5%-91.6%）。49 例 HER2（+）患者未接受 AT 治疗；AT 未使用的主要原因是临床判断乳腺癌风险较低。与未接受治疗的患者相比，接受 AT 治疗的患者复发风险显著降低（HR 0.27 [95%CI，0.08-0.97]；P=0.04）。未接受治疗的复发患者中，多数为原本打算使用 AT 的患者。接受辅助 CT、新辅助 CT 和未接受 AT 治疗的患者 3 年生存率分别为 100%、74.5%和 92.7%。
在常规临床环境下，AT 的总体疗效和安全性与大型随机试验相当。与接受辅助 CT 后序贯曲妥珠单抗治疗的患者相比，接受新辅助 CT 的 HER2（+）患者疾病复发风险显著增加。未接受治疗的患者复发风险增加。
