Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, New York 10065, USA.
Cancer. 2011 Dec 15;117(24):5461-8. doi: 10.1002/cncr.26171. Epub 2011 Jun 16.
Several large, randomized trials established the benefits of adjuvant trastuzumab with chemotherapy. However, the benefit for women with small, node-negative HER2-positive (HER2+) disease is unknown, as these patients were largely excluded from these trials. Therefore, a retrospective, single-institution, sequential cohort study of women with small, node-negative, HER2+ breast cancer who did or did not receive adjuvant trastuzumab was conducted.
Women with ≤ 2 cm, node-negative, HER2+ (immunohistochemistry 3+ or fluorescence in situ hybridization ≥ 2) breast cancer were identified through an institutional database. A "no-trastuzumab" cohort of 106 trastuzumab-untreated women diagnosed between January 1, 2002 and May 14, 2004 and a "trastuzumab" cohort of 155 trastuzumab-treated women diagnosed between May 16, 2005 and December 31, 2008 were described. Survival and recurrence outcomes were estimated by Kaplan-Meier methods.
The cohorts were similar in age, median tumor size, histology, hormone receptor status, hormone therapy, and locoregional therapy. Chemotherapy was administered in 66% and 100% of the "no trastuzumab" and "trastuzumab" cohorts, respectively. The median recurrence-free and survival follow-up was: 6.5 years (0.7-8.5) and 6.8 years (0.7-8.5), respectively, for the "no trastuzumab" cohort and 3.0 years (0.5-5.2) and 3.0 years (0.6-5.2), respectively, for the "trastuzumab" cohort. The 3-year locoregional invasive recurrence-free, distant recurrence-free, invasive disease-free, and overall survival were 92% versus 98% (P = .0137), 95% versus 100% (P = .0072), 82% versus 97% (P < .0001), and 97% versus 99% (P = .18) for the "no trastuzumab" and "trastuzumab" cohorts, respectively.
Women with small, node-negative, HER2+ primary breast cancers likely derive significant benefit from adjuvant trastuzumab with chemotherapy.
几项大型随机试验证实了曲妥珠单抗联合化疗辅助治疗的益处。然而，对于肿瘤较小、淋巴结阴性、HER2 阳性（HER2+）的患者，其获益情况尚不清楚，因为这些患者在这些试验中基本被排除在外。因此，我们对接受或未接受辅助曲妥珠单抗治疗的肿瘤较小、淋巴结阴性、HER2+的乳腺癌患者进行了回顾性、单机构、连续队列研究。
通过机构数据库确定了肿瘤最大径为≤2cm、淋巴结阴性、HER2+（免疫组织化学染色 3+或荧光原位杂交检测≥2）的乳腺癌患者。本研究描述了 2002 年 1 月 1 日至 2004 年 5 月 14 日期间诊断的 106 例未接受曲妥珠单抗治疗的患者（无曲妥珠单抗组）和 2005 年 5 月 16 日至 2008 年 12 月 31 日期间诊断的 155 例接受曲妥珠单抗治疗的患者（曲妥珠单抗组）。采用 Kaplan-Meier 法估计生存和复发结局。
两组患者的年龄、中位肿瘤大小、组织学、激素受体状态、激素治疗和局部区域治疗相似。无曲妥珠单抗组和曲妥珠单抗组分别有 66%和 100%的患者接受了化疗。无曲妥珠单抗组和曲妥珠单抗组的中位无复发生存期和总生存期分别为 6.5 年（0.7-8.5）和 6.8 年（0.7-8.5）和 3.0 年（0.5-5.2）和 3.0 年（0.6-5.2）。无曲妥珠单抗组和曲妥珠单抗组的 3 年局部区域无复发生存率、远处无复发生存率、无侵袭性疾病生存率和总生存率分别为 92%和 98%（P=0.0137）、95%和 100%（P=0.0072）、82%和 97%（P<0.0001）和 97%和 99%（P=0.18）。
对于肿瘤较小、淋巴结阴性、HER2 阳性的原发性乳腺癌患者，曲妥珠单抗联合化疗辅助治疗可能会带来显著获益。
