Medical Oncology Unit, Department of Experimental and Clinical Sciences, University G d'Annunzio, 66013 Chieti, Italy.
J Cancer Res Clin Oncol. 2013 Jul;139(7):1229-40. doi: 10.1007/s00432-013-1436-y. Epub 2013 Apr 20.
Trastuzumab and chemotherapy is the current standard of care in HER2+ early or locally advanced breast cancer, but there are scanty literature data of its real world effectiveness.
We retrospectively reviewed 205 patients with HER2+ breast cancer diagnosed in 10 Italian Medical Oncology Units between July 2003 and October 2011. All patients received neoadjuvant systemic therapy (NST) with trastuzumab in association with chemotherapy. Many different chemotherapy regimens were used, even if 90 % of patients received schemes including anthracyclines and 99 % received taxanes. NST was administered for more than 21 weeks (median: 24) in 130/205 (63.4 %) patients, while trastuzumab was given for more than 12 weeks (median: 12 weeks) in 101/205 (49.3 %) patients. pCR/0 was defined as ypT0+ypN0, and pCR/is as ypT0/is+ypN0.
pCR/0 was obtained in 24.8 % and pCR/is in 46.8 % of the patients. At multivariate logistic regression, nonluminal/HER2+ tumors (P < 0.0001) and more than 12 weeks of neoadjuvant trastuzumab treatment (P = 0.03) were independent predictors of pCR/0. Median disease-free survival (DFS) and cancer-specific survival (CSS) have not been reached at the time of analysis. At multivariate analysis, nonluminal/HER2+ subclass (DFS: P = 0.01 and CSS: P = 0.01) and pathological stage II-III at surgery (DFS: P < 0.0001 and CSS: P = 0.001) were the only variables significantly associated with a worse long-term outcome.
Our data set the relevance of molecular subclasses and residual tumor burden after neoadjuvant as the most relevant prognostic factors for survival in this cohort of patients.
曲妥珠单抗联合化疗是目前 HER2+早期或局部晚期乳腺癌的标准治疗方法，但关于其真实世界疗效的文献数据很少。
我们回顾性分析了 205 例 2003 年 7 月至 2011 年 10 月期间在意大利 10 个医学肿瘤学单位诊断为 HER2+乳腺癌的患者。所有患者均接受曲妥珠单抗联合化疗的新辅助全身治疗（NST）。使用了许多不同的化疗方案，尽管 90%的患者接受了包含蒽环类药物的方案，99%的患者接受了紫杉类药物的方案。130/205 例（63.4%）患者的 NST 治疗时间超过 21 周（中位数：24 周），101/205 例（49.3%）患者的曲妥珠单抗治疗时间超过 12 周（中位数：12 周）。ypT0+ypN0 定义为 pCR/0，ypT0/is+ypN0 定义为 pCR/is。
24.8%的患者获得了 pCR/0，46.8%的患者获得了 pCR/is。多变量逻辑回归分析显示，非腔面/HER2+肿瘤（P<0.0001）和超过 12 周的新辅助曲妥珠单抗治疗（P=0.03）是 pCR/0 的独立预测因素。分析时中位无病生存（DFS）和癌症特异性生存（CSS）尚未达到。多变量分析显示，非腔面/HER2+亚组（DFS：P=0.01，CSS：P=0.01）和手术时病理分期 II-III（DFS：P<0.0001，CSS：P=0.001）是唯一与长期预后较差显著相关的变量。
我们的数据表明，分子亚类和新辅助治疗后残留肿瘤负荷是该患者队列生存的最重要预后因素。
