Bonifazi Martina, Franchi Matteo, Rossi Marta, Zambelli Alberto, Moja Lorenzo, Zambon Antonella, Corrao Giovanni, La Vecchia Carlo, Zocchetti Carlo, Negri Eva
Department of Epidemiology, IRCCS Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.
Medical Oncology Unit, S. Maugeri Foundation-IRCCS, Pavia, Italy.
Breast. 2014 Oct;23(5):573-8. doi: 10.1016/j.breast.2014.05.022. Epub 2014 Jun 13.
Trastuzumab-based regimens for the adjuvant treatment of HER2-positive early breast cancer significantly prolonged overall survival (OS) and disease free survival (DFS) in large randomized trials, with sustained benefits at four-year follow-up. We assessed long-term survival estimates and predictors in a large cohort of Italian women with early breast cancer treated with trastuzumab in clinical practice. Through a record linkage between five regional healthcare databases, we identified women treated with trastuzumab for early breast cancer in Lombardy (2006-2009). DFS and OS were estimated using the Kaplan-Meier method, and independent predictors were assessed using proportional hazard models. 2046 women received trastuzumab in early breast cancer adjuvant setting. Overall, the proportion of patients surviving free of disease was 93.9% at one year, 85.8% at 2 years, 79.4% at 3 years, and 75.0% at 4 years. OS estimates were 98.7%, 95.4%, 91.5% and 89.4% at 1, 2, 3 and 4 years, respectively. Significant independent predictors of worse survival outcomes were age <40 or ≥70 years compared to age 40-69 years, positive nodal status, radical breast surgery, combination therapy with paclitaxel, having at least one comorbidity (i.e. diabetes, cardiovascular disease), and a trastuzumab-based regimen lasting less than six months. Long term survival rates of women treated with trastuzumab for early breast cancer in clinical practice were consistent with estimates from clinical trials testing the drug in the adjuvant setting.
在大型随机试验中，基于曲妥珠单抗的方案用于HER2阳性早期乳腺癌的辅助治疗可显著延长总生存期（OS）和无病生存期（DFS），在四年随访期内仍有持续获益。我们评估了在临床实践中接受曲妥珠单抗治疗的一大群意大利早期乳腺癌女性患者的长期生存估计值及预测因素。通过五个地区医疗保健数据库之间的记录链接，我们确定了伦巴第地区（2006 - 2009年）接受曲妥珠单抗治疗的早期乳腺癌女性患者。使用Kaplan-Meier方法估计DFS和OS，并使用比例风险模型评估独立预测因素。2046名女性在早期乳腺癌辅助治疗中接受了曲妥珠单抗。总体而言，无病生存患者的比例在1年时为93.9%，2年时为85.8%，3年时为79.4%，4年时为75.0%。OS估计值在1年、2年、3年和4年时分别为98.7%、95.4%、91.5%和89.4%。生存结果较差的显著独立预测因素包括：与40 - 69岁相比，年龄＜40岁或≥70岁、淋巴结阳性状态、根治性乳房手术、与紫杉醇联合治疗、至少有一种合并症（即糖尿病、心血管疾病）以及基于曲妥珠单抗的方案持续时间少于六个月。在临床实践中接受曲妥珠单抗治疗的早期乳腺癌女性患者的长期生存率与在辅助治疗中测试该药物的临床试验估计值一致。
