Neoplasma. 2016;63(5):761-7. doi: 10.4149/neo_2016_513.
Addition of trastuzumab to chemotherapy is the cornerstone of adjuvant treatment of early HER2 positive breast cancer. Clinical trials and metaanalyses of adjuvant trastuzumab have shown significant reduction in risk of recurrence and death. Nevertheless, the real magnitude of the effect of any drug must be reevaluated in daily clinical conditions, due to the fact that daily clinical practice often differs from conditions in clinical trials. In order to measure the benefit of adding adjuvant trastuzumab in HER 2 positive early breast cancer treatment, we have performed retrospective analysis in a single institution on consecutive patients divided in 2 cohorts: one, treated in "pre - trastuzumab" and the other in "trastuzumab era". Between 2003 and 2012, 258 consecutive HER 2 positive patients with early breast cancer have been treated with adjuvant chemotherapy, 103 patients did not received trastuzumab (patients treated from 2003 till 2007), and 155 (patients treated from 2008 till 2012) received trastuzumab. Patients who received trastuzumab experienced significantly longer median disease-free survival (107 vs. 92 months, LR: 11.6, p <0.001); breast cancer-specific survival (130 vs. 117 months, LR: 10.7, p < 0.001) and median overall survival (123 vs. 108 months LR = 11.6, p < 0.001). The benefits of adding trastuzumab were independent of chemotherapy regimen and hormonal therapy. This retrospective analysis has shown a clear, statistically significant benefit of adjuvant trastuzumab in treatment of early, HER2 positive breast cancer in daily clinical practice, and confirmed the results of the registration clinical trials.
曲妥珠单抗联合化疗是早期 HER2 阳性乳腺癌辅助治疗的基石。辅助曲妥珠单抗的临床试验和荟萃分析显示，复发和死亡风险显著降低。然而，由于日常临床实践与临床试验条件往往不同，任何药物的实际效果都必须在日常临床条件下重新评估。为了衡量在 HER2 阳性早期乳腺癌治疗中添加辅助曲妥珠单抗的益处，我们在一家机构对连续患者进行了回顾性分析，将患者分为 2 个队列：一个队列在“曲妥珠单抗前”治疗，另一个队列在“曲妥珠单抗时代”治疗。2003 年至 2012 年间，258 例连续 HER2 阳性早期乳腺癌患者接受辅助化疗，103 例未接受曲妥珠单抗（2003 年至 2007 年治疗的患者），155 例（2008 年至 2012 年治疗的患者）接受了曲妥珠单抗治疗。接受曲妥珠单抗治疗的患者无病生存期（107 个月 vs. 92 个月，LR：11.6，p<0.001）、乳腺癌特异性生存期（130 个月 vs. 117 个月，LR：10.7，p<0.001）和总生存期（123 个月 vs. 108 个月，LR = 11.6，p<0.001）中位数均显著延长。添加曲妥珠单抗的益处与化疗方案和激素治疗无关。这项回顾性分析表明，在日常临床实践中，辅助曲妥珠单抗在治疗早期 HER2 阳性乳腺癌方面具有明显的、统计学意义的益处，并证实了注册临床试验的结果。
