Department of Medical Oncology, University General Hospital of Heraklion, Crete, Greece.
Breast. 2011 Dec;20(6):485-90. doi: 10.1016/j.breast.2011.06.009. Epub 2011 Jul 23.
To perform a meta-analysis in order to quantify the actual cumulative randomized evidence for the benefit and toxicity of trastuzumab combined with neoadjuvant chemotherapy in HER2-positive breast cancer.
Potentially eligible trials were located through PubMed and Cochrane Library searches and abstracts of major international conferences. The endpoints that we assessed were pathologic complete response (pCR) rate, breast-conserving surgery (BCS) rate and toxicity.
Five trials were identified with 515 eligible patients. The probability to achieve pCR was higher for the trastuzumab plus chemotherapy arm (RR 1.85, 95% CI: 1.39-2.46; p-value < 0.001). No significant difference in terms of breast-conserving surgery between the two treatment arms was observed (OR: 0.98, 95% CI: 0.80-1.19, p-value = 0.82). Regarding toxicity, the addition of trastuzumab did not increase the incidence of neutropenia, neutropenic fever, and cardiac adverse events.
The addition of trastuzumab in HER2-positive breast cancer in the neoadjuvant setting improves the probability of achieving higher pCR with no additional toxicity. Based on the available evidence, the use of trastuzumab combined with neoadjuvant chemothetherapy in patients with HER2-positive breast cancer seems to offer substantial benefit in terms of pCR.
进行荟萃分析，以量化曲妥珠单抗联合新辅助化疗治疗 HER2 阳性乳腺癌的获益和毒性的实际累积随机证据。
通过 PubMed 和 Cochrane 图书馆搜索以及主要国际会议的摘要来定位潜在的合格试验。我们评估的终点是病理完全缓解（pCR）率、保乳手术（BCS）率和毒性。
确定了五项试验，共纳入 515 名合格患者。曲妥珠单抗联合化疗组的 pCR 概率更高（RR 1.85，95%CI：1.39-2.46；p 值 < 0.001）。两组间保乳手术无显著差异（OR：0.98，95%CI：0.80-1.19，p 值 = 0.82）。关于毒性，添加曲妥珠单抗并未增加中性粒细胞减少、中性粒细胞减少性发热和心脏不良事件的发生率。
在新辅助治疗中，HER2 阳性乳腺癌中添加曲妥珠单抗可提高获得更高 pCR 的概率，且无额外毒性。基于现有证据，曲妥珠单抗联合新辅助化疗治疗 HER2 阳性乳腺癌似乎在 pCR 方面具有显著获益。
