Division of Oncology/Hematology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Int J Clin Oncol. 2009 Oct;14(5):431-5. doi: 10.1007/s10147-009-0898-z. Epub 2009 Oct 25.
Recently, randomized trials revealed that trastuzumab as adjuvant treatment was effective in human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients. Safety information on adjuvant trastuzumab use in Japanese patients, especially cardiac toxicity data, is needed.
We retrospectively reviewed 48 patients with early-stage HER2-positive breast cancer who were treated with curative surgery and adjuvant trastuzumab at the National Cancer Center Hospital East (Kashiwa, Japan). The cardiac safety as well as the short-term efficacy of trastuzumab were evaluated.
The median age of the patients was 54 years. All patients received adjuvant or neoadjuvant cytotoxic chemotherapy. Twenty-seven patients (56%) received adjuvant radiation therapy. Forty-four patients (92%) received trastuzumab without concurrent cytotoxic chemotherapy and 4 patients (8%) on taxanes received trastuzumab concurrently. Twenty-five patients completed 1 year of trastuzumab treatment and 5 patients completed 2 years of trastuzumab treatment. Nine patients discontinued trastuzumab treatment, because of progressive disease (1 patient), decrease in left ventricular ejection fraction (LVEF; 2 patients), patient's refusal (4 patients), and other reasons (2 patients). There were five cardiac events. A decrease in LVEF to less than 50% was seen in 2 patients. The relationship between trastuzumab treatment and the cardiac events was unclear in 3 patients. The median follow-up time was 21.2 months. The disease-free survival (DFS) was 97.5% at 1 year and 92.9% at 2 years.
The incidence of cardiac events caused by trastuzumab treatment was low in our analysis. Adjuvant trastuzumab treatment for up to at least 1 year should be safe for Japanese breast cancer patients.
最近，随机试验表明曲妥珠单抗作为辅助治疗对人表皮生长因子受体 2（HER2）阳性乳腺癌患者有效。需要了解在日本患者中使用辅助曲妥珠单抗的安全性信息，特别是心脏毒性数据。
我们回顾性分析了在日本国立癌症中心东医院（柏市）接受根治性手术和辅助曲妥珠单抗治疗的 48 例早期 HER2 阳性乳腺癌患者。评估了曲妥珠单抗的心脏安全性和短期疗效。
患者的中位年龄为 54 岁。所有患者均接受辅助或新辅助细胞毒性化疗。27 例（56%）接受辅助放疗。44 例（92%）患者未接受同期细胞毒性化疗而接受曲妥珠单抗治疗，4 例（8%）接受紫杉类药物同期曲妥珠单抗治疗。25 例患者完成了 1 年的曲妥珠单抗治疗，5 例患者完成了 2 年的曲妥珠单抗治疗。9 例患者因疾病进展（1 例）、左心室射血分数（LVEF）下降（2 例）、患者拒绝（4 例）和其他原因（2 例）而停止曲妥珠单抗治疗。发生了 5 例心脏事件。2 例患者的 LVEF 下降至<50%。3 例患者曲妥珠单抗治疗与心脏事件之间的关系尚不清楚。中位随访时间为 21.2 个月。1 年时无病生存率（DFS）为 97.5%，2 年时为 92.9%。
在我们的分析中，曲妥珠单抗治疗引起的心脏事件发生率较低。日本乳腺癌患者接受至少 1 年的辅助曲妥珠单抗治疗应该是安全的。
