PURPOSE In the CLEOPATRA study of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer, the Japanese patient subgroup did not demonstrate the improved progression-free survival (PFS) of pertuzumab plus trastuzumab and docetaxel vs. placebo that was seen in the overall population. Therefore, COMACHI was conducted to confirm the efficacy and safety of this treatment regimen in this patient subgroup. METHODS This was a phase IV study of pertuzumab plus trastuzumab and docetaxel in Japanese patients with histologically/cytologically confirmed inoperable or recurrent HER2-positive breast cancer. All patients received pertuzumab, trastuzumab, and docetaxel intravenously every 3 weeks until disease progression/unacceptable toxicity. The primary endpoint was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR). Safety was also assessed. RESULTS At final analysis, median investigator-assessed PFS was 22.8 months (95% CI 16.9-37.5). From first dose, OS rate at 1 year was 97.7%; and at 2 and 3 years were 88.5% and 79.1%, respectively. Of the 118 patients with measurable disease at baseline, response rate was 83.9% (95% CI 77.3-90.5) and median investigator-assessed DoR was 26.3 months (95% CI 17.1-not evaluable). Treatment was well tolerated, with no new safety signals detected. CONCLUSIONS Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.

中文翻译：

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帕妥珠单抗联合曲妥珠单抗和多西紫杉醇作为一线疗法治疗日本不能手术或复发性 HER2 阳性乳腺癌患者的疗效和安全性：COMACHI 研究。

目的 在针对人表皮生长因子受体 2 (HER2) 阳性复发性或转移性乳腺癌患者的 CLEOPATRA 研究中，日本患者亚组并未证明帕妥珠单抗加曲妥珠单抗和多西他赛与安慰剂相比可改善无进展生存期 (PFS)这在总人口中可见一斑。因此，进行 COMACHI 是为了确认该治疗方案在此患者亚组中的有效性和安全性。方法 这是一项帕妥珠单抗联合曲妥珠单抗和多西紫杉醇在经组织学/细胞学证实不能手术或复发性 HER2 阳性乳腺癌的日本患者中进行的 IV 期研究。所有患者每 3 周静脉注射帕妥珠单抗、曲妥珠单抗和多西紫杉醇，直至疾病进展/出现不可接受的毒性。主要终点是研究者评估的 PFS。次要终点是总生存期（OS）、研究者评估的客观缓解率和缓解持续时间（DoR）。还评估了安全性。结果 最终分析时，研究者评估的中位 PFS 为 22.8 个月（95% CI 16.9-37.5）。从第一次给药开始，1 年 OS 率为 97.7%；2 年和 3 年分别为 88.5% 和 79.1%。在 118 名基线时患有可测量疾病的患者中，缓解率为 83.9%（95% CI 77.3-90.5），研究者评估的中位 DoR 为 26.3 个月（95% CI 17.1-不可评估）。治疗耐受性良好，没有检测到新的安全信号。结论 我们的结果表明，与 CLEOPATRA 总体人群相比，帕妥珠单抗联合曲妥珠单抗和多西他赛在日本患者中的疗效和安全性相似，为该联合疗法作为日本不能手术或复发性 HER2 阳性乳腺癌患者的标准治疗提供了进一步的支持。