PURPOSE Neoadjuvant combination treatment with chemotherapy (CTX), trastuzumab (TZM), and pertuzumab (PTZ) has been shown to result in higher pathological complete response rates (pCR) in comparison with treatment with chemotherapy and trastuzumab (CTX/TZM). This analysis was aimed at real-world validation of these results from prospective randomized trials. METHODS In a retrospective analysis conducted in the PRAEGNANT network, patients were eligible for inclusion if they had either received neoadjuvant therapy with CTX/TZM or chemotherapy, trastuzumab, and pertuzumab (CTX/TZM/PTZ) and subsequently underwent surgery for their primary breast cancer. The effect of the two neoadjuvant regimens on pCR in addition to commonly applicable predictors of pCR was analyzed in 300 patients from three study sites, using logistic regression analyses with treatment arm, age, clinical tumor stage, grading, and hormone receptor status as predictors. RESULTS pCR with complete disappearance of all tumor cells was seen in 30.2% (n = 58) of patients treated with CTX/TZM and in 52.8% (n = 57) of those treated with CTX/TZM/PTZ. CTX/TZM/PTZ was positively associated with pCR (adjusted odds ratio 2.44; 95% CI 1.49-4.02). Mastectomy rates were not influenced by the therapy. CONCLUSIONS The results of clinical trials were confirmed in this dataset of patients who were treated outside of clinical trials in everyday routine work. pCR rates can be improved by 20% with pertuzumab in routine clinical use.

中文翻译：

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新辅助治疗的帕妥珠单抗，化疗和曲妥珠单抗在原发性乳腺癌患者常规临床治疗中的疗效：多中心分析。

用途与化疗和曲妥珠单抗（CTX / TZM）相比，已证实使用化学疗法（CTX），曲妥珠单抗（TZM）和帕妥珠单抗（PTZ）的新辅助疗法可导致更高的病理完全缓解率（pCR）。该分析旨在对前瞻性随机试验的这些结果进行真实验证。方法在PRAEGNANT网络中进行的回顾性分析中，如果患者接受过CTX / TZM或化疗，曲妥珠单抗和帕妥珠单抗（CTX / TZM / PTZ）的新辅助治疗，随后接受了原发性乳腺癌手术，则符合入选条件。 。除来自三个研究地点的300名患者外，还分析了两种新辅助方案对pCR的影响以及pCR的普遍适用预测因素，使用逻辑回归分析，以治疗组，年龄，临床肿瘤分期，分级和激素受体状态为预测指标。结果在接受CTX / TZM治疗的患者中，有30.2％（n = 58）和在接受CTX / TZM / PTZ治疗的患者中有52.8％（n = 57），看到所有肿瘤细胞均完全消失的pCR。CTX / TZM / PTZ与pCR正相关（校正比值比2.44； 95％CI 1.49-4.02）。乳房切除率不受治疗的影响。结论在该例行日常临床工作之外接受治疗的患者数据集中，证实了临床试验的结果。帕妥珠单抗在常规临床应用中可将pCR率提高20％。接受CTX / TZM治疗的患者为2％（n = 58），接受CTX / TZM / PTZ治疗的患者为52.8％（n = 57）。CTX / TZM / PTZ与pCR正相关（校正比值比2.44； 95％CI 1.49-4.02）。乳房切除率不受治疗的影响。结论在该例行日常临床工作之外接受治疗的患者数据集中证实了临床试验的结果。帕妥珠单抗在常规临床应用中可将pCR率提高20％。接受CTX / TZM治疗的患者为2％（n = 58），接受CTX / TZM / PTZ治疗的患者为52.8％（n = 57）。CTX / TZM / PTZ与pCR正相关（校正比值比2.44； 95％CI 1.49-4.02）。乳房切除率不受治疗的影响。结论在该例行日常临床工作之外接受治疗的患者数据集中证实了临床试验的结果。帕妥珠单抗在常规临床应用中可将pCR率提高20％。结论在该例行日常临床工作之外接受治疗的患者数据集中证实了临床试验的结果。帕妥珠单抗在常规临床应用中可将pCR率提高20％。结论在该例行日常临床工作之外接受治疗的患者数据集中证实了临床试验的结果。帕妥珠单抗在常规临床应用中可将pCR率提高20％。