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随机2期ABCSG-52/ATHENE试验

原文发布日期：2025-01-16

英文摘要：

摘要翻译：

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随机2期ABCSG-52/ATHENE试验

the randomized phase 2 ABCSG-52/ATHENE trial

原文发布日期：2025-01-16

英文摘要：

The role of anthracyclines in the treatment of early breast cancer (EBC) is increasingly being challenged, especially in de-escalation strategies. However, owing to their immunogenic effects, anthracyclines are promising combination partners with immunotherapies. In the randomized phase 2 trial ABCSG-52 (EudraCT no. 2019-002364-27), we investigated epirubicin plus immunotherapy in women with human epidermal growth factor receptor 2 (HER2)-positive EBC. A total of 58 patients were randomized 1:1 to two cycles of a chemotherapy-free induction phase (part 1) of dual HER2 blockade with trastuzumab and pertuzumab (TP) plus the anti-programmed death ligand 1 antibody atezolizumab (TP-A) or TP alone. Thereafter, all patients received four cycles of TP-A in combination with epirubicin (part 2). The primary endpoint, pathological complete response (pCR), was met in 35 patients (60.3%; 95% confidence interval (CI) 47.5% to 71.9%), 19 patients (65.5%) in the TP-A group and 16 patients (55.2%) in the TP group. The residual cancer burden 0/I rate and objective response rate (secondary endpoints) in all patients with evaluable data were 80.0% (n = 44/55; 95% CI 67.6% to 88.4%) and 89.3% (n = 50/56; 95% CI 78.5% to 95.0%), respectively. Grade ≥3 adverse events were reported in 17 patients (29.3%). Based on our findings, we conclude that a neoadjuvant chemotherapy de-escalation immunotherapy regimen with trastuzumab, pertuzumab, atezolizumab and epirubicin is effective and safe in patients with HER2-positive EBC.

摘要翻译：

蒽环类药物在治疗早期乳腺癌（EBC）中的作用越来越受到质疑，尤其是在降级策略中。然而，由于其免疫原性效应，蒽环类药物可能是与免疫治疗临床试验的理想组合伙伴。在随机型二期试验ABC-SSG-52（EudraCT编号：2019-002364-27）中，我们研究了伊西美坦联合免疫治疗用于HER2阳性 EBC患者的女性患者。共58名受试者被随机分配到采用联合阻断剂的诱导期（部分1），即使用替妥珠单抗、铂拉望珠单抗和爱祖单抗或单独使用替妥珠单抗。在此之后，所有受试者都接受了爱祖单抗与伊西美坦联合作为部分2进行四次化疗方案。主要终点病理完全反应（pCR）在35名受试者（60.3%，95%置信区间（CI）47.5%-71.9%）和TP-A组19名受试者（65.5%）及TP组16名受试者（55.2%）中得到满足。所有评估数据的受试者残余肿瘤负担0/I率和客观缓解率（次要终点）分别为80.0%（n=44/55；95%CI 67.6%-88.4%）和89.3%（n=50/56；95%CI 78.5%-95.0%）。17名受试者（29.3%）报告了≥3级不良事件。基于我们的发现，我们得出结论：一种基于替妥珠单抗、铂拉望珠单抗、爱祖单抗和伊西美坦的Neoadjuvant化疗降级免疫治疗方案在HER2阳性 EBC患者中是有效的且安全的。