GAIN2 试验了早期乳腺癌中强化化疗与定制剂量密集化疗的总体生存率。
GAIN2 trial overall survival with intense versus tailored dose dense chemotherapy in early breast cancer.
发表日期：2024 Jul 30
作者：
Volker Möbus, Hans-Joachim Lück, Ekkehart Ladda, Peter Klare, Knut Engels, Marcus Schmidt, Andreas Schneeweiss, Eva-Maria Grischke, Grischa Wachsmann, Helmut Forstbauer, Michael Untch, Frederik Marmé, Jens-Uwe Blohmer, Christian Jackisch, Jens Huober, Elmar Stickeler, Mattea Reinisch, Theresa Link, Bruno Sinn, Wolfgang Janni, Carsten Denkert, Sabine Seiler, Christine Solbach, Sabine Schmatloch, Julia Rey, Sibylle Loibl
来源：
npj Breast Cancer
摘要：
GAIN-2 试验评估了高危早期乳腺癌的最佳强剂量密集 (idd) 策略。本研究报告了次要终点病理完全缓解（pCR）和总生存期（OS）。患者 (n = 2887) 按 1:1 的比例随机分配到 idd 表柔比星、白蛋白结合型紫杉醇和环磷酰胺 (iddEnPC) 与基于白细胞最低点的剂量密集 EC 和多西紫杉醇 (dtEC-dtD) 定制方案作为辅助治疗，并结合新辅助治疗修改后允许。中位随访时间为 6.5 年（总体队列）和 5.7 年（新辅助队列，N = 593），两种方案显示出可比的 5 年 OS 率（iddEnPC 90.8%，dtEC-dtD 90.0%，p = 0.320）。在新辅助治疗中，iddEnPC 的 pCR 率高于 dtEC-dtD（51.2% vs. 42.6%，p = 0.045）。达到 pCR 的患者的 5 年 iDFS 显着改善（88.7% vs. 70.1%，HR 0.33，p<0.001）和 OS 率（93.9% vs. 83.1%，HR 0.32，p<0.001），但 OS 结果具有可比性，无论如何pCR 状态。因此，与 dtEC-dtD 相比，iddEnPC 表现出更高的 pCR 率，但生存结果相当。© 2024。作者。
GAIN-2 trial evaluated the optimal intense dose-dense (idd) strategy for high-risk early breast cancer. This study reports the secondary endpoints pathological complete response (pCR) and overall survival (OS). Patients (n = 2887) were randomized 1:1 between idd epirubicin, nab-paclitaxel, and cyclophosphamide (iddEnPC) versus leukocyte nadir-based tailored regimen of dose-dense EC and docetaxel (dtEC-dtD) as adjuvant therapy, with neoadjuvant therapy allowed after amendment. At median follow-up of 6.5 years (overall cohort) and 5.7 years (neoadjuvant cohort, N = 593), both regimens showed comparable 5-year OS rates (iddEnPC 90.8%, dtEC-dtD 90.0%, p = 0.320). In the neoadjuvant setting, iddEnPC yielded a higher pCR rate than dtEC-dtD (51.2% vs. 42.6%, p = 0.045). Patients achieving pCR had significantly improved 5-year iDFS (88.7% vs. 70.1%, HR 0.33, p < 0.001) and OS rates (93.9% vs. 83.1%, HR 0.32, p < 0.001), but OS outcomes were comparable regardless of pCR status. Thus, iddEnPC demonstrates superior pCR rates compared to dtEC-dtD, yet with comparable survival outcomes.© 2024. The Author(s).