GAIN2 trial overall survival with intense versus tailored dose dense chemotherapy in early breast cancer.

IF 6.5 2区医学 Q1 ONCOLOGY

NPJ Breast Cancer Pub Date : 2024-07-30 DOI:10.1038/s41523-024-00675-x

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

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Abstract

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.

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GAIN2试验：早期乳腺癌密集化疗与定制剂量密集化疗的总体生存率。

GAIN-2试验评估了治疗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反应（pCR）和总生存期（OS）。患者（n = 2887）按1:1的比例随机接受idd表柔比星、纳布-紫杉醇和环磷酰胺（iddEnPC）与基于白细胞纳迪值的剂量密集EC和多西他赛定制方案（dtEC-dtD）的辅助治疗，修正后可接受新辅助治疗。在中位随访6.5年（总体队列）和5.7年（新辅助队列，N = 593）时，两种方案的5年OS率相当（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% 对 42.6%，p = 0.045）。获得 pCR 的患者的 5 年 iDFS 显著提高（88.7% vs. 70.1%，HR 0.33，p = 0.045）。

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来源期刊

NPJ Breast Cancer Medicine-Pharmacology (medical)

CiteScore

10.10

自引率

1.70%

发文量

122

审稿时长

9 weeks

期刊介绍： npj Breast Cancer publishes original research articles, reviews, brief correspondence, meeting reports, editorial summaries and hypothesis generating observations which could be unexplained or preliminary findings from experiments, novel ideas, or the framing of new questions that need to be solved. Featured topics of the journal include imaging, immunotherapy, molecular classification of disease, mechanism-based therapies largely targeting signal transduction pathways, carcinogenesis including hereditary susceptibility and molecular epidemiology, survivorship issues including long-term toxicities of treatment and secondary neoplasm occurrence, the biophysics of cancer, mechanisms of metastasis and their perturbation, and studies of the tumor microenvironment.