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    • Benefit from Dose-Dense Adjuvant Chemotherapy for Breast Cancer: Subgroup Analyses from the Randomised Phase 3 PANTHER Trial

    Alexios Matikas,Andri Papakonstantinou,Sibylle Loibl,Guenther G. Steger,Michael Untch,Hemming Johansson,Nikos Tsiknakis,Mats Hellstrom, Richard Greil,Volker Moebus,Michael Gnant,Jonas Bergh,Theodoros Foukakis

    LANCET REGIONAL HEALTH-EUROPE（2025）

    Karolinska Univ Hosp Solna | Karolinska Inst | Karolinska Comprehens Canc Ctr | German Breast Grp | Med Univ Vienna | Karolinska Institutet | HELIOS Klinikum Berlin Buch | Paracelsus Med Univ | Goethe Univ Frankfurt

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    Abstract
    Background It is unclear whether some patients with high-risk breast cancer do not warrant adjuvant dose-dense chemotherapy due to small expected absolute benefit. Methods The phase 3 PANTHER trial (NCT00798070) compared adjuvant sequential epirubicin/cyclophosphamide (EC) and docetaxel (D) administered in either tailored dose-dense (tDD EC/D) or standard interval schedule (FEC/D) to patients with high-risk resected early breast cancer (n = 2003). We compared outcomes across key subgroups of interest, evaluated the performance of the online prognostication and treatment benefit estimation tool PREDICT and conducted a subpopulation treatment effect pattern plot (STEPP) analysis. Primary endpoint was breast cancer recurrence free survival (BCRFS). Findings Median follow-up was 10.3 years. Treatment with tDD EC/D improved 10-year BCRFS across all subgroups including according to menopausal status, with an absolute benefit of 2% or more, as well as in luminal (Hazard Ratio [HR] = 0.83, 95% Confidence Interval [CI] 0.65-1.05) and Human Epidermal Growth Factor Receptor 2 (HER2) positive (HR = 0.53, 95% CI 0.30-0.93), but not triple negative breast cancer patients (HR = 1.02, 95% CI 0.66-1.57). PREDICT underestimated overall survival in the entire population and across all subgroups. In STEPP analysis, absolute benefit from tDD EC/D in BCRFS was stable across risk-defined subpopulations, from 3.8% in the lowest risk patients to 3.6% in the highest risk ones. There was no differential treatment effect over time. Interpretation We could not reliably identify any subgroup not benefiting from dose-dense treatment, which should be considered for patients with primary resected high-risk breast cancer. Funding Cancerfonden, Br & ouml;stcancerf & ouml;rbundet, Radiumhemmets Forskningsfonder, Amgen, Roche, sanofi-aventis. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
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    Adjuvant chemotherapy,Amenorrhea,Breast cancer,Dose-dense,PREDICT,STEPP
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    【要点】：研究通过随机III期PANTHER试验的亚组分析表明，剂量密集型辅助化疗对于所有高风险早期乳腺癌患者均具有显著获益，无法准确识别出哪些亚组患者不需要此类治疗。
    

    【方法】：研究者对接受剂量密集型（tDD EC/D）或标准间隔化疗（FEC/D）的2003名高风险早期乳腺癌患者进行了亚组分析，并评估了在线预后和治疗效果预测工具PREDICT的表现以及进行了亚人群治疗效应模式图（STEPP）分析。
    

    【实验】：经过10.3年的中位随访，实验发现tDD EC/D治疗提高了所有亚组的10年无乳腺癌复发存活率（BCRFS），包括绝经状态、Luminal型和HER2阳性患者，但对三阴性乳腺癌患者无显著效果。PREDICT工具在预测整体生存率时低估了所有人群及亚组的生存率。STEPP分析显示，tDD EC/D在BCRFS的绝对获益在风险定义的亚人群中保持稳定，从最低风险患者的3.8%到最高风险患者的3.6%。治疗效应随时间没有差异。使用的数据集名称未在摘要中提及。