Durvalumab in Combination With Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer: Long-Term Analysis From the GeparNuevo Trial.

With 86.4 months of median follow-up compared with the previously reported 43.7 months, durvalumab showed sustained significant improvements in long-term outcomes as defined by STEEP compared with placebo regarding not only invasive disease-free survival (iDFS; hazard ratio[HR], 0.56 [95% CI, 0.32 to 0.99]; stratified log-rank P = .0431), but also distant disease-free survival (DDFS; HR, 0.41 [95% CI, 0.21 to 0.80]; P = .0069) and overall survival(OS; HR, 0.33 [95% CI, 0.14 to 0.79]; P = .0085).

与先前报告的43.7个月相比，中位随访时间为86.4个月，与安慰剂相比，durvalumab在STEEP定义的长期结果方面显示出持续显著的改善，不仅在侵袭性疾病无进展生存（iDFS；风险比[HR]，0.56 [95%置信区间，0.32至0.99]；分层对数秩P = .0431），还在远处疾病无进展生存（DDFS；HR，0.41 [95%置信区间，0.21至0.80]；P = .0069）和总生存（OS；HR，0.33 [95%置信区间，0.14至0.79]；P = .0085）方面。

All analyses were stratified by stromal tumor-infiltrating lymphocytes (sTILs) at baseline (low [≤10%], intermediate [11%-59%], high [≥60%]).

所有分析均按基线时的间质肿瘤浸润淋巴细胞（sTILs）进行分层（低[≤10%]，中[11%-59%]，高[≥60%]）。

In exploratory subgroup analysis, patients with nodal involvement at baseline demonstrated a greater iDFS benefit (HR, 0.33 [95% CI, 0.144 to 0.771]; P = .01; Pinteraction = 0.045). sTILs in residual disease (RD) could be assessed in 39/71 patients without pCR.

在探索性亚组分析中，基线时有淋巴结受累的患者显示出更大的无病生存期（iDFS）获益（HR，0.33 [95% 置信区间，0.144至0.771]；P = .01；Pinteraction = 0.045）。

Post hoc analyses by sTILs high (>10%) versus low (≤10%) in RD showed estimated 7-year iDFS rates of 92.3% (95% CI, 56.6 to 98.9) and 51.4% (95% CI, 29.2 to 69.7), respectively.

通过sTILs高（>10%）与低（≤10%）的回顾性分析显示，RD中估计的7年iDFS率分别为92.3%（95% CI，56.6至98.9）和51.4%（95% CI，29.2至69.7）。

Hence, adding durvalumab to dose-dense NACT without adjuvant continuation of checkpoint inhibition improved long-term survival outcomes, irrespective of the extent of pathologic response.

因此，无论病理反应的程度如何，将durvalumab加入密集NACT中并在没有辅助性检查点抑制的情况下继续使用，改善了长期生存结果。

This underscores the necessity to re-evaluate the adjuvant continuation of checkpoint inhibition.

这强调了重新评估辅助性检查点抑制疗法继续使用的需求。