Abstract：
OBJECTIVE: For operable triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy (NAC), clinical prognostication and postoperative decision-making relies exclusively on whether a pathologic complete response (pCR) is achieved or not. We evaluated whether extent of disease at presentation further influenced overall survival (OS) among patients with pCR or with residual disease (RD) following NAC.
METHODS: Patients with stage I-III TNBC who underwent NAC were identified from the National Cancer Database from 2010 to 2019. Overall survival was assessed by disease extent using the Kaplan-Meier method and Cox proportional hazards regression for univariate and multivariable analysis.
RESULTS: A total of 35,598 patients met inclusion criteria, and 11,967 achieved pCR. Ten-year OS was 88.5% and varied by cT and cN category at presentation. Best 10-year OS was seen in patients with cT1-2, cN0 (90.9%) and was worst in those with cT3-4, cN2-3 disease (72.0%). A total of 23,631 patients had RD. Ten-year OS was 60.1% and varied by cT and cN category at presentation. Best 10-year OS was seen in patients with cT1-2, cN0 (73.0%) and was worst in those with cT3-4, cN2-3 disease (36.3%). Notably, OS was significantly poorer for patients with cT3-4, cN2-3 disease at diagnosis and pCR versus those with cT1-2 cN0 and RD (aHR 1.30, 95% confidence interval 1.03-1.63, p = 0.03).
CONCLUSIONS: Among patients with TNBC, extent of disease at presentation was prognostic for OS independently of response to NAC. Patients with advanced stage at presentation had poorer OS even in the context of pCR. Further investigation is needed to evaluate whether additional adjuvant therapy strategies should be considered for these patients.
METHODS: Patients with stage I-III TNBC who underwent NAC were identified from the National Cancer Database from 2010 to 2019. Overall survival was assessed by disease extent using the Kaplan-Meier method and Cox proportional hazards regression for univariate and multivariable analysis.
RESULTS: A total of 35,598 patients met inclusion criteria, and 11,967 achieved pCR. Ten-year OS was 88.5% and varied by cT and cN category at presentation. Best 10-year OS was seen in patients with cT1-2, cN0 (90.9%) and was worst in those with cT3-4, cN2-3 disease (72.0%). A total of 23,631 patients had RD. Ten-year OS was 60.1% and varied by cT and cN category at presentation. Best 10-year OS was seen in patients with cT1-2, cN0 (73.0%) and was worst in those with cT3-4, cN2-3 disease (36.3%). Notably, OS was significantly poorer for patients with cT3-4, cN2-3 disease at diagnosis and pCR versus those with cT1-2 cN0 and RD (aHR 1.30, 95% confidence interval 1.03-1.63, p = 0.03).
CONCLUSIONS: Among patients with TNBC, extent of disease at presentation was prognostic for OS independently of response to NAC. Patients with advanced stage at presentation had poorer OS even in the context of pCR. Further investigation is needed to evaluate whether additional adjuvant therapy strategies should be considered for these patients.
摘要：
目的：对于接受新辅助化疗（NAC）治疗的可手术的三阴性乳腺癌（TNBC），临床预后和术后决策完全依赖于病理完全缓解(pCR)与否.我们评估了NAC后pCR或残留疾病（RD）患者的表现程度是否进一步影响了总生存期（OS）。
方法：从2010年至2019年的国家癌症数据库中确定了接受NAC的I-III期TNBC患者。使用Kaplan-Meier方法和Cox比例风险回归进行单变量和多变量分析，通过疾病程度评估总生存期。
结果：共有35,598名患者符合纳入标准，和11,967达到pCR。十年OS为88.5%，按cT和cN类别划分。最佳10年OS见于cT1-2，cN0患者（90.9％），而在cT3-4，cN2-3疾病患者中最差（72.0％）。共有23,631例患者发生RD。十年OS为60.1%，按cT和cN类别划分。在cT1-2，cN0患者中观察到最佳的10年OS（73.0％），在cT3-4，cN2-3疾病患者中最差（36.3％）。值得注意的是,与cT1-2cN0和RD患者相比，cT3-4，cN2-3疾病在诊断和pCR时的OS明显较差（aHR1.30，95％置信区间1.03-1.63，p=0.03）。
结论：在TNBC患者中，出现时的疾病程度与OS的预后无关，与对NAC的反应无关。即使在pCR的情况下，晚期患者的OS也较差。需要进一步的研究来评估这些患者是否应该考虑额外的辅助治疗策略。
方法：从2010年至2019年的国家癌症数据库中确定了接受NAC的I-III期TNBC患者。使用Kaplan-Meier方法和Cox比例风险回归进行单变量和多变量分析，通过疾病程度评估总生存期。
结果：共有35,598名患者符合纳入标准，和11,967达到pCR。十年OS为88.5%，按cT和cN类别划分。最佳10年OS见于cT1-2，cN0患者（90.9％），而在cT3-4，cN2-3疾病患者中最差（72.0％）。共有23,631例患者发生RD。十年OS为60.1%，按cT和cN类别划分。在cT1-2，cN0患者中观察到最佳的10年OS（73.0％），在cT3-4，cN2-3疾病患者中最差（36.3％）。值得注意的是,与cT1-2cN0和RD患者相比，cT3-4，cN2-3疾病在诊断和pCR时的OS明显较差（aHR1.30，95％置信区间1.03-1.63，p=0.03）。
结论：在TNBC患者中，出现时的疾病程度与OS的预后无关，与对NAC的反应无关。即使在pCR的情况下，晚期患者的OS也较差。需要进一步的研究来评估这些患者是否应该考虑额外的辅助治疗策略。
