Impact of capecitabine maintenance on survival outcomes in triple-negative breast cancer patients not attaining pathological complete response following neoadjuvant chemotherapy: Real-world data from a tertiary care center from India.
Impact of capecitabine maintenance on survival outcomes in triple-negative breast cancer patients not attaining pathological complete response following neoadjuvant chemotherapy: Real-world data from a tertiary care center from India.
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卡培他滨维持治疗对新辅助化疗后未达到病理完全缓解的三阴性乳腺癌患者生存结果的影响：来自印度三级护理中心的真实世界数据。
DOI：
10.1200/jco.2022.40.16_suppl.e12593
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发表时间：
2022
影响因子：
45.3
通讯作者：
S. Mathur
中科院分区：
文献类型：
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作者：
Ranjan Sharma;A. Gogia;H. Sagiraju;S. Deo;D. Sharma;S. Mathur
e12593背景：卡培他滨维持治疗在新辅助化疗（NACT）后未达到病理学完全缓解（pCR）的三阴性乳腺癌（TNBC）患者中显示出生存获益。然而，缺乏来自印度次大陆的数据证实卡培他滨维持治疗的获益。研究方法：这项回顾性研究包括2013年5月至2020年12月期间在我们研究所登记的161例TNBC患者，他们接受了NACT（序贯蒽环类和紫杉烷），但未达到pCR。自2017年以来，卡培他滨被添加到机构方案中，用于NACT后未达到pCR的TNBC患者的维持治疗。使用Kaplan-Meir生存分析和多变量Cox比例风险模型，我们分析了接受卡培他滨维持治疗的患者（n=80）与未接受卡培他滨维持治疗的患者（n = 81）之间无复发生存期（RFS）和总生存期（OS）的差异。结果如下：除了绝经状态（对照组50% vs卡培他滨组33%）外，研究组之间的年龄、家族史、基线体能评分、肿瘤大小、淋巴结阳性和临床分期分布相似。卡培他滨组的中位（IQR）随访时间为22.2（16.2-27.4）个月，对照组为19.3（11.7-35.1）个月。卡培他滨组中有23名（28.8%）妇女发生疾病复发，而对照组中有45.7%（n=37）复发（p=0.026）。对照组的中位RFS为20.4（17.8-25.9）个月，而卡培他滨组未达到（对数秩p=0.007）。校正其他基线临床特征后，卡培他滨组的疾病复发风险显著低于对照组[校正风险比（aHR），95% CI：0.57（0.34-0.96），p=0.035]。两个研究组均未达到中位OS，但是，卡培他滨组的死亡风险低于对照组[aHR（95%CI）：0.44（0.20-1.01），p-0.053]。按绝经状态分层，卡培他滨维持治疗对疾病复发和RFS的影响仅在绝经后女性中显著[aHR（95%CI）：0.24（0.10-0.59）]。结论：这是我国的第一项研究，证明了卡培他滨维持治疗在NACT后未达到pCR的TNBC患者中的生存获益，特别是在绝经后女性中。这是一个重要的观察结果，因为我们的大多数患者都患有局部晚期疾病，pCR率较低。
e12593 Background: Capecitabine maintenance has demonstrated a survival benefit in triple-negative breast cancer (TNBC) patients not achieving pathological complete response (pCR) following neo-adjuvant chemotherapy (NACT). However, there is scarcity of data from Indian sub-continent corroborating the benefit of capecitabine maintenance. Methods: This retrospective study comprised of 161 TNBC patients registered at our institute between a period of May 2013 to Dec 2020, who received NACT (sequential anthracycline and taxane) but did not achieve pCR. Capecitabine was added to the institutional protocol since 2017 for maintenance therapy of TNBC patients who didn’t achieve pCR post NACT. Using Kaplan-Meir survival analysis and multivariate cox-proportional hazard models, we analysed differences in the relapse-free survival (RFS) and overall survival (OS) among those who received capecitabine maintenance therapy (n=80) versus those who did not receive it (n=81). Results: Distribution of age, family history, baseline performance score, tumor size, node positivity and clinical stage at time of presentation were comparable between the study groups, except for menopausal status (50% in control vs 33% in capecitabine group). Median(IQR) follow up time was 22.2 (16.2-27.4) months in capecitabine groups vs 19.3 (11.7-35.1) in control group. Twenty-three (28.8%) women in the capecitabine group had a disease-relapse while 45.7% (n=37) had relapsed in control group (p=0.026). Median RFS was 20.4 (17.8-25.9) months in control group while it was not reached in capecitabine group (log rank p=0.007). Adjusted for other baseline clinical characteristics, hazard of disease-relapse was significantly lower in the capecitabine group compared to controls [adjusted Hazard Ratio (aHR), 95% CI: 0.57 (0.34-0.96), p=0.035]. Median OS was not achieved in both the study groups, however, the hazard of death was lower in capecitabine group compared to control [aHR(95%CI): 0.44 (0.20-1.01), p-0.053]. Stratified by menopausal status, effect of capecitabine maintenance on disease relapse and RFS was only significant among the post-menopausal women [aHR (95%CI): 0.24 (0.10-0.59)]. Conclusions: This is the first study from our country, demonstrating a survival benefit with capecitabine maintenance in patients with TNBC not achieving pCR following NACT, particularly in post-menopausal women. It is an important observation as most of our patients present with locally advanced disease where pCR rate is low.