Ntellas Panagiotis, Spathas Nikolaos, Agelaki Sofia, Zintzaras Elias, Saloustros Emmanouil
Department of Medical Oncology, University Hospital of Ioannina, Ioannina, Greece.
Department of Biostatistics and Clinical Bioinformatics, Faculty of Medicine, University of Thessaly, Larissa, Greece.
Oncotarget. 2019 Feb 5;10(11):1209-1216. doi: 10.18632/oncotarget.26632.
Adjuvant chemotherapy has an indisputable value for early breast cancer patients. Anthracycline and taxane-based regimens (TaxAC) have not been proven superior to taxane & cyclophosphamide (TC), a less toxic combination. Our objective was to estimate the cumulative evidence for non-inferiority of TC against TaxAC, in the adjuvant setting of patients with HER2-negative, breast cancer.
Overall, 7,341 patients were included in this analysis. Superiority of TaxAC or non-inferiority of TC was not established either for the overall population (DFS HR, 1.11; 95% CI, 0.95-1.30; = 0.18), or for the node-negative patients (HR, 1.05; 95% CI, 0.82-1.34; = 0.71). A difference in DFS of 1.28% (TC DFS, 89.04%; 95% CI, 88%-90% & TaxAC DFS, 90.32%; 95% CI, 89%-91%) was found in favor of TaxAC. Lower risk of death was not established for either treatment regimen (OS-HR, 1.02; 95% CI, 0.82-1.25; = 0.88). Overall, the toxicity profile favored TC.
Although non-inferiority of TC was not proven, superiority of TaxAC is still questioned. The present analysis narrows the risk of recurrence between the treatment groups. Considering TC has a more favorable safety profile, the question as to which treatment regimen should be preferred under what circumstances, needs to be individualized according to patients' characteristics and desires.
Treatment efficacy data from The ABC trials, the Plan B trial and a trial by the Hellenic Oncology Research group (HORG) were pooled. Disease free survival (DFS) and overall survival (OS) were scrutinized. A HR of 1.18 for TC versus TaxAC was chosen to demonstrate inferiority.
辅助化疗对早期乳腺癌患者具有无可争议的价值。基于蒽环类和紫杉烷的方案（TaxAC）尚未被证明优于毒性较小的紫杉烷与环磷酰胺联合方案（TC）。我们的目的是评估在HER2阴性乳腺癌患者的辅助治疗中，TC不劣于TaxAC的累积证据。
总体而言，本分析纳入了7341例患者。无论是在总体人群中（无病生存期风险比，1.11；95%置信区间，0.95 - 1.30；P = 0.18），还是在淋巴结阴性患者中（风险比，1.05；95%置信区间，0.82 - 1.34；P = 0.71），均未确立TaxAC的优越性或TC的非劣效性。发现无病生存期存在1.28%的差异（TC组无病生存率为89.04%；95%置信区间，88% - 90%，TaxAC组无病生存率为90.32%；95%置信区间，89% - 91%），支持TaxAC组。两种治疗方案均未显示出较低的死亡风险（总生存期风险比，1.02；95%置信区间，0.82 - 1.25；P = 0.88）。总体而言，毒性特征更倾向于TC组。
尽管未证明TC的非劣效性，但TaxAC的优越性仍受到质疑。本分析缩小了治疗组之间的复发风险。考虑到TC具有更有利的安全性，在何种情况下应优先选择哪种治疗方案的问题，需要根据患者的特征和意愿进行个体化考量。
汇总了ABC试验、B计划试验以及希腊肿瘤研究组（HORG）的一项试验中的治疗疗效数据。对无病生存期（DFS）和总生存期（OS）进行了审查。选择TC与TaxAC的风险比为1.18来证明劣效性。
