Primary Systemic Therapy for HER2/Neu-Positive Operable Breast Cancer Increases the Number of Breast-Conserving Surgery and Disease-Free Survival: Retrospective Cohort Analysis at Single Institution

Y. Azhar, H. Agustina, B. Hernowo
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Abstract

Abstract Objective The aim of this study was to evaluate the efficacy and cardiotoxicity profile, and to reduce the extend of breast cancer surgery in primary systemic therapy (PST) HER2/neu–positive operable breast cancer patients. Materials and Methods A total of 152 patients diagnosed from 2010 to 2015 were included in the study. The PST consisted of a sequential regimen of taxanes and anthracyclines plus trastuzumab. The clinical and pathological responses and the type of breast cancer surgery were evaluated and correlated with clinical and biological factors. The cardiotoxicity profile and long-term benefits were analyzed. Results The median patient age was 47 (37–67) years, with T2 and T3 67 (44.1%) and 85 (55.9%), respectively. Axillary lymph node breast cancer at diagnosis N0 was 104 (68.4%) and N1 and N2 were 28.9% and 2.6%, respectively. A total of 95.7% of patients had nonspecific type of breast cancer, 67% of tumors were hormonal receptor–negative, 75.5% were grade III, 100% Ki67 > 20%, and 90% of tumors were confirmed to be HER2/neu–positive through immunohistochemistry. Following PST, pathological complete response (pCR) rate was achieved in 44.7% evaluable patients. The pCR rate was higher in HR-negative (93.1% vs. 6.9%) cancer and in grade III (86.2%) than in grade I and II (13.8%) cancer; only 75.5% of complete response (CR) on ultrasound and magnetic resonance imaging were also CR on pathology results. Breast conserving surgery was performed in 41.4%. Regarding type of chemotherapy, there were no significant differences between chemotherapy with anthracycline backbone or taxanes to achieved pathological complete response. Despite that, we were unable to demonstrate an association between pCR and better DFS with p = 0.096; HR 5.7 95.0% CI (0.73–45.52). Patients who are hormonal receptor positive tend to have lower disease-free survival (DFS) than those who are hormonal receptor negative; HR = 6.34, 95.0% CI (1.54–26.00) and p = 0.010. Five years DFS was higher for those who achieved pCR compare with those who did not. Even in this research we failed to show it is statistically significant. Conclusion A sequential regimen of taxanes and anthracyclines plus trastuzumab was effective with high pCR rates and increases the possibility to do breast conservation surgery and had tolerable cardiotoxicity profile.
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HER2/ new阳性可手术乳腺癌的主要全身治疗增加了保乳手术的数量和无病生存率:单一机构的回顾性队列分析
摘要目的本研究旨在评估原发性全身治疗(PST) HER2/新阳性可手术乳腺癌患者的疗效和心脏毒性,并减少乳腺癌手术的范围。材料与方法本研究共纳入2010 - 2015年诊断的152例患者。PST包括紫杉烷和蒽环类药物加曲妥珠单抗的顺序方案。评价两组患者的临床、病理反应及乳腺癌手术类型,并与临床、生物学因素进行相关性分析。分析了心脏毒性概况和长期效益。结果患者年龄中位数为47(37 ~ 67)岁,其中T2和T3分别为67(44.1%)和85(55.9%)岁。腋窝淋巴结乳腺癌诊断为N0时为104例(68.4%),N1和N2分别为28.9%和2.6%。共有95.7%的患者为非特异性乳腺癌,67%的肿瘤为激素受体阴性,75.5%的肿瘤为III级,100%的Ki67 > 20%, 90%的肿瘤通过免疫组织化学证实HER2/ new阳性。PST后,44.7%的可评估患者达到病理完全缓解(pCR)率。hr阴性肿瘤(93.1% vs. 6.9%)和III级肿瘤(86.2%)的pCR率高于I级和II级肿瘤(13.8%);超声和磁共振完全缓解(CR)病理完全缓解者仅为75.5%。保乳手术占41.4%。在化疗类型方面,蒽环类主链化疗与紫杉烷类化疗在病理完全缓解方面无显著差异。尽管如此,我们无法证明pCR与更好的DFS之间存在关联(p = 0.096);Hr 5.7, 95.0% ci(0.73-45.52)。激素受体阳性患者的无病生存期(DFS)往往低于激素受体阴性患者;HR = 6.34, 95.0% CI (1.54 ~ 26.00), p = 0.010。获得pCR的患者的5年DFS高于未获得pCR的患者。即使在这项研究中,我们也没有证明它在统计上是显著的。结论紫杉烷类、蒽环类药物加曲妥珠单抗序贯治疗是有效的,pCR率高,增加了保乳手术的可能性,心脏毒性谱可耐受。
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