Cvetanovic Ana, Filipovic Sladjana, Zivkovic Nikola, Popovic Lazar, Kostic Milos, Djordjevic Miodrag, Karanikolic Aleksandar, Krtinic Dane
Medical Faculty, University of Nis, Nis, Serbia.
J BUON. 2018 Mar-Apr;23(2):353-360.
The purpose of this study was to determinate disease-free interval (DFI) and overall survival (OS) in HER2-positive breast cancer patients who received adjuvant trastuzumab at the University Clinic of Nis, Serbia, and to investigate the influence of clinicopathological and biological characteristics of the tumor on prognosis. The second aim was to determinate the most frequent cause for the treatment discontinuation, recurrence rate, as well as the site of most common localization of the first recurrence of disease.
This research was conducted as a retrospective study at the University Oncology Clinic, Clinical Centre in Nis. The study included 238 patients who were operated and treated for HER2-positive breast cancer between January 1st, 2007 to September 30th, 2012 and followed up until December 31st, 2016. Trastuzumab was administered concurrently with taxanes, if administered, or after the completed anthracycline-based chemotherapy.
After a median follow up of 69 months the 5-year DFI was 65.9% and 5-year OS was 81.8% and, as expected, significantly longer in the group of patients with smaller tumors, a smaller number of positive axillary lymph nodes, as well as a lower stage of disease (p<0.0001). Patients older than 65 years had a longer DFI compared to the 45-65 and under 45 age groups of patients (p=0.01). No statistical significance was found in the length of DFI in relation to the histological tumor subtype, tumor grade, or the status of hormone receptors. Unlike DFI, a longer OS was recorded in the group of patients with lower tumor grade (p=0.03) and there was no statistically significant difference in survival regarding the age of patients (p=0.07). Recurrence occurred in approximately one third of the patients (38.23%), mostly in the form of local recurrence. Adjuvant therapy with trastuzumab was not completely carried out in 18.49% of the patients, the most common reason being the progression of disease.
A long median follow up period of 69 months indicated that anti-HER2 monoclonal antibody trastuzumab, after anthracycline-based chemotherapy or concurrently with taxanes, is efficient and safe in treating early breast cancer.
本研究旨在确定在塞尔维亚尼斯大学临床中心接受辅助曲妥珠单抗治疗的HER2阳性乳腺癌患者的无病生存期（DFI）和总生存期（OS），并探讨肿瘤的临床病理和生物学特征对预后的影响。第二个目的是确定治疗中断的最常见原因、复发率以及疾病首次复发最常见的部位。
本研究在尼斯临床中心大学肿瘤诊所进行，为回顾性研究。研究纳入了238例在2007年1月1日至2012年9月30日期间接受手术并治疗的HER2阳性乳腺癌患者，并随访至2016年12月31日。曲妥珠单抗与紫杉烷类药物（若使用）同时给药，或在完成基于蒽环类药物的化疗后给药。
中位随访69个月后，5年无病生存率为65.9%，5年总生存率为81.8%，正如预期的那样，肿瘤较小、腋窝淋巴结阳性数目较少以及疾病分期较低的患者组生存时间明显更长（p<0.0001）。65岁以上患者的无病生存期比45 - 65岁和45岁以下患者组更长（p = 0.01）。在无病生存期长度方面，未发现与肿瘤组织学亚型、肿瘤分级或激素受体状态相关的统计学意义。与无病生存期不同，肿瘤分级较低的患者组记录到更长的总生存期（p = 0.03），并且在患者年龄方面的生存情况未发现统计学显著差异（p = 0.07）。约三分之一的患者（38.23%）出现复发，主要为局部复发形式。18.49%的患者未完全进行曲妥珠单抗辅助治疗，最常见的原因是疾病进展。
69个月的长中位随访期表明，基于蒽环类药物的化疗后或与紫杉烷类药物同时使用的抗HER2单克隆抗体曲妥珠单抗在治疗早期乳腺癌方面有效且安全。
