Zhumakayeva A, Rakhimov K, Sirota V, Arystan L, Madiyarov A, Adekenov S
Karaganda State Medical University; International Research and Production Holding "Phytochemistry"; S.D. Asfendiyarov Kazakh National Medical University, Kazakhstan.
Georgian Med News. 2018 Sep(282):30-35.
Breast cancer ranks first among the malignant tumors in women. In locally advanced breast cancer (LABC) treatment starts with neoadjuvant chemotherapy (CTx) with the standard regimens CMF, FAC, АС. A cytostatic drug, Arglabin, isolated and produced from Artemisia glabella Kar. et Kir., an endemic plant growing in Central Kazakhstan, has been under investigation in clinical trials. The research is aimed at investigating the long-term results of combination therapy of locally advanced breast cancer including different chemotherapy regimens and Arglabin as monotherapy. The present research includes 93 patients diagnosed with LABC aged from 35 to 75 years, including 60 patients with Stage 2, and 33 patients with Stage 3 breast cancer. All patients were split into 3 groups, two experimental and one control group. The control group consisted of 36 patients with LABC who underwent 4 cycles of neoadjuvant chemotherapy according to AC regimen (doxorubicine 50 mg/m2, cyclophosphamide 500 mg/m2). The experimental group 1 consisted of 30 patients who received 4 cycles of chemotherapy according to AC+Arglabin regimen (Arglabin 370 mg/m2 within 7 days), while experimental group 2 consisted of 27 patients who underwent 4 cycles of Arglabin as monotherapy. Actuarial calculations of the overall survival (OS) and disease-free survival (DFS) rates were done according to the Kaplan-Meier method, while the differences in indicators of control and experimental groups were estimated using the following methods: Cox's F-Test, χ2, Gehan's Wilcoxon Test. Overall one- and two-year survival in all groups of patients was 100%. Three-year survival rate in patients treated with chemotherapy according to AC regimen was (40,0±8,2)%, in patients combining AC chemotherapy with Arglabin it was (60,0±8,9)%. The lowest three-year survival rate (28,0±8,6)% was observed in patients treated with Arglabin as a monotherapy. The three-year survival rate in patients with breast cancer is statistically insignificant (χ2=4,407 at p=0,11042) between all groups; however, at the paired comparison by Gehan's Wilcoxon criterion a statistically significant difference has been observed between the group treated with Arglabin as monotherapy, and the group receiving chemotherapy according to AC+Arglabin regimen. The highest disease-free survival rates have been observed in the group of patients receiving chemotherapy according to AC+Arglabin regimen: 1-2-3-year survival rates are 100%, 100%, and 58%, respectively. In the group of patients who underwent chemotherapy according to AC regimen, 1-2-3-year disease-free survival rates are 92%, 92%, and 30%, respectively. Arglabin included in AC regimen positively increases a 3-year disease-free survival rate by 28% as compared to the standard regimen.
乳腺癌在女性恶性肿瘤中位居首位。在局部晚期乳腺癌（LABC）的治疗中，首先采用新辅助化疗（CTx），标准方案为CMF、FAC、AC。一种从哈萨克斯坦中部特有的植物光叶蒿（Artemisia glabella Kar. et Kir.）中分离并生产的细胞毒性药物阿格拉宾，正在进行临床试验研究。该研究旨在调查局部晚期乳腺癌联合治疗的长期结果，包括不同的化疗方案以及阿格拉宾单药治疗。本研究纳入了93例年龄在35至75岁之间被诊断为LABC的患者，其中60例为2期患者，33例为3期乳腺癌患者。所有患者分为3组，两个试验组和一个对照组。对照组由36例LABC患者组成，他们按照AC方案（多柔比星50mg/m²，环磷酰胺500mg/m²）接受4个周期的新辅助化疗。试验组1由30例患者组成，他们按照AC + 阿格拉宾方案（7天内阿格拉宾370mg/m²）接受4个周期的化疗，而试验组2由27例患者组成，他们接受4个周期的阿格拉宾单药治疗。根据Kaplan - Meier方法对总生存（OS）率和无病生存（DFS）率进行精算计算，而对照组和试验组指标的差异使用以下方法估计：Cox's F检验、χ²检验、Gehan's Wilcoxon检验。所有患者组的1年和2年总生存率均为100%。按照AC方案化疗的患者3年生存率为（40.0±8.2）%，AC化疗联合阿格拉宾的患者为（60.0±8.9）%。阿格拉宾单药治疗的患者3年生存率最低，为（28.0±8.6）%。乳腺癌患者的3年生存率在所有组之间无统计学意义（χ² = 4.407，p = 0.11042）；然而，根据Gehan's Wilcoxon标准进行配对比较时，阿格拉宾单药治疗组与接受AC + 阿格拉宾方案化疗的组之间观察到统计学显著差异。接受AC + 阿格拉宾方案化疗的患者组无病生存率最高：1 - 2 - 3年生存率分别为100%、100%和58%。按照AC方案接受化疗的患者组，1 - 2 - 3年无病生存率分别为92%、92%和30%。与标准方案相比，AC方案中加入阿格拉宾可使3年无病生存率提高28%。
