German Breast Group, Neu-Isenburg, Universitätsklinikum München, Klinikum Offenbach, Germany.
Frauenklinik, Universitätsklinikum München, Klinikum Offenbach, Germany.
Breast Care (Basel). 2013 Mar;8(1):60-6. doi: 10.1159/000346834.
Elderly breast cancer patients are underrepresented in clinical trials and this leads to a lack of knowledge regarding the tolerance and side effects of modern chemotherapy regimens, especially in dose-dense (dd) or dose-intensified combination.
In this analysis, data from 4 German, randomized (neo-)adjuvant trials, including anthracycline-based chemotherapy, were evaluated for toxicity, compliance and feasibility. Patients were grouped according to age.
Of the 4,775 patients, 73.6% were < 60 years, 15.8% were 60-64 years and 10.6% were > 64 years. The patients' compliance decreased with increasing age, the rate of therapy discontinuations was 10.3%; 16.0% were > 64 years old (p < 0.001). The rate of dose reductions also increased with increasing age in the docetaxel/doxorubicin/cyclophosphamide (TAC) (p overall = 0.02) and 5-fluorouracil/epirubicin-cyclophosphamide (FE120C) (p overall < 0.001) treatment groups. Neutropenia grade 3 + 4 in patients of > 64 years was 77% in FE120C- compared to 55% in TAC-treated patients (with primary granulocyte colony-stimulating factors (G-CSFs)). The incidence of febrile neutropenia (FN) was lowest in the regimens without additional taxanes. FN in patients aged > 64 years was lower in the FE120C- than in TAC-and dd-doxorubicin/docetaxel-treated groups.
The range and intensity of toxicity increased with age. Neutropenia did not increase significantly in the dd groups; the highest rate was seen in FE120C-treated patients. FE120C without G-CSFs is not an option in patients older than 64 years.
临床试验中老年人乳腺癌患者代表性不足，这导致缺乏对现代化疗方案的耐受性和副作用的了解，尤其是在密集型（dd）或剂量强化联合方案中。
在这项分析中，对来自 4 项德国随机（新）辅助临床试验的数据进行了评估，这些试验包括基于蒽环类药物的化疗，以评估毒性、依从性和可行性。患者根据年龄分组。
在 4775 名患者中，73.6%的患者年龄<60 岁，15.8%的患者年龄为 60-64 岁，10.6%的患者年龄>64 岁。随着年龄的增长，患者的依从性下降，治疗中断率为 10.3%；年龄>64 岁的患者中断率为 16.0%（p<0.001）。随着年龄的增长，多西紫杉醇/多柔比星/环磷酰胺（TAC）（p 总=0.02）和 5-氟尿嘧啶/表柔比星-环磷酰胺（FE120C）（p 总<0.001）治疗组的剂量减少率也随之增加。年龄>64 岁的患者中性粒细胞减少症 3+4 级的发生率在 FE120C 组为 77%，而在 TAC 治疗组为 55%（有初级粒细胞集落刺激因子（G-CSFs））。无额外紫杉烷类药物的方案中发热性中性粒细胞减少症（FN）的发生率最低。年龄>64 岁的患者中，FE120C 组的 FN 发生率低于 TAC 和 dd-多柔比星/多西紫杉醇组。
毒性的范围和强度随年龄增长而增加。dd 组中性粒细胞减少症无显著增加；FE120C 组发生率最高。年龄>64 岁的患者不适合使用无 G-CSFs 的 FE120C。
