Martín M, Lluch A, Seguí M A, Ruiz A, Ramos M, Adrover E, Rodríguez-Lescure A, Grosse R, Calvo L, Fernandez-Chacón C, Roset M, Antón A, Isla D, del Prado P Martínez, Iglesias L, Zaluski J, Arcusa A, López-Vega J M, Muñoz M, Mel J R
Hospital Universitario San Carlos, Madrid, Spain.
Ann Oncol. 2006 Aug;17(8):1205-12. doi: 10.1093/annonc/mdl135. Epub 2006 Jun 9.
The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG).
This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment).
The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2-4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P<0.03).
The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.
本研究旨在分析接受FAC（5-氟尿嘧啶、阿霉素、环磷酰胺）和TAC（多西他赛、阿霉素、环磷酰胺）治疗的乳腺癌患者在使用和不使用原发性预防性粒细胞集落刺激因子（PPG）情况下的毒性和健康相关生活质量（HRQoL）。
这是一项III期研究，比较FAC和TAC作为高危淋巴结阴性乳腺癌患者辅助治疗的效果。在前237例患者入组后，由于发热性中性粒细胞减少症的高发生率，研究方案进行了修订，在TAC组中加入PPG。该试验共纳入了来自西班牙49个中心、波兰2个中心和德国4个中心的1047例可评估患者。比较了三组（FAC、修订前的TAC和修订后的TAC）的副作用以及欧洲癌症研究与治疗组织QLQ-C30和QLQ BR-23问卷的得分。
在TAC中加入PPG显著降低了中性粒细胞减少性发热、2-4级贫血、乏力、厌食、指甲病变、口腔炎、肌痛和味觉障碍的发生率。化疗期间患者的生活质量下降，TAC组比FAC组下降得更多，但之后恢复到基线值。在化疗结束时，在TAC中加入PPG显著降低了临床相关全球健康状况恶化（比基线值高10分或更多）的患者百分比（64%对46%，P<0.03）。
加入PPG显著降低了与TAC化疗相关的中性粒细胞减少性发热的发生率以及一些TAC诱导的血液学和血液学外副作用的发生率。接受TAC治疗的患者的HRQoL比接受FAC治疗的患者差，但加入PPG后有所改善，尤其是在化疗治疗的最后阶段。
