Fountzilas G, Papadimitriou C, Aravantinos G, Nicolaides C, Stathopoulos G, Bafaloukos D, Kalofonos H, Ekonomopoulos T, Skarlos D, Pavlidis N, Dimopoulos A M
AHEPA Hospital, Aristotle University of Thessaloniki, Greece.
Oncology. 2001;60(3):214-20. doi: 10.1159/000055321.
Dose-dense sequential chemotherapy appears to be a promising approach in the management of patients with operable breast cancer. We evaluated the tolerability of such a novel chemotherapeutic regimen in high-risk patients. From February 1995 until September 1997, 49 women with histologically confirmed breast cancer and > or =10 involved axillary nodes were treated postoperatively with three cycles of epirubicin (110 mg/m(2)) followed by three cycles of paclitaxel (250 mg/m(2) in a 3-hour infusion) followed by three cycles of 'intensified' CMF (cyclophosphamide 840 mg/m(2), methotrexate 57 mg/m(2), fluorouracil 840 mg/m(2); E-T-CMF). All cycles were repeated every 2 weeks with G-CSF support. Ovarian ablation with monthly injections of triptorelin for 1 year was performed in premenopausal patients and tamoxifen was prescribed for 5 years to all women with positive receptor status after the completion of chemotherapy. A total of 456 cycles of chemotherapy were administered, 363 (80%) of them at full dose. Forty-seven (96%) patients received all 9 cycles of chemotherapy. Relative dose intensity of epirubicin was 0.98, of paclitaxel 0.97, of cyclophosphamide 0.99, of methotrexate 0.98 and of fluorouracil 0.99. Grade 3--4 toxicities included anemia (8%), leukopenia (8%), peripheral neuropathy (6%), neutropenia (4%), thrombocytopenia (4%), stomatitis (2%), diarrhea (2%), fatigue (2%) and hypersensitivity reaction (2%). Febrile neutropenia occurred in 2 patients. Alopecia was universal. After a median follow-up of 3 years, 11 women (22%) relapsed and 4 (8%) died. The 3-year actuarial disease-free survival rate was 72% and the 3-year overall survival rate 90%. The E-T-CMF regimen is well tolerated, as adjuvant treatment, in patients with operable breast cancer with promising activity and deserves further evaluation in phase III studies.
剂量密集序贯化疗似乎是治疗可手术乳腺癌患者的一种有前景的方法。我们评估了这种新型化疗方案在高危患者中的耐受性。从1995年2月至1997年9月，49例经组织学确诊为乳腺癌且腋窝淋巴结转移≥10个的女性患者术后接受了三个周期的表柔比星（110mg/m²）治疗，随后是三个周期的紫杉醇（250mg/m²，静脉输注3小时），接着是三个周期的“强化”CMF（环磷酰胺840mg/m²、甲氨蝶呤57mg/m²、氟尿嘧啶840mg/m²；E-T-CMF）。所有周期每2周重复一次，并给予粒细胞集落刺激因子（G-CSF）支持。绝经前患者每月注射曲普瑞林进行卵巢去势1年，所有化疗结束后受体状态阳性的女性均接受5年他莫昔芬治疗。共进行了456个周期的化疗，其中363个（80%）为全剂量。47例（96%）患者接受了全部9个周期的化疗。表柔比星的相对剂量强度为0.98，紫杉醇为0.97，环磷酰胺为0.99，甲氨蝶呤为0.98，氟尿嘧啶为0.99。3 - 4级毒性包括贫血（8%）、白细胞减少（8%）、周围神经病变（6%）、中性粒细胞减少（4%）、血小板减少（4%）、口腔炎（2%）、腹泻（2%）、疲劳（2%）和过敏反应（2%）。2例患者发生发热性中性粒细胞减少。脱发普遍存在。中位随访3年后，11例女性（22%）复发，4例（8%）死亡。3年无病生存率为72%，3年总生存率为90%。E-T-CMF方案作为辅助治疗，在可手术乳腺癌患者中耐受性良好，具有良好的活性，值得在III期研究中进一步评估。
