多柔比星序贯紫杉醇和环磷酰胺与紫杉醇和环磷酰胺同步给药的比较：一项针对淋巴结阳性乳腺癌女性辅助剂量密集化疗的II期随机试验的5年结果
Doxorubicin followed by sequential paclitaxel and cyclophosphamide versus concurrent paclitaxel and cyclophosphamide: 5-year results of a phase II randomized trial of adjuvant dose-dense chemotherapy for women with node-positive breast carcinoma.
作者信息
Fornier M N, Seidman A D, Theodoulou M, Moynahan M E, Currie V, Moasser M, Sklarin N, Gilewski T, D'Andrea G, Salvaggio R, Panageas K S, Norton L, Hudis C
机构信息
Breast Cancer Medicine Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
出版信息
Clin Cancer Res. 2001 Dec;7(12):3934-41.
PURPOSE
We conducted a randomized Phase II trial to directly compare toxicity, feasibility, and delivered dose intensities of two adjuvant dose-intensive regimens containing doxorubicin, paclitaxel, and cyclophosphamide for patients with node-positive breast carcinoma.
EXPERIMENTAL DESIGN
Forty-two patients with resected breast carcinoma involving one or more ipsilateral axillary lymph nodes, were randomized to receive two different schedules of adjuvant chemotherapy using 14-day dosing intervals: either (a) three cycles of doxorubicin 80 mg/m(2) as i.v. bolus followed sequentially by three cycles of paclitaxel 200 mg/m(2) as a 24-h infusion and then by three cycles of cyclophosphamide 3.0 g/m(2) as a 1-h infusion (arm A); or (b) the same schedule of doxorubicin followed by three cycles of concurrent cyclophosphamide and paclitaxel at the same doses (arm B). All cycles were supported by granulocyte colony-stimulating factor administration.
RESULTS
Forty-one patients were assessable for toxicity and feasibility; 37 (90%) completed all planned chemotherapy. There was no treatment-related mortality; however, increased toxicity was observed on arm B compared with arm A, manifested by an increase in hospitalization for toxicity, mainly neutropenic fever, and an increased incidence of transfusion of packed RBCs transfusions for anemia. The mean delivered dose intensities for paclitaxel and cyclophosphamide were significantly greater for arm A compared with arm B (P =.01 and P =.05, respectively). There is no long-term, treatment-related toxicity, and no cases of acute myelogenous leukemia or myelodysplastic syndrome have been observed.
CONCLUSIONS
Dose-dense sequential single-agent chemotherapy is more feasible than doxorubicin with subsequent concurrent paclitaxel and cyclophosphamide.
目的
我们进行了一项随机II期试验，以直接比较两种含阿霉素、紫杉醇和环磷酰胺的辅助剂量密集方案对淋巴结阳性乳腺癌患者的毒性、可行性和给药剂量强度。
实验设计
42例切除的乳腺癌累及一个或多个同侧腋窝淋巴结的患者，被随机分配接受两种不同的辅助化疗方案，给药间隔为14天：（a）三个周期的阿霉素静脉推注80mg/m²，随后依次为三个周期的紫杉醇24小时输注200mg/m²，然后是三个周期的环磷酰胺1小时输注3.0g/m²（A组）；或（b）相同的阿霉素方案，随后是三个周期的相同剂量的环磷酰胺和紫杉醇联合应用（B组）。所有周期均给予粒细胞集落刺激因子支持。
结果
41例患者可评估毒性和可行性；37例（90%）完成了所有计划的化疗。无治疗相关死亡；然而，与A组相比，B组观察到毒性增加，表现为毒性住院率增加，主要是中性粒细胞减少性发热，以及贫血患者红细胞输注发生率增加。A组紫杉醇和环磷酰胺的平均给药剂量强度显著高于B组（分别为P = 0.01和P = 0.05）。未观察到长期的治疗相关毒性，也未观察到急性髓性白血病或骨髓增生异常综合征病例。
结论
剂量密集序贯单药化疗比阿霉素联合随后的紫杉醇和环磷酰胺联合应用更可行。
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