Prospective evaluation of paclitaxel versus combination chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with operable breast cancer
Prospective evaluation of paclitaxel versus combination chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with operable breast cancer
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DOI：
10.1200/jco.1999.17.11.3412
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发表时间：
1999-11-01
影响因子：
45.3
通讯作者：
Hortobagyi, GN
中科院分区：
文献类型：
--
作者：
Buzdar, AU;Singletary, SE;Hortobagyi, GN
目的：前瞻性比较紫杉醇单药与氟尿嘧啶、阿霉素和环磷酰胺（FAC）三联疗法作为新辅助治疗可手术乳腺癌患者的抗肿瘤活性。患者和方法：T1- 3 N 0 - 1 M0期乳腺癌患者随机接受紫杉醇（250 mg/m2）24小时输注或FAC标准剂量每3周输注一次。每例患者术前化疗4个周期。四个周期的诱导chemotherapy.Results：共登记了174例患者，87例被随机分配到研究的临床反应，即完全和部分反应，在研究的两个手臂是相似的，在乳腺癌和淋巴结战争的残留疾病的临床反应和程度进行评估。PAC组3例患者和紫杉醇亚组1例患者发生疾病进展。残留疾病的程度，在手术时的意向治疗分析是相似的两个手臂的study.Conclusion：这项前瞻性研究的结果表明，单药紫杉醇作为新辅助治疗具有显着的抗肿瘤活性，这是临床可比的FAC。相似比例的患者具有临床完全和部分应答，极少数患者对任一治疗均无应答。本方案中使用的替代非交叉耐药疗法对该疾病临床病程的价值需要更长时间的随访。(C)1999年，美国临床肿瘤学会。
Purpose: To compare prospectively the antitumor activity of single-agent paclitaxel to the three-drug combination of fluorouracil, doxorubicin, and cyclophosphamide (FAC) as neoadjuvant therapy in patients with operable breast cancer.Patients and Methods: Patients with T1-3N0-1M0 disease were randomized to receive either paclitaxel (250 mg/m(2)) as 24-hour infusion or FAC in standard doses at every-3-week intervals. Each patient was treated with four cycles of preoperative chemotherapy. Clinical response and extent of residual disease in the breast and lymph nodes war assessed after four cycles of induction chemotherapy.Results: A total of 174 patients were registered, and 87 were randomized to each arm of the study Clinical response, ie, complete and partial responses, was similar in both arms of the study. Three patients in the PAC arm and one patient in the paclitaxel subgroup had progressive disease. The extent of residual disease by intent-to-treat analysis at the time of surgery was similar between the two arms of the study.Conclusion: The results of this prospective study demonstrated that single-agent paclitaxel as neoadjuvant therapy has significant antitumor activity, and this was clinically comparable to FAC. Similar fractions of patients had clinical complete and partial responses, and very few patients had no response to either therapy. The value of alternate non-cross-resistant therapies as used in this protocol on the clinical course of this disease would require longer follow-up. (C) 1999 by American Society of Clinical Oncology.