Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: An intergroup trial (E1193)
Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: An intergroup trial (E1193)
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DOI：
10.1200/jco.2003.08.013
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发表时间：
2003-02-15
影响因子：
45.3
通讯作者：
Wood, WC
中科院分区：
文献类型：
--
作者：
Sledge, GW;Neuberg, D;Wood, WC
目的：1993年2月至1995年9月，739例转移性乳腺癌患者参加了一项组间试验（E1193），（60 mg/m2），紫杉醇（175 mg/m2/24 h），以及多柔比星和紫杉醇的组合（AT，50 mg/m2和150 mg/m2/24 h，加粒细胞集落刺激因子5 mg/ kg）作为一线治疗。接受阿霉素或紫杉醇单药治疗的患者在疾病进展时交叉使用其他药物。患者和方法：患者在研究期间的特征平衡良好。响应（完全反应和部分反应）在36%的阿霉素、34%的紫杉醇和479%的AT患者中观察到（多柔比星对紫杉醇P = 0.84，vAT P = 0.007，紫杉醇vAT P = 0.004）。多柔比星、紫杉醇和AT的中位至治疗失败时间（TTF）分别为5.8、6.0和8.0个月（多柔比星vs紫杉醇P = 0.68，多柔比星vs AT P = 0.003，紫杉醇vs AT P = 0.009）。服用阿霉素的患者的中位生存期为18.9个月，服用紫杉醇的患者为22.2个月，服用AT的患者为22.0个月（P =不显著）。20%的患者从阿霉素-紫杉醇交叉，22%的患者从紫杉醇-阿霉素交叉（P =不显著）。结论：（1）阿霉素和紫杉醇在本研究中使用的剂量具有相同的活性，（2）AT的组合导致上级总有效率和TTF时间的优越性;（3）尽管有这些结果，与序贯单药治疗相比，AT联合治疗不能改善生存率或生活质量。
Purpose : Between February 1993 and September 1995, 739 patients with metastatic breast cancer were entered on an Intergroup trial (E 1193) comparing doxorubicin (60 mg/ m(2)), paclitaxel (175 mg/m(2)/24 h), and the combination of doxrubicin and paclitaxel (AT, 50 mg/m(2) and 150 mg/ m(2)/24 h, plus granulocyte colony-stimulating factor 5 mg/ kg) as first-line therapy. Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression.Patients and Methods: Patients were well balanced for on-study characteristics.Results: Responses (complete response and partial response) were seen in 36% of doxrubicin, 34% of paclitaxel, and 479% of AT patients (P =.84 for doxorubicin v paclitaxel, P =.007 for vAT, P =.004 for paclitaxel vAT). Median time to treatment failure (TTF) is 5.8, 6.0, and 8.0 months for doxorubicin, paclitaxel, and AT, respectively (P =.68 for doxorubicin v paclitaxel, P =.003 for doxorubicin v AT, P =.009 for paclitaxel v AT). Median survivals are 18.9 months for patients taking doxorubicin, 22.2 months for patients taking paclitaxel, and 22.0 months for patients taking AT (P = not significant). Responses were seen in 20% of patients crossing from doxrubicin --> paclitaxel and 22% of patients crossing from paclitaxel --> doxorubicin (P = not significant). Changes in global quality-of-life measurements from on-study to week 16 were similar in all three groups.Conclusion: (1) doxorubicin and paclitaxel, in the doses used here, have equivalent activity, (2) the combination of AT results in superior overall response rates and time to TTF; and (3) despite these results, combination therapy with AT did not improve either survival or quality of life compared to sequential single-agent therapy.