Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: Cancer and Leukemia Group B Trial 9342
Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: Cancer and Leukemia Group B Trial 9342
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DOI：
10.1200/jco.2004.08.048
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发表时间：
2004-06-01
影响因子：
45.3
通讯作者：
Norton, L
中科院分区：
文献类型：
--
作者：
Winer, EP;Berry, DA;Norton, L
目的 癌症和白血病 B 组方案 9342 旨在确定转移性乳腺癌女性每 3 周输注 3 小时的紫杉醇最佳剂量。 患者和方法 474 名既往接受过一种或未接受过化疗方案的转移性乳腺癌女性被随机分配至三种紫杉醇给药方案之一：175 mg/m(2)、210 mg/m(2) 或250 mg/m(2) - 每 3 周一次 3 小时输注。女性在基线和三个治疗周期后完成了自我管理的生活质量和症状评估问卷。结果 在评估的剂量范围内没有证据表明存在显着的剂量反应关系。三种方案的缓解率分别为 23%、26% 和 21%。剂量和进展时间之间存在轻微显着关联 (P = .04)；然而，在多变量分析中，差异甚至更不明显。生存率未见统计学显着差异。高剂量组的神经毒性和血液毒性更严重。三组的生活质量没有显着差异。结论 对于患有转移性乳腺癌的女性，以 3 小时输注的方式给予更高剂量的紫杉醇并没有提高缓解率、生存率或生活质量。高剂量治疗的进展时间略有改善，但被更大的毒性所抵消。当每 3 周输注 3 小时紫杉醇时，175 mg/m(2) 应被视为最佳剂量。 (C) 2004 年，美国临床肿瘤学会。
Purpose Cancer and Leukemia Group B Protocol 9342 was initiated to determine the optimal dose of paclitaxel administered as a 3-hour infusion every 3 weeks to women with metastatic breast cancer.Patients and Methods Four hundred seventy-four women with metastatic breast cancer who had received one or no prior chemotherapy regimens were randomly assigned to one of three paclitaxel dosing regimens-175 mg/m(2), 210 mg/m(2), or 250 mg/m(2)-each administered as a 3-hour infusion every 3 weeks. Women completed self-administered quality of life and symptom assessment questionnaires at baseline and after three cycles of treatment.Results No evidence of a significant dose-response relationship was demonstrated over the dose range assessed. Response rates were 23%, 26%, and 21% for the three regimens, respectively. A marginally significant association (P = .04) was seen between dose and time to progression; however, in a multivariate analysis, the difference was even less apparent. No statistically significant difference was seen in survival. Neurotoxicity and hematologic toxicity were more severe on the higher dose arms. There was no significant difference in quality of life on the three arms.Conclusion Higher doses of paclitaxel administered as a 3-hour infusion to women with metastatic breast cancer did not improve response rate, survival, or quality of life. There was a slight improvement in time to progression with higher dose therapy, which was offset by greater toxicity. When a 3-hour infusion of paclitaxel is administered every 3 weeks, 175 mg/m(2) should be considered the optimal dose. (C) 2004 by American Society of Clinical Oncology.