Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer
Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer
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DOI：
10.1200/jco.2005.05.0294
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发表时间：
2006-11-01
影响因子：
45.3
通讯作者：
Cold, Soeren
中科院分区：
文献类型：
--
作者：
Harvey, Vernon;Mouridsen, Henning;Cold, Soeren
PurposeTo evaluate a relationship between docetaxel dose and clinical response in treatment of patients with advanced breast cancer.Patients and MethodsPatients whose cancer has progressed after one prior chemotherapy regimen for advanced breast cancer or have recurred during or within 6 months of adjuvant chemotherapy were randomly assigned to docetaxel 60，75，或100 mg/m2静脉注射，每3 weeks.Results527例患者被随机分配（意向治疗[ITT]），和524可评估的毒性。在可评估疗效的人群（n = 407）中，logistic回归分析显示多西他赛剂量增加与更高的缓解率（P = 0.007）和更长的至疾病进展时间（TTP; P = 0.014）显著相关。在ITT分析中，观察到肿瘤缓解（P = 0.026）但TTP（P = 0.067）无显著剂量-反应关系。大多数血液学和非血液学毒性的发生率与剂量增加有关，在60、75和100 mg/m2剂量组中，3 - 4级中性粒细胞减少的发生率分别为76.4%、83.7%和93.4%，发热性中性粒细胞减少的发生率分别为4.7%、7.4%和14.1%。1例死亡被认为与治疗相关。结论多西他赛剂量增加与肿瘤反应增加之间存在关系，剂量范围为60 ~ 100 mg/m2，每3周1次。毒性与剂量增加相关。根据治疗目标，研究的任何剂量都可能适用于晚期乳腺癌的二线治疗。
PurposeTo evaluate whether a relationship exists between docetaxel dose and clinical response in the treatment of patients with advanced breast cancer.Patients and MethodsPatients whose cancer had progressed after one prior chemotherapy regimen for advanced breast cancer or had recurred during or within 6 months of adjuvant chemotherapy were randomly assigned to docetaxel 60, 75, or 100 mg/m(2) intravenously every 3 weeks.ResultsFive hundred twenty-seven patients were randomly assigned ( intent to treat [ITT]), and 524 were assessable for toxicity. In the population assessable for efficacy (n = 407), logistic regression analysis showed that increasing docetaxel dose was significantly associated with higher response rate ( P =.007) and improved time to progression (TTP; P =.014). In the ITT analysis, a significant dose-response relationship was observed for tumor response ( P =.026) but not for TTP ( P =.067). The incidences of most hematologic and nonhematologic toxicities were related to increasing dose, with grade 3 to 4 neutropenia occurring in 76.4%, 83.7%, and 93.4% and febrile neutropenia occurring in 4.7%, 7.4%, and 14.1% of patients administered the 60, 75, and 100 mg/m(2) doses, respectively. One death was considered treatment related.ConclusionA relationship between increasing dose of docetaxel and increased tumor response was observed across the dose range of 60 to 100 mg/m(2) every 3 weeks. Toxicities were related to increasing dose. Depending on the therapy goal, any of the doses studied may be appropriate for second-line treatment of advanced breast cancer.