Diéras V
Medical Oncology Service, Institut Curie, Paris, France.
Oncology (Williston Park). 1997 Aug;11(8 Suppl 8):31-3.
Docetaxel (Taxotere) and doxorubicin (Adriamycin) have each demonstrated significant activity in metastatic breast cancer. Thus, the combination of docetaxel and doxorubicin has been evaluated in phase I trials to establish the dose-limiting toxicity, maximum tolerated dose, recommended dose for future phase II and III studies, and toxicity profile of the two agents used in combination. Results from phase I trials in patients with metastatic breast cancer indicate that the docetaxel/doxorubicin combination is well tolerated. The recommended dose for the combination regimen is either 50 mg/m2 of doxorubicin followed by 75 mg/m2 of docetaxel or 60 mg/m2 of both drugs, without granulocyte colony-stimulating factor (G-CSF) support. Febrile neutropenia complicated by grade 3 infection was the dose-limiting effect at the maximum tolerated dose. The response rate at this dose level was 90%. Based on the preliminary results of phase I studies, further phase II and III studies of a docetaxel/doxorubicin combination regimen are warranted.
多西他赛（泰索帝）和阿霉素（阿霉素）在转移性乳腺癌中均已显示出显著活性。因此，多西他赛和阿霉素的联合用药已在I期试验中进行评估，以确定剂量限制性毒性、最大耐受剂量、为未来II期和III期研究推荐的剂量，以及联合使用这两种药物的毒性特征。转移性乳腺癌患者I期试验的结果表明，多西他赛/阿霉素联合用药耐受性良好。联合方案的推荐剂量为阿霉素50mg/m²，随后是多西他赛75mg/m²，或两种药物均为60mg/m²，无需粒细胞集落刺激因子（G-CSF）支持。在最大耐受剂量时，发热性中性粒细胞减少并发3级感染是剂量限制性效应。该剂量水平的缓解率为90%。基于I期研究的初步结果，有必要对多西他赛/阿霉素联合方案进行进一步的II期和III期研究。
