A phase II study of neoadjuvant docetaxel plus doxorubicin (KBCS-01) in stage II, III breast cancer
A phase II study of neoadjuvant docetaxel plus doxorubicin (KBCS-01) in stage II, III breast cancer
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DOI：
10.1007/s10549-005-9131-6
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发表时间：
2006-07-01
影响因子：
3.8
通讯作者：
Park, Hee-Sook
中科院分区：
文献类型：
--
作者：
Han, Sehwan;Kim, Sung-Bae;Park, Hee-Sook
后面。这项多中心II期研究旨在评价多西他赛联合阿霉素作为II、III期乳腺癌新辅助治疗的反应和安全性。II期或III期乳腺癌患者接受了3个周期的新辅助化疗，阿霉素50 mg/m2和多西他赛75 mg/m2，每3周一次，随后进行根治性手术。未使用预防性GCSF。90例患者入组研究，86例可评价疗效。中位年龄为43岁（范围：30-69岁）。多西他赛和多柔比星的平均相对剂量强度分别为0.98和0.98。12例（13.7%）患者行保乳手术。临床总有效率为86%，病理完全缓解率为10.5%。在总共258个周期中，26%观察到3/4级中性粒细胞减少，15.8%观察到发热性中性粒细胞减少。1例患者出现肺炎，3例患者出现3级粘膜炎。多西他赛和阿霉素是一种有效的和耐受性良好的新辅助化疗II期和III期乳腺癌。这种治疗的临床获益将通过长期随访的生存数据来证实。
Backround. This multicenter phase II study was conducted to evaluate the response and safety of a combination of docetaxel plus doxorubicin as neoadjuvant therapy for stage II, III breast cancer.Methods. Patients with stage II or III breast cancer underwent three cycles of neoadjuvant chemotherapy with doxorubicin 50 mg/m(2) and docetaxel 75 mg/m(2) every 3 weeks followed by curative surgery. Prophylactic GCSF was not used.Results. Ninety patients were enrolled in the study and 86 were evaluable for efficacy. The median age was 43 years (range, 30-69). The mean relative dose intensity was 0.98 for docetaxel and 0.98 for doxorubicin. Breast-conserving surgery was performed in 12 (13.7%) patients. The clinical overall response rate was 86% and pathologic complete response was 10.5%. Grade 3/4 neutropenia was observed in 26% of total 258 cycles and febrile neutropenia was observed in 15.8%. Pneumonia was observed in one patient and grade 3 mucositis was observed in three patients.Conclusion. Docetaxel and doxorubicin was an effective and well-tolerated neoadjuvant chemotherapy for stage II and III breast cancer. Clinical benefit of this treatment will be confirmed by survival data with long term follow up.