早期乳腺癌患者使用阿霉素和紫杉醇进行原发性化疗：一项多中心II期研究的最终结果
Primary chemotherapy with doxorubicin and paclitaxel in patients with early breast cancer: final results of a multicenter phase II study.
作者信息
Schmid P, Krocker J, Morack G, Heilmann V, Blohmer J-U, Michniewicz K, Köhler G, Schaller-Kranz T, Possinger K, Elling D
机构信息
Medizinische Klinik II, Department of Oncology and Hematology, Charité Campus Mitte, Humboldt University Berlin, Schumannstrasse 20/21, 10117, Berlin, Germany.
出版信息
J Cancer Res Clin Oncol. 2004 Nov;130(11):657-63. doi: 10.1007/s00432-004-0599-y. Epub 2004 Aug 20.
PURPOSE
To assess the efficacy and safety of primary systemic treatment with doxorubicin and paclitaxel in patients with early breast cancer.
PATIENTS AND METHODS
Forty patients with newly diagnosed, histologically confirmed breast cancer (T2, N0-1, M0) received primary chemotherapy with doxorubicin (60 mg/m2) and paclitaxel (200 mg/m2) in 3-week intervals for up to four courses.
RESULTS
A total of 151 cycles were administered. The clinical response rate as assessed by sonographic measurement was 70%, and complete remissions of the primary tumor occurred in two patients. Eight patients (20%) had histologically confirmed complete responses. Predominant toxicity was myelosuppression with grade 3/4 neutropenia in 70% of patients. Non-hematological toxicity was generally moderate. Grade 4 non-hematological toxicities were not observed and grade 3 toxicity was reported with alopecia (98%) and stomatitis (10%).
CONCLUSIONS
The combination of doxorubicin and paclitaxel is safe and highly active in patients with early breast cancer. The evaluated schedule is suitable for phase III studies.
目的
评估阿霉素和紫杉醇进行原发性全身治疗对早期乳腺癌患者的疗效和安全性。
患者与方法
40例新诊断的、经组织学确诊的乳腺癌患者（T2，N0 - 1，M0）接受阿霉素（60 mg/m²）和紫杉醇（200 mg/m²）的原发性化疗，每3周进行一次，共进行4个疗程。
结果
共进行了151个周期的治疗。通过超声测量评估的临床缓解率为70%，两名患者的原发性肿瘤完全缓解。8例患者（20%）经组织学确认达到完全缓解。主要毒性为骨髓抑制，70%的患者出现3/4级中性粒细胞减少。非血液学毒性一般为中度。未观察到4级非血液学毒性，3级毒性报告有脱发（98%）和口腔炎（10%）。
结论
阿霉素和紫杉醇联合用药对早期乳腺癌患者安全且活性高。所评估的方案适用于III期研究。
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