[Preoperative chemotherapy in primary operable breast cancer with a dose-dense combination of doxorubicin and docetaxel (ADoc) - Experience of the GEPARDO-GABG study group].

[Preoperative chemotherapy in primary operable breast cancer with a dose-dense combination of doxorubicin and docetaxel (ADoc) - Experience of the GEPARDO-GABG study group].
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[原发性可手术乳腺癌术前化疗采用阿霉素和多西他赛剂量密集组合 (ADoc) - GEPARDO-GABG 研究组的经验]。

DOI：
10.1055/s-2001-18222
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发表时间：
2001
期刊：
Zentralblatt fur Gynakologie
影响因子：
--
通讯作者：
M. Kaufmann
M. Kaufmann
中科院分区：
--
文献类型：
--
作者：
G. von Minckwitz;G. Raab;M. Schütte;J. Hilfrich;J. Blohmer;B. Gerber;S. Costa;E. Merkle;H. Eidtmann;D. Lampe;C. Jackisch;A. du Bois;A. Tulusan;G. Gademann;H. Sinn;A. Caputo;E. Graf;M. Kaufmann

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目标 德国辅助乳腺癌研究组 (GABG) 对原发性乳腺癌患者联合使用阿霉素和多西他赛 (ADoc) 进行术前化疗试验。 - 患者和方法 We conducted a parallel-grouped phase IIa-study with 42 patients with a conventionally dosed and a dose-dense ADoc-schedule (4 cycles of Doxorubicin 50 mg/m(2), Docetaxel 75 mg/m(2) i. v. day 1, q day 15 or 22; G-CSF day 3-15 only for the dose-dense schedule) and a randomized phase IIb-study （GEPARDO 研究）250 名接受 ADoc +/- 他莫昔芬治疗的患者。在治疗前对 197 个核心活检组织进行免疫组织化学测定生物学因素。最近完成了与序贯 AC-Doc 方案（包括 913 名患者）的比较。 - 结果 ADoc 可以按时应用于 93% 的患者。剂量密集的方案显示出毒性更大的趋势，但也显示出更有效的趋势。病理完全缓解（pCR）率为9.7%。化疗和化疗内分泌治疗之间没有发现差异。临床阴性淋巴结和阴性雌激素受体状态预示着较高的 pCR 率。迄今为止，ADoc 和 AC-Doc 之间尚未发现毒性差异。 - 结论 剂量密集的 ADoc 方案作为乳腺癌的术前治疗具有良好的耐受性和高效性。
OBJECTIVE The German Adjuvant Breast Cancer Study Group (GABG) conducts trials of preoperative chemotherapy in patients with primary breast cancer using a combination of doxorubicin and docetaxel (ADoc). - PATIENTS AND METHODS We conducted a parallel-grouped phase IIa-study with 42 patients with a conventionally dosed and a dose-dense ADoc-schedule (4 cycles of Doxorubicin 50 mg/m(2), Docetaxel 75 mg/m(2) i. v. day 1, q day 15 or 22; G-CSF day 3-15 only for the dose-dense schedule) and a randomized phase IIb-study (GEPARDO-Study) with 250 patients with ADoc +/- Tamoxifen. Biological factors were determined immunohistochemically on 197 core biopsies before treatment. A comparison to a sequential AC-Doc regimen including 913 patients has been completed recently. - RESULTS ADoc can be applicated on schedule in 93 % of all patients. The dose-dense regimen shows a tendency to more toxicity but also to more efficacy. The rate of complete pathological remissions (pCR) was 9.7 %. No difference was found between chemo- and chemoendocrine treatment. Clinically negative lymphnodes and a negative estrogen receptor status is predictive for a higher pCR-rate. To date no differences in toxicity could be found between ADoc and AC-Doc. - CONCLUSIONS The dose-dense ADoc regimen is well tolerated and highly effective as preoperative therapy of breast cancer.