alexa Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: a randomized, controlled, open phase IIb study.
Molecular Biology

Molecular Biology

Journal of Cell Science & Therapy

Author(s): von Minckwitz G, Costa SD, Raab G, Blohmer JU, Eidtmann H,

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Abstract PURPOSE: To investigate the effect of adding tamoxifen to a preoperative dose-dense doxorubicin and docetaxel regimen on the pathologic response of primary operable breast cancer. PATIENTS AND METHODS: Patients (tumor size > or = 3 cm, N0 to 2, M0) were prospectively randomized to receive every 14 days a total of four cycles of doxorubicin 50 mg/m2 and docetaxel 75 mg/m(2), either with (ADocT) or without (ADoc) simultaneous tamoxifen. Granulocyte colony-stimulating factor (G-CSF) was routinely given on days 5 to 10. Surgery followed 8 to 10 weeks after the start of treatment. RESULTS: Within 14 months, 250 patients were included in the study at 56 centers. Of 992 planned cycles, 97.9\% were administered. Pathologically complete remission (pCR) with no detectable viable tumor cells was achieved in 9.7\%. There was a nonsignificant difference of -1.2\% in favor of ADoc, with a 95\% confidence interval of -8.6\% to 6.2\%. A further 2.4\% had only noninvasive tumor residues, and 13.8\% had focal invasive residues. Complete and partial responses detected by palpation were observed in 28.9\% and 52.4\%, respectively. The response rates (complete and partial) by best appropriate imaging methods were 77.5\% and 67.5\% for ADocT and ADoc, respectively. Breast conservation was possible in 68.8\% of the patients. A tendency toward more frequent toxic events was observed with ADocT treatment. Significant predictors of pCR to chemotherapy were negative lymph node and negative estrogen receptor status. CONCLUSION: A dose-dense regimen of ADoc with G-CSF offers high compliance, moderate toxicity, and rapid efficacy as a form of preoperative chemotherapy in operable breast cancer. Concurrent treatment with tamoxifen for 8 weeks could not improve the pathologic response rate.
This article was published in J Clin Oncol and referenced in Journal of Cell Science & Therapy

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