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Dose-dense adjuvant Taxotere containing regimens for breast cancer

Posted Jun 24 2009 7:01pm

Dose dense Taxotere after CA chemotehrapy has not beenstudied in dose dense fashion.

Dose dense therapy has ben studied in the metastatic, adjuvant and neoadjuvant setting. To my knowledge, Taxotere there is only one study in the adjuvant setting in dose dense fashion. A European study using the TEC regimen concluded: "Dose-dense regimens yield more frequent and severe nonhematological toxic effects than standard dose TEC regimen. Though grade 4 toxicity rates appear acceptable with the TEC regimen, the incidence of grade 3–4 events makes it difficult to recommend either dose-dense regimen for further investigation." However, in 2008, a phase II study did look at the Ac + Taxotere dose dense regimen.

Fifty-six patients with axillary node-positive, nonmetastatic breast cancer were randomly assigned either to group A (docetaxel [DOC] 75 mg/m2 intravenously [IV] every 14 days for four cycles followed by doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 [AC] IV every 14 days for four cycles); or to group B (AC followed by DOC) at the identical doses and schedule. Pegfilgrastim 6 mg subcutaneous injection was administered 1 day after the chemotherapy in all treatment cycles. The primary objective was to administer DOC without dose reductions or delays before or after AC and calculate the relative dose intensity (RDI) of DOC and AC. The administration of DOC before AC resulted in fewer DOC dose reductions and a higher RDI than the reverse sequence. IT concluded that larger trials evaluating the sequence of DOC before anthracyclines are justified. To my knowledge there are no studied using doise dense AC followed by q 3 weekly Taxotere. It should be considered experimental.

Jackisch C, Von Minckwitz G, Raab G, et al. Primary endpoint analysis of the GEPARDUO study -- preoperative chemotherapy comparing dose-dense versus sequential Adriamycin/docetaxel combination in operable breast cancer. Program and abstracts of the 25th Annual San Antonio Breast Cancer Symposium; December 11-14, 2002; San Antonio, Texas. Abstract 152.

Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C.Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840.J Clin Oncol. 2008 Apr 1;26(10):1642-9. Comment in: J Clin Oncol. 2008 Apr 1;26(10):1585-7.

Piedbois P, Serin D, Priou F, Laplaige P, Greget S, Angellier E, Teissier E, Berdah JF, Fabbro M, Valenza B, Herait P, Jehl V, Buyse M.
Dose-dense adjuvant chemotherapy in node-positive breast cancer: docetaxel followed by epirubicin/cyclophosphamide (T/EC), or the reverse sequence (EC/T), every 2 weeks, versus docetaxel, epirubicin and cyclophosphamide (TEC) every 3 weeks. AERO B03 randomized phase II study. Ann Oncol. 2007 Jan;18(1):52-7.

S. Puhalla, E. Mrozek, D. Young, S. Ottman, A. McVey, K. Kendra, N. J. Merriman, M. Knapp, T. Patel, M. E. Thompson, et al.
Randomized Phase II Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin Plus Cyclophosphamide in Axillary Node-Positive Breast Cancer
J. Clin. Oncol., April 1, 2008; 26(10): 1691 - 1697.

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