This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Fornier, M. N. Articles by Hudis, C. Search for Related Content PubMed PubMed Citation Articles by Fornier, M. N. Articles by Hudis, C.

Doxorubicin Followed by Sequential Paclitaxel and Cyclophosphamide versus Concurrent Paclitaxel and Cyclophosphamide

5-Year Results of a Phase II Randomized Trial of Adjuvant Dose-dense Chemotherapy for Women with Node-positive Breast Carcinoma

Breast Cancer Medicine Service, Division of Solid Tumor Oncology, Department of Medicine [M. N. F., A. D. S., M. T., M. E. M., V. C., M. M., N. S., T. G., G. D., R. S., L. N., C. H.] and Department of Epidemiology and Biostatistics [K. S. P.], Memorial Sloan-Kettering Cancer Center, New York, New York 10021, and Department of Medicine, Weill Medical College of Cornell University, New York, New York 10021 [M. N. F., A. D. S., M. T., M. E. M., V. C., M. M., N. S., T. G., G. D., R. S., L. N., C. H.]

Purpose: We conducted a randomized Phase II trial to directly compare toxicity, feasibility, and delivered dose intensities of two adjuvant dose-intensive regimens containing doxorubicin, paclitaxel, and cyclophosphamide for patients with node-positive breast carcinoma.

Experimental Design: Forty-two patients with resected breast carcinoma involving one or more ipsilateral axillary lymph nodes, were randomized to receive two different schedules of adjuvant chemotherapy using 14-day dosing intervals: either (a) three cycles of doxorubicin 80 mg/m² as i.v. bolus followed sequentially by three cycles of paclitaxel 200 mg/m² as a 24-h infusion and then by three cycles of cyclophosphamide 3.0 g/m² as a 1-h infusion (arm A); or (b) the same schedule of doxorubicin followed by three cycles of concurrent cyclophosphamide and paclitaxel at the same doses (arm B). All cycles were supported by granulocyte colony-stimulating factor administration.

Results: Forty-one patients were assessable for toxicity and feasibility; 37 (90%) completed all planned chemotherapy. There was no treatment-related mortality; however, increased toxicity was observed on arm B compared with arm A, manifested by an increase in hospitalization for toxicity, mainly neutropenic fever, and an increased incidence of transfusion of packed RBCs transfusions for anemia. The mean delivered dose intensities for paclitaxel and cyclophosphamide were significantly greater for arm A compared with arm B (P = .01 and P = .05, respectively). There is no long-term, treatment-related toxicity, and no cases of acute myelogenous leukemia or myelodysplastic syndrome have been observed.

Conclusions: Dose-dense sequential single-agent chemotherapy is more feasible than doxorubicin with subsequent concurrent paclitaxel and cyclophosphamide.

This article has been cited by other articles:

				M. N. Fornier, A. D. Seidman, D. Lake, G. D'Andrea, J. Bromberg, M. Robson, C. Van Poznak, K. S. Panageas, M. Atienza, L. Norton, et al. Increased Dose Density Is Feasible: A Pilot Study of Adjuvant Epirubicin and Cyclophosphamide followed by Paclitaxel, at 10- or 11-Day Intervals with Filgrastim Support in Women with Breast Cancer Clin. Cancer Res., January 1, 2007; 13(1): 223 - 227. [Abstract] [Full Text] [PDF]

				G. Fountzilas, D. Skarlos, U. Dafni, H. Gogas, E. Briasoulis, D. Pectasides, C. Papadimitriou, C. Markopoulos, A. Polychronis, H. P. Kalofonos, et al. Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group Ann. Onc., November 1, 2005; 16(11): 1762 - 1771. [Abstract] [Full Text] [PDF]

				C. T. Dang, G. M. D'Andrea, M. E. Moynahan, M. N. Dickler, A. D. Seidman, M. Fornier, M. E. Robson, M. Theodoulou, D. Lake, V. E. Currie, et al. Phase II Study of Feasibility of Dose-Dense FEC Followed by Alternating Weekly Taxanes in High-Risk, Four or More Node-Positive Breast Cancer Clin. Cancer Res., September 1, 2004; 10(17): 5754 - 5761. [Abstract] [Full Text] [PDF]

				M. J. Piccart-Gebhart Mathematics and Oncology: A Match for Life? J. Clin. Oncol., April 15, 2003; 21(8): 1425 - 1428. [Full Text] [PDF]