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 Journal Article


Authors: Fornier, M. N.; Seidman, A. D.; Theodoulou, M.; Moynahan, M. E.; Currie, V.; Moasser, M.; Sklarin, N.; Gilewski, T.; D'Andrea, G.; Salvaggio, R.; Panageas, K. S.; Norton, L.; Hudis, C.
Article Title: 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
Abstract: 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.
Keywords: adult; clinical article; controlled study; treatment outcome; middle aged; cancer surgery; clinical trial; doxorubicin; drug efficacy; paclitaxel; cancer adjuvant therapy; combined modality therapy; drug megadose; follow-up studies; lymph node metastasis; lymphatic metastasis; bolus injection; controlled clinical trial; phase 2 clinical trial; anemia; randomized controlled trial; antineoplastic combined chemotherapy protocols; drug administration schedule; cyclophosphamide; continuous infusion; breast neoplasms; febrile neutropenia; hospitalization; feasibility study; mammography; breast carcinoma; granulocyte colony stimulating factor receptor; toxicity testing; tamoxifen; erythrocyte transfusion; mastectomy, modified radical; erythrocyte concentrate; humans; human; female; priority journal; article; chronotherapy
Journal Title: Clinical Cancer Research
Volume: 7
Issue: 12
ISSN: 1078-0432
Publisher: American Association for Cancer Research  
Date Published: 2001-12-01
Start Page: 3934
End Page: 3941
Language: English
PUBMED: 11751485
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 21 May 2015 -- Source: Scopus