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Breast Diseases: A Year Book ® Quarterly 87 Vol 19 No 1 2008 87 Intensive Dose-dense Compared With High-dose Adjuvant Chemotherapy for High-risk Operable Breast Cancer: Southwest Oncology Group/Intergroup Study 9623 Moore HC, Green SJ, Gralow JR, et al (Cleveland Clinic Foundation, Ohio; Southwest Oncology Group Statistical Center, Seattle WA; Puget Sound Oncology Consortium, Seattle, WA; et al) J Clin Oncol 25:1677-1682, 2007 Purpose.—Southwest Oncology Group (SWOG)/Intergroup study 9623 was undertaken to compare treatment with an anthracycline-based adjuvant chemotherapy regimen followed by high- dose chemotherapy (HDC) with autolo- gous hematopoietic progenitor cell sup- port (AHPCS) with a modern dose-dense dose-escalated (nonstandard) regimen including both an anthracycline and a taxane. Patients and Methods.—Participants in this phase III randomized study had operable breast cancer involving four or more axillary lymph nodes and had com- pleted mastectomy or breast-conserving surgery. Patients were randomly assigned to receive four cycles of doxorubicin and cyclophosphamide followed by HDC with AHPCS or to receive sequential dose-dense and dose-escalated chemo- therapy with doxorubicin, paclitaxel, and cyclophosphamide. The primary end point of this study was disease-free sur- vival (DFS). Results.—Among 536 eligible pa- tients, there was no significant difference between the two arms for DFS or overall survival (OS). Estimated five-year DFS was 80% (95% CI, 76% to 85%) for dose- dense therapy and 75% (95% CI, 69% to 80%) for transplantation. Estimated 5- year OS was 88% (95% CI, 84% to 92%) for dose-dense therapy and 84% (95% CI, 79% to 88%) for transportation. Conclusion.—There is no evidence that transplantation was superior to dose- dense dose-escalated therapy. Trans- plantation was associated with an increase in toxicity and a possibly inferior out- come, although the hazard ratios were not significantly different from 1. Moore and colleagues reported the first set of complete results of a random- ized phase III trial comparing dose- dense/dose-escalated sequential doxoru- bicin, paclitaxel, and cyclophosphamide and filgrastim support with doxorubicin and cyclophosphamide, high-dose che- motherapy, and autologous stem cell transplantation in the treatment of node- positive (> 4 nodes) early-stage breast cancer. The primary end point was disease-free survival. Because of disappointing results from other studies, this study was closed early because of slow accrual, with only 536 of the planned 1,000 participants. The second interim analysis showed no statistically significant difference in disease-free or overall survival between the arms and no reduction in recurrence risk. Further, toxicity was higher in the transplantation arm, leading the authors to conclude that chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation is not more effective than a modern regi- men of dose-dense sequential chemo- therapy that includes an anthracycline and a taxane. This study adds to the body of evi- dence that suggests that high-dose che- motherapy with autologous stem cell transplantation has no place in the treat- ment of breast cancer. The lack of a survival benefit for high-dose chemo- therapy and autologous stem cell trans- plantation has been reported in large phase III studies of metastatic breast cancer and in the adjuvant therapy set- ting in women with at least 10 involved axillary lymph nodes, although a re- duced recurrence risk was found in pre- vious adjuvant-treatment studies. 1-3 However, previous studies used conventional-dose regimens and did not include taxanes, which are known to im- prove outcomes in node-positive patients who do not undergo transplantation. 4,5 This study represents the first compari- son of sequential dose–dense anthracy- cline and taxane therapy with high-dose chemotherapy and stem cell support, and the findings suggest that paclitaxel and anthracycline-based therapy is as effec- tive as intensive ablative regimen without the accompanying toxicity. The addition of paclitaxel appears to abrogate any risk reduction previously seen with autologous stem cell transplantation and confirms the benefit of taxanes in node-positive disease. The role of stem cell transplantation as an immune