Originally published as JCO Early Release 10.1200/JCO.2006.08.9383 on April 2 2007

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Intensive Dose-Dense Compared With High-Dose Adjuvant Chemotherapy for High-Risk Operable Breast Cancer: Southwest Oncology Group/Intergroup Study 9623

Halle C.F. Moore, Stephanie J. Green, Julie R. Gralow, Scott I. Bearman, Danika Lew, William E. Barlow, Clifford Hudis, Antonio C. Wolff, James N. Ingle, Helen K. Chew, Anthony D. Elias, Robert B. Livingston, Silvana Martino

From the Cleveland Clinic Foundation, Cleveland, OH; Southwest Oncology Group Statistical Center; Puget Sound Oncology Consortium, Seattle, WA; University of Colorado Health Sciences Center, Denver, CO; Memorial Sloan-Kettering Cancer Center, New York, NY; Sidney Kimmel Comprehensive Cancer at Johns Hopkins, Baltimore, MD; Mayo Clinic, Rochester, MN; University of California-Davis, Sacramento; and The Angeles Clinic and Research Institute, Santa Monica, CA

Address reprint requests to Southwest Oncology Group (S9623) Operations Office, 14980 Omicron Dr, San Antonio, TX 78245-3217

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 autologous hematopoietic progenitor cell support (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 completed 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 chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide. The primary end point of this study was disease-free survival (DFS).

Results Among 536 eligible patients, 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 transplantation.

Conclusion There is no evidence that transplantation was superior to dose-dense dose-escalated therapy. Transplantation was associated with an increase in toxicity and a possibly inferior outcome, although the hazard ratios were not significantly different from 1.

published online ahead of print at www.jco.org on April 2, 2007.

Supported in part by the following PHS Cooperative Agreement grants from the National Cancer Institute, Department of Health and Human Services: Grants No. CA38926, CA32102, CA46441, CA42777, CA45377, CA68183, CA76429, CA63844, CA22433, CA04919, CA35281, CA46368, CA58658, CA46113, CA76447, CA46282, CA13612, CA35090, CA35262, CA12644, CA20319, CA45450, CA76448, CA58416, CA58686, CA45560, CA58415, CA37981, CA35192, CA58861, CA45807, CA27057, CA35996, CA14028, CA35176, CA76462, CA04920, CA77651, CA16116, CA21115, and CA25224.

Presented in abstract format at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005 (abstr 572). This article is an update and the first complete reporting of SWOG/Intergroup study 9623.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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  Aman U. Buzdar
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