Originally published as JCO Early Release 10.1200/JCO.2005.10.202 on March 14 2005

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Peters, W. P. Articles by Hurd, D. D. Search for Related Content PubMed PubMed Citation Articles by Peters, W. P. Articles by Hurd, D. D. Social Bookmarking                            What's this?

Prospective, Randomized Comparison of High-Dose Chemotherapy With Stem-Cell Support Versus Intermediate-Dose Chemotherapy After Surgery and Adjuvant Chemotherapy in Women With High-Risk Primary Breast Cancer: A Report of CALGB 9082, SWOG 9114, and NCIC MA-13

From Adherex Technologies Inc; Duke Comprehensive Cancer Center; CALGB Statistical Center; Department of Medicine-JJV, Department of Radiation Oncology-LBM, Duke University Medical Center, Durham, NC; Department of Bone and Marrow Transplantation, M.D. Anderson Cancer Center, Houston, TX; Department of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, Canada; Dana-Farber Cancer Institute, Boston, MA; North Shore–Long Island Jewish Medical Center, Manhasset, NY; Division of Solid Tumor Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY; University of California San Francisco Cancer Center, San Francisco, CA; CALGB Central Office of the Chairman, Chicago, IL; Section of Hematology Oncology, Wake Forest University School of Medicine, Winston-Salem, NC.

Address reprint requests to Richard L. Schilsky, Cancer and Leukemia Group B, 230 W Monroe St, Suite 2050, Chicago, IL 60606; e-mail: rs27{at}uchicago.edu

PURPOSE: The prognosis for women with primary breast cancer involving multiple axillary nodes remains poor. High-dose chemotherapy with stem-cell support produced promising results in initial clinical trials conducted at single institutions.

PATIENTS AND METHODS: Seven hundred eighty-five women aged 22 to 66 years with stage IIA, IIB, or IIIA breast cancer involving 10 or more axillary lymph nodes were randomized after surgery and standard adjuvant chemotherapy to either high-dose cyclophosphamide, cisplatin, and carmustine (HD-CPB) with stem-cell support or intermediate-dose cyclophosphamide, cisplatin, and carmustine (ID-CPB) with G-CSF support but without stem cells. Planned treatment for all patients included locoregional radiation therapy. Hormone-receptor–positive patients were to receive 5 years of tamoxifen. Event-free survival (EFS) was the primary end point.

RESULTS: Median follow-up was 7.3 years. Event-free survival was not significantly different between the two treatment groups (P = .24). The probability of being free of an event at 5 years with HD-CPB was 61% (95% CI, 56% to 65%), and was 58% (95% CI, 53% to 63%) for ID-CPB.

Thirty-three patients died of causes attributed to HD-CPB, compared with no therapy-related deaths among women treated with ID-CPB. Overall survival for the two arms was identical at 71% at 5 years (P = .75).

CONCLUSION: HD-CPB with stem-cell support was not superior to ID-CPB for event-free or overall survival among all randomized women with high-risk primary breast cancer.

Supported in part by grants from the National Cancer Institute (CA31946) to the Cancer and Leukemia Group B (Richard L. Schilsky, Chairman), and by grants CA33601, CA14028, CA33601, CA47577, CA42777, CA77202, CA32291, CA35279, CA77651, CA60138, CA41287, and CA03927.

The manuscript contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. Colleoni, Z. Sun, G. Martinelli, R. L. Basser, A. S. Coates, R. D. Gelber, M. D. Green, F. Peccatori, S. Cinieri, S. Aebi, et al. The effect of endocrine responsiveness on high-risk breast cancer treated with dose-intensive chemotherapy: results of International Breast Cancer Study Group Trial 15-95 after prolonged follow-up Ann. Onc., August 1, 2009; 20(8): 1344 - 1351. [Abstract] [Full Text] [PDF]

				A. R. Zander, C. Schmoor, N. Kroger, W. Kruger, V. Mobus, N. Frickhofen, B. Metzner, W. E. Berdel, M. Koenigsmann, E. Thiel, et al. Randomized trial of high-dose adjuvant chemotherapy with autologous hematopoietic stem-cell support versus standard-dose chemotherapy in breast cancer patients with 10 or more positive lymph nodes: overall survival after 6 years of follow-up Ann. Onc., June 1, 2008; 19(6): 1082 - 1089. [Abstract] [Full Text] [PDF]

				O. Gluz, U. A. Nitz, N. Harbeck, E. Ting, R. Kates, A. Herr, W. Lindemann, C. Jackisch, W. E. Berdel, H. Kirchner, et al. Triple-negative high-risk breast cancer derives particular benefit from dose intensification of adjuvant chemotherapy: results of WSG AM-01 trial Ann. Onc., May 1, 2008; 19(5): 861 - 870. [Abstract] [Full Text] [PDF]

				Y. Nieto, F. Nawaz, R. B. Jones, E. J. Shpall, and S. Nawaz Prognostic Significance of Overexpression and Phosphorylation of Epidermal Growth Factor Receptor (EGFR) and the Presence of Truncated EGFRvIII in Locoregionally Advanced Breast Cancer J. Clin. Oncol., October 1, 2007; 25(28): 4405 - 4413. [Abstract] [Full Text] [PDF]

				H. C.F. Moore, S. J. Green, J. R. Gralow, S. I. Bearman, D. Lew, W. E. Barlow, C. Hudis, A. C. Wolff, J. N. Ingle, H. K. Chew, et al. Intensive Dose-Dense Compared With High-Dose Adjuvant Chemotherapy for High-Risk Operable Breast Cancer: Southwest Oncology Group/Intergroup Study 9623 J. Clin. Oncol., May 1, 2007; 25(13): 1677 - 1682. [Abstract] [Full Text] [PDF]

				N Wilking, E Lidbrink, T Wiklund, B Erikstein, H Lindman, P Malmstrom, P Kellokumpu-Lehtinen, N-O Bengtsson, G Soderlund, G Anker, et al. Long-term follow-up of the SBG 9401 study comparing tailored FEC-based therapy versus marrow-supported high-dose therapy Ann. Onc., April 1, 2007; 18(4): 694 - 700. [Abstract] [Full Text] [PDF]

				C. A. Hudis and E. P. Winer Cancer and leukemia group B breast committee: decades of progress and plans for the future. Clin. Cancer Res., June 1, 2006; 12(11): 3576s - 3580s. [Abstract] [Full Text] [PDF]

				C. Linker and D. Hurd The cancer and leukemia group B transplant committee. Clin. Cancer Res., June 1, 2006; 12(11): 3635s - 3637s. [Abstract] [Full Text] [PDF]

				A. Bertuzzi, G. Gullo, L. Rimassa, L. Castagna, and A. Santoro High-dose chemotherapy as adjuvant treatment for high-risk primary breast cancer patients Ann. Onc., April 1, 2006; 17(4): 719 - 720. [Full Text] [PDF]

				S. Rodenhuis, M. Bontenbal, Q. G. C. M. van Hoesel, W. M. Smit, M. A. Nooij, E. E. Voest, E. van der Wall, P. Hupperets, H. van Tinteren, J. L. Peterse, et al. Efficacy of high-dose alkylating chemotherapy in HER2/neu-negative breast cancer Ann. Onc., April 1, 2006; 17(4): 588 - 596. [Abstract] [Full Text] [PDF]

				International Breast Cancer Study Group Multicycle Dose-Intensive Chemotherapy for Women With High-Risk Primary Breast Cancer: Results of International Breast Cancer Study Group Trial 15-95 J. Clin. Oncol., January 20, 2006; 24(3): 370 - 378. [Abstract] [Full Text] [PDF]