Adjuvant chemotherapy in older women with early-stage breast cancer

Hyman B. Muss, Donald A. Berry, Constance T. Cirrincione, Maria Theodoulou, Ann M. Mauer, Alice B. Kornblith, Ann H. Partridge, Lynn G. Dressler, Harvey J. Cohen, Heather P. Becker, Patricia A. Kartcheske, Judith D. Wheeler, Edith A. Perez, Antonio C Wolff, Julie R. Gralow, Harold J. Burstein, Ahmad A. Mahmood, Gutav Magrinat, Barbara A. Parker, Ronald D. HartDebjani Grenier, Larry Norton, Clifford A. Hudis, Eric P. Winer

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Older women with breast cancer are underrepresented in clinical trials, and data on the effects of adjuvant chemotherapy in such patients are scant. We tested for the noninferiority of capecitabine as compared with standard chemotherapy in women with breast cancer who were 65 years of age or older. METHODS: We randomly assigned patients with stage I, II, IIIA, or IIIB breast cancer to standard chemotherapy (either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin) or capecitabine. Endocrine therapy was recommended after chemotherapy in patients with hormone-receptor-positive tumors. A Bayesian statistical design was used with a range in sample size from 600 to 1800 patients. The primary end point was relapse-free survival. RESULTS: When the 600th patient was enrolled, the probability that, with longer follow-up, capecitabine therapy was highly likely to be inferior to standard chemotherapy met a prescribed level, and enrollment was discontinued. After an additional year of follow-up, the hazard ratio for disease recurrence or death in the capecitabine group was 2.09 (95% confidence interval, 1.38 to 3.17; P

Original languageEnglish (US)
Pages (from-to)2055-2065
Number of pages11
JournalNew England Journal of Medicine
Volume360
Issue number20
DOIs
StatePublished - May 14 2009
Externally publishedYes

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Adjuvant Chemotherapy
Breast Neoplasms
Drug Therapy
Cyclophosphamide
Recurrence
Methotrexate
Fluorouracil
Sample Size
Doxorubicin
Clinical Trials
Hormones
Confidence Intervals
Survival
Capecitabine
Therapeutics
Neoplasms

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Muss, H. B., Berry, D. A., Cirrincione, C. T., Theodoulou, M., Mauer, A. M., Kornblith, A. B., ... Winer, E. P. (2009). Adjuvant chemotherapy in older women with early-stage breast cancer. New England Journal of Medicine, 360(20), 2055-2065. https://doi.org/10.1056/NEJMoa0810266

Adjuvant chemotherapy in older women with early-stage breast cancer. / Muss, Hyman B.; Berry, Donald A.; Cirrincione, Constance T.; Theodoulou, Maria; Mauer, Ann M.; Kornblith, Alice B.; Partridge, Ann H.; Dressler, Lynn G.; Cohen, Harvey J.; Becker, Heather P.; Kartcheske, Patricia A.; Wheeler, Judith D.; Perez, Edith A.; Wolff, Antonio C; Gralow, Julie R.; Burstein, Harold J.; Mahmood, Ahmad A.; Magrinat, Gutav; Parker, Barbara A.; Hart, Ronald D.; Grenier, Debjani; Norton, Larry; Hudis, Clifford A.; Winer, Eric P.

In: New England Journal of Medicine, Vol. 360, No. 20, 14.05.2009, p. 2055-2065.

Research output: Contribution to journalArticle

Muss, HB, Berry, DA, Cirrincione, CT, Theodoulou, M, Mauer, AM, Kornblith, AB, Partridge, AH, Dressler, LG, Cohen, HJ, Becker, HP, Kartcheske, PA, Wheeler, JD, Perez, EA, Wolff, AC, Gralow, JR, Burstein, HJ, Mahmood, AA, Magrinat, G, Parker, BA, Hart, RD, Grenier, D, Norton, L, Hudis, CA & Winer, EP 2009, 'Adjuvant chemotherapy in older women with early-stage breast cancer', New England Journal of Medicine, vol. 360, no. 20, pp. 2055-2065. https://doi.org/10.1056/NEJMoa0810266
Muss HB, Berry DA, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB et al. Adjuvant chemotherapy in older women with early-stage breast cancer. New England Journal of Medicine. 2009 May 14;360(20):2055-2065. https://doi.org/10.1056/NEJMoa0810266
Muss, Hyman B. ; Berry, Donald A. ; Cirrincione, Constance T. ; Theodoulou, Maria ; Mauer, Ann M. ; Kornblith, Alice B. ; Partridge, Ann H. ; Dressler, Lynn G. ; Cohen, Harvey J. ; Becker, Heather P. ; Kartcheske, Patricia A. ; Wheeler, Judith D. ; Perez, Edith A. ; Wolff, Antonio C ; Gralow, Julie R. ; Burstein, Harold J. ; Mahmood, Ahmad A. ; Magrinat, Gutav ; Parker, Barbara A. ; Hart, Ronald D. ; Grenier, Debjani ; Norton, Larry ; Hudis, Clifford A. ; Winer, Eric P. / Adjuvant chemotherapy in older women with early-stage breast cancer. In: New England Journal of Medicine. 2009 ; Vol. 360, No. 20. pp. 2055-2065.
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T1 - Adjuvant chemotherapy in older women with early-stage breast cancer

AU - Muss, Hyman B.

AU - Berry, Donald A.

AU - Cirrincione, Constance T.

AU - Theodoulou, Maria

AU - Mauer, Ann M.

AU - Kornblith, Alice B.

AU - Partridge, Ann H.

AU - Dressler, Lynn G.

AU - Cohen, Harvey J.

AU - Becker, Heather P.

AU - Kartcheske, Patricia A.

AU - Wheeler, Judith D.

AU - Perez, Edith A.

AU - Wolff, Antonio C

AU - Gralow, Julie R.

AU - Burstein, Harold J.

AU - Mahmood, Ahmad A.

AU - Magrinat, Gutav

AU - Parker, Barbara A.

AU - Hart, Ronald D.

AU - Grenier, Debjani

AU - Norton, Larry

AU - Hudis, Clifford A.

AU - Winer, Eric P.

PY - 2009/5/14

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N2 - BACKGROUND: Older women with breast cancer are underrepresented in clinical trials, and data on the effects of adjuvant chemotherapy in such patients are scant. We tested for the noninferiority of capecitabine as compared with standard chemotherapy in women with breast cancer who were 65 years of age or older. METHODS: We randomly assigned patients with stage I, II, IIIA, or IIIB breast cancer to standard chemotherapy (either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin) or capecitabine. Endocrine therapy was recommended after chemotherapy in patients with hormone-receptor-positive tumors. A Bayesian statistical design was used with a range in sample size from 600 to 1800 patients. The primary end point was relapse-free survival. RESULTS: When the 600th patient was enrolled, the probability that, with longer follow-up, capecitabine therapy was highly likely to be inferior to standard chemotherapy met a prescribed level, and enrollment was discontinued. After an additional year of follow-up, the hazard ratio for disease recurrence or death in the capecitabine group was 2.09 (95% confidence interval, 1.38 to 3.17; P

AB - BACKGROUND: Older women with breast cancer are underrepresented in clinical trials, and data on the effects of adjuvant chemotherapy in such patients are scant. We tested for the noninferiority of capecitabine as compared with standard chemotherapy in women with breast cancer who were 65 years of age or older. METHODS: We randomly assigned patients with stage I, II, IIIA, or IIIB breast cancer to standard chemotherapy (either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin) or capecitabine. Endocrine therapy was recommended after chemotherapy in patients with hormone-receptor-positive tumors. A Bayesian statistical design was used with a range in sample size from 600 to 1800 patients. The primary end point was relapse-free survival. RESULTS: When the 600th patient was enrolled, the probability that, with longer follow-up, capecitabine therapy was highly likely to be inferior to standard chemotherapy met a prescribed level, and enrollment was discontinued. After an additional year of follow-up, the hazard ratio for disease recurrence or death in the capecitabine group was 2.09 (95% confidence interval, 1.38 to 3.17; P

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