Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer Journal Article


Authors: Hughes, K. S.; Schnaper, L. A.; Berry, D.; Cirrincione, C.; McCormick, B.; Shank, B.; Wheeler, J.; Champion, L. A.; Smith, T. J.; Smith, B. L.; Shapiro, C.; Muss, H. B.; Winer, E.; Hudis, C.; Wood, W.; Sugarbaker, D.; Henderson, I. C.; Norton, L.
Article Title: Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer
Abstract: BACKGROUND: In women 70 years of age or older who have early breast cancer, it is unclear whether lumpectomy plus tamoxifen is as effective as lumpectomy followed by tamoxifen plus radiation therapy. METHODS: Between July 1994 and February 1999, we randomly assigned 636 women who were 70 years of age or older and who had clinical stage I (T1N0M0 according to the tumor-node-metastasis classification), estrogen-receptor-positive breast carcinoma treated by lumpectomy to receive tamoxifen plus radiation therapy (317 women) or tamoxifen alone (319 women). Primary end points were the time to local or regional recurrence, the frequency of mastectomy for recurrence, breast-cancer-specific survival, the time to distant metastasis, and overall survival. RESULTS: The only significant difference between the two groups was in the rate of local or regional recurrence at five years (1 percent in the group given tamoxifen plus irradiation and 4 percent in the group given tamoxifen alone, P<0.001). There were no significant differences between the two groups with regard to the rates of mastectomy for local recurrence, distant metastases, or five-year rates of overall survival (87 percent in the group given tamoxifen plus irradiation and 86 percent in the tamoxifen group, P=0.94). Assessment by physicians and patients of cosmetic results and adverse events uniformly rated tamoxifen plus irradiation inferior to tamoxifen alone. CONCLUSIONS: Lumpectomy plus adjuvant therapy with tamoxifen alone is a realistic choice for the treatment of women 70 years of age or older who have early, estrogen-receptor-positive breast cancer. © 2004 Massachusetts Medical Society.
Keywords: survival; controlled study; human tissue; aged; survival analysis; survival rate; major clinical study; clinical trial; cancer recurrence; multimodality cancer therapy; cancer adjuvant therapy; cancer radiotherapy; combined modality therapy; cancer staging; follow up; follow-up studies; lymph node metastasis; lymphatic metastasis; neoplasm staging; neoplasm; edema; metastasis; controlled clinical trial; neoplasm recurrence, local; breast cancer; randomized controlled trial; radiotherapy; breast neoplasms; cancer hormone therapy; thorax pain; early cancer; multicenter study; tumor recurrence; breast tumor; partial mastectomy; tamoxifen; aging; esthetics; antineoplastic agents, hormonal; estrogen receptor; antineoplastic hormone agonists and antagonists; segmental mastectomy; mastectomy, segmental; neoplasms, hormone-dependent; mastalgia; arm edema; skin fibrosis; skin color; shoulder pain; humans; prognosis; human; female; priority journal; article
Journal Title: New England Journal of Medicine
Volume: 351
Issue: 10
ISSN: 0028-4793
Publisher: Massachusetts Medical Society  
Date Published: 2004-09-02
Start Page: 971
End Page: 977
Language: English
DOI: 10.1056/NEJMoa040587
PROVIDER: scopus
PUBMED: 15342805
DOI/URL:
Notes: New Engl. J. Med. -- Cited By (since 1996):464 -- Export Date: 16 June 2014 -- CODEN: NEJMA -- Source: Scopus
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  1. Clifford Hudis
    905 Hudis
  2. Larry Norton
    758 Norton
  3. Beryl McCormick
    372 McCormick