© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 18, 1420-1421,
September 19, 2001
© 2001 Oxford University Press
CORRESPONDENCE |
Re: Prognosis and Treatment of Patients With Breast Tumors of One Centimeter or Less and Negative Axillary Lymph Nodes
Affiliation of authors: Kaplan Comprehensive Cancer Center, New York University School of Medicine, NY.
Correspondence to: Deepu Mirchandani, M.D., Kaplan Comprehensive Cancer Center, New York University, 462 First Ave., Bldg. C + D, Rm. 556, New York, NY 10016. (e-mail: mirdeep{at}aol.com).
Fisher et al. (1) recommend adjuvant chemohormonal therapy for all patients with small breast cancers. The editorial by Lippman and Hayes (2) emphasizes the need for definitive clinical trials before routine acceptance of adjuvant chemotherapy. Our letter extends the discussion on risks and benefits to adjuvant hormonal treatment, in relation to age and ethnicity.
Of the 1024 estrogen receptor-positive patients evaluated in this article (1), 7% of the tumors were T1a and 93% were T1b, and 60% of all tumors were measured as 10 mm (where T1a is
0.5 cm in greatest dimension and T1b is larger than 0.5 but not larger than 1 cm in greatest dimension). Most patients were younger than 70 years, and 37% were younger than 50 years. Although adjuvant tamoxifen improved relapse-free survival (P = .01), overall survival was not statistically significantly improved (P = .41). Recurrences in younger patients were 1.7 times more common than in patients over 50 years of age. Moreover, it should be noted that conditions other than breast cancer accounted for half the mortality at 8 years. In a study of more than 300 000 breast cancer patients, Diab et al. (3) found an association between increasing age at diagnosis and favorable biologic features. Thus the impact of breast cancer recurrence is comparatively smaller in older patients. These findings indicate the need for including the age of the patient and the risk of morbidity and mortality from side effects in decisions regarding adjuvant interventions, including tamoxifen.
In the Early Breast Cancer Trialists' (EBCTG) overview of tamoxifen for early breast cancer (4), the only statistically significant increase in deaths attributable to tamoxifen was from endometrial cancer. However, older women, African-American women, and patients with small breast cancers were underrepresented. In the Breast Cancer Chemoprevention Trial of the National Surgical Adjuvant Breast and Bowel Project (NSABP) (5), 36% of the participants were older than 59 years. In women older than 50 years of age, tamoxifen was also associated with an increase in relative risks for pulmonary emboli of 3.01 (95% confidence interval [CI] = 1.15 to 9.27) and stroke of 1.59 (95% CI = 0.93 to 2.77). Furthermore the National Center for Health Statistics Database reports a twofold increased incidence of and mortality from pulmonary embolism in African-American women (6). A twofold increase in relative risk for hospitalized strokes and a relative risk for ischemic strokes of 1.38 (95% CI = 1.01 to 1.89)even after adjusting for hypertension, diabetes mellitus, educational status, smoking, and coronary artery diseasehave been reported for African-American women (7). Moreover, these risks start a decade earlier than for Caucasian women. Hence, one must consider the effects of hormonal interventions on these complications in relation to age and ethnicity.
In summary, several factors must be considered in advising hormonal therapy to patients with T1a/lymph node-negative hormone-receptor-positive breast cancers. With increasing detection of small breast tumors, trials addressing the overall benefit from adjuvant hormonal interventions should be designed. Such trials should ensure adequate representation of women older than 70 years of age and African-American women older than 60 years of age, who have an increased predisposition to and morbidity and mortality from thromboembolic events. As noted by Fisher et al., the NSABP trials represent a start for discussing these issues, but only through additional prospective trials may questions concerning the risk/benefit ratios of adjuvant hormonal interventions be answered.
REFERENCES
1
Fisher B, Dignam J, Tan-Chiu E, Anderson S, Fisher ER, Wittliff JL, et al. Prognosis and treatment of patients with breast tumors of one centimeter or less and negative axillary lymph nodes. J Natl Cancer Inst 2001;93:11220.
2
Lippman ME, Hayes DF. Adjuvant therapy for all patients with breast cancer? [editorial]. J Natl Cancer Inst 2001;93:802.
3
Diab SG, Elledge RM, Clark GM. Tumor characteristics and clinical outcome of elderly women with breast cancer. J Natl Cancer Inst 2000;92:5506.
4 Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998;351:145167.[CrossRef][Web of Science][Medline]
5
Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998;90:137188.
6 National Center for Health Statistics. Vital statistics of the United States, 1992. Vol. II. Mortality, part A. Washington (DC): Public Health Service; DHHS Publ No. (PHS)961101, Table 127; 1996.
7
Rosamond WD, Folsom AR, Chambless LE, Wang CH, McGovern PG, Howard G, et al. Stroke incidence and survival among middle-aged adults: 9-year follow-up of the Atherosclerosis Risk in Communities (ARIC) Cohort. Stroke 1999;30:73643.
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