Affiliations of authors: Edinburgh Cancer Centre, Western General Hospital, Edinburgh, U.K. (IK); Medical Statistics Unit, Medical School, University of Edinburgh, Edinburgh (LW, RP, CK)
Correspondence to: Ian Kunkler, MBBChir, FRCP (Ed), Edinburgh Cancer Centre, Western General Hospital, Crewe Rd., Edinburgh, U.K. EH4 2XU (e-mail: i.kunkler{at}ed.ac.uk)
In a recent article in the Journal, Vinh-Hung and Verschraegen (1) provided a valuable pooled analysis of randomized trials of postoperative radiotherapy after breast-conserving surgery. They reported a small increase in breast cancer mortality and a substantial risk of local recurrence from the omission of breast radiotherapy. These important observations should not be interpreted to imply that all patients require breast radiotherapy after breast-conserving surgery and appropriate systemic therapy. We believe, however, that in contrast to younger patients, there are insufficient data to draw this conclusion in older patients. Indeed, the U.S. National Institutes of Health, in its 2000 consensus statement for breast cancer (2), makes no specific recommendation on adjuvant therapy for patients aged 70 years or older because of the paucity of data for this group of patients. Of the 15 randomized trials assessing the role of breast radiotherapy or its omission included in the pooled analysis by Vinh-Hung (1), only three (Uppsala-Orebro, Tokyo, and the Cancer and Leukemia Group B [CALGB]) included patients over age 70. In this older group of patients, there are competing risks of mortality from predominantly vascular comorbidity. In addition, a body of data from both randomized and nonrandomized trials suggests that the risks of local recurrence decrease with age (3). This observation reflects, in part, the increasing proportion of older patients with good prognostic characteristics.
Large, adequately powered trials with older patients are needed to assess the role of breast radiotherapy in local recurrence and breast cancer mortality. The dramatic impact of the competing risks of nonbreast cancer mortality in the elderly is shown in the CALGB 9343 trial (4), cited in table 1 of Vinh-Hung and Verschraegen (1), which randomly assigned patients with T1, node-negative, ER-positive tumors to breast radiotherapy or no further treatment after breast-conserving therapy and tamoxifen. Of the 39 deaths among the 647 patients in the trial, only one was due to breast cancer. Ongoing trials, such as the Post-operative Radiotherapy In Minimum-risk Elderly (PRIME) trial (5), are addressing issues of local control, morbidity, and quality of life in older, low-risk patients to establish a firm basis for the selection of patients for radiotherapy in this age group. We feel that until the results of randomized trials focused on evaluating breast radiotherapy in the elderly are available, the role of breast radiotherapy in this age group remains uncertain. For many such women, their informed recruitment into appropriately designed, randomized, controlled trials may be the most ethical way of determining treatment.
REFERENCES
1 Vinh-Hung V, Verschraegen C. Breast-conserving surgery with and without radiotherapy: pooled-analysis for risks of ipsilateral breast tumor recurrence and mortality. J Natl Cancer Inst 2004;96:11521.
2 Consensus statement: treatment of early-stage breast cancer. National Institutes of Health Consensus Development Panel. J Natl Cancer Inst Monogr 1992;(11):15.
3 Kunkler IH, King CC, Williams LJ, Prescott RJ, Jack W. What is the evidence for a reduced risk of local recurrence with age among older patients treated by breast conserving therapy? Breast 2001;10:4649.[CrossRef][ISI][Medline]
4 Hughes KS, Schnaper L, Berry D, Cirrincione C, McCormick B, Shank B, et al. Comparison of lumpectomy plus tamoxifen with and without radiotherapy (RT) in women 70 years of age or older who have clinical stage I, estrogen receptor positive (ER+) breast carcinoma [abstract 93]. Proc ASCO 2001;20:24a.
5 National Cancer Research Network (NCRN). Trials portfolio. Available at: http://www.ncrn.org.uk/portfolio/dbase.asp. Details on PRIME II can be found by selecting "PRIME II" from the Find Acronym pulldown menu. [Last accessed: July 19, 2004.]
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