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Originally published as JCO Early Release 10.1200/JCO.2009.22.6332 on August 17 2009 © 2009 American Society of Clinical Oncology.
Consenting the Patient With Early-Stage Breast Cancer: "Informed" Only After Multi-Discliplinary Evaluation
Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD To the Editor: The article by Collins et al1 with the accompanying editorial by Throckmorton et al2 is worrisome for a number of reasons. First, there is a surgeon's assumption by Throckmorton et al that there is a "slightly higher local recurrence rate associated with BCS [breast-conserving surgery]... [though] the difference is small."2 In the questionnaire by Collins et al, the investigators assume that the correct response to question 2 comparing local failure (LF) rates is that "BCS has a slightly higher local recurrence risk."1 Sixty-three percent of patients felt that this was true after receiving standardized decision support. In the six modern prospective studies that evaluated mastectomy versus breast-conserving therapy (BCT) and showed equal survival; four show no significant difference between the two modalities, with BCT having a lower LF rate in two of the four.3–8 In the other two studies, BCT had a higher local failure rate but this likely represents inadequate surgery: in the National Cancer Institute study,5 only gross tumor removal was required, and in the European Organisation for Research and Treatment of Cancer study,8 48% of patients had microscopically positive margins.5,8 In the Milan study,7 the authors admitted that the use of radical Halstedian mastectomy and not modified radical mastectomy (MRM) may have provided an unusually lower baseline for comparison in the surgery-only arm (LF rate: 2% mastectomy versus 9% BCT at 20 years).7 It's also important to note that long-term "local failures" in BCT may in fact be new primaries in the ipsilateral breast. This new primary risk is the same as the risk to develop a contralateral cancer (0.5% per year).6,7 The randomized trials were powered for disease-free and overall survival and may have been too small in patient numbers to detect differences in recurrence reliably. But, based on the early experience from these trials, modern BCT patient selection has been refined as we have learned more about the importance of young age, negative margins, tumor size, systemic therapies, and the use of a radiation boost. Thus, institutional reports in the modern era with long-term follow-up have shown even lower local failure rates of less than 5% to 15% in BCT.8a–10 In fact, in patients who are carefully selected, there is no substantial difference between the two modalities, as noted in the large Early Breast Cancer Trialists' Collaborative Group meta-analysis that reports local failure rates of 6.2% for MRM versus 5.9% for BCT at 10 years.11 Secondly, when it comes to BCT, physicians need to realize that lumpectomy and radiation counseling go hand in hand. In Collins et al,1 "the desire to avoid radiation" was a major factor for increasing the odds of choosing a mastectomy, but there was no upfront consultation with a radiation oncologist. The standardized decision support process includes surgical consultation only (with additional support for reconstructive plastic surgery). This omission is particularly important because the historical morbidity and mortality of radiation has decreased significantly with improvement in delivery techniques. Thus, a multidisciplinary approach is key to informed consent. The fact that a number of patients who wanted MRM upfront but chose BCT after talking to the surgeon is encouraging (most of them didn't know BCT was an option), but this still doesn't rule out the fact that even more of these patients may have done so with secondary input. All of the three patients who had wanted BCT upfront but switched to MRM did so because of their surgeon's recommendation. Third, the other factor that greatly increases the odds of choosing a mastectomy was removal of breast for peace of mind. The use of magnetic resonance imaging with false biopsies and associated treatment delays may drive patients to more mastectomies, as noted by Throckmorton et al.2 But even accounting for this, one needs to keep in mind that removal of the breast is not always complete after MRM, and that there is still a nonzero recurrence risk that is the same as BCT. In some patients with node-positive disease, we often have to add postmastectomy radiation because of the increased local failure rate. Peace of mind is an important end point for patient satisfaction, as Throckmorton et al point out, but using this same criterion is also driving a recent increase (4% in 1998% to 11% in 2003) in unnecessary contralateral prophylactic mastectomies in patients who do not benefit from them at all.11a Lastly, there are also 5-year data from a prospective European Organisation for Research and Treatment of Cancer study of 990 patients about inferior quality of life after mastectomy, and how the fear of recurrence was not a factor for BCT.12 Mastectomy patients had statistically significantly lower body image, role, and sexual functioning scores, and more disrupted lives than those undergoing BCT. This was even true for patients older than 70 years.13 The satisfaction with BCT over MRM gradually increases with time.14 Janni et al15 reported that many mastectomy patients in their series would have made a different decision in retrospect had they known about their outcome. Peace of mind has to be evaluated at many different time points, not just at the moment of consultation and anxiety-ridden decision making. Thus, providing peace of mind for the best treatment options after full informed consent from all physicians is the best solution. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. REFERENCES
1. Collins ED, Moore CP, Clay KF, et al: Can women with early-stage breast cancer make an informed decision for mastectomy? J Clin Oncol 27:519–525, 2009. 2. Throckmorton AD, Esserman LJ: When informed, all women do not prefer breast conservation. J Clin Oncol 27:484–486, 2009. 3. Arriagada R, Le MG, Rochard F, et al: Conservative treatment versus mastectomy in early breast cancer: Patterns of failure with 15 years of follow-up data—Institut Gustave-Roussy breast cancer group. J Clin Oncol 14:1558–1564, 1996. 4. Fisher B, Anderson S, Bryant J, et al: Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med 347:1233–1241, 2002. 5. Poggi MM, Danforth DN, Sciuto LC, et al: Eighteen-year results in the treatment of early breast carcinoma with mastectomy versus breast conservation therapy: The National Cancer Institute randomized trial. Cancer 98:697–702, 2003.[CrossRef][Medline] 6. Blichert-Toft M, Nielsen M, During M, et al: Long-term results of breast conserving surgery vs. mastectomy for early stage invasive breast cancer: 20-year follow-up of the Danish randomized DBCG-82TM protocol. Acta Oncol 47:672–681, 2008.[CrossRef][Medline] 7. Veronesi U, Cascinelli N, Mariani L, et al: Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med 347:1227–1232, 2002. 8. van Dongen JA, Voogd AC, Fentiman IS, et al: Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst 92:1143–1150, 2000. 8a. Kini VR, White JR, Horwitz EM, et al: Long term results with breast-conserving therapy for patients with early-stage breast carcinoma in a community hospital setting. Cancer 82:127–133, 1998.[CrossRef][Medline] 9. Cabioglu N, Hunt KK, Buchholz TA, et al: Improving local control with breast-conserving therapy: A 27-year single-institution experience. Cancer 104:20–29, 2005.[CrossRef][Medline] 10. Knauerhase H, Strietzel M, Gerber B, et al: Tumor location, interval between surgery and radiotherapy, and boost technique influence local control after breast-conserving surgery and radiation: Retrospective analysis of monoinstitutional long-term results. Int J Radiat Oncol Biol Phys 72:1048–1055, 2008.[Medline] 11. Clarke M, Collins R, Darby S, et al: Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: An overview of the randomised trials. Lancet 366:2087–2106, 2005.[Medline] 11a. Tuttle TM, Habermann EB, Grund EH, et al: Increasing use of contralateral prophylactic mastectomy for breast cancer patients: A trend toward more aggressive surgical treatment. J Clin Oncol 25:5203–5209, 2007. 12. Curran D, van Dongen JP, Aaronson NK, et al: Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: Results of EORTC trial 10801—The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Co-Operative Group (BCCG). Eur J Cancer 34:307–314, 1998.[CrossRef][Medline] 13. Engel J, Kerr J, Schlesinger-Raab A, et al: Quality of life following breast-conserving therapy or mastectomy: Results of a 5-year prospective study. Breast J 10:223–231, 2004.[CrossRef][Medline] 14. Arndt V, Stegmaier C, Ziegler H, et al: Quality of life over 5 years in women with breast cancer after breast-conserving therapy versus mastectomy: A population-based study. J Cancer Res Clin Oncol 134:1311–1318, 2008.[CrossRef][Medline] 15. Janni W, Rjosk D, Dimpfl TH, et al: Quality of life influenced by primary surgical treatment for stage I-III breast cancer-long-term follow-up of a matched-pair analysis. Ann Surg Oncol 8:542–548, 2001.[Medline]
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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