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Originally published as JCO Early Release 10.1200/JCO.2009.22.6951 on August 17 2009 © 2009 American Society of Clinical Oncology.
Reply to M.M. Mohiuddin et alProfessor of Surgery, Dartmouth Medical School, Hanover; Comprehensive Breast Program, Norris Cotton Cancer Center, Lebanon, NH
Integrating Decision Support in Breast Cancer Care, The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH
Center for Shared Decision Making, Dartmouth Hitchcock Medical Center, Lebanon, NH
SDM Analytics, The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH
School of Nursing, Faculty of Health Sciences, University of Ottawa, Ottowa, Ontario, Canada
Department of Community & Family Medicine, Dartmouth Medical School, Hanover, NH
Department of Surgery, Dartmouth Medical School, Hanover, NH
Health Decision Research Unit, Massachusetts General Hospital, Boston, MA We would like to thank Drs Mohiuddin and Regine1 for their interest in our article regarding the surgical treatment choices for early-stage breast cancer. Their letter raises four key issues. The first relates to the interpretation, presentation, and patients' understanding of the evidence about ipsilateral recurrence. The second and third issues relate to whether or not a woman's feelings about radiation therapy or a sense of peace of mind are valid concerns for her to factor into the decision about the surgical treatment of breast cancer. Lastly, they point to some evidence that quality of life (QOL) is better with breast-conserving therapy (BCT) and use that as justification for the primacy of that therapy over mastectomy for all patients. We appreciate the opportunity to address these issues. The issue of ipsilateral recurrence is complicated, partly because of the inconsistent manner in which recurrence has been defined and counted in studies comparing BCT versus mastectomy. For example, in National Surgical Adjuvant Breast and Bowel Project study B06, "a first recurrence of the tumor in the chest wall or scar was considered a recurrence, but not in the ipsilateral breast...the occurrence of a tumor in the ipsilateral breast after lumpectomy was considered to be a cosmetic failure...and was not included in disease-free or overall survival calculations."2 When these are added back in the local recurrence figures, the comparison of mastectomy and BCT is 10.2% and 23.4%, respectively, at 20 years.2 In the case of the Veronisi et al3 study, the rates are lower (as noted, likely due to the extensive surgery in both arms), but there is still a significant difference of 2.2% versus 8.8% at 20 years. The Poggi e al4 study found rates of local recurrence for mastectomy and BCT of 0% and 22%, respectively, at 18 years, when the censored ipsilateral recurrences are included. Two other studies cited by the commentators did not report a statistically significant difference, but these were small studies that were not powered to detect such a difference.5,6 The women in our study were presented with consistent information about recurrence, in the form of a 55-minute video decision aid (DA) before their surgical consultations.7 The DA provides factual information about options and potential outcomes, including probabilities. In the case of recurrence, women were told that the risk of recurrence at 10 years was 8% for mastectomy and 10% for BCT. These numbers were based on a reflective analysis of the available data by national experts. After watching the video, 110 (88%) of 125 patients responded that the rates of recurrence were either slightly higher with lumpectomy (50%) or the same (38%). We could not include the latter response as technically accurate; however, we believe that some women may have interpreted the difference between 8% and 10% as so small that they responded that the rates were the same. In any case, only a small number responded that the recurrence rate was much higher with lumpectomy (1%), or slightly lower with lumpectomy (7%), or much lower with lumpectomy (4%). The DA contains substantial detail about the benefits and risks of radiation therapy. Women are told that most women are pleased about how normal the breast appears after BCT. The DA also clarifies the potential need for postmastectomy radiation (eg, for women with tumors > 5 cm, or with four or more positive nodes), and presents the concept of partial breast irradiation. In regard to treatment adverse effects, they are told about the possibility of fatigue, skin redness, and temporary or permanent skin changes, as well as the risk of less common adverse effects such as heart and lung damage and increased risk of other cancers. This information is presented in a balanced fashion, noting that heart and lung damage is much less of a problem with newer techniques. Further, patients with additional questions about radiation oncology are referred for consultation. Mohiuddin and Regine1 suggest that there are no longer valid reasons that patients may want to avoid radiation or that they may gain peace of mind from having a mastectomy. While we agree that, if patients are not well informed either about the radiation therapy and its likely benefits and harms or about the chance of recurrence after mastectomy (or even that some women may need radiation after mastectomy), then those "naïve" preferences may be misguided. However, the knowledge scores indicate that women did understand the issues surrounding the treatment choices. Whose preferences should guide treatment decisions? We feel that the preferences ofwomen who are fully informed can and should. Finally, Mohiuddin and Regine1 present some data indicating that BCT provides greater QOL benefits for patients. The European Organisation for Research and Treatment of Cancer study from 1998 compared women treated with Halstead mastectomies (30% of the mastectomy group) and had extremely low response rates, and QOL items that demonstrated pretty low validity—the relevance of that data to women today is suspect.8 Other studies likely included many women in the mastectomy arm who were not candidates for breast conservation.9,10 Whether or not there would be as many differences in women who were eligible for both surgeries is unclear. Also, whether or not these women were offered the opportunity for breast reconstruction and the impact that may have on attenuating any differences in QOL—particularly relating to body image—needs to be examined. In the study by Janni et al,11 a matched study design was used, with pairs of women selected according to surgical treatment, nodal status, tumor size, and age. In Janni et al, the primary surgical treatment modality appeared to have no long-term impact on general QOL. They did identify certain problems related to body image which may be caused by mastectomy. However, it is important to note that breast reconstruction was not an option for women in Janni et al. While not presented in our article, we found no differences in decisional regret or distress between BCT and mastectomy patients at 1 year. Other studies of patients who were eligible for either option have found that how women feel after treatment is influenced more by their participation in choosing their treatment than by what type of surgery they choose.12–14 In closing, we wish to highlight the importance of not only informing patients, but also eliciting and tailoring care to individual values and treatment preferences. Providers need to be aware that some patients may choose treatments that we may not choose for ourselves. In these cases, it is easier to support their choices when one is confident that the decision is informed by the best evidence available. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. ACKNOWLEDGMENT We thank the Foundation for Informed Medical Decision Making for providing funding for this research. REFERENCES
1. Mohiuddin MM, Regine WF: Consenting the patient with early-stage breast cancer: "Informed" only after multi-discliplinary evaluation. J Clin Oncol 27:e158–e159, 2009. 2. 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. 3. 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. 4. 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] 5. 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. 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. Foundation for Informed Medical Decision Making. Early Stage Breast Cancer: Choosing Your Surgery. Boston, MA: Foundation for Informed Medical Decision Making, 2004. 8. 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] 9. 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] 10. 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] 11. 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] 12. Morris J, Ingham R: Choice of surgery for early breast cancer: Psychosocial considerations. Soc Sci Med 27:1257–1262, 1988.[CrossRef][Medline] 13. Katz SJ, Lantz PM, Janz NK, et al: Patient involvement in surgery treatment decisions for breast cancer. J Clin Oncol 23:5526–5533, 2005. 14. Lanz PM, Janz NK, Fagerlin A, et al: Satisfaction with surgery outcomes and decision process in a population-based sample of women with breast cancer. Health Serv Res 40:745–768, 2005.[CrossRef][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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