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In Reply

Departments of Surgery and Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, the Netherlands

On behalf of the European Organisation for Research and Treatment of Cancer (EORTC) ductal carcinoma in situ (DCIS) study team, we thank Thorat et al for their valuable comments on the recently updated results of the EORTC 10853 DCIS trial. We completely agree that the benefit of a treatment should always be weighed against a possible harm. However, this study showed that radiotherapy reduced the number of invasive local recurrences (48%; P = .0011) without observing an increased risk of cardiovascular death due to radiotherapy at 10.5 years of follow-up. Seven patients died of cardiovascular disease: four in the local excision alone group (0.8%) and three in the local excision plus radiotherapy group (0.6%).¹ We found an invasive local recurrence rate of 13% for patients treated with excision alone at 10 years. The National Surgical Adjuvant Breast and Bowel Project B-17 study reported a rate of 17% for these patients at 12 years.² It is therefore likely that this rate will be at least 16% in the EORTC study at 15 years. If one quarter of these patients will develop additional distant metastases, radiotherapy will prevent 2% of such events. In addition, recurrent disease is known to have a negative effect on the quality of life of women treated for DCIS.³ Despite that the findings from the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) analysis could not be confirmed in our study, we acknowledge the possible long-term risks associated with radiotherapy.⁴ The EBCTCG analysis reported that some of the radiotherapy regimens used in the older trials of postmastectomy radiotherapy appreciably increased nonbreast cancer mortality more than 5 years later, with most of this excess mortality involving heart disease and lung cancer. The radiotherapy regimens of the early 1970s involved greater hazards than many recent regimens. This is reflected by a decrease in the cardiac mortality ratio 5 to 9 years after breast cancer diagnosis for left-sided versus right-sided breast cancer from 1.21 for patients diagnosed between 1973 and 1982 to 0.99 for patients diagnosed between 1993 and 2001.⁵ In addition, it should be noted that the EBCTCG study reporting on excess 15-year nonbreast cancer mortality effect of radiotherapy does not specify this risk by type of radiation fields used. Regional lymph node irradiation, with notable radiotherapy of the internal mammary nodes, which can lead to relatively high cardiac doses, is irrelevant to DCIS. Finally, the favorable prognostic outcome of DCIS compels identification of patients who benefit most from radiotherapy by selecting those patients with a high risk of local recurrence. However, none of the large randomized clinical trials have identified a large subgroup that clearly does not benefit from radiotherapy. This is corroborated by results from the early stopped prospective study of wide excision alone.⁶

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The authors indicated no potential conflicts of interest.

REFERENCES

1. Bijker N, Meijnen P, Peterse JL, et al: Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: Ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853–a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol 24:3381-3387, 2006[Abstract/Free Full Text]

2. Fisher B, Land S, Mamounas E, et al: Prevention of invasive breast cancer in women with ductal carcinoma in situ: An update of the national surgical adjuvant breast and bowel project experience. Semin Oncol 28:400-418, 2001[CrossRef][Medline]

3. Rakovitch E, Franssen E, Kim J, et al: A comparison of risk perception and psychological morbidity in women with ductal carcinoma in situ and early invasive breast cancer. Breast Cancer Res Treat 77:285-293, 2003[CrossRef][Medline]

4. 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]

5. Darby SC, McGale P, Taylor CW, et al: Long-term mortality from heart disease and lung cancer after radiotherapy for early breast cancer: Prospective cohort study of about 300,000 women in US SEER cancer registries. Lancet Oncol 6:557-565, 2005[CrossRef][Medline]

6. Wong JS, Kaelin CM, Troyan SL, et al: Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol 24:1031-1036, 2006[Abstract/Free Full Text]

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