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Journal of Clinical Oncology, Vol 23, No 18 (June 20), 2005: pp. 4241-4242 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.01.0611
In Reply:Yale University School of Medicine, New Haven, CT The three articles evaluating the sequential or concurrent use of tamoxifen reported in the January 1, 2005, issue of the Journal of Clinical Oncology all concluded that the use of tamoxifen, either concurrently or sequentially, did not impact local control rates.1-3 Although it is reassuring that all three trials reached the same conclusion independently, all of these trials suffer from the usual biases and caveats of retrospective reviews. We concur with Drs Whelan and Levine, that the most appropriate and rigorous approach to definitively answering this question would be through a large multi-institutional randomized trial.4 Whether the level of enthusiasm and funding become available to conduct such trials remains to be seen. Although the data from the three studies on tamoxifen sequencing presented suggest that there is not a significant difference in local control as a function of concurrent or sequential use of tamoxifen with radiation, the data on fibrosis, complications, and cosmesis from these trials are much less robust. If a randomized trial evaluating tamoxifen sequencing is conducted, the end points of fibrosis, complications, and cosmesis would be equally important to evaluate. Furthermore, molecular studies, including radiation sensitivity assays such as those suggested in the letter by Azria et al would be important parallel companion studies to conduct.5 The data presented by Azria et al do suggest increased fibrosis and perhaps poorer cosmesis with the use of tamoxifen and radiation. How the sequencing of tamoxifen, or other hormonal therapies, impact these end points can best be answered through controlled clinical trials. Even if the trials confirm our retrospective findings that sequential or concurrent use of tamoxifen do not significantly impact on local control or cosmesis, we can learn substantive and clinically meaningful information from the companion molecular studies. Since the use of hormonal agents in combination with radiation therapy is likely to continue into the foreseeable future, we concur with Drs Whelan and Levine that the onus is on investigators to answer such questions in as rigorous a manner as possible. This would, in our opinion, include clinical end points of local control, cosmesis, and complications, accompanied by well-designed companion molecular studies which can help to explain the results. Authors' Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest. REFERENCES
1. Ahn PH, Vu HT, Lannin D, et al: Sequence of radiotherapy with tamoxifen in conservatively managed breast cancer does not affect local relapse rates. J Clin Oncol 23:17-23, 2005
2. Harris EE, Christensen VJ, Hwang WT, et al: Impact of concurrent versus sequential tamoxifen with radiation therapy in early-stage breast cancer patients undergoing breast conservation treatment. J Clin Oncol 23:11-16, 2005
3. Pierce LJ, Hutchins LF, Green SR, et al: Sequencing of tamoxifen and radiotherapy after breast-conserving surgery in early-stage breast cancer. J Clin Oncol 23:24-29, 2005
4. Whelan T, Levine M: Radiation therapy and tamoxifen: Concurrent or sequential? That is the question. J Clin Oncol 23:1-4, 2005 5. Azria D, Gourgou S, Sozzi WJ, et al: Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer 91:1251-1260, 2004[CrossRef][Medline] Related Correspondence
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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