Originally published as JCO Early Release 10.1200/JCO.2007.15.2488 on February 19 2008

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A Multicenter Randomized Trial of Breast Intensity-Modulated Radiation Therapy to Reduce Acute Radiation Dermatitis

Jean-Philippe Pignol, Ivo Olivotto, Eileen Rakovitch, Sandra Gardner, Katharina Sixel, Wayne Beckham, Thi Trinh Thuc Vu, Pauline Truong, Ida Ackerman, Lawrence Paszat

From the Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Toronto, Ontario; Department of Radiation Oncology, Vancouver Island Cancer Centre, Victoria, British Columbia; Department of Medical Physics, Durham Regional Cancer Centre, Oshawa, Ontario; and Department of Radiation Oncology, Hôpital Notre-Dame, Montreal, Quebec, Canada

Corresponding author: Jean-Philippe Pignol, MD, PhD, Sunnybrook Health Sciences Centre T2-144, 2075, Bayview Ave, Toronto, Ontario, M4N 3M5 Canada; e-mail: Jean-Philippe.Pignol{at}sunnybrook.ca

Purpose Dermatitis is a frequent adverse effect of adjuvant breast radiotherapy. It is more likely in full-breasted women and when the radiation is distributed nonhomogeneously in the breast. Breast intensity-modulated radiation therapy (IMRT) is a technique that ensures a more homogeneous dose distribution.

Patients and Methods A multicenter, double-blind, randomized clinical trial was performed to test if breast IMRT would reduce the rate of acute skin reaction (notably moist desquamation), decrease pain, and improve quality of life compared with standard radiotherapy using wedges. Patients were assessed each week during and up to 6 weeks after radiotherapy.

Results A total of 358 patients were randomly assigned between July 2003 and March 2005 in two Canadian centers, and 331 were included in the analysis. Breast IMRT significantly improved the dose distribution compared with standard radiation. This translated into a lower proportion of patients experiencing moist desquamation during or up to 6 weeks after their radiation treatment; 31.2% with IMRT compared with 47.8% with standard treatment (P = .002). A multivariate analysis found the use of breast IMRT (P = .003) and smaller breast size (P < .001) were significantly associated with a decreased risk of moist desquamation. The use of IMRT did not correlate with pain and quality of life, but the presence of moist desquamation did significantly correlate with pain (P = .002) and a reduced quality of life (P = .003).

Conclusion Breast IMRT significantly reduced the occurrence of moist desquamation compared with a standard wedged technique. Moist desquamation was correlated with increased pain and reduction in the quality of life.

published online ahead of print at www.jco.org on February 19, 2008.

Supported by Grant No. CIHR MCT-63156 from the Canadian Institute for Health Research.

Presented at the 48th American Society for Therapeutic Radiology and Oncology meeting, November 5, 2006, Philadelphia, PA; at the Radiological Society of North America, April 29, 2006, Chicago, IL; and at the Annual Meeting of the Canadian Association of Radiation Oncologists, October 9, 2007, Toronto, Ontario, Canada.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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