Pignol, J.P., Olivotto, I., Rakovitch, E., Gardner, S., Sixel, K., Beckham, W., . . . Paszat, L. (2008). A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. Journal of Clinical Oncology, 26, 2085–2092.

To determine if breast intensity-modulated radiation therapy (IMRT) can lead to significant reduction in radiation-induced skin toxicity

Participants randomly assigned to receive 50 Gy in 25 fractions to the whole breast using either standard RT or breast IMRT. Random assignment was stratified for use of boost and breast size. Standard skin care during the radiation treatment was similar between groups. Patients were assessed weekly during and up to six weeks after RT.

• The sample was comprised of 331 female patients receiving either IMRT (n = 170) or conventional RT (CRT) (n = 161).
• Mean age in the IMRT group was 57.1 years, with a standard deviation (SD) of 10.7 years.
• Mean age in the CRT group was 56.4 years, with a SD of 10.5 years.
• All patients had early-stage breast cancer treated by breast conserving surgery with three or fewer involved lymph nodes.

The study too place at two cancer centers in Canada.

The study used a phase III, double-blind, randomized, controlled trial design.

• Acute skin reaction or pain was measured using the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale and ccurrence of moist desquamation.
• Quality-of-life (QOL) data was coded using the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 general module and the BR-23 module self-assessment questionnaires.
• Breast size was defined as small (bra sizes 32A or 32B, 34A or 34B, and 36A), medium (bra sizes 32C, 34C, 36B, or 36C and 38A, 38B, or 38C), or large (larger bra sizes).

A lower proportion of patients experienced moist desquamation during or up to six weeks after radiation treatment with IMRT (31.2%) compared to 47.8% with standard treatment (p = 0.002). Multivariate analysis found IMRT (p = 0.003) and smaller breast size (p = 0.001) significantly associated with a decreased risk of moist desquamation. Breast IMRT (31.2%) significantly reduced the occurrence of moist desquamation compared to a standard wedged technique (47.8%) (p = 0.002).

IMRT was associated with reduced risk and prevalence of moist desquamation.

No information was given on what the standard skin care was during the radiation treatments, just that it was similar between sites.