Randomized, Prospective, Open-label Phase III Trial Comparing Mebo Ointment With Biafine Cream for the Management of Acute Dermatitis During Radiotherapy for Breast Cancer.

PURPOSE: Acute radiation dermatitis is a common side-effect of radiotherapy in breast cancer and has a profound impact on patients' quality of life, due to pain and discomfort. The aim of this study is to compare the effect of ß-sitosterol (Mebo) ointment to trolamine (Biafine) cream for the prevention and treatment of radiation dermatitis in breast cancer patients receiving adjuvant radiation therapy. MATERIALS AND METHODS: This is a prospective open-label randomized phase III study developed to assess the efficacy of 2 topical agents used for management of acute radiation dermatitis. Female breast cancer patients who needed a course of radiation therapy in our institution were enrolled and randomized into 2 groups 1 with Mebo ointment and 1 with Biafine cream. Both medications were applied twice per day during the whole period of treatment and skin reactions and related symptoms were assessed weekly during the entire course. Grading of skin reactions was done according to the Radiation Therapy Oncology Group grading system. RESULTS: Between September 2015 and May 2017, a total of 161 patients were recruited for this trial. Mean age was similar for both groups (50.19±12.57 vs. 51.73±11.23, respectively, P=0.41). All other patients and treatment characteristics were similar in both groups, except for the use of boost (82.7% in the Biafine group vs. 36.7% in Mebo group, P=0.012). Analysis was done for reactions recorded before the beginning of the boost and for the entire course including the boost. Using univariate and multivariate analysis, there was no significant difference in grades 2 and 3 dermatitis between the 2 groups. However, the incidence of severe pruritus and severe local skin pain were both significantly reduced in the Mebo group (14.1% in Biafine vs. 2.9% in Mebo, P=0.016 for pruritus and 11.5% vs. 1.4%, respectively, P=0.02 for severe pain). CONCLUSIONS: This study showed no difference between Mebo and Biafine in the incidence and severity of breast skin dermatitis during radiation therapy. However, the use of Mebo ointment was associated with decreased severe pruritus and pain which could positively affect patient comfort and quality of life.

A simple technique for an accurate shielding of the lungs during total body irradiation.

PURPOSE: During total body irradiation (TBI), customized shielding blocks are positioned in front of the lungs to reduce radiation dose. The difficulty is to accurately position the blocks to cover the entire lungs. A new technique based on Computed Tomography (CT) simulation was developed to determine the exact position of lung blocks prior to treatment in order to decrease overall treatment time and reduce patient discomfort. MATERIAL/METHODS: Patients were CT simulated and lungs were contoured using a treatment planning system. Anteroposterior/posteroanterior (AP/PA) fields were designed with MLC aperture conforming to lung contours. The fields were used to represent the extent of the lungs, which was subsequently marked on the patient's skin. The lung blocks were positioned with their shadow matching the lungs' marks. Their position was radiographically verified prior to the delivery of each beam. To evaluate the efficiency of this technique, the treatment session time and the number of repeated attempts to correctly position the shielding blocks was recorded for each beam. Exact treatment times for patients treated with the old technique were not available and were hence approximated based on previous experience. RESULTS: We succeeded in positioning the shielding blocks from the first attempt in 10/12 beams. The position of the shielding blocks was adjusted only one time prior to treatment in 2/12 beams. These results are compared to an average of 3 attempts per beam for each patient using the conventional technique of trial and error. The average time of a treatment session was 29 min with a maximum of 41 min versus approximately 60 min in past treatments and a maximum of 120 min. CONCLUSION: This new technique succeeded in reducing the length of the overall treatment session of the conventional TBI procedure and hence reduced patient discomfort while ensuring accurate shielding of the lungs.