Geara Fady B, Eid Toufic, Zouain Nicolas, Thebian Ranim, Andraos Therese, Chehab Chirine, Ramia Paul, Youssef Bassem, Zeidan Youssef H
Department of Radiation Oncology, American University of Beirut Medical Center.
Department of Radiation Oncology, Clemenceau Medical Center, Beirut, Lebanon.
Am J Clin Oncol. 2018 Dec;41(12):1257-1262. doi: 10.1097/COC.0000000000000460.
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 β-sitosterol (Mebo) ointment to trolamine (Biafine) cream for the prevention and treatment of radiation dermatitis in breast cancer patients receiving adjuvant radiation therapy.
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.
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).
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.
急性放射性皮炎是乳腺癌放疗常见的副作用，因其疼痛和不适，对患者生活质量有深远影响。本研究旨在比较β-谷甾醇（美宝）软膏与三乙醇胺（比亚芬）乳膏在接受辅助放疗的乳腺癌患者中预防和治疗放射性皮炎的效果。
这是一项前瞻性开放标签随机III期研究，旨在评估两种用于治疗急性放射性皮炎的外用药物的疗效。纳入在我院需要进行一个疗程放疗的女性乳腺癌患者，并随机分为两组，一组使用美宝软膏，另一组使用比亚芬乳膏。在整个治疗期间，两种药物均每天涂抹两次，在整个疗程中每周评估皮肤反应和相关症状。根据放射肿瘤学组的分级系统对皮肤反应进行分级。
2015年9月至2017年5月，本试验共招募了161例患者。两组的平均年龄相似（分别为50.19±12.57和51.73±11.23，P = 0.41）。除了使用强化放疗外（比亚芬组为82.7%，美宝组为36.7%，P = 0.012），两组的所有其他患者和治疗特征相似。对强化放疗开始前记录的反应以及包括强化放疗在内的整个疗程进行了分析。使用单因素和多因素分析，两组2级和3级皮炎无显著差异。然而，美宝组严重瘙痒和严重局部皮肤疼痛的发生率均显著降低（比亚芬组瘙痒发生率为14.1%，美宝组为2.9%，瘙痒P = 0.016；严重疼痛发生率分别为11.5%和1.4%，严重疼痛P = 0.02）。
本研究表明，美宝和比亚芬在放疗期间乳腺皮肤皮炎的发生率和严重程度方面无差异。然而，使用美宝软膏可减少严重瘙痒和疼痛，这可能对患者的舒适度和生活质量产生积极影响。
