Breast Cancer

PV QA 4 - Poster Viewing Q&A 4

TU_11_3426 - Randomized, Prospective, Open-Label Phase III Trial Comparing β-Sitosterol (mebo) Ointment with Trolamine (biafine) Cream for the Management of Acute Skin Reaction during Radiation Therapy for Breast Cancer

Tuesday, October 23
2:45 PM - 4:15 PM
Location: Innovation Hub, Exhibit Hall 3

Randomized, Prospective, Open-Label Phase III Trial Comparing β-Sitosterol (mebo®) Ointment with Trolamine (biafine®) Cream for the Management of Acute Skin Reaction during Radiation Therapy for Breast Cancer
F. B. Geara1, T. A. Eid1, B. Y. Youssef1, N. G. Zouain2, R. Thebian1, T. Andraos1, C. Chehab1, P. Ramia1, and Y. Zeidan1; 1American University of Beirut Medical Center, Beirut, Lebanon, 2Clemenceau Medical Center, Beirut, Lebanon

Purpose/Objective(s): Acute radiation dermatitis is a common side-effect of radiotherapy in breast cancer and has a profound impact on the quality of patient's life, due to pain and discomfort. It can also disrupt the treatment course resulting in premature interruption and inadequate disease treatment. Various topical agents are used for the prevention and management of acute radiation-induced skin reaction, but none has shown satisfactory and optimal response. 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.

Materials/Methods: This is a prospective open label randomized phase III study developed to assess the efficacy and compare these two products. Female breast cancer patients who needed a course of radiation therapy in our institution were enrolled and randomized into two groups one with Mebo® ointment and one 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 used the Radiation Therapy and 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, 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 grade 2 and 3 dermatitis between the two 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 pruritis and 11.5% vs 1.4 % respectively, p=0.02 for severe pain).

Conclusion: This study showed no difference between Mebo and Biafine in the incidence and severity of breast skin dermatitis during breast radiation therapy. However, the use of Mebo ointment was associated with less severe pruritus and less severe pain which could positively affect patient comfort and quality of life.

Author Disclosure: F.B. Geara: None. T.A. Eid: None. B.Y. Youssef: None. N.G. Zouain: None. C. Chehab: None.

Fady Geara, MD, PhD

Biography:
Personal Information
Fady Geara MD, PhD
Professor and Chairman, Department of Radiation Oncology,
Founding Director, The Naef K. Basile Cancer Institute (2007-2012)
American University of Beirut, Beirut, Lebanon.
Education and Degrees:
1994: American Board of Radiology, Radiation Oncology section
1991-93 Clinical Fellowship, Radiation Oncology; University of Texas MD Anderson Cancer Center
1993: Ph.D. in Radiation Biology
1989-93: Visiting Scientist and Clinical Fellow; University of Texas MD Anderson Cancer Center
1990: Radiation Oncology Diploma (DES); Tours, France
1985 MD Degree, University of Paris XI, France
Professional experience
2003- : Professor and Chairman, Department of Radiation Oncology,
American University of Beirut, Beirut Lebanon
2007-12: Founding Director, The Naef K. Basile Cancer Institute at The American University of Beirut Medical Center
1997- 2003: Associate Professor and Chairman, Department of Radiation Oncology,
American University of Beirut, Beirut Lebanon
1994-97: Assistant Professor, Department of Radiation Oncology,
The University of Texas, M. D. Anderson Cancer Center, Houston, Texas
1993-94: Faculty Associate, Department of Radiation Oncology,
The University of Texas, M. D. Anderson Cancer Center, Houston, Texas
1991-93: Clinical Fellow, Radiation Oncology,
The University of Texas, M.D. Anderson Cancer Center, Houston TX
1989-91: Visiting Scientist, Experimental Radiation Oncology,
The University of Texas, M.D. Anderson Cancer Center, Houston TX
1985-89: Resident in Radiation Oncology, France.
Honors and Awards
2004: Elected to the Alpha Omega Alpha Honor Medical Society
1999- 01; 2011-12: President, The Lebanese Society of Radiation Oncology
1995-97 The American Cancer Society Career Development Award in Clinical Oncology
1991-92 "The University Cancer Foundation Clinical Fellow for the year 1991-1992."The University of Texas, M. D. Anderson Cancer Center, Houston, Texas.
Research and Teaching
Number of published papers: 96
Number of published abstracts: 66
Number of invited lectures: 213

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TU_11_3426 - Randomized, Prospective, Open-Label Phase III Trial Comparing β-Sitosterol (mebo) Ointment with Trolamine (biafine) Cream for the Management of Acute Skin Reaction during Radiation Therapy for Breast Cancer



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