Breast Cancer

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TU_3_3349 - A Prospective International Study on Safety and Efficacy of Hypofractionated Radiation Therapy for Post-Operative Breast Cancer Patients in Asian Countries

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

A Prospective International Study on Safety and Efficacy of Hypofractionated Radiation Therapy for Post-Operative Breast Cancer Patients in Asian Countries
K. Karasawa1, A. P. Banu2, A. Tasbolat3, Y. Erdentuya4, D. Erawati5, X. Xu6, M. J. Calaguas7, K. Thephamongkhol8, N. Okonogi9, and W. Jang10; 1Department of Radiation Oncology, Tokyo Women's Medical University, Tokyo, Japan, 2Delta Medical College & Hospital, Dhaka, Bangladesh, 3Semey State Medical University, Semey city, Kazakhstan, 4National Cancer Center of Mongolia, Ulaanbaatar, Mongolia, 5Erawati, Surabaya, Indonesia, 6Department of Radiotherapy, The First Affiliated Hospital of Soochow University, Suzhou, China, 7St. Luke's Medical Center, Quezon city, Philippines, 8Siriraj Hospital, Bangkok, Thailand, 9National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan, 10Korea Institute of Radiological & Medical Sciences, Soul, Korea, Republic of (South)

Purpose/Objective(s): Forum for Nuclear Cooperation in Asia (FNCA) radiation oncology project has been conducted clinical trial of hypo fractionated radiotherapy for post-operative breast cancer since 2013 with the participation of Bangladesh, China, Indonesia, Kazakhstan, Korea, Malaysia, Mongolia, Philippines, Thailand and Vietnam. The aim of this protocol is to prove that hypofractionated whole breast irradiation (HF-WBI) and hypofractionated post mastectomy regional radiothetapy (HF-PMRT) are as safe and as effective as conventionally fractionated radiotherapy and superior in terms of convenience.

Materials/Methods: The eligibility criteria for HF-WBI are patients who have undergone breast conserving surgery with a lymph node dissection or sentinel lymph node biopsy, tumor size is either Tis, T1 or T2, and has been histopathologically confirmed to have 3 positive lymph nodes or less. The eligibility criteria for HF-PMRT are patients who have undergone mastectomy and a lymph node dissection, without positive margin, and has been histopathologically confirmed to have less than 8 positive lymph nodes. Radiotherapy consisted of 2.7 Gy per fraction, 16 times, up to the total dose of 43.2 Gy to conserving breast on HF-WBI, or chest wall and supraclavicular fossa on HF-PMRT. The patients who have high grade factors, which are age less than 50, positive axillary lymph node metastasis, lymph vascular invasion, positive surgical margin are added 3 times boost irradiation to the tumor bed up to the total dose of 51.3 Gy. The accumulation number of cases was set as 200 cases in both arms.

Results: From February 2013 to October 2017, 235 cases of HF-WBI and 171 cases of HF-PMRT were registered. In HF-WBI arm, the median age was 49 years old (range, 24–79). The clinical stage 0 was in 38 patients, IA in 116, IB in 3, IIA in 49, and IIB in 20, respectively. One hundred sixty-three patients received boost radiotherapy to tumor bed. The median treatment duration was 26 days (range, 18–54). Acute dermatitis of grade 2 or higher was observed in 26 patients. In regards with the late toxicity, grade 2 lung toxicity was observed in 1 patient, grade 2 skin toxicity in 1 , and grade 2 subcutaneous toxicity in 1. One loco-regional recurrence, 3 distant metastases, and 2 breast cancer death were observed. In HF-PMRT arm, The median age was 49 years old (range, 24–80). The clinical stage was IIA in 65 patients, IIB in 60, IIIA in 35, IIIB in 3, and IIIC in 1, respectively. The median treatment duration was 21 days (range, 16–256). Acute dermatitis of grade 2 or higher was observed in 3 patients. Late toxicity of grade 2 or higher has not been observed. Five loco-regional recurrence, 13 distant metastases and 8 breast cancer deaths had been observed.

Conclusion: In the intermediate analysis, HF-WBI and HF-PMRT have almost the same effectiveness and safety as conventional fractionation. Additional registration and longer follow up must be needed to obtain final results.

Author Disclosure: K. Karasawa: None. A.P. Banu: None. Y. Erdentuya: None. D. Erawati: None. X. Xu: None. K. Thephamongkhol: None. W. Jang: None.

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