TY - JOUR
T1 - Individual case review in a phase 3 randomized trial to investigate the role of internal mammary lymph node irradiation for breast cancer
T2 - Korean Radiation Oncology Group 08-06 study
AU - Yoon, Hong In
AU - Yoon, Jeongmin
AU - Chung, Yoonsun
AU - Nam, Chung Mo
AU - Cha, Hyejung
AU - Choi, Jinhyun
AU - Lee, Jeongshim
AU - Han, Hee Ji
AU - Cho, Yeona
AU - Kim, Yong Bae
AU - Suh, Chang Ok
N1 - Publisher Copyright:
© 2017 Elsevier B.V.
PY - 2017/4/1
Y1 - 2017/4/1
N2 - Purpose/objective This study aimed to assess protocol compliance based on an individual case review (ICR) of the Korean Radiation Oncology Group-0806 trial. Methods and materials For the ICR, 747 participants were divided into eight subgroups based on internal mammary node irradiation (IMNI), tumor laterality, and surgery type. Next, 15% of patients were randomly selected within each subgroup, and corresponding hospitals were subsequently requested to upload information related to radiation therapy (RT) planning. We reviewed the dose distributions of targets and organs at risk to determine protocol compliance. Results Data of 102 patients were collected. Overall, RT plans were found to be mostly protocol-compliant, with acceptability rates of 60–80% despite deviations in the ipsilateral lung in Arm 2 (IMNI group). However, despite few deviations, a subgroup analysis revealed significant differences in protocol compliance. Among RT techniques, plans using standard and partial wide tangents were most compliant in both Arms. In this ICR, the estimated survival benefits based on IMN doses were 7.7%, 8.4%, and 7.2% for all, breast-conserving surgery, and mastectomy cases, respectively. Conclusion This ICR demonstrated overall protocol compliance, despite significant differences with regard to IMN irradiation and organs at risk according to subgroups and adopted field arrangements.
AB - Purpose/objective This study aimed to assess protocol compliance based on an individual case review (ICR) of the Korean Radiation Oncology Group-0806 trial. Methods and materials For the ICR, 747 participants were divided into eight subgroups based on internal mammary node irradiation (IMNI), tumor laterality, and surgery type. Next, 15% of patients were randomly selected within each subgroup, and corresponding hospitals were subsequently requested to upload information related to radiation therapy (RT) planning. We reviewed the dose distributions of targets and organs at risk to determine protocol compliance. Results Data of 102 patients were collected. Overall, RT plans were found to be mostly protocol-compliant, with acceptability rates of 60–80% despite deviations in the ipsilateral lung in Arm 2 (IMNI group). However, despite few deviations, a subgroup analysis revealed significant differences in protocol compliance. Among RT techniques, plans using standard and partial wide tangents were most compliant in both Arms. In this ICR, the estimated survival benefits based on IMN doses were 7.7%, 8.4%, and 7.2% for all, breast-conserving surgery, and mastectomy cases, respectively. Conclusion This ICR demonstrated overall protocol compliance, despite significant differences with regard to IMN irradiation and organs at risk according to subgroups and adopted field arrangements.
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U2 - 10.1016/j.radonc.2017.01.017
DO - 10.1016/j.radonc.2017.01.017
M3 - Article
C2 - 28236539
AN - SCOPUS:85013460568
SN - 0167-8140
VL - 123
SP - 15
EP - 21
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
IS - 1
ER -
