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Dummy run of quality assurance program in a phase 3 randomized trial investigating the role of internal mammary lymph node irradiation in breast cancer patients: Korean Radiation Oncology Group 08-06 study

Authors
 Yoonsun Chung  ;  Jun Won Kim  ;  Kyung Hwan Shin  ;  Su Ssan Kim  ;  Sung-Ja Ahn  ;  Won Park  ;  Hyung-Sik Lee  ;  Dong Won Kim  ;  Kyu Chan Lee  ;  Hyun Suk Suh  ;  Jin Hee Kim  ;  Hyun Soo Shin  ;  Yong Bae Kim  ;  Chang-Ok Suh 
Citation
 INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, Vol.91(2) : 419-426, 2015 
Journal Title
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
ISSN
 0360-3016 
Issue Date
2015
MeSH
Breast Neoplasms/therapy* ; Disease-Free Survival ; Female ; Humans ; Korea ; Lymph Nodes/radiation effects* ; Lymphatic Irradiation/standards* ; Lymphatic Metastasis ; Mastectomy ; Pilot Projects ; Quality Assurance, Health Care/standards* ; Radiotherapy Dosage ; Radiotherapy Planning, Computer-Assisted/standards* ; Radiotherapy, Conformal/standards* ; Reproducibility of Results ; Research Design ; Sensitivity and Specificity ; Treatment Outcome
Abstract
PURPOSE: The Korean Radiation Oncology Group (KROG) 08-06 study protocol allowed radiation therapy (RT) technique to include or exclude breast cancer patients from receiving radiation therapy to the internal mammary lymph node (IMN). The purpose of this study was to assess dosimetric differences between the 2 groups and potential influence on clinical outcome by a dummy run procedure.

METHODS AND MATERIALS: All participating institutions were asked to produce RT plans without irradiation (Arm 1) and with irradiation to the IMN (Arm 2) for 1 breast-conservation treatment case (breast-conserving surgery [BCS]) and 1 mastectomy case (modified radical mastectomy [MRM]) whose computed tomography images were provided. We assessed interinstitutional variations in IMN delineation and evaluated the dose-volume histograms of the IMN and normal organs. A reference IMN was delineated by an expert panel group based on the study guidelines. Also, we analyzed the potential influence of actual dose variation observed in this study on patient survival.

RESULTS: Although physicians intended to exclude the IMN within the RT field, the data showed almost 59.0% of the prescribed dose was delivered to the IMN in Arm 1. However, the mean doses covering the IMN in Arm 1 and Arm 2 were significantly different for both cases (P<.001). Due to the probability of overdose in Arm 1, the estimated gain in 7-year disease-free survival rate would be reduced from 10% to 7.9% for BCS cases and 7.1% for MRM cases. The radiation doses to the ipsilateral lung, heart, and coronary artery were lower in Arm 1 than in Arm 2.

CONCLUSIONS: Although this dummy run study indicated that a substantial dose was delivered to the IMN, even in the nonirradiation group, the dose differences between the 2 groups were statistically significant. However, this dosimetric profile should be studied further with actual patient samples and be taken into consideration when analyzing clinical outcomes according to IMN irradiation.
Full Text
http://www.sciencedirect.com/science/article/pii/S0360301614042928
DOI
10.1016/j.ijrobp.2014.10.022
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
Yonsei Authors
Kim, Yong Bae(김용배) ORCID logo https://orcid.org/0000-0001-7573-6862
Kim, Jun Won(김준원) ORCID logo https://orcid.org/0000-0003-1358-364X
Suh, Chang Ok(서창옥)
Chung, Yoon Sun(정윤선)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/139316
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