Miwako Nozaki1, Yoshikazu Kagami2, Mitsuhiro Takahashi3, Ryunosuke Machida4, Yuta Sekino4, Taro Shibata4, Yoshinori Ito2, Yasumasa Nishimura5, Teruki Teshima6, Hiroki Ushijima7, Yasushi Nagata8, Yasuo Matsumoto9, Tetsuo Akimoto10, Kana Takahashi11, Shigeyuki Murayama12, Takashi Uno13, Kayoko Tsujino14, Yasushi Hamamoto15, Keiichi Nakagawa16, Takeshi Kodaira17, Masahiro Hiraoka18. 1. Department of Radiology, Dokkyo Medical University Saitama Medical Center, Minami-Koshigaya 2-1-50, Koshigaya, Saitama, 343-8555, Japan. miwako@dokkyomed.ac.jp. 2. Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan. 3. Department of Radiology, Kiryu Kosei General Hospital, Gunma, Japan. 4. Japan Clinical Oncology Group Data Center, National Cancer Center Hospital, Tokyo, Japan. 5. Department of Radiation Oncology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan. 6. Department of Radiation Oncology, International Cancer Institute, Osaka, Japan. 7. Division of Radiation Oncology, Saitama Cancer Center, Saitama, Japan. 8. Department of Radiation Oncology, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan. 9. Department of Radiation Oncology, Niigata Cancer Center Hospital, Niigata, Japan. 10. Division of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Chiba, Japan. 11. Department of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan. 12. Department of Radiation Oncology, Shizuoka Cancer Center, Shizuoka, Japan. 13. Department of Radiology, Chiba University Graduate School of Medicine, Chiba, Japan. 14. Department of Radiation Oncology, Hyogo Cancer Center, Hyogo, Japan. 15. Department of Radiation Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan. 16. Department of Radiology, The University of Tokyo Hospital, Tokyo, Japan. 17. Department of Radiation Oncology, Aichi Cancer Center Hospital, Aichi, Japan. 18. Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.
Abstract
BACKGROUND: A good cosmetic outcome has been defined as an important endpoint in breast-conserving therapy (BCT). Various evaluation methods have been studied, but the optimal method has yet to be identified. The present supplementary analysis of JCOG0906 focused on comparing evaluation methods for breast cosmetic outcomes following hypofractionated whole breast irradiation (HFWBI) to examine whether a computer-software (the Breast Cancer Conservative Treatment cosmetic results [BCCT. core])-based program evaluation (CE) can be used for Asian women in clinical trials of BCT. METHODS: Of 306 women, 292 underwent institutional evaluation (IE) for breast cosmetic outcomes before (pre) and 3 years after (post) HFWBI using a 4-point scale (excellent/good/fair/poor), and they were evaluated by CE and a central panel evaluation (PE) on the same scale using 292 pairs of pre/post-HFWBI photographs. PE was performed twice by consensus of the same two experts with a 3-year interval. CE was assessed individually by two radiation oncologists, an expert and a non-expert. Intra-observer variability and inter-observer variability were calculated using the kappa (k) and weighted kappa (wk) statistics. RESULTS: The agreement between the first and second PE using pre/post-HFWBI photographs was moderate (k = 0.60, wk = 0.64. k = 0.53, wk = 0.60). The agreement between the expert and non-expert on CE was substantial (k = 0.72, wk = 0.76. k = 0.72, wk = 0.77). The inter-observer variability of CE was smaller than the intra-observer variability of PE. CONCLUSION: CE with BCCT. core was considered a reproducible and an appropriate evaluation method for Asian women in clinical trials of BCT, when breast cosmetic changes were compared between pre/post therapy.
BACKGROUND: A good cosmetic outcome has been defined as an important endpoint in breast-conserving therapy (BCT). Various evaluation methods have been studied, but the optimal method has yet to be identified. The present supplementary analysis of JCOG0906 focused on comparing evaluation methods for breast cosmetic outcomes following hypofractionated whole breast irradiation (HFWBI) to examine whether a computer-software (the Breast Cancer Conservative Treatment cosmetic results [BCCT. core])-based program evaluation (CE) can be used for Asian women in clinical trials of BCT. METHODS: Of 306 women, 292 underwent institutional evaluation (IE) for breast cosmetic outcomes before (pre) and 3 years after (post) HFWBI using a 4-point scale (excellent/good/fair/poor), and they were evaluated by CE and a central panel evaluation (PE) on the same scale using 292 pairs of pre/post-HFWBI photographs. PE was performed twice by consensus of the same two experts with a 3-year interval. CE was assessed individually by two radiation oncologists, an expert and a non-expert. Intra-observer variability and inter-observer variability were calculated using the kappa (k) and weighted kappa (wk) statistics. RESULTS: The agreement between the first and second PE using pre/post-HFWBI photographs was moderate (k = 0.60, wk = 0.64. k = 0.53, wk = 0.60). The agreement between the expert and non-expert on CE was substantial (k = 0.72, wk = 0.76. k = 0.72, wk = 0.77). The inter-observer variability of CE was smaller than the intra-observer variability of PE. CONCLUSION: CE with BCCT. core was considered a reproducible and an appropriate evaluation method for Asian women in clinical trials of BCT, when breast cosmetic changes were compared between pre/post therapy.
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