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.
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Acknowledgements
The authors would like to express their sincere thanks to all participating patients and the Data and Safety Monitoring Committee, Audit Committee of JCOG, and JCOG Data Center/Operation Office: Dr. Haruhiko Fukuda (Director of JCOG Data Center), Dr. Tomoko Kataoka, Dr. Keita Sasaki (Science Section), Ms. Chikako Aibara, Michiko Murai, Shoko Todo (Data Management Section), and the Radiation Therapy Study Group of the JCOG.
List of Authors under the Radiation Therapy Study Group of the JCOG: Miwako Nozaki, Yoshikazu Kagami, Yoshinori Ito, Yasumasa Nishimura, Teruki Teshima, Hiroki Ushijima, Yasushi Nagata, Yasuo Matsumoto, Tetsuo Akimoto, Kana Takahashi, Shigeyuki Murayama, Takeshi Uno, Kayoko Tsujino, Yasushi Hamamoto, Keiichi Nakagawa, Takeshi Kodaira, Masahiro Hiraoka.
List of Participating institutions from the Radiation Therapy Study Group of the JCOG (*Authors): Koichi Inoue, Tochigi Cancer Center Hospital; Hideyuki Sakurai, University of Tsukuba, Faculty of Medicine; Hiroki Ushijima*, Saitama Cancer Center; Shingo Kato, Saitama Medical University International Medical Center; Miwako Nozaki*, Dokkyo Medical University Saitama Medical Center; Takashi Uno*, Chiba University Graduate School of Medicine; Tetsuo Akimoto*, National Cancer Center Hospital East, National Cancer Center Hospital; Yoshinori Ito*, Showa University School of Medicine; Katsuyuki Karasawa, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital; Kumiko Karasawa, Tokyo Women’s Medical University; Keiichi Nakagawa*, The University of Tokyo Hospital; Hiromichi Ishiyama, Kitasato University School of Medicine; Hiroshi Ohnishi, University of Yamanashi Faculty of Medicine; Yasuo Matsumoto*, Niigata Cancer Center Hospital; Shigeyuki Murayama*, Shizuoka Cancer Center; Takeshi Kodaira*, Aichi Cancer Center Hospital; Takashi Mizowaki, Kyoto University Hospital; Masahiro Tanaka, Osaka City General Hospital; Teruki Teshima*, Osaka International Cancer Institute; Kazuhiko Ogawa, Osaka University Graduate School of Medicine; Kayoko Tsujino*, Hyogo Cancer Center; Yasushi Nagata*, Hiroshima University Hospital; Yasushi Hamamoto*, National Hospital Organization Shikoku Cancer Center; Joichi Heiannna, University of the Ryukyus Hospital; Masahiro Hiraoka. Japanese Red Cross Wakaya Medical Center.
Funding
This study was supported by a Grant-in-Aid for Cancer Research (20S-5), and a Health and Labour Sciences Research Grant for Clinical Cancer Research (H21-081, H24-007) from the Japanese Ministry of Health, Labour and Welfare, and the National Cancer Center Research and Development Fund (2020-J-3).
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List of authors under Radiation Therapy Study Group of the JCOG are listed in Acknowledgement.
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Nozaki, M., Kagami, Y., Takahashi, M. et al. Evaluation of breast cosmetic changes with a computer-software; the breast cancer conservative treatment cosmetic results (BCCT. core) in hypofractionated whole breast irradiation after breast-conserving surgery-supplementary analysis of multicenter single-arm confirmatory trial: JCOG0906. Breast Cancer 29, 1042–1049 (2022). https://doi.org/10.1007/s12282-022-01384-8
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DOI: https://doi.org/10.1007/s12282-022-01384-8