Validation of the prognosis of patients with ER‑positive, HER2‑negative and node‑negative invasive breast cancer classified as low risk by Curebest<sup>™</sup> 95GC Breast in a multi‑institutional registry study

Naoi,Yasuto; Naoi,Yasuto; Tsunashima,Ryo; Tsunashima,Ryo; Shimazu,Kenzo; Shimazu,Kenzo; Oikawa,Masahiro; Oikawa,Masahiro; Imanishi,Seiichi; Imanishi,Seiichi; Koyama,Hiroshi; Koyama,Hiroshi; Kamada,Yoshihiko; Kamada,Yoshihiko; Ishihara,Kazuhiro; Ishihara,Kazuhiro; Suzuki,Masahiko; Suzuki,Masahiko; Osako,Tomo; Osako,Tomo; Kinoshita,Takayuki; Kinoshita,Takayuki; Suto,Akihiko; Suto,Akihiko; Nakamura,Seigo; Nakamura,Seigo; Tsuda,Hitoshi; Tsuda,Hitoshi; Noguchi,Shinzaburo; Noguchi,Shinzaburo

doi:10.3892/ol.2023.13794

Validation of the prognosis of patients with ER‑positive, HER2‑negative and node‑negative invasive breast cancer classified as low risk by Curebest^™ 95GC Breast in a multi‑institutional registry study

Authors:
- Yasuto Naoi
- Ryo Tsunashima
- Kenzo Shimazu
- Masahiro Oikawa
- Seiichi Imanishi
- Hiroshi Koyama
- Yoshihiko Kamada
- Kazuhiro Ishihara
- Masahiko Suzuki
- Tomo Osako
- Takayuki Kinoshita
- Akihiko Suto
- Seigo Nakamura
- Hitoshi Tsuda
- Shinzaburo Noguchi
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Affiliations: Department of Surgery, Division of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto 602‑8566, Japan, Department of Breast Surgery, Rinku General Medical Center, Izumisano, Osaka 598‑8577, Japan, Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Suita, Osaka 565‑0871, Japan, Department of Breast Surgery, New‑wa‑kai Oikawa Hospital, Hukuoka 810‑0014, Japan, Department of Breast Surgery, Osaka Rosai Hospital, Sakai, Osaka 591‑8025, Japan, Department of Breast Surgery, Nara City Hospital, Nara 630‑8305, Japan, Department of Breast Surgery, Nahanishi Clinic, Naha, Okinawa 902‑0068, Japan, Department of Breast Surgery, Gihoku Kosei Hospital, Yamagata, Gihu 501‑2105, Japan, Department of Breast Surgery, Kitamurayama Hospital, Higashine, Yamagata 999‑3792, Japan, Division of Pathology, Cancer Institute, Japanese Foundation for Cancer Research, Tokyo 135‑8550, Japan, Division of Breast Surgery, NHO Tokyo Medical Center, Tokyo 152‑8902, Japan, Department of Breast Surgery, National Cancer Center Hospital, Tokyo 104‑0045, Japan, Division of Breast Surgical Oncology, Department of Surgery, Showa University School of Medicine, Tokyo 142‑8555, Japan, Department of Basic Pathology, National Defense Medical College, Tokorozawa, Saitama 359-8513, Japan, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Hyogo 662‑0918, Japan
Published online on: April 5, 2023 https://doi.org/10.3892/ol.2023.13794
Article Number: 209
Copyright: © Naoi et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

Curebest^™ 95GC breast (95GC) is a multigene classifier we developed for the prognostic prediction of patients with estrogen receptor (ER)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative and node‑negative (ER⁺/HER2^‑/n0) invasive breast cancer treated with adjuvant endocrine therapy alone. The aim of the preset study was to evaluate the clinical utility of 95GC in a multiinstitutional registry study. Patients (n=215) with ER⁺/HER2^‑/n0 invasive breast cancer who had undergone the 95GC assay in seven hospitals were consecutively recruited in the registry study at various postoperative times. At recruitment, no patients had disease recurrences and were prospectively followed up for a median of 62 (range, 6‑91) postoperative months. Of the 124 patients classified as 95GC low risk, 118 received adjuvant endocrine therapy alone and six received adjuvant chemo‑endocrine therapy. Only two patients developed distant recurrences, and the 5‑year distant recurrence‑free survival (DRFS) was as high as 98.0%. Of the 91 patients classified as 95GC high risk, 81 received adjuvant chemo‑endocrine therapy and 10 received adjuvant endocrine therapy alone. A total of four of these patients developed distant recurrences (5‑year DRFS=95.5%). Among the 95GC high‑risk patients, prognosis was significantly improved for the 81 treated with adjuvant chemo‑endocrine therapy compared with for the 77 (historical controls) treated with adjuvant endocrine therapy alone (P=0.0002; hazard ratio, 0.24). Compared with the St. Gallen 2013 guideline, a significant de‑escalation from 73.1% (155/212) to 40.6% (86/212) in adjuvant chemotherapy was achieved. The excellent prognosis of patients with ER⁺/HER2^‑/n0 invasive breast cancer classified as 95GC low risk could be validated in the present registry study, indicating that 95GC is useful for safe de‑escalation of adjuvant chemotherapy in patients with ER+/HER2‑/n0 invasive breast cancer.

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