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Changes in Recurrence Score by neoadjuvant endocrine therapy of breast cancer and their prognostic implication
  1. Takayuki Ueno1,
  2. Shigehira Saji2,
  3. Norikazu Masuda3,
  4. Hiroji Iwata4,
  5. Katsumasa Kuroi5,
  6. Nobuaki Sato6,
  7. Hiroyuki Takei7,
  8. Yutaka Yamamoto8,
  9. Shinji Ohno9,
  10. Hiroko Yamashita10,
  11. Kazufumi Hisamatsu11,
  12. Kenjiro Aogi12,
  13. Hironobu Sasano13,
  14. Masakazu Toi14
  1. 1Breast Surgical Oncology, Cancer Institute Hospital, Tokyo, Japan
  2. 2Medical Oncology, Fukushima Medical University, Fukushima, Japan
  3. 3Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan
  4. 4Department of Breast Oncology, Aichi Cancer Center, Nagoya, Japan
  5. 5Surgery, Tokyo Metropolitan Health and Medical Treatment Cooperation Ebara Hospital, Tokyo, Japan
  6. 6Department of Breast Oncology, Niigata Cancer Center Hospital, Niigata, Japan
  7. 7Department of Breast Surgery and Oncology, Nippon Medical School, Tokyo, Japan
  8. 8Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan
  9. 9Breast Oncology Center, Cancer Institute Hospital, Tokyo, Japan
  10. 10Department of Breast Surgery, Hokkaido University Hospital, Sapporo, Japan
  11. 11Oikawa Hospital, Fukuoka, Japan
  12. 12Department of Breast Surgery, National Hospital Organization Shikoku Cancer Center, Ehime, Japan
  13. 13Department of Pathology, Tohoku University School of Medicine, Sendai, Japan
  14. 14Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  1. Correspondence to ProfessorShigehiraSaji; ss-saji{at}wa2.so-net.ne.jp

Abstract

Background Neoadjuvant endocrine therapy (NET) can improve surgical outcomes in postmenopausal patients with hormone receptor-positive breast cancer. The Ki67 labelling index after NET has a better prognostic power than that at baseline. However, it remains unknown whether a multigene assay with post-treatment samples could predict the prognosis better than that with pretreatment samples.

Methods The prognostic value of the multigene assay Oncotype DX Recurrence Score (RS) was investigated using pretreatment and post-treatment samples from a multicentre NET trial, JFMC34-0601 (UMIN C000000345), where exemestane was given at 25 mg/day for 24 weeks.

Results Both pretreatment and post-treatment RSs were significantly associated with disease-free survival (DFS) (p=0.005 and 0.002, respectively). The combination of pretreatment and post-treatment RSs was also a predictor of DFS (p=0.002) and superior to preoperative endocrine prognostic index (PEPI). Furthermore, combined RS was the only independent prognostic factor in the multivariate analysis among the three RSs (p=0.04). In addition, combined RS could differentiate early recurrence in the high-risk group from mid/late recurrence in the intermediate-risk group, suggesting possible differential treatment strategies based on the risk categories indicated by the combined RS.

Conclusions The combination of pretreatment and post-treatment RSs could provide pivotal information for predicting DFS and differentiating early recurrence in the high-risk group from mid/late recurrence in the intermediate-risk group in patients with hormone receptor-positive breast cancer. A larger study is required to validate the results.

  • endocrine therapy
  • neoadjuvant
  • Recurrence Score
  • Oncotype DX
  • hormone receptor

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Footnotes

  • Contributors SS and MT have contributed to the conception and design of the study and drafting the study. TU has contributed to the data analysis and manuscript writing. NM, KK, NS, HT, YY, SO, HY, KH, KA and HI have contributed to acquisition of data. HS has contributed to pathological analyses.

  • Funding This trial was supported by The Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC). Pfizer Inc made donation to JFMC. Paper preparation was partly supported by JSPS KAKENHI Grant Number 15K10059 and 15K10067.

  • Competing interests TU has received honoraria from Chugai Pharmaceutical Co, Eisai Co, Novartis Pharma K.K. MT has received honoraria from Novartis Pharma K.K., MSD K.K., Takeda Pharmaceutical Co, Astra Zeneca K.K., Eisai Co, Ltd., Genomic Health, Chugai Pharmaceutical Co, Taiho Pharmaceutical Co, Bayer AG, Eli Lilly and Co, Daiichi-Sankyo Co. Kyowa Hakko Kirin Co, C&C Research Laboratories, Yakult Pharmaceutical Industry Co, Sanofi K.K., Shimadzu Corporation and Pfizer; research funding from Taiho Pharmaceutical Co, Chugai Pharmaceutical Co, Shimadzu Corporation, Astellas Pharma, AFI Corporation, C&C Research Laboratories and Japan Breast Cancer Research Group Association; intellectual property: JP 2017-143763 WO2017/131162A, 1 Institution, PCT/JP2016/004374; advisory board meeting: Genomic Health; travel support: Genomic Health and Eli Lilly and Co; Board of directors: Japan Breast Cancer Research Group Organization, Japan Breast Cancer Research Group Association, Kyoto Breast Cancer Research Network and Organization for Oncology and Translational Research. SS has received honoraria from Astra Zeneca K.K., Chugai Pharmaceutical Co, Eisai Co, Novartis Pharma K.K. and Pfizer. NM has received honoraria from Chugai Pharmaceutical Co, Astra Zeneca K.K., Eisai Co, Kyowa Hakko Kirin Co, and Pfizer and funding from Chugai Pharmaceutical Co and Eisai Co and is Board of directors: Japan Breast Cancer Research Group Association. HI has received honoraria from Chugai Pharmaceutical Co, Astra Zeneca K.K., Pfizer, Eli Lilly and Co, Novartis Pharma K.K. and Daiichi-Sankyo Co. NS has received remuneration from Chugai Pharmaceutical Co, Astra Zeneca K.K., Eisai Co, Pfizer and Taiho Pharmaceutical Co. YY has received remuneration from Astra Zeneca K.K., Chugai Pharmaceutical Co, Daiichi-Sankyo Co, Eisai Co, Genomic Health, Kyowa Hakko Kirin Co, Novartis Pharma K.K., Pfizer, Taiho Pharmaceutical Co and Takeda Pharmaceutical Co and is Board of directors: Japan Breast Cancer Research Group Organization and Japanese Breast Cancer Society. SO has received remuneration from Chugai Pharmaceutical Co, Astra Zeneca K.K., Eisai Co, Kyowa Hakko Kirin Co, Novartis Pharma K.K., Sanofi K.K., Taiho Pharmaceutical Co and Pfizeris; is Board of directors: Japan Breast Cancer Research Group Association. KK has received honoraria from Taiho Pharmaceutical Co, Kyowa Hakko Kirin Co, Astellas Pharma Inc, and Eisai Co, Novartis Pharma K.K.; Board of directors: Japan Breast Cancer Research Group Organization, Japan Breast Cancer Research Group Association. KA has received honoraria from Chugai Pharmaceutical Co, Eisai Co,Sanofi K.K., SRL, AstraZeneca K.K., Taiho Pharmaceutical Co, Novartis Pharma K.K., DaiichiSankyo Co, Mochida Pharmaceutical, Ono Pharmaceutical, Otsuka Pharmaceutical,and Eli Lilly Japan, and his institution received researchfunds from Chugai Pharmaceutical Co, Eisai Co and Sanofi K.K. HS serves as an advisory board of Eli Lilly, and received honoraria for the lectures from Roche、Eli Lilly and Pfizer Oncology. HY reports personal fees from Takeda Pharmaceutical Co, personal fees from Astra Zeneca K.K., personal fees from Pfizer, personal fees from Chugai Pharmaceutical Co., personal fees from Hitachi, Ltd., outside the submitted work.

  • Patient consent for publication Not required.

  • Ethics approval The study protocol was approved by the Ethics Committees of participating institutions.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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