Abstract
Background: Previous large trials of trastuzumab (TZM) demonstrated improved outcomes in patients with HER2-positive early breast cancer. However, its effectiveness and safety in Japanese patients is not yet clear. Recently, new anti-HER2 agents were developed to improve treatment outcomes, but the patient selection criteria remain controversial. Purpose: The aim of this study was to evaluate the long-term effectiveness of TZM therapy as perioperative therapy for HER2-positive operable breast cancer in daily clinical practice and to create a recurrence prediction model for therapeutic selection. Methods: An observational study was conducted in Japan (UMIN000002737) to observe the prognosis of women (n = 2024) with HER2-positive invasive breast cancer who received TZM for stage I–III C disease between July 2009 and June 2011. Moreover, a recurrence-predicting model was designed to evaluate the risk factors for recurrence. Results: The 5- and 10-year disease-free survival (DFS) rates were 88.9 (95% CI 87.5–90.3%) and 82.4% (95% CI 79.2–85.6%), respectively. The 5- and 10-year overall survival (OS) rates were 96% (95% CI 95.1–96.9%) and 92.7% (95% CI 91.1–94.3%), respectively. Multivariate analysis revealed that the risk factors for recurrence were an age of ≥ 70 years, T2 or larger tumors, clinically detected lymph node metastasis, histological tumor diameter of > 1 cm, histologically detected lymph node metastasis (≥ n2), and the implementation of preoperative treatment. The 5-year recurrence rate under the standard treatment was estimated to be > 10% in patients with a score of 3 or greater on the recurrence-predicting model. Conclusion: The recurrence-predicting model designed in this study may improve treatment selection of patients with stage I–III C disease. However, further studies are needed to validate the scores generated by this model.
| Original language | English |
|---|---|
| Pages (from-to) | 631-641 |
| Number of pages | 11 |
| Journal | Breast Cancer |
| Volume | 27 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Jul 1 2020 |
Keywords
- Breast cancer
- Cohort study
- HER2-positive breast cancer
- Prediction model
- Trastuzumab
ASJC Scopus subject areas
- Oncology
- Radiology Nuclear Medicine and imaging
- Pharmacology (medical)
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Outcomes of trastuzumab therapy in HER2-positive early breast cancer patients : extended follow-up of JBCRG-cohort study 01. / the JBCRG-C01 Collaborative Group.
In: Breast Cancer, Vol. 27, No. 4, 01.07.2020, p. 631-641.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Outcomes of trastuzumab therapy in HER2-positive early breast cancer patients
T2 - extended follow-up of JBCRG-cohort study 01
AU - the JBCRG-C01 Collaborative Group
AU - Yamashiro, Hiroyasu
AU - Iwata, Hiroji
AU - Masuda, Norikazu
AU - Yamamoto, Naohito
AU - Nishimura, Reiki
AU - Ohtani, Shoichiro
AU - Sato, Nobuaki
AU - Takahashi, Masato
AU - Kamio, Takako
AU - Yamazaki, Kosuke
AU - Saito, Tsuyoshi
AU - Kato, Makoto
AU - Lee, Tecchuu
AU - Kuroi, Katsumasa
AU - Takano, Toshimi
AU - Yasuno, Shinji
AU - Morita, Satoshi
AU - Ohno, Shinji
AU - Toi, Masakazu
AU - Yamagami, K.
AU - Morimoto, T.
AU - Hasegawa, Y.
AU - Shigematsu, H.
AU - Hosoda, M.
AU - Abe, H.
AU - Yotsumoto, D.
AU - Tanino, H.
AU - Yamamoto, Y.
AU - Hisamatsu, K.
AU - Aihara, T.
AU - Bando, H.
AU - Yoshibayashi, H.
AU - Tagaya, N.
AU - Doihara, H.
AU - Narui, K.
AU - Mukai, H.
AU - Aogi, K.
AU - Tsuyuki, S.
AU - Kawabuchi, Y.
AU - Wada, Y.
AU - Kakugawa, Y.
AU - Moriguchi, Y.
AU - Kawaguchi, Y.
AU - Suwa, H.
AU - Tanaka, F.
AU - Nakagomi, H.
AU - Ito, T.
AU - Nakamura, S.
AU - Takeuchi, H.
AU - Inokuchi, M.
N1 - Funding Information: 1 Dr. Yamashiro reports personal fees from Chugai, personal fees from Daiich-Sankyo, personal fees from Pfizer, personal fees from Kyowa Kirin, personal fees from Eisai, personal fees from Eli Lilly, personal fees from Takeda, and personal fees from Taiho outside the submitted work. 2 Dr. Iwata reports grants and personal fees from Chugai during the conduct of the study, and grants and personal fees from Novartis, grants and personal fees from AstraZeneca, grants and personal fees from Pfizer, grants and personal fees from Eli Lilly, grants and personal fees from Daiichi Sankyo, grants from MSD, personal fees from Eisai, grants and personal fees from Kyowa Kirin, and grants from Byer outside the submitted work. Dr Iwata is a member of an organized committee in the Japan Breast Cancer Research Group. 3 Dr. Masuda reports grants, personal fees and other from Chugai, personal fees and other from AstraZeneca, personal fees and other from Pfizer, personal fees and other from Eli Lilly, grants, personal fees and other from Eisai, personal fees and other from Takeda, personal fees and other from Kyowa Kirin, other from MSD, personal fees and other from Novartis, and personal fees and other from Daiichi Sankyo outside the submitted work. 4 Dr. Yamamoto reports other from the Japan Breast Cancer Research Group during the conduct of the study, and other from MSD, other from Eli Lilly, and other from Nippon Kayaku outside the submitted work. 5 Dr. Nishimura reports personal fees from Pfizer, personal fees from Novartis, and personal fees from Chugai outside the submitted work. 6 Dr. Ohtani reports personal fees from Chugai, personal fees from AstraZeneca, personal fees from Eisai, personal fees from Pfizer, and personal fees from Eli Lilly outside the submitted work. 7 Dr. Sato reports personal fees from Chugai, personal fees from Eisai, personal fees from Pfizer, and personal fees from Taiho outside the submitted work. 8 Dr. Takahashi reports personal fees from AstraZeneca, grants and personal fees from Chugai, grants and personal fees from Eisai, personal fees from Eli Lilly, grants and personal fees from Kyowa Kirin, grants and personal fees from Nippon Kayaku, personal fees from Novartis, personal fees from Pfizer, and grants and personal fees from Taiho outside the submitted work. 9 Dr. Kamio has nothing to disclose. 10 Dr. Yamazaki has nothing to disclose. 11 Dr. Saito reports personal fees from Pfizer, personal fees from AstraZeneca, personal fees from Nippon Kayaku, and personal fees from Chugai outside the submitted work. 12 Dr. Kato has nothing to disclose. 13 Dr. Lee has nothing to disclose. 14 Dr. Kuroi reports personal fees from Taiho, Kyowa Kirin, Astellas, Eisai, and Novartis outside the submitted work, and from the Board of directors: Japan Breast Cancer Research Group Organization, Japan Breast Cancer Research Group Association. 15 Dr. Takano reports grants and personal fees from Daiichi Sankyo, grants and personal fees from Kyowa Kirin, grants and personal fees from Eisai, grants from Ono, grants from MSD, grants from Merck Serono, grants from Taiho, grants from Novartis, grants from Chugai, personal fees from Pfizer, and personal fees from Eli Lilly outside the submitted work. 16 Dr. Yasuno has nothing to disclose. 17 Dr. Morita reports personal fees from AstraZeneca, personal fees from Bristol-Myers Squibb, personal fees from Chugai, personal fees from Eisai, personal fees from Eli Lilly, personal fees from MSD, personal fees from Pfizer, and personal fees from Taiho outside the submitted work. 18 Dr. Ohno reports grants and personal fees from Eisai, personal fees from Chugai, personal fees from Pfizer, grants and personal fees from Taiho, personal fees from Nippon Kayaku, personal fees from Kyowa Kirin, personal fees from Novartis, personal fees from AstraZeneca, and personal fees from Eli Lilly outside the submitted work. 19 Dr. Toi reports grants and personal fees from Chugai during the conduct of the study, and grants and personal fees from Taiho, grants and personal fees from Takeda, grants and personal fees from Shimadzu, grants and personal fees from Eisai, grants, personal fees and other from Daiichi Sankyo, personal fees from Yakult, grants, personal fees and other from Kyowa Kirin, personal fees and other from Konica-Minolta, grants and personal fees from Pfizer, personal fees from Eli Lilly, personal fees from MSD, personal fees and other from Genomic Health, grants and personal fees from AstraZeneca, personal fees from Novartis, personal fees from Bayer, personal fees from Sanofi, grants and personal fees from C&C Res Lab, grants and personal fees from Nippon Kayaku, grants from Bizcom Japan, grants from AFI technologies, grants and non-financial support from the Japan Breast Cancer Research Group Association, grants from Astellas, grants from DSK, non-financial support from the Organisation for Oncology and Translational Research, grants and non-financial support from the Kyoto Breast Cancer Research Network, grants from Terumo, and other from BMS outside the submitted work. Funding Information: The authors are grateful to all of the co-investigators and patients for their cooperation in the JBCRG C-01 study. The authors also thank the following additional investigators for their contributions to this study: K. Yamagami (Shinko Hospital), T. Morimoto (Yao Municipal Hospital), Y. Hasegawa (Hirosaki Municipal Hospital), H. Shigematsu (Hiroshima University Hospital), M. Hosoda (Hokkaido University Hospital), H. Abe (Bell Land General Hospital), D. Yotsumoto (Social Medical Corporation Hakuaikai Sagara Hospital), H. Tanino (Kitasato University Hospital), Y. Yamamoto (Kumamoto University Hospital), K. Hisamatsu (Oikawa Hospital), T. Aihara (Aihara Hospital), H. Bando (University of Tsukuba Hospital), H. Yoshibayashi (Japanese Red Cross Wakayama Medical Center), N. Tagaya (Dokkyo Medical University), H. Doihara (Okayama University Hospital), K. Narui (Yokohama City University Medical Center), H. Mukai (National Cancer Center Higashi Hospital), K. Aogi (National Hospital Organization Shikoku Cancer Center), S. Tsuyuki (Osaka Red Cross Hospital), Y. Kawabuchi (Hiroshima General Hospital), Y. Wada (National Hospital Organization Himeji Medical Center), Y. Kakugawa (Miyagi Cancer Center), Y. Moriguchi (Kyoto City Hospital), Y. Kawaguchi (Murakami Memorial Hospital Asahi University), H. Suwa (Hyogo Prefectural Tsukaguchi Hospital), F. Tanaka (Fukui Red Cross Hospital), H. Nakagomi (Yamanashi Prefectural Central Hospital), T. Ito (Rinku General Medical Center), S. Nakamura (Showa University Hospital), H. Takeuchi (Beppu Medical Center), M. Inokuchi (Kanazawa University Hospital), Y. Teramura (Hikone Municipal Hospital), K. Ito (Shinshu University School of Medicine), S. Sato (Ichinomiya Municipal Hospital), F. Yotsumoto (Shiga Medical Center for Adults), T. Okino (Kohka Public Hospital), Y. Mitsudo (Mitsubishi Kyoto Hospital), K. Yoshidome (Osaka Police Hospital), and Y. Tokunaga (Osakakita Teishin Hospital). The authors also thank the following additional investigators for their contributions to this study: Tetsuo Takeuchi and Yosuke Sasaki for statistical work, Sachiko Inoue and Miyoko Hasebe for data management, and Kiyomi Kashiwa and Nobuko Aoki for secretarial work. This study was conducted using our own funds from JBCRG. The Department of EBM Research, Institute for Advancement of Clinical and Translational Science was partially funded by Chugai Pharmaceutical Co., Ltd. Funding Information: The authors are grateful to all of the co-investigators and patients for their cooperation in the JBCRG C-01 study. The authors also thank the following additional investigators for their contributions to this study: K. Yamagami (Shinko Hospital), T. Morimoto (Yao Municipal Hospital), Y. Hasegawa (Hirosaki Municipal Hospital), H. Shigematsu (Hiroshima University Hospital), M. Hosoda (Hokkaido University Hospital), H. Abe (Bell Land General Hospital), D. Yotsumoto (Social Medical Corporation Hakuaikai Sagara Hospital), H. Tanino (Kitasato University Hospital), Y. Yamamoto (Kumamoto University Hospital), K. Hisamatsu (Oikawa Hospital), T. Aihara (Aihara Hospital), H. Bando (University of Tsukuba Hospital), H. Yoshibayashi (Japanese Red Cross Wakayama Medical Center), N. Tagaya (Dokkyo Medical University), H. Doihara (Okayama University Hospital), K. Narui (Yokohama City University Medical Center), H. Mukai (National Cancer Center Higashi Hospital), K. Aogi (National Hospital Organization Shikoku Cancer Center), S. Tsuyuki (Osaka Red Cross Hospital), Y. Kawabuchi (Hiroshima General Hospital), Y. Wada (National Hospital Organization Himeji Medical Center), Y. Kakugawa (Miyagi Cancer Center), Y. Moriguchi (Kyoto City Hospital), Y. Kawaguchi (Murakami Memorial Hospital Asahi University), H. Suwa (Hyogo Prefectural Tsukaguchi Hospital), F. Tanaka (Fukui Red Cross Hospital), H. Nakagomi (Yamanashi Prefectural Central Hospital), T. Ito (Rinku General Medical Center), S. Nakamura (Showa University Hospital), H. Takeuchi (Beppu Medical Center), M. Inokuchi (Kanazawa University Hospital), Y. Teramura (Hikone Municipal Hospital), K. Ito (Shinshu University School of Medicine), S. Sato (Ichinomiya Municipal Hospital), F. Yotsumoto (Shiga Medical Center for Adults), T. Okino (Kohka Public Hospital), Y. Mitsudo (Mitsubishi Kyoto Hospital), K. Yoshidome (Osaka Police Hospital), and Y. Tokunaga (Osakakita Teishin Hospital). The authors also thank the following additional investigators for their contributions to this study: Tetsuo Takeuchi and Yosuke Sasaki for statistical work, Sachiko Inoue and Miyoko Hasebe for data management, and Kiyomi Kashiwa and Nobuko Aoki for secretarial work. This study was conducted using our own funds from JBCRG. The Department of EBM Research, Institute for Advancement of Clinical and Translational Science was partially funded by Chugai Pharmaceutical Co., Ltd. Publisher Copyright: © 2020, The Author(s).
PY - 2020/7/1
Y1 - 2020/7/1
N2 - Background: Previous large trials of trastuzumab (TZM) demonstrated improved outcomes in patients with HER2-positive early breast cancer. However, its effectiveness and safety in Japanese patients is not yet clear. Recently, new anti-HER2 agents were developed to improve treatment outcomes, but the patient selection criteria remain controversial. Purpose: The aim of this study was to evaluate the long-term effectiveness of TZM therapy as perioperative therapy for HER2-positive operable breast cancer in daily clinical practice and to create a recurrence prediction model for therapeutic selection. Methods: An observational study was conducted in Japan (UMIN000002737) to observe the prognosis of women (n = 2024) with HER2-positive invasive breast cancer who received TZM for stage I–III C disease between July 2009 and June 2011. Moreover, a recurrence-predicting model was designed to evaluate the risk factors for recurrence. Results: The 5- and 10-year disease-free survival (DFS) rates were 88.9 (95% CI 87.5–90.3%) and 82.4% (95% CI 79.2–85.6%), respectively. The 5- and 10-year overall survival (OS) rates were 96% (95% CI 95.1–96.9%) and 92.7% (95% CI 91.1–94.3%), respectively. Multivariate analysis revealed that the risk factors for recurrence were an age of ≥ 70 years, T2 or larger tumors, clinically detected lymph node metastasis, histological tumor diameter of > 1 cm, histologically detected lymph node metastasis (≥ n2), and the implementation of preoperative treatment. The 5-year recurrence rate under the standard treatment was estimated to be > 10% in patients with a score of 3 or greater on the recurrence-predicting model. Conclusion: The recurrence-predicting model designed in this study may improve treatment selection of patients with stage I–III C disease. However, further studies are needed to validate the scores generated by this model.
AB - Background: Previous large trials of trastuzumab (TZM) demonstrated improved outcomes in patients with HER2-positive early breast cancer. However, its effectiveness and safety in Japanese patients is not yet clear. Recently, new anti-HER2 agents were developed to improve treatment outcomes, but the patient selection criteria remain controversial. Purpose: The aim of this study was to evaluate the long-term effectiveness of TZM therapy as perioperative therapy for HER2-positive operable breast cancer in daily clinical practice and to create a recurrence prediction model for therapeutic selection. Methods: An observational study was conducted in Japan (UMIN000002737) to observe the prognosis of women (n = 2024) with HER2-positive invasive breast cancer who received TZM for stage I–III C disease between July 2009 and June 2011. Moreover, a recurrence-predicting model was designed to evaluate the risk factors for recurrence. Results: The 5- and 10-year disease-free survival (DFS) rates were 88.9 (95% CI 87.5–90.3%) and 82.4% (95% CI 79.2–85.6%), respectively. The 5- and 10-year overall survival (OS) rates were 96% (95% CI 95.1–96.9%) and 92.7% (95% CI 91.1–94.3%), respectively. Multivariate analysis revealed that the risk factors for recurrence were an age of ≥ 70 years, T2 or larger tumors, clinically detected lymph node metastasis, histological tumor diameter of > 1 cm, histologically detected lymph node metastasis (≥ n2), and the implementation of preoperative treatment. The 5-year recurrence rate under the standard treatment was estimated to be > 10% in patients with a score of 3 or greater on the recurrence-predicting model. Conclusion: The recurrence-predicting model designed in this study may improve treatment selection of patients with stage I–III C disease. However, further studies are needed to validate the scores generated by this model.
KW - Breast cancer
KW - Cohort study
KW - HER2-positive breast cancer
KW - Prediction model
KW - Trastuzumab
UR - http://www.scopus.com/inward/record.url?scp=85079713537&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85079713537&partnerID=8YFLogxK
U2 - 10.1007/s12282-020-01057-4
DO - 10.1007/s12282-020-01057-4
M3 - Article
C2 - 32060785
AN - SCOPUS:85079713537
SN - 1340-6868
VL - 27
SP - 631
EP - 641
JO - Breast Cancer
JF - Breast Cancer
IS - 4
ER -