caa a22 4500 605491372 CHVBK 20210128100509.0 cr unu---uuuuu 210128e20150801xx s 000 0 eng 10.1007/s10147-015-0785-8 doi (NATIONALLICENCE)springer-10.1007/s10147-015-0785-8 Outcomes of trastuzumab therapy in HER2-positive early breast cancer patients [Elektronische Daten] [Hiroyasu Yamshiro, Hiroji Iwata, Norikazu Masuda, Naohito Yamamoto, Reiki Nishimura, Shoichiro Ohtani, Nobuki Sato, Masato Takahashi, Takako Kamio, Kosuke Yamazaki, Tsuyoshi Saito, Makoto Kato, Tecchuu Lee, Shinji Ohno, Katsumasa Kuroi, Toshimi Takano, Masahiro Takada, Shinji Yasuno, Satoshi Morita, Masakazu Toi] Background: Previous large trials with trastuzumab (TZM) showed improved outcome in patients with HER2-positive early-stage breast cancer. However, the efficacy and safety of TZM in Japanese patients have not been fully evaluated. We have therefore conducted an observational study in Japan. Methods: This was a retrospective and a prospective observational study in which data on women with histologically confirmed HER2-positive invasive breast cancer who received TZM for stage I-IIIC disease were collected from 56 institutions that participated in the Japan Breast Cancer Research Group and the efficacy of each treatment regimen analyzed. Results: A total of 2,024 patients treated between July 2009 and June 2011 were initially enrolled in this study; in August 2013, the patient cohort comprised 2,009 patients. Of these, 142 (7.5%) were aged ≥70 years, 1,097 (58.1%) had clinically node-negative (cN0) breast cancer, and 883 (47.4%) were estrogen receptor-positive. Treatment options were neoadjuvant therapy (662 patients) and adjuvant therapy with TZM (1,228 patients). Three-year overall survival (OS) rates in the entire cohort and in the neoadjuvant and adjuvant cohorts, respectively, were 98.9 [95% confidence interval (CI) 98.2-99.3], 98.3 (95% CI 96.8-99.1 %), and 99.2% (95% CI 98.4-99.6), respectively. Three-year disease-free survival (DFS) rates in the entire cohort and in the neoadjuvant and adjuvant cohorts, respectively were 94.2 (95% CI 93.0-95.2), 94.8 (95% CI 93.0-95.9), and 93.1 (95% CI 90.7-94.9 %), respectively. Multivariate analysis showed that age and nodal status negatively correlated with DFS. Age was the only factor which correlated with OS rate. Adverse events (AEs) associated with TZM and grade 3/4 AEs were reported in 356 (18.8%) and 14 (0.6 %) patients, respectively. Grade 3/4 cardiac toxicities were reported in 11 patients. Conclusion: Based on data from our patient cohort of Japanese women with HER2-positive early-stage breast cancer, the efficacy and safety of systemic therapy with TZM are comparable to data from previously conducted large trials. Progress in anti-HER2 therapy for patients aged ≥70 years who have a poorer prognosis is needed. Japan Society of Clinical Oncology, 2015 Trastuzumab nationallicence HER2-positive early-stage breast cancer nationallicence Cohort study nationallicence Japanese patient population nationallicence Treatment outcome nationallicence Yamshiro Hiroyasu Department of Breast Surgery, Tenri Hospital, 200 Mishima-cho, 632-8552, Tenri, Nara, Japan aut Iwata Hiroji Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, 464-8681, Nagoya, Aichi, Japan aut Masuda Norikazu Surgery, Breast Oncology, NHO Osaka National Hospital, 2-1-14 Hohenzaka, 540-0006, Chuo-ku, Osaka, Japan aut Yamamoto Naohito Division of Breast Surgery, Chiba Cancer Center, 666-2 Nitona-cho, 260-8717, Chuo-ku, Chiba, Japan aut Nishimura Reiki Department of Breast and Endocrine Surgery, Kumamoto City Hospital, 1-1-60 Kotoh, Higashi-ku, 862-8505, Kumamoto City, Kumamoto, Japan aut Ohtani Shoichiro Breast Surgery, Hiroshima City Hospital, 7-33 Motomachi, Naka-ku, 730-8518, Hiroshima-sh, Hiroshima, Japan aut Sato Nobuki Department of Breast Oncology, Niigata Cancer Center Hospital, 2-15-3 Kawagishi Town, 951-8566, Chuo-ku, Niigata, Japan aut Takahashi Masato Department of Breast Surgery, NHO Hokkaido Cancer Center, 4-2 Kikusui, Shiroishi-ku, 090-0011, Sapporo, Hokkaido, Japan aut Kamio Takako Department of Surgery II, Tokyo Women's Medical University, 8-1 Kawadacho, 162-8666, Shinjuku-ku, Tokyo, Japan aut Yamazaki Kosuke Japanese Red Cross Hokkaido, College of Nursing, 664-1 Akebono-cho, 090-0011, Kitami, Hokkaido, Japan aut Saito Tsuyoshi Department of Breast Surgery, Saitama Red Cross Hospital, 8-3-33 Kamiochiai, Chuo-ku, 338-8553, Saitama-shi, Saitama, Japan aut Kato Makoto Kato Breast Surgery Clinic, 8-12 Nishiojicho, 525-0037, Kusatsu, Shiga, Japan aut Lee Tecchuu Department of Breast Surgery, Japanese Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, 605-0981, Higashiyama-ku, Kyoto, Japan aut Ohno Shinji Clinical Research Institute, NHO Kyusyu Cancer Center, 3-1-1 Notame, 811-1395, Minami-ku, Fukuoka, Japan aut Kuroi Katsumasa Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, 113-8677, Bunkyo-ku, Tokyo, Japan aut Takano Toshimi Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, 105-8470, Minato-ku, Tokyo, Japan aut Takada Masahiro Department of Surgery (Breast Surgery), Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut Yasuno Shinji Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut Morita Satoshi Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut Toi Masakazu Department of Surgery (Breast Surgery), Graduate School of Medicine, Kyoto University, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut International Journal of Clinical Oncology Springer Japan 20/4(2015-08-01), 709-722 1341-9625 20:4<709 2015 20 10147 https://doi.org/10.1007/s10147-015-0785-8 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-015-0785-8 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Yamshiro Hiroyasu Department of Breast Surgery, Tenri Hospital, 200 Mishima-cho, 632-8552, Tenri, Nara, Japan aut NATIONALLICENCE 700 1- Iwata Hiroji Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, 464-8681, Nagoya, Aichi, Japan aut NATIONALLICENCE 700 1- Masuda Norikazu Surgery, Breast Oncology, NHO Osaka National Hospital, 2-1-14 Hohenzaka, 540-0006, Chuo-ku, Osaka, Japan aut NATIONALLICENCE 700 1- Yamamoto Naohito Division of Breast Surgery, Chiba Cancer Center, 666-2 Nitona-cho, 260-8717, Chuo-ku, Chiba, Japan aut NATIONALLICENCE 700 1- Nishimura Reiki Department of Breast and Endocrine Surgery, Kumamoto City Hospital, 1-1-60 Kotoh, Higashi-ku, 862-8505, Kumamoto City, Kumamoto, Japan aut NATIONALLICENCE 700 1- Ohtani Shoichiro Breast Surgery, Hiroshima City Hospital, 7-33 Motomachi, Naka-ku, 730-8518, Hiroshima-sh, Hiroshima, Japan aut NATIONALLICENCE 700 1- Sato Nobuki Department of Breast Oncology, Niigata Cancer Center Hospital, 2-15-3 Kawagishi Town, 951-8566, Chuo-ku, Niigata, Japan aut NATIONALLICENCE 700 1- Takahashi Masato Department of Breast Surgery, NHO Hokkaido Cancer Center, 4-2 Kikusui, Shiroishi-ku, 090-0011, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Kamio Takako Department of Surgery II, Tokyo Women's Medical University, 8-1 Kawadacho, 162-8666, Shinjuku-ku, Tokyo, Japan aut NATIONALLICENCE 700 1- Yamazaki Kosuke Japanese Red Cross Hokkaido, College of Nursing, 664-1 Akebono-cho, 090-0011, Kitami, Hokkaido, Japan aut NATIONALLICENCE 700 1- Saito Tsuyoshi Department of Breast Surgery, Saitama Red Cross Hospital, 8-3-33 Kamiochiai, Chuo-ku, 338-8553, Saitama-shi, Saitama, Japan aut NATIONALLICENCE 700 1- Kato Makoto Kato Breast Surgery Clinic, 8-12 Nishiojicho, 525-0037, Kusatsu, Shiga, Japan aut NATIONALLICENCE 700 1- Lee Tecchuu Department of Breast Surgery, Japanese Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, 605-0981, Higashiyama-ku, Kyoto, Japan aut NATIONALLICENCE 700 1- Ohno Shinji Clinical Research Institute, NHO Kyusyu Cancer Center, 3-1-1 Notame, 811-1395, Minami-ku, Fukuoka, Japan aut NATIONALLICENCE 700 1- Kuroi Katsumasa Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, 113-8677, Bunkyo-ku, Tokyo, Japan aut NATIONALLICENCE 700 1- Takano Toshimi Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, 105-8470, Minato-ku, Tokyo, Japan aut NATIONALLICENCE 700 1- Takada Masahiro Department of Surgery (Breast Surgery), Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut NATIONALLICENCE 700 1- Yasuno Shinji Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut NATIONALLICENCE 700 1- Morita Satoshi Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut NATIONALLICENCE 700 1- Toi Masakazu Department of Surgery (Breast Surgery), Graduate School of Medicine, Kyoto University, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/4(2015-08-01), 709-722 1341-9625 20:4<709 2015 20 10147