Outcomes of trastuzumab therapy in HER2-positive early breast cancer patients

Verfasser / Beitragende:
[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]
Ort, Verlag, Jahr:
2015
Enthalten in:
International Journal of Clinical Oncology, 20/4(2015-08-01), 709-722
Format:
Artikel (online)
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245 0 0 |a Outcomes of trastuzumab therapy in HER2-positive early breast cancer patients  |h [Elektronische Daten]  |c [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] 
520 3 |a 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. 
540 |a Japan Society of Clinical Oncology, 2015 
690 7 |a Trastuzumab  |2 nationallicence 
690 7 |a HER2-positive early-stage breast cancer  |2 nationallicence 
690 7 |a Cohort study  |2 nationallicence 
690 7 |a Japanese patient population  |2 nationallicence 
690 7 |a Treatment outcome  |2 nationallicence 
700 1 |a Yamshiro  |D Hiroyasu  |u Department of Breast Surgery, Tenri Hospital, 200 Mishima-cho, 632-8552, Tenri, Nara, Japan  |4 aut 
700 1 |a Iwata  |D Hiroji  |u Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, 464-8681, Nagoya, Aichi, Japan  |4 aut 
700 1 |a Masuda  |D Norikazu  |u Surgery, Breast Oncology, NHO Osaka National Hospital, 2-1-14 Hohenzaka, 540-0006, Chuo-ku, Osaka, Japan  |4 aut 
700 1 |a Yamamoto  |D Naohito  |u Division of Breast Surgery, Chiba Cancer Center, 666-2 Nitona-cho, 260-8717, Chuo-ku, Chiba, Japan  |4 aut 
700 1 |a Nishimura  |D Reiki  |u Department of Breast and Endocrine Surgery, Kumamoto City Hospital, 1-1-60 Kotoh, Higashi-ku, 862-8505, Kumamoto City, Kumamoto, Japan  |4 aut 
700 1 |a Ohtani  |D Shoichiro  |u Breast Surgery, Hiroshima City Hospital, 7-33 Motomachi, Naka-ku, 730-8518, Hiroshima-sh, Hiroshima, Japan  |4 aut 
700 1 |a Sato  |D Nobuki  |u Department of Breast Oncology, Niigata Cancer Center Hospital, 2-15-3 Kawagishi Town, 951-8566, Chuo-ku, Niigata, Japan  |4 aut 
700 1 |a Takahashi  |D Masato  |u Department of Breast Surgery, NHO Hokkaido Cancer Center, 4-2 Kikusui, Shiroishi-ku, 090-0011, Sapporo, Hokkaido, Japan  |4 aut 
700 1 |a Kamio  |D Takako  |u Department of Surgery II, Tokyo Women's Medical University, 8-1 Kawadacho, 162-8666, Shinjuku-ku, Tokyo, Japan  |4 aut 
700 1 |a Yamazaki  |D Kosuke  |u Japanese Red Cross Hokkaido, College of Nursing, 664-1 Akebono-cho, 090-0011, Kitami, Hokkaido, Japan  |4 aut 
700 1 |a Saito  |D Tsuyoshi  |u Department of Breast Surgery, Saitama Red Cross Hospital, 8-3-33 Kamiochiai, Chuo-ku, 338-8553, Saitama-shi, Saitama, Japan  |4 aut 
700 1 |a Kato  |D Makoto  |u Kato Breast Surgery Clinic, 8-12 Nishiojicho, 525-0037, Kusatsu, Shiga, Japan  |4 aut 
700 1 |a Lee  |D Tecchuu  |u Department of Breast Surgery, Japanese Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, 605-0981, Higashiyama-ku, Kyoto, Japan  |4 aut 
700 1 |a Ohno  |D Shinji  |u Clinical Research Institute, NHO Kyusyu Cancer Center, 3-1-1 Notame, 811-1395, Minami-ku, Fukuoka, Japan  |4 aut 
700 1 |a Kuroi  |D Katsumasa  |u Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, 113-8677, Bunkyo-ku, Tokyo, Japan  |4 aut 
700 1 |a Takano  |D Toshimi  |u Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, 105-8470, Minato-ku, Tokyo, Japan  |4 aut 
700 1 |a Takada  |D Masahiro  |u Department of Surgery (Breast Surgery), Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
700 1 |a Yasuno  |D Shinji  |u Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
700 1 |a Morita  |D Satoshi  |u Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
700 1 |a Toi  |D Masakazu  |u Department of Surgery (Breast Surgery), Graduate School of Medicine, Kyoto University, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
773 0 |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/4(2015-08-01), 709-722  |x 1341-9625  |q 20:4<709  |1 2015  |2 20  |o 10147 
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900 7 |a Metadata rights reserved  |b Springer special CC-BY-NC licence  |2 nationallicence 
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950 |B NATIONALLICENCE  |P 700  |E 1-  |a Yamshiro  |D Hiroyasu  |u Department of Breast Surgery, Tenri Hospital, 200 Mishima-cho, 632-8552, Tenri, Nara, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Iwata  |D Hiroji  |u Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, 464-8681, Nagoya, Aichi, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Masuda  |D Norikazu  |u Surgery, Breast Oncology, NHO Osaka National Hospital, 2-1-14 Hohenzaka, 540-0006, Chuo-ku, Osaka, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Yamamoto  |D Naohito  |u Division of Breast Surgery, Chiba Cancer Center, 666-2 Nitona-cho, 260-8717, Chuo-ku, Chiba, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Nishimura  |D Reiki  |u Department of Breast and Endocrine Surgery, Kumamoto City Hospital, 1-1-60 Kotoh, Higashi-ku, 862-8505, Kumamoto City, Kumamoto, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Ohtani  |D Shoichiro  |u Breast Surgery, Hiroshima City Hospital, 7-33 Motomachi, Naka-ku, 730-8518, Hiroshima-sh, Hiroshima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Sato  |D Nobuki  |u Department of Breast Oncology, Niigata Cancer Center Hospital, 2-15-3 Kawagishi Town, 951-8566, Chuo-ku, Niigata, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Takahashi  |D Masato  |u Department of Breast Surgery, NHO Hokkaido Cancer Center, 4-2 Kikusui, Shiroishi-ku, 090-0011, Sapporo, Hokkaido, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Kamio  |D Takako  |u Department of Surgery II, Tokyo Women's Medical University, 8-1 Kawadacho, 162-8666, Shinjuku-ku, Tokyo, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Yamazaki  |D Kosuke  |u Japanese Red Cross Hokkaido, College of Nursing, 664-1 Akebono-cho, 090-0011, Kitami, Hokkaido, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Saito  |D Tsuyoshi  |u Department of Breast Surgery, Saitama Red Cross Hospital, 8-3-33 Kamiochiai, Chuo-ku, 338-8553, Saitama-shi, Saitama, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Kato  |D Makoto  |u Kato Breast Surgery Clinic, 8-12 Nishiojicho, 525-0037, Kusatsu, Shiga, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Lee  |D Tecchuu  |u Department of Breast Surgery, Japanese Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, 605-0981, Higashiyama-ku, Kyoto, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Ohno  |D Shinji  |u Clinical Research Institute, NHO Kyusyu Cancer Center, 3-1-1 Notame, 811-1395, Minami-ku, Fukuoka, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Kuroi  |D Katsumasa  |u Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, 113-8677, Bunkyo-ku, Tokyo, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Takano  |D Toshimi  |u Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, 105-8470, Minato-ku, Tokyo, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Takada  |D Masahiro  |u Department of Surgery (Breast Surgery), Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Yasuno  |D Shinji  |u Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Morita  |D Satoshi  |u Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Toi  |D Masakazu  |u Department of Surgery (Breast Surgery), Graduate School of Medicine, Kyoto University, 54 Kawaharacho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 773  |E 0-  |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/4(2015-08-01), 709-722  |x 1341-9625  |q 20:4<709  |1 2015  |2 20  |o 10147