Abstract | BACKGROUND: AIM: METHOD: An observational study was conducted on patients who relapsed after primary systemic therapy with TZM using the central registration system. The primary end point was progression-free survival (PFS). Secondary end points consisted of the response rate, overall survival (OS), and safety. RESULT: In total, 34 patients were registered between July 2009 and June 2012. The median follow-up time was 23.7 months (2-24 months). The 1- and 2-year PFS rates were 46.9% (95% confidence interval (95% CI): 29.2%-62.9%) and 29.8% (95% CI: 15.0%-46.3%), respectively (median 10.6 months). The median PFS time for patients receiving TZM combined with CTx was 13.9 months. The 1-and 2-year OR rates were 93.9 (95% CI: 77.9%-98.4%) and 84.8% (95% CI: 67.4%-93.4%). Trastuzumab-induced grade 3/4 adverse events were not observed. CONCLUSIONS: This study suggests that the PFS and OS in Japanese patients who relapsed after perioperative TZM therapy improved or were similar to those in previous reports. Differences in patient backgrounds and treatments must be considered when interpreting the results. Trastuzumab should be used combination with CTx and/or HTx for retreatment. Retreatment with TZM is safe.Trial registration: UMIN000002738.
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Authors | Hiroyasu Yamashiro, Masataka Sawaki, Norikazu Masuda, Yasuhiro Okumura, Toshimi Takano, Eriko Tokunaga, Tsuyoshi Saito, Yasuaki Sagara, Kosuke Yamazaki, Yoshihiro Kawaguchi, Tecchuu Lee, Shinji Ozaki, Kazuhiko Yamagami, Naohito Yamamoto, Katsumasa Kuroi, Hirofumi Suwa, Shoichiro Ohtani, Toshikazu Ito, Shinji Yasuno, Satoshi Morita, Shinji Ohno, Masakazu Toi |
Journal | Breast cancer : basic and clinical research
(Breast Cancer (Auckl))
Vol. 12
Pg. 1178223418786243
( 2018)
ISSN: 1178-2234 [Print] United States |
PMID | 30013356
(Publication Type: Journal Article)
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