Academic Journal
A randomized study comparing docetaxel/cyclophosphamide (TC), 5-fluorouracil/epirubicin/cyclophosphamide (FEC) followed by TC, and TC followed by FEC for patients with hormone receptor-positive HER2-negative primary breast cancer
| العنوان: | A randomized study comparing docetaxel/cyclophosphamide (TC), 5-fluorouracil/epirubicin/cyclophosphamide (FEC) followed by TC, and TC followed by FEC for patients with hormone receptor-positive HER2-negative primary breast cancer |
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| المؤلفون: | Ishiguro, Hiroshi, Masuda, Norikazu, Sato, Nobuaki, Higaki, Kenji, Morimoto, Takashi, Yanagita, Yasuhiro, Mizutani, Makiko, Ohtani, Shoichiro, Kaneko, Koji, Fujisawa, Tomomi, Takahashi, Masato, Kadoya, Takayuki, Matsunami, Nobuki, Yamamoto, Yutaka, Ohno, Shinji, Takano, Toshimi, Morita, Satoshi, Tanaka-Mizuno, Sachiko, Toi, Masakazu |
| المساهمون: | Sanofi K.K. |
| المصدر: | Breast Cancer Research and Treatment ; volume 180, issue 3, page 715-724 ; ISSN 0167-6806 1573-7217 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2020 |
| الوصف: | Purpose Our primary objective was to determine the benefit/risk of anthracycline-free regimens by comparing docetaxel + cyclophosphamide (TC) alone, fluorouracil + epirubicin + cyclophosphamide (FEC) followed by TC, or TC followed by FEC as a primary treatment for patients with HR-positive, HER2-negative BC. Methods We randomized patients with stage I–III HR-positive HER2-negative, operable BC to receive either six cycles of TC (TC6), three cycles of FEC followed by three cycles of TC (FEC-TC), or three cycles of TC followed by three cycles of FEC (TC-FEC). The primary endpoint was the pathological response. Secondary endpoints included clinical response, type of surgical procedure, recurrence, death, and adverse events (by NCI-Common Terminology Criteria for Adverse Events v.3.0). We conducted all statistical analyses using SAS Version 9.2. Results We enrolled 195 patients and analyzed data from 193 as the intention-to-treat population. Pathological complete response rates were numerically higher in the TC6 group than in the other groups ( p = 0.321). The breast conservation rate was significantly higher in the TC6 group (73%) than in the other groups (FEC-TC 51%, TC-FEC 45%, p = 0.007). Adverse events with grade > 3 were not common in the treatment groups ( p = 0.569). The overall and distant disease-free survivals were similar among the groups with median follow-up of 5.80 years. Conclusions Despite similar long-term efficacy and safety profile, the higher breast conservation rate in the TC6 group suggests that preoperative chemotherapy without an anthracycline may benefit patients with HR-positive HER2-negative BC. Trial registration UMIN000003283 https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003873 . |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1007/s10549-020-05590-w |
| DOI: | 10.1007/s10549-020-05590-w.pdf |
| DOI: | 10.1007/s10549-020-05590-w/fulltext.html |
| الاتاحة: | http://dx.doi.org/10.1007/s10549-020-05590-w https://link.springer.com/content/pdf/10.1007/s10549-020-05590-w.pdf https://link.springer.com/article/10.1007/s10549-020-05590-w/fulltext.html |
| Rights: | https://creativecommons.org/licenses/by/4.0 ; https://creativecommons.org/licenses/by/4.0 |
| رقم الانضمام: | edsbas.45A84744 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1007/s10549-020-05590-w |
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