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Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404

PURPOSE: A prospective randomized clinical trial was conducted to evaluate the efficacy of tamoxifen plus doxorubicin and cyclophosphamide compared to tamoxifen plus tegafur-uracil as an adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC). METHODS: Eligibility criteria inclu...

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Autores principales: Shien, Tadahiko, Iwata, Hiroji, Fukutomi, Takashi, Inoue, Kenichi, Aogi, Kenjiro, Kinoshita, Takayuki, Ando, Jiro, Takashima, Seiki, Nakamura, Kenichi, Shibata, Taro, Fukuda, Haruhiko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4143604/
https://www.ncbi.nlm.nih.gov/pubmed/25055938
http://dx.doi.org/10.1007/s00280-014-2545-2
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author Shien, Tadahiko
Iwata, Hiroji
Fukutomi, Takashi
Inoue, Kenichi
Aogi, Kenjiro
Kinoshita, Takayuki
Ando, Jiro
Takashima, Seiki
Nakamura, Kenichi
Shibata, Taro
Fukuda, Haruhiko
author_facet Shien, Tadahiko
Iwata, Hiroji
Fukutomi, Takashi
Inoue, Kenichi
Aogi, Kenjiro
Kinoshita, Takayuki
Ando, Jiro
Takashima, Seiki
Nakamura, Kenichi
Shibata, Taro
Fukuda, Haruhiko
author_sort Shien, Tadahiko
collection PubMed
description PURPOSE: A prospective randomized clinical trial was conducted to evaluate the efficacy of tamoxifen plus doxorubicin and cyclophosphamide compared to tamoxifen plus tegafur-uracil as an adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC). METHODS: Eligibility criteria included pathologically node-positive (n = 1–9) preMBC with curative resection, in stages I–IIIA. Patients were randomized to receive either tamoxifen 20 mg/day plus tegafur-uracil 400 mg/day (TU) for 2 years or six courses of a 28-day cycle of doxorubicin 40 mg/m(2) plus cyclophosphamide 500 mg/m(2) on day 1 along with tamoxifen (ACT) given for 2 years as adjuvant therapy. Primary endpoint was overall survival (OS), and secondary endpoint was recurrence-free survival (RFS). RESULTS: In total, 169 patients were recruited (TU arm 87, ACT arm 82) between October 1994 and September 1999. The HR for OS was 0.76 (95 % CI 0.35, 1.66, log-rank p = 0.49) and that for RFS was 0.77 (95 % CI 0.44, 1.36, log-rank p = 0.37), with ACT resulting in a better HR. The 5-year OS was 79.7 % for patients in the TU arm and 83 % for those in the ACT arm. The 5-year RFS was 66.1 % for patients in the TU arm and 70.6 % for those in the ACT arm. A higher proportion of patients in the ACT arm experienced grade 3 leucopenia (0 % in the TU arm, 4 % in the ACT arm). CONCLUSIONS: There were no significant differences in the efficacy of TU and ACT as adjuvant therapy.
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spelling pubmed-41436042014-08-26 Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404 Shien, Tadahiko Iwata, Hiroji Fukutomi, Takashi Inoue, Kenichi Aogi, Kenjiro Kinoshita, Takayuki Ando, Jiro Takashima, Seiki Nakamura, Kenichi Shibata, Taro Fukuda, Haruhiko Cancer Chemother Pharmacol Original Article PURPOSE: A prospective randomized clinical trial was conducted to evaluate the efficacy of tamoxifen plus doxorubicin and cyclophosphamide compared to tamoxifen plus tegafur-uracil as an adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC). METHODS: Eligibility criteria included pathologically node-positive (n = 1–9) preMBC with curative resection, in stages I–IIIA. Patients were randomized to receive either tamoxifen 20 mg/day plus tegafur-uracil 400 mg/day (TU) for 2 years or six courses of a 28-day cycle of doxorubicin 40 mg/m(2) plus cyclophosphamide 500 mg/m(2) on day 1 along with tamoxifen (ACT) given for 2 years as adjuvant therapy. Primary endpoint was overall survival (OS), and secondary endpoint was recurrence-free survival (RFS). RESULTS: In total, 169 patients were recruited (TU arm 87, ACT arm 82) between October 1994 and September 1999. The HR for OS was 0.76 (95 % CI 0.35, 1.66, log-rank p = 0.49) and that for RFS was 0.77 (95 % CI 0.44, 1.36, log-rank p = 0.37), with ACT resulting in a better HR. The 5-year OS was 79.7 % for patients in the TU arm and 83 % for those in the ACT arm. The 5-year RFS was 66.1 % for patients in the TU arm and 70.6 % for those in the ACT arm. A higher proportion of patients in the ACT arm experienced grade 3 leucopenia (0 % in the TU arm, 4 % in the ACT arm). CONCLUSIONS: There were no significant differences in the efficacy of TU and ACT as adjuvant therapy. Springer Berlin Heidelberg 2014-07-24 2014 /pmc/articles/PMC4143604/ /pubmed/25055938 http://dx.doi.org/10.1007/s00280-014-2545-2 Text en © The Author(s) 2014 https://creativecommons.org/licenses/by/4.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Article
Shien, Tadahiko
Iwata, Hiroji
Fukutomi, Takashi
Inoue, Kenichi
Aogi, Kenjiro
Kinoshita, Takayuki
Ando, Jiro
Takashima, Seiki
Nakamura, Kenichi
Shibata, Taro
Fukuda, Haruhiko
Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404
title Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404
title_full Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404
title_fullStr Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404
title_full_unstemmed Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404
title_short Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404
title_sort tamoxifen plus tegafur-uracil (tuft) versus tamoxifen plus adriamycin (doxorubicin) and cyclophosphamide (act) as adjuvant therapy to treat node-positive premenopausal breast cancer (prembc): results of japan clinical oncology group study 9404
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4143604/
https://www.ncbi.nlm.nih.gov/pubmed/25055938
http://dx.doi.org/10.1007/s00280-014-2545-2
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