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

Tadahiko Shien, Hiroji Iwata, Takashi Fukutomi, Kenichi Inoue, Kenjiro Aogi, Takayuki Kinoshita, Jiro Ando, Seiki Takashima, Kenichi Nakamura, Taro Shibata, Haruhiko Fukuda

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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/m2 plus cyclophosphamide 500 mg/m2 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.

Original languageEnglish
Pages (from-to)603-609
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume74
Issue number3
DOIs
Publication statusPublished - 2014

Fingerprint

Tegafur
Oncology
Uracil
Medical Oncology
Tamoxifen
Doxorubicin
Cyclophosphamide
Japan
Breast Neoplasms
Survival
Recurrence
Therapeutics
Leukopenia
Randomized Controlled Trials

Keywords

  • Adjuvant treatment
  • Breast cancer
  • Node-positive
  • Premenopausal

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

Cite this

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.

In: Cancer Chemotherapy and Pharmacology, Vol. 74, No. 3, 2014, p. 603-609.

Research output: Contribution to journalArticle

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. In: Cancer Chemotherapy and Pharmacology. 2014 ; Vol. 74, No. 3. pp. 603-609.
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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",
abstract = "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/m2 plus cyclophosphamide 500 mg/m2 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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T1 - Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC)

T2 - Results of Japan Clinical Oncology Group Study 9404

AU - Shien, Tadahiko

AU - Iwata, Hiroji

AU - Fukutomi, Takashi

AU - Inoue, Kenichi

AU - Aogi, Kenjiro

AU - Kinoshita, Takayuki

AU - Ando, Jiro

AU - Takashima, Seiki

AU - Nakamura, Kenichi

AU - Shibata, Taro

AU - Fukuda, Haruhiko

PY - 2014

Y1 - 2014

N2 - 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/m2 plus cyclophosphamide 500 mg/m2 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.

AB - 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/m2 plus cyclophosphamide 500 mg/m2 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.

KW - Adjuvant treatment

KW - Breast cancer

KW - Node-positive

KW - Premenopausal

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