Tamoxifen versus tamoxifen plus doxorubicin and cyclophosphamide as adjuvant therapy for node-positive postmenopausal breast cancer: results of a Japan Clinical Oncology Group Study (JCOG9401)

Tadahiko Shien, Hiroji Iwata, Kenjiro Aogi, Takashi Fukutomi, Kenichi Inoue, Takayuki Kinoshita, Masato Takahashi, Akira Matsui, Taro Shibata, Haruhiko Fukuda

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Abstract

Background: Cancer subtype has recently become an increasingly important consideration when deciding the treatment strategy for breast cancer. For the estrogen receptor positive (ER+) subtype, the efficacy of adjuvant endocrine therapy is definitive, but that of adjuvant chemotherapy is controversial.

Results: One hundred twenty-nine patients were recruited (TAM 64, ACT 65) between October 1994 and July 1999. The hazard ratios for OS and relapse-free survival (RFS) were 0.58 (95 % CI 0.24–1.39; log-rank p = 0.22) and 0.45 (95 %CI 0.24–0.86; log-rank p = 0.013), respectively, in favor of ACT. The 5-year OS and RFS were 76.9 % (ER+ 87.1 %, ER− 53.3 %) and 54.9 % (ER+ 59.3 %, ER− 42.9 %) for TAM and 85.0 % (ER+ 90.0 %, ER− 77.1 %) and 76.7 % (ER+ 76.9 %, ER− 76.0 %) for ACT. A higher proportion of the patients receiving ACT than those receiving TAM experienced grade 3 decreased white blood cell count and grade 2–3 nausea.

Methods: In order to evaluate the effect of adding doxorubicin (A) and cyclophosphamide (C) to tamoxifen (TAM) (ACT) on the overall survival (OS) of node-positive postmenopausal breast cancer (PMBC) patients, we conducted a randomized trial. Eligibility criteria included pathologically node-positive (n = 1–9) PMBC, stage I–IIIA disease. Patients were randomized to receive either TAM (20 mg daily) for 2 years or A (40 mg/m2) and C (500 mg/m2) plus TAM (ACT) as adjuvant therapy following surgery.

Conclusion: The efficacy of adding AC to TAM was not high for ER+, node-positive PMBC. However, adjuvant ACT therapy was considered to be effective for ER−, node-positive PMBC.

Original languageEnglish
Pages (from-to)982-988
Number of pages7
JournalInternational Journal of Clinical Oncology
Volume19
Issue number6
DOIs
Publication statusPublished - Dec 10 2014

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Medical Oncology
Tamoxifen
Doxorubicin
Cyclophosphamide
Japan
Breast Neoplasms
Survival
Therapeutics
Recurrence
Adjuvant Chemotherapy
Leukocyte Count
Estrogen Receptors
Nausea
Neoplasms

Keywords

  • Adjuvant treatment
  • Breast cancer
  • Node-positive
  • Postmenopausal women

ASJC Scopus subject areas

  • Oncology
  • Surgery
  • Hematology
  • Medicine(all)

Cite this

Tamoxifen versus tamoxifen plus doxorubicin and cyclophosphamide as adjuvant therapy for node-positive postmenopausal breast cancer : results of a Japan Clinical Oncology Group Study (JCOG9401). / Shien, Tadahiko; Iwata, Hiroji; Aogi, Kenjiro; Fukutomi, Takashi; Inoue, Kenichi; Kinoshita, Takayuki; Takahashi, Masato; Matsui, Akira; Shibata, Taro; Fukuda, Haruhiko.

In: International Journal of Clinical Oncology, Vol. 19, No. 6, 10.12.2014, p. 982-988.

Research output: Contribution to journalArticle

Shien, Tadahiko ; Iwata, Hiroji ; Aogi, Kenjiro ; Fukutomi, Takashi ; Inoue, Kenichi ; Kinoshita, Takayuki ; Takahashi, Masato ; Matsui, Akira ; Shibata, Taro ; Fukuda, Haruhiko. / Tamoxifen versus tamoxifen plus doxorubicin and cyclophosphamide as adjuvant therapy for node-positive postmenopausal breast cancer : results of a Japan Clinical Oncology Group Study (JCOG9401). In: International Journal of Clinical Oncology. 2014 ; Vol. 19, No. 6. pp. 982-988.
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abstract = "Background: Cancer subtype has recently become an increasingly important consideration when deciding the treatment strategy for breast cancer. For the estrogen receptor positive (ER+) subtype, the efficacy of adjuvant endocrine therapy is definitive, but that of adjuvant chemotherapy is controversial.Results: One hundred twenty-nine patients were recruited (TAM 64, ACT 65) between October 1994 and July 1999. The hazard ratios for OS and relapse-free survival (RFS) were 0.58 (95 {\%} CI 0.24–1.39; log-rank p = 0.22) and 0.45 (95 {\%}CI 0.24–0.86; log-rank p = 0.013), respectively, in favor of ACT. The 5-year OS and RFS were 76.9 {\%} (ER+ 87.1 {\%}, ER− 53.3 {\%}) and 54.9 {\%} (ER+ 59.3 {\%}, ER− 42.9 {\%}) for TAM and 85.0 {\%} (ER+ 90.0 {\%}, ER− 77.1 {\%}) and 76.7 {\%} (ER+ 76.9 {\%}, ER− 76.0 {\%}) for ACT. A higher proportion of the patients receiving ACT than those receiving TAM experienced grade 3 decreased white blood cell count and grade 2–3 nausea.Methods: In order to evaluate the effect of adding doxorubicin (A) and cyclophosphamide (C) to tamoxifen (TAM) (ACT) on the overall survival (OS) of node-positive postmenopausal breast cancer (PMBC) patients, we conducted a randomized trial. Eligibility criteria included pathologically node-positive (n = 1–9) PMBC, stage I–IIIA disease. Patients were randomized to receive either TAM (20 mg daily) for 2 years or A (40 mg/m2) and C (500 mg/m2) plus TAM (ACT) as adjuvant therapy following surgery.Conclusion: The efficacy of adding AC to TAM was not high for ER+, node-positive PMBC. However, adjuvant ACT therapy was considered to be effective for ER−, node-positive PMBC.",
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T2 - results of a Japan Clinical Oncology Group Study (JCOG9401)

AU - Shien, Tadahiko

AU - Iwata, Hiroji

AU - Aogi, Kenjiro

AU - Fukutomi, Takashi

AU - Inoue, Kenichi

AU - Kinoshita, Takayuki

AU - Takahashi, Masato

AU - Matsui, Akira

AU - Shibata, Taro

AU - Fukuda, Haruhiko

PY - 2014/12/10

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N2 - Background: Cancer subtype has recently become an increasingly important consideration when deciding the treatment strategy for breast cancer. For the estrogen receptor positive (ER+) subtype, the efficacy of adjuvant endocrine therapy is definitive, but that of adjuvant chemotherapy is controversial.Results: One hundred twenty-nine patients were recruited (TAM 64, ACT 65) between October 1994 and July 1999. The hazard ratios for OS and relapse-free survival (RFS) were 0.58 (95 % CI 0.24–1.39; log-rank p = 0.22) and 0.45 (95 %CI 0.24–0.86; log-rank p = 0.013), respectively, in favor of ACT. The 5-year OS and RFS were 76.9 % (ER+ 87.1 %, ER− 53.3 %) and 54.9 % (ER+ 59.3 %, ER− 42.9 %) for TAM and 85.0 % (ER+ 90.0 %, ER− 77.1 %) and 76.7 % (ER+ 76.9 %, ER− 76.0 %) for ACT. A higher proportion of the patients receiving ACT than those receiving TAM experienced grade 3 decreased white blood cell count and grade 2–3 nausea.Methods: In order to evaluate the effect of adding doxorubicin (A) and cyclophosphamide (C) to tamoxifen (TAM) (ACT) on the overall survival (OS) of node-positive postmenopausal breast cancer (PMBC) patients, we conducted a randomized trial. Eligibility criteria included pathologically node-positive (n = 1–9) PMBC, stage I–IIIA disease. Patients were randomized to receive either TAM (20 mg daily) for 2 years or A (40 mg/m2) and C (500 mg/m2) plus TAM (ACT) as adjuvant therapy following surgery.Conclusion: The efficacy of adding AC to TAM was not high for ER+, node-positive PMBC. However, adjuvant ACT therapy was considered to be effective for ER−, node-positive PMBC.

AB - Background: Cancer subtype has recently become an increasingly important consideration when deciding the treatment strategy for breast cancer. For the estrogen receptor positive (ER+) subtype, the efficacy of adjuvant endocrine therapy is definitive, but that of adjuvant chemotherapy is controversial.Results: One hundred twenty-nine patients were recruited (TAM 64, ACT 65) between October 1994 and July 1999. The hazard ratios for OS and relapse-free survival (RFS) were 0.58 (95 % CI 0.24–1.39; log-rank p = 0.22) and 0.45 (95 %CI 0.24–0.86; log-rank p = 0.013), respectively, in favor of ACT. The 5-year OS and RFS were 76.9 % (ER+ 87.1 %, ER− 53.3 %) and 54.9 % (ER+ 59.3 %, ER− 42.9 %) for TAM and 85.0 % (ER+ 90.0 %, ER− 77.1 %) and 76.7 % (ER+ 76.9 %, ER− 76.0 %) for ACT. A higher proportion of the patients receiving ACT than those receiving TAM experienced grade 3 decreased white blood cell count and grade 2–3 nausea.Methods: In order to evaluate the effect of adding doxorubicin (A) and cyclophosphamide (C) to tamoxifen (TAM) (ACT) on the overall survival (OS) of node-positive postmenopausal breast cancer (PMBC) patients, we conducted a randomized trial. Eligibility criteria included pathologically node-positive (n = 1–9) PMBC, stage I–IIIA disease. Patients were randomized to receive either TAM (20 mg daily) for 2 years or A (40 mg/m2) and C (500 mg/m2) plus TAM (ACT) as adjuvant therapy following surgery.Conclusion: The efficacy of adding AC to TAM was not high for ER+, node-positive PMBC. However, adjuvant ACT therapy was considered to be effective for ER−, node-positive PMBC.

KW - Adjuvant treatment

KW - Breast cancer

KW - Node-positive

KW - Postmenopausal women

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