Feasibility study of docetaxel with cyclophosphamide as adjuvant chemotherapy for Japanese Breast Cancer patients

Daisuke Takabatake, Naruto Taira, Fumikata Hara, Tadahiko Sien, Sachiko Kiyoto, Seiki Takashima, Kenjiro Aogi, Shozo Ohsumi, Hiroyoshi Doihara, Shigemitu Takashima

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Abstract

Objective: The 7-year follow-up of the US oncology 9735 trial demonstrated the superiority of TC [docetaxel (DTX)/cyclophosphamide (CPA)] to doxorubicin/CPA therapy. To introduce TC therapy in Japan, the verification of the safety and tolerability is essential. We performed a collaborative prospective safety study with Okayama University to introduce TC therapy. Methods: The subjects were 53 patients aged from 33 to 67 years at intermediate risk based on the St Gallen risk classification who underwent radical surgery for primary breast cancer between August 2007 and December 2008. As post-operative adjuvant chemotherapy, four cycles of TC (DTX 75 mg/m2 + CPA 600 mg/m2) were administered at 3-week intervals. Adverse events were evaluated based on National Cancer Institute - Common Terminology Criteria for Adverse Events ver. 3.0. The safety and completion rate were evaluated as the primary and secondary endpoints, respectively. Results: Regarding hematological toxicity, Grade (G) 4 neutropenia occurred in 71.7% and G3 in 26.4%. G3-4 leukopenia developed in 32.1% and 56.6%, respectively, G4 anemia in 1.9% and G1-2 anemia in 26.4%. Regarding non-hematological toxicity, systemic malaise, skin eruption, edema, myalgia, arthralgia and nausea were noted in most patients. The completion rate was 94.3%, dose reduction was necessary in 7.5% and granulocyte colony-stimulating factor (G-CSF) support was required in 17.0%. On comparison between patients aged 65 years or older and younger than 65 years, the completion rate, dose reduction and incidence of febrile neutropenia (FN) were higher in the elderly patients. G-CSF support was more often needed in this subgroup. Conclusions: TC therapy is tolerable for Japanese patients, but attention should be paid to the development of FN and neutropenia. The completion rate was lower in the elderly patients, showing that tolerability was not necessarily favorable.

Original languageEnglish
Pages (from-to)478-483
Number of pages6
JournalJapanese Journal of Clinical Oncology
Volume39
Issue number8
DOIs
Publication statusPublished - 2009

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docetaxel
Feasibility Studies
Adjuvant Chemotherapy
Cyclophosphamide
Breast Neoplasms
Febrile Neutropenia
Granulocyte Colony-Stimulating Factor
Neutropenia
Safety
Anemia
National Cancer Institute (U.S.)
Myalgia
Leukopenia
Arthralgia
Therapeutics
Terminology
Doxorubicin
Nausea
Edema
Japan

Keywords

  • Adjuvant therapy
  • Breast cancer
  • Cyclophosphamide
  • Docetaxel
  • Safety

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Feasibility study of docetaxel with cyclophosphamide as adjuvant chemotherapy for Japanese Breast Cancer patients. / Takabatake, Daisuke; Taira, Naruto; Hara, Fumikata; Sien, Tadahiko; Kiyoto, Sachiko; Takashima, Seiki; Aogi, Kenjiro; Ohsumi, Shozo; Doihara, Hiroyoshi; Takashima, Shigemitu.

In: Japanese Journal of Clinical Oncology, Vol. 39, No. 8, 2009, p. 478-483.

Research output: Contribution to journalArticle

Takabatake, Daisuke ; Taira, Naruto ; Hara, Fumikata ; Sien, Tadahiko ; Kiyoto, Sachiko ; Takashima, Seiki ; Aogi, Kenjiro ; Ohsumi, Shozo ; Doihara, Hiroyoshi ; Takashima, Shigemitu. / Feasibility study of docetaxel with cyclophosphamide as adjuvant chemotherapy for Japanese Breast Cancer patients. In: Japanese Journal of Clinical Oncology. 2009 ; Vol. 39, No. 8. pp. 478-483.
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abstract = "Objective: The 7-year follow-up of the US oncology 9735 trial demonstrated the superiority of TC [docetaxel (DTX)/cyclophosphamide (CPA)] to doxorubicin/CPA therapy. To introduce TC therapy in Japan, the verification of the safety and tolerability is essential. We performed a collaborative prospective safety study with Okayama University to introduce TC therapy. Methods: The subjects were 53 patients aged from 33 to 67 years at intermediate risk based on the St Gallen risk classification who underwent radical surgery for primary breast cancer between August 2007 and December 2008. As post-operative adjuvant chemotherapy, four cycles of TC (DTX 75 mg/m2 + CPA 600 mg/m2) were administered at 3-week intervals. Adverse events were evaluated based on National Cancer Institute - Common Terminology Criteria for Adverse Events ver. 3.0. The safety and completion rate were evaluated as the primary and secondary endpoints, respectively. Results: Regarding hematological toxicity, Grade (G) 4 neutropenia occurred in 71.7{\%} and G3 in 26.4{\%}. G3-4 leukopenia developed in 32.1{\%} and 56.6{\%}, respectively, G4 anemia in 1.9{\%} and G1-2 anemia in 26.4{\%}. Regarding non-hematological toxicity, systemic malaise, skin eruption, edema, myalgia, arthralgia and nausea were noted in most patients. The completion rate was 94.3{\%}, dose reduction was necessary in 7.5{\%} and granulocyte colony-stimulating factor (G-CSF) support was required in 17.0{\%}. On comparison between patients aged 65 years or older and younger than 65 years, the completion rate, dose reduction and incidence of febrile neutropenia (FN) were higher in the elderly patients. G-CSF support was more often needed in this subgroup. Conclusions: TC therapy is tolerable for Japanese patients, but attention should be paid to the development of FN and neutropenia. The completion rate was lower in the elderly patients, showing that tolerability was not necessarily favorable.",
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AU - Takabatake, Daisuke

AU - Taira, Naruto

AU - Hara, Fumikata

AU - Sien, Tadahiko

AU - Kiyoto, Sachiko

AU - Takashima, Seiki

AU - Aogi, Kenjiro

AU - Ohsumi, Shozo

AU - Doihara, Hiroyoshi

AU - Takashima, Shigemitu

PY - 2009

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N2 - Objective: The 7-year follow-up of the US oncology 9735 trial demonstrated the superiority of TC [docetaxel (DTX)/cyclophosphamide (CPA)] to doxorubicin/CPA therapy. To introduce TC therapy in Japan, the verification of the safety and tolerability is essential. We performed a collaborative prospective safety study with Okayama University to introduce TC therapy. Methods: The subjects were 53 patients aged from 33 to 67 years at intermediate risk based on the St Gallen risk classification who underwent radical surgery for primary breast cancer between August 2007 and December 2008. As post-operative adjuvant chemotherapy, four cycles of TC (DTX 75 mg/m2 + CPA 600 mg/m2) were administered at 3-week intervals. Adverse events were evaluated based on National Cancer Institute - Common Terminology Criteria for Adverse Events ver. 3.0. The safety and completion rate were evaluated as the primary and secondary endpoints, respectively. Results: Regarding hematological toxicity, Grade (G) 4 neutropenia occurred in 71.7% and G3 in 26.4%. G3-4 leukopenia developed in 32.1% and 56.6%, respectively, G4 anemia in 1.9% and G1-2 anemia in 26.4%. Regarding non-hematological toxicity, systemic malaise, skin eruption, edema, myalgia, arthralgia and nausea were noted in most patients. The completion rate was 94.3%, dose reduction was necessary in 7.5% and granulocyte colony-stimulating factor (G-CSF) support was required in 17.0%. On comparison between patients aged 65 years or older and younger than 65 years, the completion rate, dose reduction and incidence of febrile neutropenia (FN) were higher in the elderly patients. G-CSF support was more often needed in this subgroup. Conclusions: TC therapy is tolerable for Japanese patients, but attention should be paid to the development of FN and neutropenia. The completion rate was lower in the elderly patients, showing that tolerability was not necessarily favorable.

AB - Objective: The 7-year follow-up of the US oncology 9735 trial demonstrated the superiority of TC [docetaxel (DTX)/cyclophosphamide (CPA)] to doxorubicin/CPA therapy. To introduce TC therapy in Japan, the verification of the safety and tolerability is essential. We performed a collaborative prospective safety study with Okayama University to introduce TC therapy. Methods: The subjects were 53 patients aged from 33 to 67 years at intermediate risk based on the St Gallen risk classification who underwent radical surgery for primary breast cancer between August 2007 and December 2008. As post-operative adjuvant chemotherapy, four cycles of TC (DTX 75 mg/m2 + CPA 600 mg/m2) were administered at 3-week intervals. Adverse events were evaluated based on National Cancer Institute - Common Terminology Criteria for Adverse Events ver. 3.0. The safety and completion rate were evaluated as the primary and secondary endpoints, respectively. Results: Regarding hematological toxicity, Grade (G) 4 neutropenia occurred in 71.7% and G3 in 26.4%. G3-4 leukopenia developed in 32.1% and 56.6%, respectively, G4 anemia in 1.9% and G1-2 anemia in 26.4%. Regarding non-hematological toxicity, systemic malaise, skin eruption, edema, myalgia, arthralgia and nausea were noted in most patients. The completion rate was 94.3%, dose reduction was necessary in 7.5% and granulocyte colony-stimulating factor (G-CSF) support was required in 17.0%. On comparison between patients aged 65 years or older and younger than 65 years, the completion rate, dose reduction and incidence of febrile neutropenia (FN) were higher in the elderly patients. G-CSF support was more often needed in this subgroup. Conclusions: TC therapy is tolerable for Japanese patients, but attention should be paid to the development of FN and neutropenia. The completion rate was lower in the elderly patients, showing that tolerability was not necessarily favorable.

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