Docetaxel plus epirubicin as first-line chemotherapy in MBC (KCSG 01-10-05)

Phase II trial and the predictive values of circulating HER2 extracellular domain and vascular endothelial growth factor

Seock Ah Im, Sung Bae Kim, Moon Hee Lee, Young Hyuck Im, Kyung Hee Lee, Hong Suk Song, Myung Ah Lee, Junglim Lee, Nam Su Lee, Hae Sun Ham, Tae You Kim, Yeon Hee Park, Kyung Eun Lee, Kee Won Kim, Jae Hong Seo, Soon Nam Lee, Young Seon Hong, Yung Jue Bang, Woo Kun Kim, Hee Sook Park

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

The anthracyclines and taxanes are considered to be the most active drags in metastatic breast cancer (MBC). We conducted a multicenter phase II study to evaluate the efficacy and tolerability of the docetaxel plus epirubicin combination chemotherapy as first-line treatment in MBC and performed a prospective assessment of the predictive values of circulating HER2 extracellular domain (ECD) and vascular endothelial growth factor (VEGF). Docetaxel 75 mg/m2 and epirubicin 75 mg/m2 were given intravenously every 3 weeks. Prophylactic G-CSF was not used. Pretreatment serum HER2 ECD and VEGF levels were measured by enzyme immunoassay. Forty MBC patients were enrolled, and 39 patients were evaluable for toxicities and 38 for response. Complete response was observed in 3 (7.9%) patients, partial response in 20 (52.6%) (overall response rate 60.5%), stable disease in 11 (28.9%) and disease progression in 4 (10.5%). After a median follow-up of 22.5 months, the median duration of response was 28 weeks, median time to disease progression was 32 weeks, and median survival was 15.8 months. Two-hundred and fifteen cycles of treatment were administered (median, 6 cycles per patient). Grade 3 and 4 neutropenia were observed during 24 (11.2%) and 74 (35%) cycles respectively, and grade 3 or 4 febrile neutropenia in 24 (11.2%) cycles. Elevated circulating HER2 ECD levels were found to be associated with a shorter response duration (p<0.005) and shorter time to progression (p<0.005). However, elevated VEGF levels were not found to be correlated with response rate or survival. We concluded that the docetaxel and epirubicin combination is an effective first-line treatment in MBC patients and that elevated serum HER2 ECD levels, but not circulating VEGF levels, predict a poor outcome.

Original languageEnglish
Pages (from-to)481-487
Number of pages7
JournalOncology Reports
Volume14
Issue number2
Publication statusPublished - 2005 Aug 1
Externally publishedYes

Fingerprint

docetaxel
Epirubicin
Vascular Endothelial Growth Factor A
Breast Neoplasms
Drug Therapy
Disease Progression
Taxoids
Febrile Neutropenia
Anthracyclines
Granulocyte Colony-Stimulating Factor
Combination Drug Therapy
Neutropenia
Serum
Immunoenzyme Techniques
Therapeutics
Survival Rate
Survival

Keywords

  • Breast cancer
  • Docetaxel
  • Epirubicin
  • HER2 extracellular domain

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Docetaxel plus epirubicin as first-line chemotherapy in MBC (KCSG 01-10-05) : Phase II trial and the predictive values of circulating HER2 extracellular domain and vascular endothelial growth factor. / Im, Seock Ah; Kim, Sung Bae; Lee, Moon Hee; Im, Young Hyuck; Lee, Kyung Hee; Song, Hong Suk; Lee, Myung Ah; Lee, Junglim; Lee, Nam Su; Ham, Hae Sun; Kim, Tae You; Park, Yeon Hee; Lee, Kyung Eun; Kim, Kee Won; Seo, Jae Hong; Lee, Soon Nam; Hong, Young Seon; Bang, Yung Jue; Kim, Woo Kun; Park, Hee Sook.

In: Oncology Reports, Vol. 14, No. 2, 01.08.2005, p. 481-487.

Research output: Contribution to journalArticle

Im, SA, Kim, SB, Lee, MH, Im, YH, Lee, KH, Song, HS, Lee, MA, Lee, J, Lee, NS, Ham, HS, Kim, TY, Park, YH, Lee, KE, Kim, KW, Seo, JH, Lee, SN, Hong, YS, Bang, YJ, Kim, WK & Park, HS 2005, 'Docetaxel plus epirubicin as first-line chemotherapy in MBC (KCSG 01-10-05): Phase II trial and the predictive values of circulating HER2 extracellular domain and vascular endothelial growth factor', Oncology Reports, vol. 14, no. 2, pp. 481-487.
Im, Seock Ah ; Kim, Sung Bae ; Lee, Moon Hee ; Im, Young Hyuck ; Lee, Kyung Hee ; Song, Hong Suk ; Lee, Myung Ah ; Lee, Junglim ; Lee, Nam Su ; Ham, Hae Sun ; Kim, Tae You ; Park, Yeon Hee ; Lee, Kyung Eun ; Kim, Kee Won ; Seo, Jae Hong ; Lee, Soon Nam ; Hong, Young Seon ; Bang, Yung Jue ; Kim, Woo Kun ; Park, Hee Sook. / Docetaxel plus epirubicin as first-line chemotherapy in MBC (KCSG 01-10-05) : Phase II trial and the predictive values of circulating HER2 extracellular domain and vascular endothelial growth factor. In: Oncology Reports. 2005 ; Vol. 14, No. 2. pp. 481-487.
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abstract = "The anthracyclines and taxanes are considered to be the most active drags in metastatic breast cancer (MBC). We conducted a multicenter phase II study to evaluate the efficacy and tolerability of the docetaxel plus epirubicin combination chemotherapy as first-line treatment in MBC and performed a prospective assessment of the predictive values of circulating HER2 extracellular domain (ECD) and vascular endothelial growth factor (VEGF). Docetaxel 75 mg/m2 and epirubicin 75 mg/m2 were given intravenously every 3 weeks. Prophylactic G-CSF was not used. Pretreatment serum HER2 ECD and VEGF levels were measured by enzyme immunoassay. Forty MBC patients were enrolled, and 39 patients were evaluable for toxicities and 38 for response. Complete response was observed in 3 (7.9{\%}) patients, partial response in 20 (52.6{\%}) (overall response rate 60.5{\%}), stable disease in 11 (28.9{\%}) and disease progression in 4 (10.5{\%}). After a median follow-up of 22.5 months, the median duration of response was 28 weeks, median time to disease progression was 32 weeks, and median survival was 15.8 months. Two-hundred and fifteen cycles of treatment were administered (median, 6 cycles per patient). Grade 3 and 4 neutropenia were observed during 24 (11.2{\%}) and 74 (35{\%}) cycles respectively, and grade 3 or 4 febrile neutropenia in 24 (11.2{\%}) cycles. Elevated circulating HER2 ECD levels were found to be associated with a shorter response duration (p<0.005) and shorter time to progression (p<0.005). However, elevated VEGF levels were not found to be correlated with response rate or survival. We concluded that the docetaxel and epirubicin combination is an effective first-line treatment in MBC patients and that elevated serum HER2 ECD levels, but not circulating VEGF levels, predict a poor outcome.",
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AU - Kim, Sung Bae

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AU - Ham, Hae Sun

AU - Kim, Tae You

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AU - Lee, Kyung Eun

AU - Kim, Kee Won

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