Safety analysis of adjuvant chemotherapy with docetaxel administered with or without anthracyclines to early stage breast cancer patients: Combined results from the Asia- Pacific Breast Initiatives I and II

Sung Bae Kim, Ahmed Sayeed, Antonio H. Villalon, Zhen Zhou Shen, Tsz Kok Yau, Mazhar Ali Shah, Meng Feng Hou, Tran Van Thuan, Duc Nguyen Ba, Tsu Yi Chao

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: The Asia-Pacific Breast Initiatives (APBI) I and II registries were established to collect safety data for patients with early stage breast cancer receiving adjuvant docetaxel-based regimens in the Asia-Pacific region. Materials and Methods: Data from the two registries were combined to perform a safety analysis. Participants in the registry were women with early stage operable breast cancer with an intermediate or high risk of recurrence. These women received adjuvant chemotherapy that included docetaxel between 2006 and 2011. Adverse events (AEs) were recorded and analyzed. Results: Data were collected from 3,224 patients from 13 countries. The mean dose intensity of docetaxel was 24.1, 22.7, 25.1 mg/m2/week among patients receiving docetaxel-based monotherapy, combination therapy and sequential therapy, respectively. Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41.8% of women and 20.6% of women receiving prophylactic antibiotics. Adverse events were reported in 86% of patients (anthracycline-containing regimens vs. non-anthracycline regimens; 87% vs. 80%). The most common adverse events were alopecia, nausea, neutropenia, vomiting, and myalgia. Adverse events NCI CTCAE =Grade 3 were reported in 45.4% of patients. Serious adverse events were reported in 13% of patients, of which 2.5% led to study discontinuation. Forty-six deaths (1.4%) were reported, with no significant difference between regimens. Conclusions: The safety parameters of adjuvant docetaxel therapy used to treat sequential Asian women were comparable to those reported in clinical trials evaluating the role of adjuvant docetaxel. No unusual adverse events linked to Asia-Pacific region patients were observed.

Original languageEnglish
Pages (from-to)697-702
Number of pages6
JournalAsian Pacific Journal of Cancer Prevention
Volume17
Issue number2
DOIs
Publication statusPublished - 2016
Externally publishedYes

Fingerprint

docetaxel
Anthracyclines
Adjuvant Chemotherapy
Breast
Breast Neoplasms
Safety
Registries
Myalgia
Alopecia
Granulocyte Colony-Stimulating Factor
Patient Safety
Neutropenia
Nausea
Vomiting
Therapeutics

Keywords

  • Adjuvant therapy
  • Docetaxel
  • Early breast cancer
  • Taxanes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Public Health, Environmental and Occupational Health
  • Epidemiology

Cite this

Safety analysis of adjuvant chemotherapy with docetaxel administered with or without anthracyclines to early stage breast cancer patients : Combined results from the Asia- Pacific Breast Initiatives I and II. / Kim, Sung Bae; Sayeed, Ahmed; Villalon, Antonio H.; Shen, Zhen Zhou; Yau, Tsz Kok; Shah, Mazhar Ali; Hou, Meng Feng; Thuan, Tran Van; Ba, Duc Nguyen; Chao, Tsu Yi.

In: Asian Pacific Journal of Cancer Prevention, Vol. 17, No. 2, 2016, p. 697-702.

Research output: Contribution to journalArticle

Kim, Sung Bae ; Sayeed, Ahmed ; Villalon, Antonio H. ; Shen, Zhen Zhou ; Yau, Tsz Kok ; Shah, Mazhar Ali ; Hou, Meng Feng ; Thuan, Tran Van ; Ba, Duc Nguyen ; Chao, Tsu Yi. / Safety analysis of adjuvant chemotherapy with docetaxel administered with or without anthracyclines to early stage breast cancer patients : Combined results from the Asia- Pacific Breast Initiatives I and II. In: Asian Pacific Journal of Cancer Prevention. 2016 ; Vol. 17, No. 2. pp. 697-702.
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abstract = "Background: The Asia-Pacific Breast Initiatives (APBI) I and II registries were established to collect safety data for patients with early stage breast cancer receiving adjuvant docetaxel-based regimens in the Asia-Pacific region. Materials and Methods: Data from the two registries were combined to perform a safety analysis. Participants in the registry were women with early stage operable breast cancer with an intermediate or high risk of recurrence. These women received adjuvant chemotherapy that included docetaxel between 2006 and 2011. Adverse events (AEs) were recorded and analyzed. Results: Data were collected from 3,224 patients from 13 countries. The mean dose intensity of docetaxel was 24.1, 22.7, 25.1 mg/m2/week among patients receiving docetaxel-based monotherapy, combination therapy and sequential therapy, respectively. Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41.8{\%} of women and 20.6{\%} of women receiving prophylactic antibiotics. Adverse events were reported in 86{\%} of patients (anthracycline-containing regimens vs. non-anthracycline regimens; 87{\%} vs. 80{\%}). The most common adverse events were alopecia, nausea, neutropenia, vomiting, and myalgia. Adverse events NCI CTCAE =Grade 3 were reported in 45.4{\%} of patients. Serious adverse events were reported in 13{\%} of patients, of which 2.5{\%} led to study discontinuation. Forty-six deaths (1.4{\%}) were reported, with no significant difference between regimens. Conclusions: The safety parameters of adjuvant docetaxel therapy used to treat sequential Asian women were comparable to those reported in clinical trials evaluating the role of adjuvant docetaxel. No unusual adverse events linked to Asia-Pacific region patients were observed.",
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T1 - Safety analysis of adjuvant chemotherapy with docetaxel administered with or without anthracyclines to early stage breast cancer patients

T2 - Combined results from the Asia- Pacific Breast Initiatives I and II

AU - Kim, Sung Bae

AU - Sayeed, Ahmed

AU - Villalon, Antonio H.

AU - Shen, Zhen Zhou

AU - Yau, Tsz Kok

AU - Shah, Mazhar Ali

AU - Hou, Meng Feng

AU - Thuan, Tran Van

AU - Ba, Duc Nguyen

AU - Chao, Tsu Yi

PY - 2016

Y1 - 2016

N2 - Background: The Asia-Pacific Breast Initiatives (APBI) I and II registries were established to collect safety data for patients with early stage breast cancer receiving adjuvant docetaxel-based regimens in the Asia-Pacific region. Materials and Methods: Data from the two registries were combined to perform a safety analysis. Participants in the registry were women with early stage operable breast cancer with an intermediate or high risk of recurrence. These women received adjuvant chemotherapy that included docetaxel between 2006 and 2011. Adverse events (AEs) were recorded and analyzed. Results: Data were collected from 3,224 patients from 13 countries. The mean dose intensity of docetaxel was 24.1, 22.7, 25.1 mg/m2/week among patients receiving docetaxel-based monotherapy, combination therapy and sequential therapy, respectively. Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41.8% of women and 20.6% of women receiving prophylactic antibiotics. Adverse events were reported in 86% of patients (anthracycline-containing regimens vs. non-anthracycline regimens; 87% vs. 80%). The most common adverse events were alopecia, nausea, neutropenia, vomiting, and myalgia. Adverse events NCI CTCAE =Grade 3 were reported in 45.4% of patients. Serious adverse events were reported in 13% of patients, of which 2.5% led to study discontinuation. Forty-six deaths (1.4%) were reported, with no significant difference between regimens. Conclusions: The safety parameters of adjuvant docetaxel therapy used to treat sequential Asian women were comparable to those reported in clinical trials evaluating the role of adjuvant docetaxel. No unusual adverse events linked to Asia-Pacific region patients were observed.

AB - Background: The Asia-Pacific Breast Initiatives (APBI) I and II registries were established to collect safety data for patients with early stage breast cancer receiving adjuvant docetaxel-based regimens in the Asia-Pacific region. Materials and Methods: Data from the two registries were combined to perform a safety analysis. Participants in the registry were women with early stage operable breast cancer with an intermediate or high risk of recurrence. These women received adjuvant chemotherapy that included docetaxel between 2006 and 2011. Adverse events (AEs) were recorded and analyzed. Results: Data were collected from 3,224 patients from 13 countries. The mean dose intensity of docetaxel was 24.1, 22.7, 25.1 mg/m2/week among patients receiving docetaxel-based monotherapy, combination therapy and sequential therapy, respectively. Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41.8% of women and 20.6% of women receiving prophylactic antibiotics. Adverse events were reported in 86% of patients (anthracycline-containing regimens vs. non-anthracycline regimens; 87% vs. 80%). The most common adverse events were alopecia, nausea, neutropenia, vomiting, and myalgia. Adverse events NCI CTCAE =Grade 3 were reported in 45.4% of patients. Serious adverse events were reported in 13% of patients, of which 2.5% led to study discontinuation. Forty-six deaths (1.4%) were reported, with no significant difference between regimens. Conclusions: The safety parameters of adjuvant docetaxel therapy used to treat sequential Asian women were comparable to those reported in clinical trials evaluating the role of adjuvant docetaxel. No unusual adverse events linked to Asia-Pacific region patients were observed.

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