Safety results of docetaxel-(Taxotere®)-based chemotherapy in early breast cancer patients of asia-pacific region

Asia-pacific breast initiative II

Sung Bae Kim, Yau Tsz Kok, Tran Van Thuan, Tsu Yi Chao, Zhen Zhou Shen

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Purpose: The goal of this registry was to collect patient characteristics and safety data from patients from the Asia-Pacific region with early breast cancer receiving adjuvant chemotherapy containing docetaxel (Taxotere®). Methods: This registry was open-label, international, longitudinal, multicenter, and observational in design and included a prospective group of consecutive early breast cancer patients with an intermediate-to-high risk of recurrence being treated with various docetaxel-based (anthracycline and non-anthracycline) adjuvant chemotherapy regimens during 2009–2013 in real-world clinical settings. Results: The analysis included 1,712 patients, 79% of whom received docetaxel-based, anthracycline-containing regimens, while 21% received non-anthracycline-containing regimens. Patients receiving adjuvant docetaxel-based chemotherapy were followed for 1.5 years. Chemotherapy-related adverse events (AEs) were reported by 76.2% of patients (anthracycline-containing vs. non-anthracycline-containing regimens: 76.8% vs. 74.1%). Serious AEs were reported in 12% of patients (12.3% vs. 10%). National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or higher neutropenia was reported in 20% of patients (21.6% vs. 13.9%), leukopenia in 7.4% of patients (5.4% vs. 14.8%), and vomiting in 1.6% of patients (1.8% vs. 0.6%). Treatment-related death was reported in 27 patients (1.6%), while only 3% of patients had a relapse. Low-density lipoprotein cholesterol/high-density lipoprotein cholesterol (HDL-C) and total cholesterol/HDL-C ratios increased after chemotherapy. A clinically insignificant reduction of 1.9% in left ventricular ejection fraction, from 66.43 to 64.53, was observed 1.5 years after therapy was completed. Conclusion: The Asia-Pacific Breast initiative II registry identified a variety of important facts regarding patient population characteristics, disease epidemiology and treatment response for early breast cancer patients of the Asia-Pacific region receiving docetaxel-based chemotherapy. Docetaxel-based chemotherapy did not show any significant safety concerns for early breast cancer patients of the Asia- Pacific region, and thus may represent a safe adjuvant chemotherapy regimen for these patients.

Original languageEnglish
Pages (from-to)356-364
Number of pages9
JournalJournal of Breast Cancer
Volume18
Issue number4
DOIs
Publication statusPublished - Dec 1 2015
Externally publishedYes

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docetaxel
Breast
Breast Neoplasms
Safety
Drug Therapy
Anthracyclines
Adjuvant Chemotherapy
Registries
HDL Cholesterol

Keywords

  • Breast neoplasms
  • Docetaxel
  • Registries
  • Safety

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Safety results of docetaxel-(Taxotere®)-based chemotherapy in early breast cancer patients of asia-pacific region : Asia-pacific breast initiative II. / Kim, Sung Bae; Kok, Yau Tsz; Van Thuan, Tran; Chao, Tsu Yi; Shen, Zhen Zhou.

In: Journal of Breast Cancer, Vol. 18, No. 4, 01.12.2015, p. 356-364.

Research output: Contribution to journalArticle

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title = "Safety results of docetaxel-(Taxotere{\circledR})-based chemotherapy in early breast cancer patients of asia-pacific region: Asia-pacific breast initiative II",
abstract = "Purpose: The goal of this registry was to collect patient characteristics and safety data from patients from the Asia-Pacific region with early breast cancer receiving adjuvant chemotherapy containing docetaxel (Taxotere{\circledR}). Methods: This registry was open-label, international, longitudinal, multicenter, and observational in design and included a prospective group of consecutive early breast cancer patients with an intermediate-to-high risk of recurrence being treated with various docetaxel-based (anthracycline and non-anthracycline) adjuvant chemotherapy regimens during 2009–2013 in real-world clinical settings. Results: The analysis included 1,712 patients, 79{\%} of whom received docetaxel-based, anthracycline-containing regimens, while 21{\%} received non-anthracycline-containing regimens. Patients receiving adjuvant docetaxel-based chemotherapy were followed for 1.5 years. Chemotherapy-related adverse events (AEs) were reported by 76.2{\%} of patients (anthracycline-containing vs. non-anthracycline-containing regimens: 76.8{\%} vs. 74.1{\%}). Serious AEs were reported in 12{\%} of patients (12.3{\%} vs. 10{\%}). National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or higher neutropenia was reported in 20{\%} of patients (21.6{\%} vs. 13.9{\%}), leukopenia in 7.4{\%} of patients (5.4{\%} vs. 14.8{\%}), and vomiting in 1.6{\%} of patients (1.8{\%} vs. 0.6{\%}). Treatment-related death was reported in 27 patients (1.6{\%}), while only 3{\%} of patients had a relapse. Low-density lipoprotein cholesterol/high-density lipoprotein cholesterol (HDL-C) and total cholesterol/HDL-C ratios increased after chemotherapy. A clinically insignificant reduction of 1.9{\%} in left ventricular ejection fraction, from 66.43 to 64.53, was observed 1.5 years after therapy was completed. Conclusion: The Asia-Pacific Breast initiative II registry identified a variety of important facts regarding patient population characteristics, disease epidemiology and treatment response for early breast cancer patients of the Asia-Pacific region receiving docetaxel-based chemotherapy. Docetaxel-based chemotherapy did not show any significant safety concerns for early breast cancer patients of the Asia- Pacific region, and thus may represent a safe adjuvant chemotherapy regimen for these patients.",
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AU - Kim, Sung Bae

AU - Kok, Yau Tsz

AU - Van Thuan, Tran

AU - Chao, Tsu Yi

AU - Shen, Zhen Zhou

PY - 2015/12/1

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N2 - Purpose: The goal of this registry was to collect patient characteristics and safety data from patients from the Asia-Pacific region with early breast cancer receiving adjuvant chemotherapy containing docetaxel (Taxotere®). Methods: This registry was open-label, international, longitudinal, multicenter, and observational in design and included a prospective group of consecutive early breast cancer patients with an intermediate-to-high risk of recurrence being treated with various docetaxel-based (anthracycline and non-anthracycline) adjuvant chemotherapy regimens during 2009–2013 in real-world clinical settings. Results: The analysis included 1,712 patients, 79% of whom received docetaxel-based, anthracycline-containing regimens, while 21% received non-anthracycline-containing regimens. Patients receiving adjuvant docetaxel-based chemotherapy were followed for 1.5 years. Chemotherapy-related adverse events (AEs) were reported by 76.2% of patients (anthracycline-containing vs. non-anthracycline-containing regimens: 76.8% vs. 74.1%). Serious AEs were reported in 12% of patients (12.3% vs. 10%). National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or higher neutropenia was reported in 20% of patients (21.6% vs. 13.9%), leukopenia in 7.4% of patients (5.4% vs. 14.8%), and vomiting in 1.6% of patients (1.8% vs. 0.6%). Treatment-related death was reported in 27 patients (1.6%), while only 3% of patients had a relapse. Low-density lipoprotein cholesterol/high-density lipoprotein cholesterol (HDL-C) and total cholesterol/HDL-C ratios increased after chemotherapy. A clinically insignificant reduction of 1.9% in left ventricular ejection fraction, from 66.43 to 64.53, was observed 1.5 years after therapy was completed. Conclusion: The Asia-Pacific Breast initiative II registry identified a variety of important facts regarding patient population characteristics, disease epidemiology and treatment response for early breast cancer patients of the Asia-Pacific region receiving docetaxel-based chemotherapy. Docetaxel-based chemotherapy did not show any significant safety concerns for early breast cancer patients of the Asia- Pacific region, and thus may represent a safe adjuvant chemotherapy regimen for these patients.

AB - Purpose: The goal of this registry was to collect patient characteristics and safety data from patients from the Asia-Pacific region with early breast cancer receiving adjuvant chemotherapy containing docetaxel (Taxotere®). Methods: This registry was open-label, international, longitudinal, multicenter, and observational in design and included a prospective group of consecutive early breast cancer patients with an intermediate-to-high risk of recurrence being treated with various docetaxel-based (anthracycline and non-anthracycline) adjuvant chemotherapy regimens during 2009–2013 in real-world clinical settings. Results: The analysis included 1,712 patients, 79% of whom received docetaxel-based, anthracycline-containing regimens, while 21% received non-anthracycline-containing regimens. Patients receiving adjuvant docetaxel-based chemotherapy were followed for 1.5 years. Chemotherapy-related adverse events (AEs) were reported by 76.2% of patients (anthracycline-containing vs. non-anthracycline-containing regimens: 76.8% vs. 74.1%). Serious AEs were reported in 12% of patients (12.3% vs. 10%). National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or higher neutropenia was reported in 20% of patients (21.6% vs. 13.9%), leukopenia in 7.4% of patients (5.4% vs. 14.8%), and vomiting in 1.6% of patients (1.8% vs. 0.6%). Treatment-related death was reported in 27 patients (1.6%), while only 3% of patients had a relapse. Low-density lipoprotein cholesterol/high-density lipoprotein cholesterol (HDL-C) and total cholesterol/HDL-C ratios increased after chemotherapy. A clinically insignificant reduction of 1.9% in left ventricular ejection fraction, from 66.43 to 64.53, was observed 1.5 years after therapy was completed. Conclusion: The Asia-Pacific Breast initiative II registry identified a variety of important facts regarding patient population characteristics, disease epidemiology and treatment response for early breast cancer patients of the Asia-Pacific region receiving docetaxel-based chemotherapy. Docetaxel-based chemotherapy did not show any significant safety concerns for early breast cancer patients of the Asia- Pacific region, and thus may represent a safe adjuvant chemotherapy regimen for these patients.

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KW - Registries

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