Safety Results of Docetaxel-(Taxotere(R))-Based Chemotherapy in Early Breast Cancer Patients of Asia-Pacific Region: Asia-Pacific Breast Initiative II.
10.4048/jbc.2015.18.4.356
- Author:
Sung Bae KIM
1
;
Yau Tsz KOK
;
Tran Van THUAN
;
Tsu Yi CHAO
;
Zhen Zhou SHEN
Author Information
1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. sbkim3@amc.seoul.kr
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Breast neoplasms;
Docetaxel;
Registries;
Safety
- MeSH:
Breast Neoplasms*;
Breast*;
Chemotherapy, Adjuvant;
Cholesterol;
Drug Therapy*;
Epidemiology;
Humans;
Leukopenia;
Lipoproteins;
National Cancer Institute (U.S.);
Neutropenia;
Population Characteristics;
Prospective Studies;
Recurrence;
Registries;
Stroke Volume;
Vomiting
- From:Journal of Breast Cancer
2015;18(4):356-364
- CountryRepublic of Korea
- Language:English
-
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(R)). 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.
