J Breast Cancer.  2015 Dec;18(4):356-364. 10.4048/jbc.2015.18.4.356.

Safety Results of Docetaxel-(Taxotere(R))-Based Chemotherapy in Early Breast Cancer Patients of Asia-Pacific Region: Asia-Pacific Breast Initiative II

• Kim SB
• Kok YT
• Thuan TV
• Chao TY
• Shen ZZ

• KMID: 2176284
• DOI: http://doi.org/10.4048/jbc.2015.18.4.356

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.

Keyword

Breast neoplasms; Docetaxel; Registries; Safety

MeSH Terms

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
Cholesterol
Lipoproteins

Figure

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  Figure 1 Patients receiving supportive medications (n=1,712). T=docetaxel; H=trastuzumab.

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  Figure 2 Summary of adverse events by regimen. T=docetaxel; H=trastuzumab.

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