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

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/m 2 /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.

Treatment patterns for adjuvant docetaxel-based chemotherapy in early-stage breast cancer in China: A pooled retrospective analysis of four observational studies

“…This was a retrospective, pooled analysis of the APBI I (2006)(2007)(2008) and II (2009-2011) registries (29,30), and two Chinese observational studies; BC Local Registry (2007-2010) and BC STATE (2011-2014). The present analysis included female Chinese adults (≥18 years) enrolled into these four observational studies with operable breast cancer who were treated with docetaxel-based adjuvant chemotherapy.…”

“…Given that most evidence for docetaxel-based regimens has been reported from controlled clinical trials, and considering the wide range of adjuvant treatment strategies available, it is important to understand the use of adjuvant docetaxel in real-world clinical practice. The Asia-Pacific Breast Initiatives (APBI) I and II were set up to collect, analyze and disseminate data on the real-world use of adjuvant docetaxel for EBC in the Asia-Pacific region (29)(30)(31). The analysis presented in this report pooled data from Chinese patients included in APBI I and II as well as two Chinese breast cancer registries to investigate patterns of adjuvant docetaxel use for EBC in real-life clinical practice in China.…”