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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
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 Title & Authors
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;
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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, 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.
 Keywords
Adjuvant therapy;docetaxel;early breast cancer;taxanes;
 Language
English
 Cited by
1.
Phase II Study of Compliance and Morbidity with 4 Cycles of Taxotere Followed by 4 of Doxorubicin-Cyclophosphamide for Adjuvant Treatment of Operable Breast Cancer Patients,;;

Asian Pacific Journal of Cancer Prevention, 2016. vol.17. 8, pp.4031-4035 crossref(new window)
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