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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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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.
Adjuvant therapy;docetaxel;early breast cancer;taxanes;
 Cited by
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)
Bordoni RE, Haislip ST, Gilmore JW, et al (2012). Estimation of the incidence of febrile neutropenia in women receiving docetaxel plus cyclophosphamide as adjuvant therapy for early-stage breast cancer: a large community-based retrospective study. Commun Oncol, 9, 158-64. crossref(new window)

de Boer RH, Chan A, Tran B, et al (2011). Use of nonanthracycline regimens in early stage breast cancer in Australia. Asia Pac J Clin Oncol, 7, 4-10.

Early Breast Cancer Trialists' Collaborative Group (EBCTCG) (2005). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet, 365, 1687-717. crossref(new window)

Fumoleau P, Roche H (2005). The Impact of docetaxel on Adjuvant Breast Cancer. Business Briefing: Eur Oncol Rev, 1, 1.

Goble S, Bear HD (2003). Emerging role of taxanes in adjuvant and neoadjuvant therapy for breast cancer: the potential and the questions. Surg Clin North Am, 83, 943-971 crossref(new window)

Grenade C, Phelps MA, Villalona-Calero MA (2014). Race and ethnicity in cancer therapy: what have we learned? Clin Pharmacol Ther, 95, 403-12 crossref(new window)

Jones S, Holmes FA, O'Shaughnessy J, et al (2009). Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735. J Clin Oncol, 27, 1177-83. crossref(new window)

Lu YS, Kuo SH, Huang CS (2004). Recent advances in the management of primary breast cancers. J Formos Med Assoc, 103, 579-98.

Martin M, Pienkowski T, Mackey J, et al (2005). Adjuvant docetaxel for node-positive breast cancer. N Engl J Med, 352, 2302-13 crossref(new window)

Martín M, Segui MA, Anton A, et al (2010). Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med, 363, 2200-10. crossref(new window)

National Collaborating Centre for Cancer (2009). NICE clinical guideline 80: Early and locally advanced breast cancer - Diagnosis and treatment.

Pant S, Chilukuri M, Ramaswamy B (2008). Docetaxel for the post-surgery treatment of patients with node-positive breast cancer. Ther Clin Risk Manag, 4, 419-24. crossref(new window)

Tack DK, Palmieri FM, Perez EA (2004). Anthracycline vs nonanthracycline adjuvant therapy for breast cancer. Oncol (Williston Park), 18, 1378-81.

von Minckwitz G, Kümmel S, Vogel P, et al (2008). German Breast Group, Intensified neoadjuvant chemotherapy in earlyresponding breast cancer: phase III randomized GeparTrio study. J Natl Cancer Inst, 100, 552-62. crossref(new window)

Yip CH (2009). Breast cancer in Asia. Methods Mol Biol, 471, 51-64. crossref(new window)

Younus J, Vandenberg T, Jawaid M (2012). Febrile neutropenia rates with adjuvant docetaxel and cyclophosphamide chemotherapy in early breast cancer: discrepancy between published reports and community practice-an updated analysis. Curr OncoL, 19, 332-4.