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

Abstract

PurposeThe 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®).MethodsThis 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.ResultsThe 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.ConclusionThe 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.

Profiles of lipids, blood pressure and weight changes among premenopausal Chinese breast cancer patients after adjuvant chemotherapy

“…The occurrence of abnormal total- and LDL-cholesterol among premenopausal patients has been attributed to chemotherapy-induced ovarian dysfunction [ 29 – 31 ]. The observation from a recent study lends support to this by showing that peri-menopausal patients undergoing taxane-based adjuvant chemotherapy had the largest change in lipids profiles when compared to pre- or post-menopausal patients, implicating that transition in hormone status may play a role [ 32 ]. Tamoxifen has been well-reported to lower total- and LDL-cholesterol [ 33 – 36 ] as early as 3 months after treatment initiation [ 34 , 35 ].…”

<p>Effects of Chemotherapy on Serum Lipids in Chinese Postoperative Breast Cancer Patients</p>

“…Anthracycline plus taxanes had a greater impact on serum lipids than taxanes. 49 It was obvious that anthracyclines plus taxanes were more likely to cause dyslipidemias than anthracyclines, which was more likely to cause dyslipidemias than taxanes. Anthracyclines had a greater effect on TG and HDL-C, while taxanes had a greater effect on TC and LDL-C.…”

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

“…A metaanalysis of three phase III studies in EBC showed that sequential administration of anthracyclines and taxanes provides a significant improvement in in OS and DFS over combination dosing (35). In contrast, a long-term followup from the Breast Cancer International Research Group (BCIRG)-005 study suggested there is no difference in OS or DFS between TAC or AC-T, although TAC was associated with higher rates of febrile neutropenia, and AC-T with higher rates of myalgia, hand-foot syndrome, and neuropathy (28). Nonetheless, sequential administration of anthracyclines and taxanes is recommended by treatment guidelines (6,9).…”

“…In women with nodepositive EBC, a sequential docetaxel regimen [doxorubicin and cyclophosphamide followed by docetaxel (AC-T)] was associated with superior survival outomes compared with concurrent doxorubicin and docetaxel (TA) and concurrent TAC (27). However, data from a 10-year follow-up of a further study revealed no long-term difference in DFS or overall survival (OS) with sequential versus concurrent docetaxel (28).…”