• Asian Pacific Journal of Cancer Prevention
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• v.17 no.2
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• pp.697-702
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• 2016

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, $25.1mg/m^2/week$ 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 ${\geq}$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.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.5
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• pp.1989-1992
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• 2014

Background: The aim of this study was to assess the response rates (clinical and pathological ) with docetaxel and epirubicin combination chemotherapy and its effect on outcome. Materials and Methods: We retrospectively analysed locally advanced breast cancer (LABC) patients who received NACT from January 2008 to December 2012 in our tertiary care centre. LABC constituted 37% of all breast cancer cases and 120 patients fulfilled the eligibility criteria. The regimens used for NACT were, six cycles of DEC (docetaxel $75mg/m^2$, epirubicin $75mg/m^2$, cyclophosphamide $50mg/m^2$ on Day 1, 3 weekly) and a sequential regimen (4 cycles of FEC, 5-flurouracil $600mg/m^2$, epirubicin $75mg/m^2$, cyclophosphamide $600mg/m^2$ followed by 4 cycles of docetaxel $85mg/m^2$). Results: The median age was 47 years (range 23-72). Ninety six ( 80 %) had T4 disease and 90% had clinically palpable lymph nodes at diagnosis. The median size of primary tumor at presentation was 5.9 cm. Hormone receptor positivity was seen in 55% and HER2/neu positivity, in 25%. Triple negative breast cancers constituted 25 % of the cases. The overall clinical response rate (complete or partial ) was 85% and pathological complete responses were obtained in 15%. Four cases defaulted, 5 patients died of treatment related toxicity and 15% developed febrile neutropenia on DEC. The median duration of follow up was 22 months. The median time to relapse was 20 months and the 3 year relapse free and overall survival rates were 50% and 70% respectively. Conclusions: LABC constituted 37% of all breast cancer cases at our institute. With NACT, pCR was seen in 15% of the cases. Sequential chemotherapy was better tolerated than concurrent anthracyline and taxane chemotherapy with a similar pCR.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.8
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• pp.4031-4035
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• 2016

Background: In the adjuvant treatment of breast cancer, anthracycline and taxane based regimens can be used concomitantly or sequentially. The best order in the sequential regimens has yet to be well established. This study evaluated the feasibility of 4 cycles of adjuvant taxotere ($100mg/m^2$) every 3 weeks followed by 4 cycles of doxorubicin ($60mg/m^2$) and cyclophosphamide ($600mg/m^2$) every 3 weeks. The primary outcome was the safety profile. Secondary outcomes were disease free survival (DFS) and overall survival (OS). Materials and Methods: This non-randomize prospective phase II stud was performed at Jordan University of Science and Technology and its affiliated King Abdulla Teaching Hospital between July 2009 and August 2010. Data collection was closed on May $31^{th}$, 2015 giving a median follow up period of 62 months. The study was approved by the institutional review board and a written informed consent was obtained for each patient. Results: Fifty patients were enrolled. The median age was 53.1 years (range 34-76). One patient (2%) had stage I disease, 17 (34%) stage II, and 32 (64.0%) stage III. Forty-six patients were evaluable for efficacy analysis. The completion rate was 95.7%. No dose modifications were needed. The incidences of grade 3-4 neutropenia and febrile neutropenia were 14 % and 10%. No grade 3-4 non-hematological adverse events were encountered. At a median follow up time of 62 months the OS and the DFS rates were 76.1% and 56.5%. Those for stages I and II combined were 100% and 75%. Conclusions: Taxotere first followed by doxorubicin-cyclophosphamide appears a feasible regimen as evidenced by an acceptable completion rate, a satisfactory safety profile, and an OS and DFS rates comparable to other studies.