Inter-ethnic differences in tolerance of anti-cancer drugs in breast cancer patients
Exploration of differences in tolerance of anthracycline-based chemotherapy between Caucasian and Asian breast cancer patients
Sydney Cancer Centre
120 participants
Jan 24, 2007
Observational
Conditions
Summary
Recent evidence shows an ethnic variability in tolerance of anticancer drugs between Asian and Caucasian breast cancer patients. Pharmacogenetic differences in drug metabolising enzymes have been proposed as the cause of these differences, however they have not been associated with altered cytotoxic drug pharmacokinetics (PK). Other possible explanations include differences in dietary/concomitant medicine intake and inflammatory status. The aim of this study was to investigate inter-ethnic differences in cytotoxic drug metabolism, inflammatory/nutritional status, genotype and outcomes between Asian and Caucasian breast cancer patients.
Eligibility
Inclusion Criteria7
- Asian or Caucasian patients.
- Histologically confirmed breast cancer.
- Women with non-metastatic breast cancer for whom adjuvant chemotherapy with AC or EC or FEC is appropriate
- Age greater than or equal to 18.
- Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2.
- Ability to comply with the planned procedures and provide written evidence of informed consent.
- Adequate haematology and biochemistry. (Haemoglobin>100 g/L, White blood cell count >4.0 x 109/L, neutrophil count > 1.5 × 109, platelets >100 x 109/L; Aspartate transaminase (AST), Alanine transaminase (ALT) and bilirubin < 1.5 x ULN (AST, ALT < 5 x upper limit of normal in case liver metastases); calculated creatinine clearance according to Corkroft formula > 60 ml/min.
Exclusion Criteria9
- Patients who require dose adjustment.
- Clinical evidence of brain metastases.
- Suspected or documented bone marrow involvement.
- Significant intercurrent illness including active infection, inflammatory bowel disease or other uncontrolled autoimmune disease.
- The requirement for ongoing systemic treatment with corticosteroids or other immunosuppressive therapy.
- Patients who have had chemotherapy 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Ongoing major side effects from radiology.
- Other active malignancy.
- Known allergy to any of the investigational agents.
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Interventions
Observe side effects, nutritional status and measure drug clearance of the cycle 1 treatment (21 days): FEC regimen: epirubicin, 5-fluorouracil (5-FU), cyclophosphamide. AC regimen: doxorubicin, cyclophosphamide. EC: epirubicin, cyclophosphamide Collect Deoxyribonucleic acid (DNA) samples for pharmacogenomics purpose
Locations(1)
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ACTRN12610000045011