Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer
- Histologically confirmed metastatic breast cancer
- All patients were required to give written informed consent.
- Prior treatment with chemotherapy, hormonal therapy, immunotherapy or local
radiotherapy was allowed (except gemcitabine or platinum agents).
- Patients were required to have at least one bidimensionally measurable lesion outside
a previous radiation port.
- Age ≥ 18 years
- Karnofsky Performance status ≥ 70 %
- Minimal life expectancy of 12 weeks
- Adequate haematological, renal, cardiac and hepatic function:
1. Leukocyte count ≥ 3.0 x 109/l
2. Absolute neutrophil count ≥ 2.0 x 109/l
3. Platelet count ≥ 100 x 109/l
4. Haemoglobin ≥ 8 g/dl
5. Total serum bilirubin ≤ 1.25 x upper limit of normal (ULN) In presence of liver
metastasis ≤ 3 x ULN
6. Transaminase (ALT,AST) level ≤ 3 x ULN In presence of liver metastasis ≤ 5 x
7. Alkaline phosphatase level ≤ 2.5 x ULN
8. Creatinine clearance was required to exceed 60 ml/min.
- Prior treatment with gemcitabine or platinum agents
- Inadequate creatinine clearance (< 60 ml/min)
- Only bone metastases
- Symptomatic brain metastases
- Women who are pregnant, lactating or refuse effective contraception
- Secondary malignancy
- History of another primary malignant disease other than in situ carcinoma of the
uterine cervix or adequately treated basal cell skin cancer
- Active infection
- Any other concomitant severe clinical condition making implementation of the protocol
including pre-hydration difficult.