IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer

A Prospective Study Assessing the Correlation Between Disease Prognosis and the Level of IL-6 and IL-8 Level in Blood and Pleural Effusion Before and After Chemotherapy in Patients With Metastatic Breast Cancer

Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

To assess the correlation between the disease prognosis and the level of IL-6 and IL-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer

Inclusion Criteria:

• Female between 18 and 70 years old;
• Patients with histologic proved metastatic breast cancer;
• Pleural effusion with the volume of more than 1000ml, as documented by CT, X ray or ultrasound;
• There are no other diseases which cause the elevation of IL-6 or IL-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis;
• With at least one measurable disease according to RECIST criteria,
• Normal laboratory results:ANC≥2.0×109/L,Hb≥80g/L,plt≥100×109/L,TB<UNL (<1.5 x UNL in patients with liver mets),ALT/AST< 1.5 x UNL (<2.5x UNL in patients with liver mets),AKP<5 x UNL(except bone mets),Cr<UNL;
• Normal functions with heart, liver,renal and bone marrow;
• Got ICF before enrollment;
• Life expectancy more than 12 weeks.

Exclusion Criteria:

• Pregnant or breast-feeding women or positive serum pregnancy test;
• Uncontrolled brain metastases;
• No recovery from previous radiation or accepted radiation within 4 weeks before enrollment;
• Participation in any investigational drug study within 4 weeks preceding treatment start;
• Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin;
• Serious uncontrolled intercurrent infections;
• Poor compliance.