High-Dose Chemotherapy With Autologous Peripheral Stem Cell Transplantation For High-Risk Breast Cancer: 5 Years Follow-up.

Breast cancer with extensive axillary-lymph node involvement has a poor prognosis after conventional treatment,In trials with historical controls,high dose chemotherapy produced outcomes.Objective:Patients who consulted postoperatively with a diagnosis of AJCC Stageâ…¡orâ…¢primary breast cancer and more than 10 positive axillary lymph nodes.in addition,patients who had Stageâ…¢or locally Advanced breast cancer and had more than 4 positive axillary lymph nodes at the time of surgical resection were considered eligible.Investigation of high-dose chemotherapy(HDCT)followed by autologous peripheral stem cell transplantation support compared with standard-dose chemotherapy(SDCT)as adjuvant treatment in patients with primary breast cancer.Methods:Between 2000.5-2005.12,All patients were randomized to receive following two-three cycles of standard-dose CAF regimens(cyclophosphamide 600mg/m~2â…£D1,ADM(E-ADM)40(50)mg/m~2â…£D1,and 5-FU 500mg/m~2â…£D1-5, every 21 days),the priming regimen was CAF(CTX 2g/m~2â…£D1,ADM(E-ADM) 40(50)mg/m~2â…£D1,5-FU 500mg/m~2â…£D1)+ G-CSF(5ug/kg,iH,Bid, D1-6)regimen,then HDCT regimen of CCE(cyclophosphamide 120mg/kg, Carboplatin 1050mg/m2,and etoposide 1050mg/m2)followed by autologous peripheral stem cell transplantation support,or SDCT regimen were be continue four cycles of CAF(cyclophosphamide 600mg/m~2â…£D1, ADM(E-ADM)40(50)mg/m~2â…£D1,and 5-FU 500mg/m~2â…£D1-5,every 21 days) regimen.The primary end point was Relapse -free survival and overall survival.Results:58 patients were enrolled;29 patients were assigned high dose chemotherapy and 29 patients standard-dose chemotherapy,After a median follow up of 68 mouths,Relapse-free survival of 5 years have been observed no difference (HDCT:56.7%,SDCT:72.4%,P=0.627),however,overall survival of 5 years have been observed significance(HDCT:86.2%,SDCT:57.9%,P=0.027).High dose chemotherapy group were no treastment -related deaths.Conclusion:With a median follow-up 68 mounths for patients,This trial continued to demonstrate no RFS but OS advantage for patients with high risk breast cancer treated with HDCT after standard-dose CAF regimen chemotherapy.