High-dose busulfan, melphalan and thiotepa as consolidation for noninflammatory high-risk breast cancer

The purpose of this study was to evaluate the toxicity and efficacy of high -dose busulfan, melphalan and thiotepa (Bu/Mel/TT) in patients with high-ri sk noninflammatory breast cancer defined as stage II disease greater than o r equal to 10 lymph nodes (n = 52) or stage III (n = 69), and prognostic fa ctors for treatment outcome. One hundred and twenty-one patients (median ag e, 46 Sears) were treated with high-dose Bu (12 mg/kg), Mel (100 mg/m(2)) a nd TT (500 mg/m(2)) (HDC) followed by autologous stem cell infusion (ASCI). One hundred patients were initially treated with surgery followed by stand ard adjuvant chemotherapy prior to HDC/ASCI, Twenty-one patients with stage III disease had inoperable tumors at diagnosis and tr ere treated with neo adjuvant chemotherapy and surgery before HDC/ASCI. Transplant-related morta lity was 6%. The probabilities of event-free survival (EFS) at 3 and 5 year s (median follow-up of 36 months) from transplant mere, for all patients: 0 .62-0.60; stage II: 0.71-0.67: stage III: 0.55-0.55 (for stage III adjuvant and neoadjuvant groups: 0.60-0.60 and 0.42-0.42, respectively). Multivaria te analysis did not identify variables associated with poor outcome. The ef ficacy of Bu/Mel/TT is similar to other HDC regimens reported for patients with high-risk non-inflammatory breast cancer. Bu/Mel/TT has high activity in stage II disease and a moderate benefit in stage III operable tumors.