Neoadjuvant high dose chemotherapy plus peripheral blood progenitor cells in inflammatory breast cancer: a multicenter phase II pilot study

Background and Objectives, With the introduction of combined modality thera py, approximately 30% of patients wth inflammatory breast cancer (IBC) are alive and free of disease at 5 years, but the lack of control of systemic d isease continues to be the main reason for treatment failure, The importanc e of the response to primary chemotherapy and, in particular, complete tumo r regression after primary chemotherapy have previously been described to b e among the most reliable prognostic factors along with the dose intensity of doxorubicin, Design and Methods. To evaluate pathologic response rate and toxicity of ne oadjuvant high dose chemotherapy (HDCT) with autologous peripheral blood pr ogenitor cell (PBPC) support in patients affected by IBC, 21 patients were enrolled in a study in which it was planned that they would receive 4 cours es of epirubicin 150 mg/m(2) plus granulocyte colony-stimulating factor (G- CSF) as induction and mobilizing chemotherapy. Patients with non-progressiv e disease were intended to receive 2 consecutive courses of a combination o f high doses of mitoxantrone 40 mg/m(2), thiotepa 500 mg/m(2) and cyclophos phamide 200 mg/kg as a conditioning regimen, Results. PBPC collection was successful in 20/21 patients. Twelve patients received a single course of HDCT, whereas 7/20 patients underwent a double procedure. At a median follow up of 48 months, 20/21 patients were evaluabl e for toxicity and 19/21 for response. At surgery 4/19 patients (21%) had n o evidence of viable tumor cells in the breast and in axillary nodes, while 4 (21%) and 11 patients (58%) had microscopic and macroscopic disease, res pectively, Eight patients have relapsed (35%) so far at a median of 16 mont hs (9-54)from diagnosis. Eleven patients remain alive without evidence of d isease. Five out of 20 patients experienced severe cardiotoxicity with cong estive heart failure (CHF) which was responsible for the only treatment-rel ated death. Interpretation and Conclusions. This neoadjuvant HDCT regimen seems to be v ery effective in terms of objective responses, but we observed a high rate of cardiotoxicity and only a few patients were able to receive the two plan ned courses of high dose chemotherapy. (C) 2001, Ferrata Storti Foundation.