Bone Marrow Transplantation, (1998) 22 , 445–448  1998 Stockton Press All rights reserved 0268–3369/98 $12.00 http:/ / www.stockton-press.co.uk/ bmt High-dose chemotherapy with autologous stem cell support in patients with responding stage IV breast cancer P Ljungman 1 , B Bjo ¨rkstrand 1 , T Fornander 2 , M Ho ¨glund 3 , G Juliusson 4 , H Lindman 5 , A Malmstro ¨m 10 , S Rotstein 6 , M So ¨derberg 7 , N Wilking 8 , K Villman 9 and J Bergh 5 1 Dept. of Hematology, 2 Dept. of Oncology, Huddinge University Hospital, Karolinska Institutet, Huddinge; 3 Dept. of Hematology, 5 Dept. of Oncology, Uppsala University Hospital, Uppsala; 4 Dept. of Hematology, University Hospital, Linko ¨ping; 6 Dept. of Oncology, Danderyd’s Hospital, Danderyd; 7 Dept. of Oncology, Karlstad Hospital, Karlstad; 8 Dept. of Oncology, Radiumhemmet, Karolinska Hospital, Stockholm; 9 Dept. of Oncology, O ¨ rebro Hospital, O ¨ rebro; and 10 Dept. of Oncology, University Hospital, Linko ¨ping, Sweden Summary: Ninety-four patients underwent high-dose chemo- therapy with stem cell support for stage IV breast can- cer. The high-dose chemotherapy consisted of the Stamp V regimen in all patients comprising cyclophosphamide, thiotepa and carboplatin (CTCb). Twenty-three patients received sequential high-dose therapies with the first consisting of high-dose melphalan and the second of Stamp V. Two patients died from chemotherapy-related complications resulting in a transplant-related mortality at 100 days of 2.2%. The progression-free survival at 3 years was 36% in patients with no evidence of disease at the first course of high-dose therapy compared with 17% in patients with remaining disease at time of the high-dose therapy (P = 0.03). There was no difference in overall survival between patients with no evidence of disease and other patients. The source of stem cells, sin- gle or double courses of high-dose therapy, positive selection of CD34 + cells, or number of involved sites had no influence on either progression-free survival or over- all survival. Further studies of more intensive induction chemotherapy followed by high-dose therapy with stem cell support are indicated. Keywords: breast cancer; stage IV; autologous SCT High-dose chemotherapy with stem cell support is increas- ingly used for therapy of women with breast cancer stage IV. 1–5 One randomized study was published showing superior outcome for patients receiving primary high-dose therapy with stem cell support compared with conventional- dose chemotherapy. 6 Patients who are refractory to stan- dard-dose chemotherapy respond poorly to high-dose ther- apy and patients who do respond have a high relapse risk. In uncontrolled pilot and phase II studies, patients with chemosensitive disease seem to do better, with progression- free survival at 3–5 years after high-dose therapy of 15– 20%. 1–4 Peripheral blood stem cells are today almost Correspondence: Dr P Ljungman, Dept. of Hematology, Huddinge Univer- sity Hospital, SE-14186 Huddinge, Sweden Received 1 December 1997; accepted 9 April 1998 exclusively used for support after high-dose therapy, which has shortened the neutropenic period and reduced the treat- ment-related morbidity and mortality. The purpose of this report was to analyze outcome in a consecutive series of patients treated with high-dose therapy. Patients and methods Patients Ninety-four patients who underwent high-dose chemo- therapy with autologous stem cell support for chemotherapy responsive stage IV breast cancer between 1 January 1991 and 1 December 1996 at one of four participating hospitals were eligible for the study. Patient characteristics are shown in Table 1. Tumor evalutation after standard chemotherapy was performed by conventional clinical examination com- bined with relevant radiographic procedures. Transplant procedure The patients could be included in either a single (n = 71) or a double high-dose (n = 23) therapy protocol. If a single transplant protocol was used, the high-dose chemotherapy consisted of the combination of cyclosphosphamide Table 1 Patient characteristics Age (median, range) 45.1 (26.0–60.8) Type of disease Primary advanced 18 Relapsed 76 Location of metastases Lung, pleura 26 Liver 9 Bone 30 Lymph nodes, chest wall, subcutaneous 51 Bone marrow 1 No of involved sites 1 61 2 24 2 9 Response to standard-dose chemotherapy NED 51 PR 43