title: Multiple cycles of dose-intensive chemotherapy with repeated stem cell support as induction treatment in metastatic breast cancer: a feasibility study.
abstract: The purpose of this trial was to study feasibility and tolerance of a dose-intensive multicyclic alternating induction chemotherapy with repeated stem cell support in a series of 43 metastatic breast cancer patients. Anthracycline-naive patients (n = 21) received cyclophosphamide 2.5 g/m(2) plus doxorubicin 80 mg/m(2) alternating every 14 days with paclitaxel 200-350 mg/m(2) plus cisplatin 120 mg/m(2). Patients who had previously received anthracyclines (n = 22) received cisplatin 120 mg/m(2) plus etoposide 600 mg/m(2) alternating with paclitaxel 200-350 mg/m(2) plus ifosfamide 8 g/m(2). Peripheral blood stem cells were infused after every course except the first, with a median CD34(+) dose of 2.1 x 10(6)/kg per cycle. Positive selection of CD34(+) cells was performed in good mobilizers. The median number of cycles administered was six (4-8), and the time interval between them was 17 days. Median summation dose intensities (SDI) actually administered for the CA-TP and PE-TI protocol were 4.95 and 4.69, respectively (87% of scheduled SDI). There were 15 complete (35%) and 21 partial responses (49%), for an overall response rate of 84% (95% CI, 73%-95%). Infection or neutropenic fever occurred in 50% of the cycles. There was one treatment-related death. After a median follow-up of 26 months, the median event-free-survival was 12 months (95% CI: 10-14) and overall survival was 31 months. These high dose-intensity induction treatments seem to be feasible with sequential stem cell support.
authors.affiliation: Oncology Department, Clínica Universitaria de Navarra, Pamplona, Spain.
authors.forename: S
authors.initials: S
authors.lastname: García-Rayo
authors.forename: J
authors.initials: J
authors.lastname: Pérez-Calvo
authors.forename: S
authors.initials: S
authors.lastname: Martín-Algarra
authors.forename: R
authors.initials: R
authors.lastname: Martínez-Monge
authors.forename: O
authors.initials: O
authors.lastname: Fernández-Hidalgo
authors.forename: L
authors.initials: L
authors.lastname: Subirá
authors.forename: M
authors.initials: M
authors.lastname: Martínez-Aguillo
authors.forename: J
authors.initials: J
authors.lastname: Rebollo
authors.forename: I
authors.initials: I
authors.lastname: Azinovic
authors.forename: A
authors.initials: A
authors.lastname: Brugarolas
mesh_terms: D000328:Adult; D018952:Antigens, CD34 / Q000032:analysis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000633:toxicity; D001943:Breast Neoplasms / Q000473:pathology / Q000556:secondary / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007239:Infections / Q000139:chemically induced; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage; D012074:Remission Induction / Q000379:methods; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D018952:Antigens, CD34; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D002945:Cisplatin; D007069:Ifosfamide