title: A randomized phase III comparative trial of immediate consolidation with high-dose chemotherapy and autologous peripheral blood progenitor cell support compared to observation with delayed consolidation in women with metastatic breast cancer and only bone metastases following intensive induction chemotherapy.
abstract: The prognosis for patients with metastatic breast cancer remains poor. Metastatic breast cancer confined to the bones may have a better prognosis, especially hormone receptor-positive disease. We performed a prospective, randomized clinical trial to compare immediate consolidation with high-dose chemotherapy and hematopoietic support versus observation with high-dose consolidation at the time of disease progression in women with metastatic breast cancer and only bone metastases. The patients received chemotherapy with doxorubicin, 5-fluorouracil and methotrexate before randomization. In all, 85 patients were enrolled and 69 were randomized. The median follow-up is 8.1 years from randomization. The median event-free survival (EFS) for the immediate transplant arm is 12 months and for the observation arm is 4.3 months (P<0.0001). The median overall survival for the immediate transplant arm is 2.97 years and for the observation arm 1.81 years, a difference that is not statistically significant. Immediate high-dose chemotherapy and radiation therapy as consolidation offers a clinically and statistically significant improvement in EFS compared with radiation therapy alone following induction chemotherapy for women with metastatic breast cancer confined to the bones.
authors.affiliation: Division of Medical Oncology/Transplantation, Duke University Medical Center, Durham, NC 27710, USA. vrede001@mc.duke.edu
authors.forename: J J
authors.initials: JJ
authors.lastname: Vredenburgh
authors.forename: B
authors.initials: B
authors.lastname: Madan
authors.forename: D
authors.initials: D
authors.lastname: Coniglio
authors.forename: M
authors.initials: M
authors.lastname: Ross
authors.forename: G
authors.initials: G
authors.lastname: Broadwater
authors.forename: D
authors.initials: D
authors.lastname: Niedzwiecki
authors.forename: J
authors.initials: J
authors.lastname: Edwards
authors.forename: L
authors.initials: L
authors.lastname: Marks
authors.forename: R
authors.initials: R
authors.lastname: Vandemark
authors.forename: C
authors.initials: C
authors.lastname: McDonald
authors.forename: M L
authors.initials: ML
authors.lastname: Affronti
authors.forename: W P
authors.initials: WP
authors.lastname: Peters
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary* / Q000628:therapy; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage; D036102:Peripheral Blood Stem Cell Transplantation; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D013997:Time Factors; D014182:Transplantation, Autologous
chemical_list: D004317:Doxorubicin; D005472:Fluorouracil; D008727:Methotrexate