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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.

Publication ,  Journal Article
Vredenburgh, JJ; Madan, B; Coniglio, D; Ross, M; Broadwater, G; Niedzwiecki, D; Edwards, J; Marks, L; Vandemark, R; McDonald, C; Affronti, ML ...
Published in: Bone Marrow Transplant
June 2006

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.

Duke Scholars

Published In

Bone Marrow Transplant

DOI

ISSN

0268-3369

Publication Date

June 2006

Volume

37

Issue

11

Start / End Page

1009 / 1015

Location

England

Related Subject Headings

  • Transplantation, Autologous
  • Time Factors
  • Survival Rate
  • Prospective Studies
  • Prognosis
  • Peripheral Blood Stem Cell Transplantation
  • Methotrexate
  • Immunology
  • Humans
  • Fluorouracil
 

Citation

APA
Chicago
ICMJE
MLA
NLM

Published In

Bone Marrow Transplant

DOI

ISSN

0268-3369

Publication Date

June 2006

Volume

37

Issue

11

Start / End Page

1009 / 1015

Location

England

Related Subject Headings

  • Transplantation, Autologous
  • Time Factors
  • Survival Rate
  • Prospective Studies
  • Prognosis
  • Peripheral Blood Stem Cell Transplantation
  • Methotrexate
  • Immunology
  • Humans
  • Fluorouracil