title: High-dose chemotherapy with haematopoietic stem cell transplantation for metastatic breast cancer patients: final results of the French multicentric randomised CMA/PEGASE 04 protocol.
abstract: The aim of our study was to evaluate the impact on time to progression (TTP) and overall survival (OS) of high-dose chemotherapy (HD-CT) over conventional CT in metastatic breast cancer patients. Between 09/92 and 12/96, 61 patients with chemosensitive metastatic breast cancer were randomised between HD-CT using the CMA regimen (Mitoxantrone, Cyclophosphamide, Melphalan) applied as consolidation (32 patients) or maintenance CT (29 patients). At randomisation, 13 patients were in complete response, 47 in partial response and one had stable disease. The median TTPs from randomisation were 6 and 12 months in the standard and intensive groups, respectively (P < 0.0056), with a relapse rate of 86.2% vs. 62.5% at 2 years, and 100% vs. 81.3% at 5 years. The median OS times were 19.3 and 44.1 months, with an OS rate of 13.8% vs. 36.8% at 5 years (P < 0.0294). The CMA regimen could prolong the TTP of patients with chemosensitive metastatic breast cancer. Further studies are needed to determine if this translates into an effect on OS.
authors.affiliation: Tenon and Saint-Louis Hospitals, Assistance Publique-Hôpitaux de Paris, 3 avenue Victoria, 75003 Paris, France. jean-pierre.lotz@tnn.ap-hop-paris.fr
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lotz
authors.forename: Hervé
authors.initials: H
authors.lastname: Curé
authors.forename: Maud
authors.initials: M
authors.lastname: Janvier
authors.forename: Bernard
authors.initials: B
authors.lastname: Asselain
authors.forename: François
authors.initials: F
authors.lastname: Morvan
authors.forename: Michel
authors.initials: M
authors.lastname: Legros
authors.forename: Bruno
authors.initials: B
authors.lastname: Audhuy
authors.forename: Pierre
authors.initials: P
authors.lastname: Biron
authors.forename: Maryse
authors.initials: M
authors.lastname: Guillemot
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Goubet
authors.forename: Abderrahmane
authors.initials: A
authors.lastname: Laadem
authors.forename: Christian
authors.initials: C
authors.lastname: Cailliot
authors.forename: Christine Le
authors.initials: CL
authors.lastname: Maignan
authors.forename: Thierry
authors.initials: T
authors.lastname: Delozier
authors.forename: Sylvie
authors.initials: S
authors.lastname: Glaisner
authors.forename: Dominique
authors.initials: D
authors.lastname: Maraninchi
authors.forename: Henri
authors.initials: H
authors.lastname: Roché
authors.forename: Christian
authors.initials: C
authors.lastname: Gisselbrecht
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000628:therapy*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005602:France; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D012307:Risk Factors; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D008942:Mitoxantrone; D008558:Melphalan