ISPO

High-dose chemotherapy (HD-CT) with haematopoietic stem cells transplantation (HSCT) for metastatic breast cancer (MBC): the French PEGASE 04 protocol.

JP Lotz, M.D., 123, H Curé, M.D. 23, M Janvier, M.D. 23, F Morvan, M.D. 23, M Legros, M.D.23, B Audhuy, M.D. 23, P Biron, M.D. 23, B Asselain, M.D. 23, M. Guillemot, Ph.D. 2, C Cailliot, M.D. 4, C Le Maignan, M.D.1, T Delozier, M.D. 2, S Glaisner, M.D. 2, D Maraninchi, M.D. 23, H Roché, M.D. 23, C Gisselbrecht, M.D

1 Tenon and Saint-Louis Hospitals, Assistance Publique - Hôpitaux de Paris ; 2 The PEGASE Group French Federation of Anti-Cancer Centers ; 3 The French Society of Bone Marrow Transplantation and Cellular Therapy, 4 Laboratoires Amgen, Paris, France.

Rationale : Based on the relationship between dose intensity and response of MBC, a number of phase II HD-CT studies have been published. It was concluded that HD-CT should only be proposed for chemosensitive diseases but has yet to be evaluated in randomised studies. Gisselbrecht et al have published in 1996 a phase II trial in which 61 patients (pts) were proposed for HD-CT using the CMA regimen [Mitoxantrone : 60 mg/m², Cyclophosphamide : 120 mg/kg, Melphalan : 140 mg/m²]. HD-CT resulted in a median OS time of 33 months and a median EFS time of 20 months from the start of therapy. These results laid the ground work for further evaluation in randomised trials. Purpose: The aim of the PEGASE 04 protocol was to evaluate the impact on PFS of HD-CT over conventional CT for MBC. To detect a difference of 25% in the 2-year progression-free rate (from 25% to 50%), 156 pts have been planned to be enrolled in 3 years. Due to a too low rate of enrollment, it was decided to prematurely stop the inclusions in 12/96. Population : Between 09/92 and 12/96, 61 pts (median age, 44 y ; premenopausal, 48, first metastatic relapse, 39 ; metastatic at diagnosis, 22) with chemosensitive MBC (13 in CR, 48 in PR) were randomised between : 1) the CMA regimen (29 pts), and 2) 4 additional courses of CT (32 pts). Population were well-balanced in term of staging and previous therapy. Results : Considering the data presented during the ASCO 1999-2001 meetings, it was decided to submit this study to an external review committee. The results of the PEGASE 04 protocol will be presented during the meeting.

For more information, contact jean-pierre.lotz@tnn.ap-hop-paris.fr

Paper presented at the International Symposium on Predictive Oncology and Intervention Strategies; Paris, France; February 9 - 12, 2002; in the section on Stem Cell Biology.

http://www.cancerprev.org/Journal/Issues/26/101/1293/4258