First-line high-dose sequential chemotherapy with rG-CSF and repeated blood stem cell transplantation in untreated inflammatory breast cancer: toxicity and response (PEGASE 02 trial).

Abstract

Despite the generalization of induction chemotherapy and a better outcome for chemosensitive diseases, the prognosis of inflammatory breast cancer (IBC) is still poor. In this work, we evaluate response and toxicity of high-dose sequential chemotherapy with repeated blood stem cell (BSC) transplantation administered as initial treatment in 100 women with non-metastatic IBC. Ninety-five patients (five patients were evaluated as non-eligible) of median age 46 years (range 26-56) received four cycles of chemotherapy associating: cyclophosphamide (C) 6 g m(-2) - doxorubicin (D) 75 mg m(-2) cycle 1, C: 3 g m(-2) - D: 75 mg m(-2) cycle 2, C: 3 g m(-2) - D: 75 mg m(-2) - 5 FU 2500 mg m(-2) cycle 3 and 4. BSC were collected after cycle 1 or 2 and reinfused after cycle 3 and 4. rG-CSF was administered after the four cycles. Mastectomy and radiotherapy were planned after chemotherapy completion. Pathological response was considered as the first end point of this trial. A total of 366 cycles of chemotherapy were administered. Eighty-seven patients completed the four cycles and relative dose intensity was respectively 0.97 (range 0.4-1.04) and 0.96 (range 0.25-1.05) for C and D. Main toxicity was haematological with febrile neutropenia ranging from 26% to 51% of cycles; one death occurred during aplasia. Clinical response rate was 90% +/- 6%. Eighty-six patients underwent mastectomy in a median of 3.5 months (range 3-9) after the first cycle of chemotherapy; pathological complete response rate in breast was 32% +/- 10%. All patients were eligible to receive additional radiotherapy. High-dose chemotherapy with repeated BSC transplantation is feasible with acceptable toxicity in IBC. Pathological response rate is encouraging but has to be confirmed by final outcome.

• Authors: P Viens, T Palangié, M Janvier, M Fabbro, H Roché, T Delozier, J P Labat, C Linassier, B Audhuy, F Feuilhade, B Costa, R Delva, H Cure, F Rousseau, A Guillot, M Mousseau, J M Ferrero, V J Bardou, J Jacquemier, P Pouillart
• Journal: British journal of cancer (Br J Cancer) Vol. 81 Issue 3 Pg. 449-56 (Oct 1999) ISSN: 0007-0920 [Print] England
• PMID: 10507769 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Doxorubicin
• Cyclophosphamide
• Filgrastim
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, mortality, pathology, radiotherapy, surgery)
• Adult
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Blood Transfusion
• Bone Marrow Diseases (chemically induced, therapy)
• Breast Neoplasms (drug therapy, mortality, pathology, radiotherapy, surgery)
• Combined Modality Therapy
• Cyclophosphamide (administration & dosage, adverse effects)
• Disease-Free Survival
• Doxorubicin (administration & dosage, adverse effects)
• Female
• Filgrastim
• Fluorouracil (administration & dosage, adverse effects)
• Granulocyte Colony-Stimulating Factor (adverse effects, therapeutic use)
• Hematopoietic Stem Cell Transplantation (adverse effects)
• Humans
• Life Tables
• Mastectomy
• Middle Aged
• Radiotherapy, Adjuvant
• Recombinant Proteins
• Remission Induction
• Survival Rate