High-dose melphalan and autologous stem cell transplantation as consolidation treatment in patients with chemosensitive ovarian cancer: results of a single-institution randomized trial.
The role of high-dose chemotherapy (HDCT) in epithelial ovarian cancer (EOC) remains controversial. This study was initiated to compare the efficacy and tolerability of HDCT as a consolidation approach in women with chemosensitive advanced EOC (FIGO stages IIC-IV). Patients who had achieved their first clinical complete remission after six cycles of conventional paclitaxel and carboplatin combination chemotherapy were randomly assigned to receive or not high-dose melphalan. The primary objective was to compare time to disease progression (TTP). A total of 80 patients were enrolled onto the trial. Patients who were randomized to receive HDCT were initially treated with cyclophosphamide 4 g/m(2) for PBPC mobilization. HDCT consisted of melphalan 200 mg/m(2). Of the 37 patients who were allocated to HDCT, 11 (29.7%) did not receive melphalan either due to patient refusal (n=5) or due to failure of PBPC mobilization (n=6). In an intent-to-treat analysis, there were no significant differences between the two arms in TTP (P=0.059) as well as in overall survival (OS) (P=0.38).
Papadimitriou
C
C
Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens, Greece. chr_papadim@yahoo.gr
Dafni
U
U
Anagnostopoulos
A
A
Vlachos
G
G
Voulgaris
Z
Z
Rodolakis
A
A
Aravantinos
G
G
Bamias
A
A
Bozas
G
G
Kiosses
E
E
Gourgoulis
G M
GM
Efstathiou
E
E
Dimopoulos
M A
MA
D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D001804:Blood Transfusion, Autologous; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D018450:Disease Progression; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D000078224:Lenograstim; D008558:Melphalan / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000401:mortality / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage; D016019:Survival Analysis; D013997:Time Factors
D000276:Adjuvants, Immunologic; D018906:Antineoplastic Agents, Alkylating; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D003520:Cyclophosphamide; D008558:Melphalan