Phase II trial of high-dose intravenous doxorubicin, etoposide, and cyclophosphamide with autologous stem cell support in patients with residual or responding recurrent ovarian cancer.
This study was performed in order to evaluate the toxicities, progression-free and overall survival of patients with responsive residual or recurrent ovarian cancer treated with high-dose chemotherapy. Twenty-seven patients were treated. Doxorubicin, 165 mg/m(2) over 96 h (days -12 to -8), etoposide 700 mg/m(2) every day x3 (days -6 to -4), and cyclophosphamide 4.2 g/m(2) on d -3 was followed by stem cells and granulocyte colony-stimulating factor. The median days of granulocyte count <500/microl was 14 (range 10-42) and platelets <20,000/microl was 13 (range 2-80). Median numbers of red cell and platelet transfusions were 15 (5-16) and 14 (4-103). Toxicity included mucositis requiring narcotic analgesia in all patients. Asymptomatic decreases in ejection fraction to values <50% were observed in four patients. No clinical congestive heart failure was observed. One death due to sepsis was observed. Median progression-free survival is 7.5 months (1.0-56 months); five patients remain alive, two of whom remain progression-free at 19.5 and 24.5 months post transplant. Median overall survival is 14.0 months (1-68 months). We conclude that high-dose anthracyclines may be safely administered to ovarian cancer patients. The short overall and progression-free survivals observed in our population suggest that this combination is not optimal.
Morgan
R J
RJ
Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA 91010, USA.
Doroshow
J H
JH
Leong
L
L
Schriber
J
J
Shibata
S
S
Forman
S
S
Hamasaki
V
V
Margolin
K
K
Somlo
G
G
Alvarnas
J
J
McNamara
M
M
Longmate
J
J
Raschko
J
J
Chow
W
W
Vasilev
S
S
McGonigle
K
K
Yen
Y
Y
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis; D018394:CA-125 Antigen / Q000032:analysis; D002277:Carcinoma / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery / Q000628:therapy; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000032:analysis; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery / Q000628:therapy; D010052:Ovariectomy; D016019:Survival Analysis; D014182:Transplantation, Autologous; D017211:Treatment Failure; D016896:Treatment Outcome
D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D009363:Neoplasm Proteins; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide