Phase II study of docetaxel-vinorelbine in platinum-resistant, paclitaxel-pretreated ovarian cancer.
BACKGROUND
This multicenter, prospective phase II study evaluated the safety and efficacy of the combination of docetaxel and vinorelbine in patients with platinum-resistant, paclitaxel-pretreated recurrent ovarian cancer.


METHODS
Treatment consisted of vinorelbine 25 mg/m(2) as a 20-min i.v. infusion (days 1 and 8), and docetaxel 70 mg/m(2), as a 1-h i.v. infusion (day 8). Granulocyte colony-stimulating factor support was administered prophylactically on days 12-16. Treatment was repeated every 21 days.


RESULTS
Forty-six patients were enrolled. The median number of previous chemotherapeutic regimens was one (range 1-3) with a median treatment-free interval of 4.3 months. Four chemotherapy cycles per patient were administered. Almost 75% of the planned doses for both drugs were given. Forty-one patients are evaluable for response. Three patients (6.5% of all patients; 7.3% of evaluable patients) achieved complete response and eight (17.4% and 19.5%, respectively) a partial response to chemotherapy, leading to overall response rates of 23.9% and 26.8%, respectively. Another 34.8% (39.0%) had stable disease. At a median follow-up of 30 months, the median disease-free survival was 13 months, relapse-free survival was 5 months, time to progression was 4.5 months, and overall survival was 9.3 months. Severe toxicities included leukopenia (31%), neutropenia (35%) and febrile neutropenia (20%).


CONCLUSIONS
The combination of docetaxel/vinorelbine is an effective regimen with manageable toxicity for the treatment of platinum-resistant, paclitaxel-pretreated ovarian cancer.
Aravantinos
G
G
Hellenic Co-operative Oncology Group, Athens, Greece. hecogaga@otenet.gr
Bafaloukos
D
D
Fountzilas
G
G
Christodoulou
C
C
Papadimitriou
C
C
Pavlidis
N
N
Kalofonos
H P
HP
Gogas
H
H
Kosmidis
P
P
Dimopoulos
M A
MA
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000494:pharmacology; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000494:pharmacology; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D011446:Prospective Studies; D043823:Taxoids; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D014747:Vinblastine; D017239:Paclitaxel; D002945:Cisplatin; D000077235:Vinorelbine