One year maintenance of carboplatin in patients with epithelial ovarian cancer--a phase II study.
BACKGROUND
The 5 year survival rate in patients with advanced epithelial ovarian cancer is 25-40% and treatment is mainly palliative once the disease recurs.


OBJECTIVE
To determine the time to progression, overall survival and toxicity of 1 year maintenance treatment with carboplatin in women with advanced EOC after achieving complete remission with platinum-based combination chemotherapy.


METHODS
Twenty-two women with epithelial ovarian cancer stage III-IV previously treated with platinum-based combinations who had achieved complete remission evidenced by symptoms, pelvic examination, computerized tomography and serum CA-125, were assigned to the study protocol consisting of: carboplatin of AUC=6, three cycles every 2 months, followed by two cycles once every 3 months for a total of five courses over 1 year.


RESULTS
Median follow-up in the 22 patients was 83 months (range 18-133 months), median disease-free survival was 36 months (range 2.5-126.4, 95% confidence interval 16.39-56.34). The 5 year survival was 59.7% with a mean overall survival of 83 months (range 18-133, 95% CI 39.11-127.29). Eleven patients have relapsed and died, 11 are alive, 6 are still in complete remission, and 5 are alive with recurrent disease. Grade III-IV toxicity was shown in some of the patients, anemia in 9%, thrombocytopenia in 9%, fatigue in 4.5%, and hypersensitivity in 4.5%.


CONCLUSIONS
A 1 year extension of treatment with a single-agent carboplatin, administered to women with advanced EOC who had achieved complete recovery on platinum-based chemotherapy as their first-line therapy, has an acceptable toxicity. The disease-free survival and overall survival values noted in this study are encouraging and warrant further investigation.
Safra
Tamar
T
Department of Oncology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Kovner
Felix
F
Barak
Nelly
N
Inbar
Moshe J
MJ
Ron
Ilan G
IG
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
D000970:Antineoplastic Agents; D016190:Carboplatin