Combined weekly carboplatin and paclitaxel as primary treatment of advanced epithelial ovarian carcinoma.
OBJECTIVE
To evaluate safety and outcome of weekly carboplatin and paclitaxel as the initial postoperative adjuvant chemotherapy for epithelial ovarian carcinoma (EOC) patients.


METHODS
Patients with stage IC-IV epithelial ovarian cancer (EOC) primary peritoneal or tubal carcinoma were enrolled in this phase II study. Intravenous carboplatin (area under the curve 2) and paclitaxel (80 mg/m(2)) were administered on days 1, 8, and 15 of a 28-day cycle for 6-8 cycles. Cytoreductive surgery was performed as primary treatment or after 3 cycles of weekly neoadjuvant chemotherapy, followed postoperatively by an additional 3 cycles of chemotherapy.


RESULTS
Sixty-four women (median age 65 years, range 39.9-82.8) were enrolled. Fifty-six of them (87.6%) were diagnosed with stage III-IV disease. Neutropenia was the most common hematological toxicity: 25% of the subjects had grade 3-4 neutropenia, 34.4% were supported by GCSF and 15.6% received epoetin. The majority (89%) of the patients had grade 1 and only 7.8% had grade 2 alopecia. 7.8% had grade 3 fatigue and 14.1% had grade 2 and 3.1% grade 3 neuropathy, none developed grade 4 neuropathy and only 6.3% had some residual neuropathy at >6 months after treatment. With a median follow-up of 31.5 months (range 5.9-57.3), estimated median survival was 52.0 months and median progression-free survival 25.74 (8.4-57.3) months (95% CI, 21.2-30.3). Overall and complete response rates were 92.1% and 64.1% respectively.


CONCLUSIONS
Weekly carboplatin and paclitaxel as the initial chemotherapy for EOC is a feasible and well tolerated regimen and should be further evaluated in a larger phase III study.
Safra
Tamar
T
Department of Oncology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Menczer
Joseph
J
Bernstein
Rinat Molho
RM
Shpigel
Shulem
S
Matcejevsky
Dianna
D
Inbar
Moshe J
MJ
Golan
Abraham
A
Grisaru
Dan
D
Levy
Tally
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004847:Epithelial Cells / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome
D016190:Carboplatin; D017239:Paclitaxel