title: Combined weekly carboplatin and paclitaxel as primary treatment of advanced epithelial ovarian carcinoma.
abstract: 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.
authors.affiliation: Department of Oncology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Tamar
authors.initials: T
authors.lastname: Safra
authors.forename: Joseph
authors.initials: J
authors.lastname: Menczer
authors.forename: Rinat Molho
authors.initials: RM
authors.lastname: Bernstein
authors.forename: Shulem
authors.initials: S
authors.lastname: Shpigel
authors.forename: Dianna
authors.initials: D
authors.lastname: Matcejevsky
authors.forename: Moshe J
authors.initials: MJ
authors.lastname: Inbar
authors.forename: Abraham
authors.initials: A
authors.lastname: Golan
authors.forename: Dan
authors.initials: D
authors.lastname: Grisaru
authors.forename: Tally
authors.initials: T
authors.lastname: Levy
mesh_terms: 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
chemical_list: D016190:Carboplatin; D017239:Paclitaxel