title: A pilot study evaluating a novel regimen comprised of carboplatin, paclitaxel, and bevacizumab for advanced-stage ovarian carcinoma.
abstract: OBJECTIVE
  The purpose of this study was to assess the toxicity, progression-free survival, and response rate of advanced stage ovarian carcinoma patients treated with a novel regimen comprising paclitaxel, carboplatin, and bevacizumab.
  
  
  METHODS
  All eligible patients were treated with intravenous paclitaxel (80 mg/m2) on days 1, 8, and 15; carboplatin (area under the curve, 5) on day 1; and bevacizumab (10 mg/kg) on days 1 and 15; Q28 days for 6 cycles. Bevacizumab was administered during cycles 2 through 6.
  
  
  RESULTS
  Twenty patients received a combined total of 102 cycles of primary induction chemotherapy (median, 6; range, 2-6) and were evaluable for toxicity assessment. Six (5.9%) cycles were associated with grades 3 and 4 neutropenia, which resulted in the removal of 2 patients. Only 1 (0.98%) cycle was associated with grade 3 thrombocytopenia. Moreover, one patient developed a colorectal fistula and was subsequently removed from the study. Grade 3 hypertension was encountered and successfully managed in 3 participants. In the group of 13 patients who were evaluated for response, the overall response rate was 61.6% (30.8% complete response). Four patients exhibited stable disease, and 1 patient had progressive disease. The patient group's mean progression-free survival was 5.8 months.
  
  
  CONCLUSIONS
  The tolerable hematologic toxicity and reasonable response rate after paclitaxel, carboplatin, and bevacizumab suggest that this regimen has moderate activity and can be safely administered to an advanced-stage ovarian carcinoma population. We were further encouraged by the reasonable incidence of hypertension. However, because 4 patients were removed from the study because of either grade ≥ 2 neutropenia or thrombocytopenia, we suggest that colony-stimulating factors and cautious patient observation should be considered with this regimen.
authors.affiliation: Gynecologic Oncology Associates, Hoag Cancer Center, Newport Beach, CA, USA.
authors.forename: John V
authors.initials: JV
authors.lastname: Brown
authors.forename: John P
authors.initials: JP
authors.lastname: Micha
authors.forename: Mark A
authors.initials: MA
authors.lastname: Rettenmaier
authors.forename: Lisa N
authors.initials: LN
authors.lastname: Abaid
authors.forename: Katrina L
authors.initials: KL
authors.lastname: Lopez
authors.forename: Bram H
authors.initials: BH
authors.lastname: Goldstein
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage; D002291:Carcinoma, Papillary / Q000188:drug therapy* / Q000473:pathology; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy* / Q000473:pathology; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel