title: A phase II trial of paclitaxel, carboplatin, and bevacizumab in advanced and recurrent endometrial carcinoma (EMCA).
abstract: OBJECTIVE
  To evaluate the effect of adding bevacizumab to adjuvant paclitaxel and carboplatin and as maintenance on progression-free survival (PFS) in advanced or recurrent endometrial carcinoma (EMCA).
  
  
  METHODS
  A phase II trial was conducted in patients with measurable disease. Paclitaxel (175mg/m(2)/3h), carboplatin (AUC 5) and bevacizumab (15mg/kg) were administered q 21 days. Patients with a complete response after 6-8cycles received maintenance therapy with bevacizumab 15mg/kg q 21 days for 16cycles. Based on GOG 177 which had a 6-month PFS rate of 59%, an increase in 6-month PFS to 72% with the treatment regimen was considered of clinical interest.
  
  
  RESULTS
  15 patients were enrolled on protocol when accrual to the study was discontinued due to the initiation of a national randomized phase II trial. A total of 127 courses (median 8, range 1-20) of carboplatin, paclitaxel, and bevacizumab combination therapy were administered. One patient suffered a bowel perforation after her first course of therapy and was inevaluable for response. Fourteen of the 15 patients (93%, 95% CI: 82-100) were progression free at 6months. The median follow-up was 36months (7-58+). The median PFS was 18months (CI: 11-25). Five complete responses and 6 partial responses were seen for an overall response rate of 73% (CI: 45-91). The median overall survival was 58months (CI: 48-68).
  
  
  CONCLUSIONS
  The bevacizumab, paclitaxel, and carboplatin regimen is active and tolerable in advanced and recurrent EMCA. Its impact awaits results of the recently completed randomized phase II trial.
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, United States.
authors.forename: Fiona
authors.initials: F
authors.lastname: Simpkins
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Cleveland Clinic Foundation, Cleveland, OH, United States.
authors.forename: Richard
authors.initials: R
authors.lastname: Drake
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Cleveland Clinic Foundation, Cleveland, OH, United States.
authors.forename: Pedro F
authors.initials: PF
authors.lastname: Escobar
authors.affiliation: Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH, United States.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Nutter
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Cleveland Clinic Foundation, Cleveland, OH, United States.
authors.forename: Nabila
authors.initials: N
authors.lastname: Rasool
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Cleveland Clinic Foundation, Cleveland, OH, United States. Electronic address: rosep@ccf.org.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Rose
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel
keywords: Advanced stage endometrial cancer; Bevacizumab; Chemotherapy