title: Phase II study of irinotecan in combination with bevacizumab in recurrent ovarian cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of irinotecan and bevacizumab in recurrent ovarian cancer. The primary objective was to estimate the progression free survival (PFS) rate at 6months. Secondary objectives included estimation of overall survival (OS), objective response rate (ORR), duration of response, and an evaluation of toxicity.
  
  
  METHODS
  Recurrent ovarian cancer patients with no limit on prior treatments were eligible. Irinotecan 250mg/m2 (amended to 175mg/m2 after toxicity assessment in first 6 patients) and bevacizumab 15mg/kg were administered every 3weeks until progression or toxicity. Response was assessed by RECIST or CA-125 criteria every 2cycles.
  
  
  RESULTS
  Twenty nine patients enrolled (10 were platinum-sensitive and 19 were platinum-resistant). The median number of prior regimens was 5 (range 1-12); 13 patients had prior bevacizumab and 11 prior topotecan. The PFS rate at 6months was 55.2% (95% CI: 40%-77%). The median number of study cycles given was 7 (range 1-34). Median PFS was 6.8months (95% CI: 5.1-12.1months); median OS was 15.4months (95% CI: 11.9-20.4months). In this study, no complete response (CR) was observed. The objective response rate (ORR; PR or CR) for all patients entered was 27.6% (95% CI: 12.7%-47.2%) and the clinical benefit rate (CR+PR+SD) was 72.4% (95% CI: 52.8%-87.3%); twelve patients experienced duration of response longer than 6months. In the 24 patients with measurable disease, a partial response (PR) was documented in 8 (30%) patients; 13 patients maintained stable disease (SD) at first assessment. The most common grade 3/4 toxicity was diarrhea. No treatment-related deaths were observed.
  
  
  CONCLUSIONS
  Irinotecan and bevacizumab has activity in heavily pre-treated patients with recurrent ovarian cancer, including those with prior bevacizumab and topoisomerase inhibitor use.
authors.affiliation: Gynecologic Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: Fernanda
authors.initials: F
authors.lastname: Musa
authors.affiliation: Gynecologic Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: Bhavana
authors.initials: B
authors.lastname: Pothuri
authors.affiliation: Gynecologic Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: Stephanie V
authors.initials: SV
authors.lastname: Blank
authors.affiliation: Medical Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: Huichung T
authors.initials: HT
authors.lastname: Ling
authors.affiliation: Medical Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: James L
authors.initials: JL
authors.lastname: Speyer
authors.affiliation: Gynecologic Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: John
authors.initials: J
authors.lastname: Curtin
authors.affiliation: Gynecologic Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: Leslie
authors.initials: L
authors.lastname: Boyd
authors.affiliation: Biostatistics, New York University School of Medicine, United States.
authors.forename: Xiaochun
authors.initials: X
authors.lastname: Li
authors.affiliation: Biostatistics, New York University School of Medicine, United States.
authors.forename: Judith D
authors.initials: JD
authors.lastname: Goldberg
authors.affiliation: Medical Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States.
authors.forename: Franco
authors.initials: F
authors.lastname: Muggia
authors.affiliation: Medical Oncology, Perlmutter Cancer Center at the New York University Langone Medical Center, United States. Electronic address: tiersten@mssn.edu.
authors.forename: Amy
authors.initials: A
authors.lastname: Tiersten
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000068258:Bevacizumab; D000077146:Irinotecan; D002166:Camptothecin
keywords: Bevacizumab; Clinical trial; Irinotecan; Ovarian cancer; Phase II