title: Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer.
abstract: OBJECTIVE
  The single-arm OCTAVIA study evaluated front-line bevacizumab plus weekly paclitaxel and q3w carboplatin.
  
  
  METHODS
  Patients with newly diagnosed ovarian cancer (International Federation of Gynecology and Obstetrics [FIGO] stage IIb-IV or grade 3/clear-cell stage I/IIA) received bevacizumab (7.5mg/kg, day 1), weekly paclitaxel (80 mg/m(2) days 1, 8, 15) and carboplatin (area under the curve 6 [AUC6], day 1) intravenously q3w for 6-8 cycles, followed by single-agent bevacizumab (total 1 year). The primary objective was to demonstrate median progression-free survival (PFS)>18 months according to the lower 90% confidence limit. Secondary end-points included objective response rate, overall survival, safety and tolerability.
  
  
  RESULTS
  Most (74%) of the 189 treated patients had stage IIIC/IV disease, similar to the ICON7 population. Patients received a median of six chemotherapy and 17 bevacizumab cycles. At the predefined cutoff 24 months after last patient enrolment, 99 patients (52%) had progressed and 19 (10%) had died, all from ovarian cancer. Median PFS was 23.7 months (95% confidence interval [CI], 19.8-26.4 months), 1-year PFS rate was 85.6%, Response Evaluation Criteria in Solid Tumors (RECIST) response rate was 84.6% and median response duration was 14.7 months. Most patients (≥90%) completed at least six chemotherapy cycles. Grade ≥3 peripheral sensory neuropathy occurred in 5% and febrile neutropenia in 0.5%. Grade ≥3 adverse events typical of bevacizumab were no more common than in phase III bevacizumab ovarian cancer trials. There was one case of gastrointestinal perforation (0.5%) and no treatment-related deaths.
  
  
  CONCLUSIONS
  OCTAVIA met its primary objective, demonstrating median PFS of approximately 2 years. This bevacizumab-containing regimen is active and tolerable.
authors.affiliation: GEICO and MD Anderson Cancer Center Spain, Madrid, Spain. Electronic address: agonzalezm@seom.org.
authors.forename: Antonio
authors.initials: A
authors.lastname: Gonzalez-Martin
authors.forename: Laurence
authors.initials: L
authors.lastname: Gladieff
authors.forename: Bengt
authors.initials: B
authors.lastname: Tholander
authors.forename: Daniel
authors.initials: D
authors.lastname: Stroyakovsky
authors.forename: Martin
authors.initials: M
authors.lastname: Gore
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Nadezhda
authors.initials: N
authors.lastname: Kovalenko
authors.forename: Ana
authors.initials: A
authors.lastname: Oaknin
authors.forename: Julian Perez
authors.initials: JP
authors.lastname: Ronco
authors.forename: Ulrich
authors.initials: U
authors.lastname: Freudensprung
authors.forename: Sandro
authors.initials: S
authors.lastname: Pignata
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; 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; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013921:Thrombocytopenia / Q000821:virology; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel
keywords: Angiogenesis; Bevacizumab; Front-line; Ovarian cancer; Weekly paclitaxel