title: A phase II evaluation of nanoparticle, albumin-bound (nab) paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: a Gynecologic Oncology Group study.
abstract: BACKGROUND
  Nab-paclitaxel is a novel Cremophor®-free nanoparticle of albumin-stabilized paclitaxel, which has favorable efficacy and toxicity characteristics relative to other solvent-based taxanes, such as paclitaxel and docetaxel.
  
  
  METHODS
  Eligible patients had platinum- and taxane-resistant ovarian cancer, defined by persistent or progressive disease following primary chemotherapy (n = 5) or recurrence within 6 months of treatment completion (n = 42). All patients had measurable disease, no prior therapy for recurrent disease and Gynecologic Oncology Group performance status of ≤ 2. Treatment was nab-paclitaxel, 100 mg/m² days 1, 8, and 15 on a 28-day schedule. The primary endpoint was Response Evaluation Criteria in Solid Tumors v1.0 response rate, evaluated in a 2-stage design (with power of 0.90 for a RR of 25% and with alpha of 0.05 for RR of 10%).
  
  
  RESULTS
  Fifty-one patients were enrolled of which 47 were evaluable; median time from frontline therapy completion to registration was 21 days. Patient demographics include median age: 59 (34-78) years, serous histology: 72%, and high-grade: 81%.
  
  
  RESULTS
  one complete and 10 partial responses were confirmed (23%); 17 patients (36%) had stable disease. The median progression-free survival was 4.5 months (95% CI: 2.2-6.7); overall survival was 17.4 months (95% CI: 13.2-20.8). Seventeen patients (36%) had PFS > 6 months.
  
  
  RESULTS
  there were no grade 4 events; grade 3 events were neutropenia (6), anemia (3), GI (2), metabolic (2), pain (2), and leukopenia (1); neurosensory toxicity was observed as grade 2:5, grade 3:1.
  
  
  CONCLUSIONS
  Nab-paclitaxel has noteworthy single-agent activity and is tolerable in this cohort of refractory ovarian cancer patients previously treated with paclitaxel.
authors.affiliation: Department of Gynecologic Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX 77030, USA. rcoleman@mdanderson.org
authors.forename: Robert L
authors.initials: RL
authors.lastname: Coleman
authors.forename: William E
authors.initials: WE
authors.lastname: Brady
authors.forename: D Scott
authors.initials: DS
authors.lastname: McMeekin
authors.forename: Peter G
authors.initials: PG
authors.lastname: Rose
authors.forename: John T
authors.initials: JT
authors.lastname: Soper
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Lentz
authors.forename: James S
authors.initials: JS
authors.lastname: Hoffman
authors.forename: Mark S
authors.initials: MS
authors.lastname: Shahin
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D019008:Drug Resistance, Neoplasm; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D053758:Nanoparticles / Q000008:administration & dosage*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel