title: Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study.
abstract: BACKGROUND
  Metastatic and recurrent, platinum resistant cervix cancer has an extremely poor prognosis. The Gynecologic Oncology Group has studied >20 cytotoxic drugs or drug combinations in the second-line, phase II setting of advanced, drug resistant cervix cancer.
  
  
  METHODS
  Nanoparticle, albumin-bound paclitaxel (nab-paclitaxel) was administered at 125 mg/m(2) IV over 30 minutes on days 1, 8 and 15 of each 28 day cycle to 37 women with metastatic or recurrent cervix cancer that had progressed or relapsed following first-line cytotoxic drug treatment. A flexible, 2-stage accrual design that allowed stopping early for lack of treatment activity was utilized. Because of slow patient accrual, the second stage was not completed.
  
  
  RESULTS
  Of 37 patients enrolled, 2 were ineligible due to no prior cytotoxic chemotherapy, which left 35 eligible patients evaluable for response and tolerability. All of the eligible patients had 1 prior chemotherapy regimen and 27 of them had prior radiation therapy with concomitant cisplatin. The median number of nab-paclitaxel cycles were 4 (range 1-15). Ten (28.6%; CI 14.6%-46.3%) of the 35 patients had a partial response and another 15 patients (42.9%) had stable disease. The median progression-free and overall survival were 5.0 and 9.4 months, respectively. The only NCI CTCAE grade 4 event was neutropenia in 2 patients (5.7%) which resolved following dose reduction. Grade 3 neurotoxicity was reported in 1 (2.9%) patient and resolved to grade 2 following dose discontinuation.
  
  
  CONCLUSIONS
  Nab-paclitaxel has considerable activity and moderate toxicity in the treatment of drug resistant, metastatic and recurrent cervix cancer.
authors.affiliation: The University of Arizona Cancer Center, University of Arizona, Tucson, AZ 85724, USA. dalberts@azcc.arizona.edu
authors.forename: David S
authors.initials: DS
authors.lastname: Alberts
authors.forename: John A
authors.initials: JA
authors.lastname: Blessing
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Landrum
authors.forename: David P
authors.initials: DP
authors.lastname: Warshal
authors.forename: Lainie P
authors.initials: LP
authors.lastname: Martin
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Rose
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Bonebrake
authors.forename: Lois M
authors.initials: LM
authors.lastname: Ramondetta
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000970:Antineoplastic Agents; D017239:Paclitaxel