title: Feasibility and Safety of Negative-Balance Isolated Pelvic Perfusion in Patients with Pretreated Recurrent or Persistent Uterine Cervical Cancer.
abstract: BACKGROUND
  Second-line therapy has limited activity in patients with recurrent or persistent uterine cervical cancer that has progressed after chemoradiation and palliative chemotherapy. The purpose of this study was to evaluate the efficacy of negative-balance isolated pelvic perfusion (NIPP) in patients with pretreated recurrent/persistent uterine cervical cancer.
  
  
  METHODS
  Between April 2004 and May 2013, a total of 26 patients with recurrent or persistent uterine cervical cancer previously treated with platinum-based systemic chemotherapy and/or chemoradiotherapy received NIPP therapy at our institution, consisting of a 30-min isolated pelvic perfusion with cisplatin and fluorouracil, followed by isolated pelvic dialysis. Primary endpoints were response rate (RR) and progression-free survival (PFS), while secondary endpoints were overall survival (OS) and safety. Platinum pharmacokinetics were also evaluated.
  
  
  RESULTS
  The RR was 57.7 % (complete response, five patients; partial response, ten patients). The median PFS and OS after NIPP therapy were 11.0 (95 % confidence interval [CI] 6.6-15.4) and 25.1 (95 % CI 17.1-33.1) months, respectively. PFS was significantly better in patients without intestinal involvement (p = 0.016) or dissemination (p < 0.001). Survival rates at 1, 2, and 3 years after initial NIPP therapy were 65.2, 50.4, and 13.4 %, respectively. The plasma pelvic-to-systemic exposure ratios were 15.4 and 15.8, based on the maximum concentration and the concentration-time curve, respectively. Most adverse events were mild (grade 1-2) (Common Terminology Criteria for Adverse Events, version 3.0). Severe neutropenia (grade 3 or higher) occurred in only 7.7 % of patients.
  
  
  CONCLUSIONS
  NIPP appears to be an effective and feasible method for patients with pretreated recurrent or persistent cervical cancer.
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan. genji@nms.ac.jp.
authors.forename: Satoru
authors.initials: S
authors.lastname: Murata
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Onozawa
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Fumie
authors.initials: F
authors.lastname: Sugihara
authors.affiliation: Department of Anesthesiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Atsuhiro
authors.initials: A
authors.lastname: Sakamoto
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Ueda
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Yamaguchi
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yasui
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Takahiko
authors.initials: T
authors.lastname: Mine
authors.affiliation: Department of Radiology, Nippon Medical School, Bunkyou-ku, Tokyo, Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Kumita
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy / Q000556:secondary; D059248:Chemoradiotherapy; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000009:adverse effects* / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D003956:Dialysis; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010388:Pelvis; D066066:Response Evaluation Criteria in Solid Tumors; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy
chemical_list: D002945:Cisplatin; D005472:Fluorouracil