title: Evaluation of low-dose intraperitoneal interferon-alpha for palliation of ascites in patients with non-ovarian gynecologic malignancies.
abstract: OBJECTIVE
  Intraperitoneal interferon-alpha (IP-IFNalpha) has shown some benefit in the treatment of patients with ovarian cancer. Our goal was to evaluate the use of low-dose IP-IFNalpha for the palliative control of ascites in non-ovarian gynecologic malignancies, including primary peritoneal and uterine papillary serous carcinomas.
  
  
  METHODS
  Fifteen patients with non-ovarian gynecologic malignancies received one or two doses of 10 MU (10 x 10(6) U/m(2)) of IP-IFNalpha via single-use drum catheter for the symptomatic control of ascites. The median age for this patient group was 61 years (range 40-84). Histopathologic diagnoses were confirmed on all patients. Eleven of 15 (73%) patients had uterine cancers. Four of 15 (27%) patients had papillary serous primary peritoneal carcinomas. Thirteen of 15 (87%) patients had Stage III disease or more. All patients had been heavily pretreated with chemotherapy and all had progressive disease.
  
  
  RESULTS
  Specific parameters used to evaluate IP-IFNalpha were (1) median survival; (2) number of days to recurrent ascites; (3) number of subsequent paracenteses required for symptomatic relief; and (4) symptomatology and side effects. Median overall survival was 3 months (range 0.5-13). Seven of 15 (47%) patients survived >3 months. Twelve of 15 (80%) patients had recurrent ascites within 30 days of treatment. However, 3/15 (20%) patients had a prolonged, >30-day period, without symptomatic ascites. One patient (6%) had a 270-day response with no ascites. Toxicity was minimal from IP-IFNalpha infusion. The most common side effect was fever in 6/15 (40%) patients.
  
  
  CONCLUSIONS
  IP-IFNalpha was well tolerated and may have some benefit in a subset of patients. Although 80% of patients had recurrent ascites within 30 days, 20% had a prolonged, >30-day response. Further study is warranted to determine the role of immune modulators, such as IP-IFNalpha, in the palliative management of patients with non-ovarian gynecologic malignancies that cause ascites.
authors.affiliation: Department of Obstetrics & Gynecology and Women's Health, Division of Gynecologic Oncology, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY 10461, USA. dkhabele@montefiore.org
authors.forename: Dineo
authors.initials: D
authors.lastname: Khabele
authors.forename: Carolyn D
authors.initials: CD
authors.lastname: Runowicz
authors.forename: Abbie L
authors.initials: AL
authors.lastname: Fields
authors.forename: Patrick S
authors.initials: PS
authors.lastname: Anderson
authors.forename: Gary L
authors.initials: GL
authors.lastname: Goldberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001201:Ascites / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007263:Infusions, Parenteral; D016898:Interferon-alpha / Q000008:administration & dosage*; D008875:Middle Aged; D009367:Neoplasm Staging; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D016898:Interferon-alpha