title: Oral thalidomide as palliative chemotherapy in women with advanced ovarian cancer.
abstract: OBJECTIVE
  We prospectively evaluated thalidomide, an oral agent with antiangiogenic and immunomodulatory properties, in patients with recurrent ovarian cancer, comparing the drug to standard intravenous chemotherapy and treatment holiday in terms of both progression-free interval and quality of life.
  
  
  METHODS
  Eligible patients had recurrent ovarian or primary peritoneal cancer and had received a minimum of two prior therapeutic regimens. Patients were offered one of three arms: (Arm A) any standard intravenous single-agent chemotherapy; (Arm B) oral thalidomide 200 mg daily; (Arm C) treatment holiday. Computed tomography (CT) scans were performed every two cycles until disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CA-125 was measured monthly as was quality of life using the Functional Assessment of Cancer Therapy (FACT-O) questionnaire.
  
  
  RESULTS
  Forty patients participated: 18 on Arm A; 18 on Arm B; and 4 on Arm C. The groups were comparable in terms of number of prior regimens and cycles of chemotherapy. The progression- free intervals were similar in Arm A and Arm B (3.7 versus 3.8 months). The PR/SD rate was 6.7%/60% for Arm A, and 7.7%/53.8% in Arm B. Of those treated with thalidomide, 53% had a drop in CA-125 greater than 50%, compared to 13% receiving intravenous chemotherapy. FACT-O scores at baseline and throughout treatment were equivalent.
  
  
  CONCLUSIONS
  The oral chemotherapeutic agent thalidomide appears to be comparable in response and quality of life, compared to single agent intravenous chemotherapy, in our population of heavily pretreated patients with ovarian cancer.
authors.affiliation: Division of Gynecologic Oncology, University of Louisville/Brown Cancer Center, 529 South Jackson Street, Louisville, KY 40202, USA. mary.gordiner@louisville.edu
authors.forename: Mary E
authors.initials: ME
authors.lastname: Gordinier
authors.forename: Don S
authors.initials: DS
authors.lastname: Dizon
authors.forename: Sherry
authors.initials: S
authors.lastname: Weitzen
authors.forename: Paul A
authors.initials: PA
authors.lastname: Disilvestro
authors.forename: Richard G
authors.initials: RG
authors.lastname: Moore
authors.forename: C O
authors.initials: CO
authors.lastname: Granai
mesh_terms: D000284:Administration, Oral; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016022:Case-Control Studies; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010166:Palliative Care; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D013792:Thalidomide