title: A phase II study of GM-CSF and rIFN-gamma1b plus carboplatin for the treatment of recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of carboplatin, granulocyte-macrophage colony-stimulating factor (GM-CSF) and recombinant interferon gamma 1b (rIFN-gamma1b) in women with recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer.
  
  
  METHODS
  In this phase II study, patients with recurrent, platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer were treated with subcutaneous GM-CSF and rIFN-gamma1b before and after intravenous carboplatin until disease progression or unacceptable toxicity. All patients had measurable disease and a chemotherapy-free interval >6 months. Response was determined using RECIST criteria and CA 125 levels.
  
  
  RESULTS
  Between 2003 and 2007, 59 patients received a median of 6 cycles of therapy (range, 1 to 13 cycles). Median age at enrollment was 61 years (range, 35 to 79 years). Median time to progression prior to enrollment was 11 months (range, 6 to 58 months). Of 54 patients evaluable for response, 9 (17%) had a complete response, 21 (39%) had a partial response, and 24 (44%) had progressive disease. The overall response rate was 56% (95% CI: 41% to 69%). With a median follow-up of 6.4 months, median time to progression was 6 months. Myeloid derived cells and platelets increased on day 9 of each chemotherapy cycle. The most common adverse effects were bone marrow suppression, carboplatin hypersensitivity, and fatigue. Responders reported improved quality of life.
  
  
  CONCLUSIONS
  This pre and post-carboplatin cytokine regimen resulted in a reasonable response and a hematologic profile that could invite further evaluation of its components in the treatment of patients with ovarian cancer.
authors.affiliation: Department of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77230-1439, USA. kschmele@mdanderson.org
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Schmeler
authors.forename: Saroj
authors.initials: S
authors.lastname: Vadhan-Raj
authors.forename: Pedro T
authors.initials: PT
authors.lastname: Ramirez
authors.forename: Sachin M
authors.initials: SM
authors.lastname: Apte
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Cohen
authors.forename: Roland L
authors.initials: RL
authors.lastname: Bassett
authors.forename: Revathy B
authors.initials: RB
authors.lastname: Iyer
authors.forename: Judith K
authors.initials: JK
authors.lastname: Wolf
authors.forename: Charles L
authors.initials: CL
authors.lastname: Levenback
authors.forename: David M
authors.initials: DM
authors.lastname: Gershenson
authors.forename: Ralph S
authors.initials: RS
authors.lastname: Freedman
mesh_terms: D000328:Adult; D000368:Aged; D000920:Antibody-Dependent Cell Cytotoxicity / Q000187:drug effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005185:Fallopian Tube Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007371:Interferon-gamma / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D010534:Peritoneal Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D011788:Quality of Life; D011994:Recombinant Proteins
chemical_list: D011994:Recombinant Proteins; D007371:Interferon-gamma; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D016190:Carboplatin