Randomized phase 3 trial of interferon gamma-1b plus standard carboplatin/paclitaxel versus carboplatin/paclitaxel alone for first-line treatment of advanced ovarian and primary peritoneal carcinomas: Results from a prospectively designed analysis of progression-free survival

David S. Alberts, Christian Marth, Ronald D. Alvarez, Gary Johnson, Mariusz Bidzinski, David R. Kardatzke, Williamson Z. Bradford, Jeff Loutit, David H. Kirn, Mary C. Clouser, Maurie Markman

Research output: Contribution to journalArticle

62 Scopus citations

Abstract

Objectives: Interferon gamma (IFN-γ) is a pleiotropic cytokine with antiproliferative, immunostimulatory, and chemosensitization properties. This trial was designed to evaluate IFN-γ 1b plus carboplatin and paclitaxel in treatment-naive ovarian cancer (OC) and primary peritoneal carcinoma (PPC) patients. Methods: Eligible patients were randomized to 6 cycles of carboplatin/paclitaxel every 3 weeks or the same in combination with IFN-γ 1b (100 μg 3×/wk subcutaneously). The primary endpoint was overall survival (OS) time (target hazard ratio (HR) = 0.77). Secondary endpoints included progression-free survival (target HR = 0.7), based on blinded review of serial imaging scans, physical exams, and CA-125 levels. Results: 847 patients were enrolled (OC 774, PPC 73) in Europe (n = 539) and North/South America (n = 308) from January 29, 2002 to March 31, 2004 and stratified according to: optimal debulking (n = 271) versus suboptimal debulking with plans for interval debulking (PID) (n = 238) or no PID (n = 338). The study stopped early following a protocol-defined second interim analysis which revealed significantly shorter OS time in patients receiving IFN-γ 1b plus chemotherapy compared to chemotherapy alone (1138 days vs. not estimable, HR = 1.45, 95% CI = 1.15-1.83). At the time of the analysis, 169 of 426 (39.7%) patients in the IFN-γ 1b plus chemotherapy group had died compared to 128 of 421 (30.4%) in the chemotherapy alone group. Serious adverse events were more common in the IFN-γ 1b plus chemotherapy group (48.5% vs. 35.4%), primarily due to a higher incidence of serious hematological toxicities (34.5% vs. 22.7%). Conclusions: Treatment with IFN-γ 1b in combination with carboplatin/paclitaxel does not have a role in the first-line treatment of advanced ovarian cancer.

Original languageEnglish (US)
Pages (from-to)174-181
Number of pages8
JournalGynecologic oncology
Volume109
Issue number2
DOIs
StatePublished - May 1 2008

Keywords

  • Advanced ovarian
  • Carboplatin
  • First-line treatment
  • Interferon γ-1b
  • Paclitaxil
  • Primary peritoneal carcinomas

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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