Preliminary results of a randomized, international Phase II trial of VEGF Trap (aflibercept) show activity in patients with recurrent epithelial ovarian cancer (EOC) who had received three or four prior chemotherapy regimens and had become resistant to platinum-based chemotherapy agents. The findings, which are being presented today at the American Society of Clinical Oncology's annual meeting, may indicate a role for this targeted therapy in women with ovarian cancer who have exhausted all other options.
To date, the trial has enrolled 162 patients with advanced ovarian cancer at 44 centers in twelve countries in Europe, Canada, and the United States. Favorable results were reported for 85 percent of participants after one month: 8 percent showed tumor shrinkage and 77 percent had stable disease. After fourteen weeks, 41 percent of patients continued to have stable disease.
"The interim analysis of the Phase II data was very promising," said Dr. William P. Tew, an oncologist at Memorial Sloan-Kettering Cancer Center and the study's lead author. "As a result, we are continuing to recruit patients to complete the study."
In this trial, VEGF Trap is administered intravenously as a single agent in one of two dose levels. It works by blocking the development of new blood vessels to the tumor (angiogenesis) which stops tumor growth and the spread of cancer to other parts of the body (metastasis). It can also result in tumor shrinkage. VEGF Trap is generally well-tolerated although both mild and severe side effects were reported. These included but were not limited to headache, fatigue, nausea, mild and severe hypertension, hoarseness, mild and severe protein in the urine, renal dysfunction, and a low incidence of bowel perforation (one percent).
"Ovarian cancer may be unusual among solid tumors because vascular-targeting agents like VEGF Trap appear to have significant single-agent activity in advanced ovarian cancer," said Dr. David R. Spriggs, Head of Solid Tumor Oncology at Memorial Sloan-Kettering and the study's senior author. "In most solid tumors, the efficacy of VEGF targeting is likely to be further enhanced by combining it with classic chemotherapy agents."
Epithelial ovarian cancer is a disease in which malignant (cancer) cells form in the tissue covering the ovary. About 85 percent to 90 percent of all ovarian cancers are this type. The American Cancer Society estimates 22,430 women in the United States will be diagnosed with ovarian cancer in 2007 and 15,280 will die.
Nicoletta Colombo MD, Instituto Europeo di Oncologia; Isabella R. Coquard MD, Centre Leon Berard; Amit Oza MD, Princess Margaret Hospital; Jose Maria del Campo MD, Hospital de la Vall d'Hebron; and Giovanni Scambia MD, Universita Cattolica del Sacro Coure participated in this study. It was funded, in part, by grants from sanofi-aventis and Regeneron.
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