May 06, 2010 - 8:18 pm
new research that came out this month:
"Tamoxifen may be a reasonable treatment alternative for patients with biochemical-recurrent ovarian cancer," concluded Dr. Jean Hurteau and his coinvestigators from the Gynecologic Oncology Group (GOG). But he cautioned that the findings need to be validated in other randomized trials.
Tamoxifen plays an important role in the treatment of hormone-driven breast cancer, but evidence for its use in recurrent ovarian cancer is lacking, according to a recent Cochrane Review article in which the authors found no randomized trials on which to base recommendations (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD001034.pub2]).
All participants had biochemical-recurrent ovarian cancer (defined as a rise in CA 125 of at least twice the upper limit of normal with no evidence of disease by RECIST [Response Evaluation Criteria in Solid Tumors] 1.0 criteria). The investigators reported on 68 women who were randomized to receive a minimum of 200 mg oral thalidomide once daily (with a weekly dose escalation of 100 mg to a maximum of 400 mg), and 70 women randomized to receive 20 mg oral tamoxifen twice daily.
The study group included women with FIGO stage III or IV confirmed epithelial ovarian, tubal, or primary peritoneal cancer who had completed first-line chemotherapy and whose CA 125 had normalized. The average age of the patients was 64 years, and 67% had grade III tumors, Dr. Hurteau said. The women were assessed for toxicity every 4 weeks, and for disease progression every 12 weeks, until either disease progression or death.
Women who received thalidomide had a 31% increased risk of disease progression (hazard ratio, 1.31), compared with those who were given tamoxifen. Median progression-free survival was 3.2 months in the thalidomide group vs. 4.5 months in the tamoxifen group.
In terms of overall survival, women in the thalidomide group had a 76% increased risk of death (HR, 1.76) after 48 months, compared with those who took tamoxifen.
In addition, women in the thalidomide group experienced more grade III/IV toxicity, compared with the tamoxifen group (55% vs. 3%, respectively). Venous thromboembolism occurred in 6% of the thalidomide group and 1.4% of the tamoxifen group.
Serum vascular endothelial growth factor (VEGF) levels were not significantly correlated with either progression-free survival or overall survival.
"The reason for the findings is uncertain," Dr. Hurteau said.