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Tamoxifen Found More Effective, Less Toxic Than Thalidomide


 

From the annual meeting of the Society of Gynecologic Oncologists

Major Finding: Risk of progression at 24 months was 31% higher with thalidomide than with tamoxifen in women with recurrent, asymptomatic ovarian cancer.

Data Source: A phase III GOG trial in 138 patients.

Disclosures: None was reported.

SAN FRANCISCO — Oral thalidomide was associated with more severe toxicity and a significantly increased risk of disease progression and death, compared with tamoxifen, in a phase III trial conducted in women with recurrent, asymptomatic ovarian cancer.

“Tamoxifen may be a reasonable treatment alternative for patients with biochemical-recurrent ovarian cancer,” said Dr. Jean Hurteau of the North Shore University Health System in Chicago. 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 Cochrane Review article in which the authors found no randomized trials on which to base recommendations (2010 [doi:10.1002/14651858.CD001034.pub2]).

The rationale for the current trial was that the comparative effectiveness of tamoxifen (a hormonal therapy) and thalidomide (an antiangiogenesis agent) was not known in recurrent ovarian cancer.

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. Dr. Hurteau and his coinvestigators from the GOG (Gynecologic Oncology Group) 198 trial reported on 68 women who were randomized to receive a minimum of 200 mg of 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 of 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%). Venous thromboembolism occurred in 6% of the thalidomide group and 1.4% of the tamoxifen group.

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