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Thalidomide Shows Promise in Ovarian Cancer Treatment: Presented at SGO

By Norra MacReady

PALM SPRINGS, F.L. -- March 24, 2006 -- Adding thalidomide to a topotecan regimen for recurrent ovarian cancer significantly enhances therapeutic response and increases progression-free survival without increasing incidence of toxicity, researchers reported here at the 37^th Annual Meeting of the Society of Gynecologic Oncologists (SGO).

Levi S. Downs, Jr., MD, medical director, Women's Health Center, University of Minnesota Medical School and Cancer Center, Minneapolis, Minnesota, United States, discussed the results in a presentation on March 24^th.

In an intention-to-treat analysis, 47% of 30 patients who received thalidomide plus topotecan experienced a complete or partial response, significantly more than the 21% of 39 patients who received topotecan alone (P =.036). These patients were 10.4 times as likely to achieve some type of response as the women who received monotherapy (P =.043). Median disease-free survival among women receiving both drugs was 6 months, compared to 4 months among women on the single-drug regimen (P =.02).

Thalidomide may exert this effect through its antiangiogenic and immunomodulatory properties, Dr. Downs explained. It inhibits the activity of basic fibroblast growth factor and angiogenesis induced by vascular endothelial growth factor. It also stimulates the production of interferon gamma and certain interleukins. Topotecan is a cytotoxic agent that inhibits topoisomerase I, and there is evidence that it inhibits the growth of endothelial cells.

Dr. Downs said his findings suggest that new molecules under development that act as antiangiogenic and immunomodulatory agents – such as thalidomide -- may be valuable adjuncts to traditional cytotoxic therapy for women with ovarian cancer.

Initially, the study enrolled 75 women from seven different research sites. Of those, 41 women were randomized to receive topotecan alone as a 30-minute, intravenous infusion of 1.25 mg/m² for 5 consecutive days every 21 days. Two women dropped out of the study before undergoing any treatment.

Thirty-four women were randomized to receive topotecan plus thalidomide, starting with an oral dose of 200 mg/day and increased by 100 mg/day every 7 days until adverse effects became too onerous. Four patients dropped out of that arm of the study.

Neither the patients nor the investigators were blinded as to treatment arm.

The incidence of toxicity was similar between the groups. Of the women receiving the combination therapy, 87% developed neutropenia, 20% developed thrombocytopenia, and 13% developed anemia. In the single-treatment arm, it was 72%, 36%, and 23%, respectively.

Fatigue and somnolence are common toxicities associated with thalidomide, but their incidence was not increased in this study, Dr. Downs said.

He concluded, "thalidomide and other antiangiogenic and immunomodulatory agents warrant further study for women with recurrent ovarian cancer, particularly in combination with cytotoxic agents."


[Presentation title: A Prospective Randomized Trial of Thalidomide with Topotecan Compared to Topotecan Alone in Women with Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma. Presentation 19]

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