New Study Reports Increased Response To Therapy With No Added Toxicity In Treatment Of Recurrent Ovarian Cancer

In a study released today
at the Society of Gynecologic Oncologists 37th Annual Meeting on Women's
Cancer, researchers found the addition of thalidomide to topotecan for the
treatment of recurrent ovarian cancer significantly increases the response to
therapy and the duration of progression free survival without additional
toxicity.


The study, "A Prospective Randomized Trial of Thalidomide with Topotecan
Compared to Topotecan Alone in Women with Recurrent Epithelial Ovarian,
Primary Peritoneal or Fallopian Tube Carcinoma," was led by Levi S. Downs Jr.,
M.D., University of Minnesota Medical School and Cancer Center, Minneapolis,
MN.


"This trial is among the first to combine a biologic agent with a
conventional chemotherapy agent for the treatment of ovarian cancer," said the
study's lead author, Dr. Levi S. Downs, Jr. "The statistically significant
improvement in overall response rate demonstrated in this experimental
treatment is promising as we continue to seek better therapies to fight
ovarian cancer."


Thalidomide is a biologic therapy that may fight tumors in two ways:
First by inhibiting the tumors ability to generate new blood vessels to feed a
growing mass of cells and second by boosting the immune response to the
abnormal tumor cells. Biologic therapies are intended to work with the body's
natural defenses to help fight tumor cells without harming healthy cells --
these therapies hold promise for effectiveness without the extreme toxicities
seen in conventional chemotherapy.


This randomized trial involved women from seven different research sites
(although a majority were from one institution) who had recurrent or
persistent epithelial ovarian carcinoma. The final analysis included 39 women
in the topotecan/control arm and 30 women in the thalidomide/topotecan arm.
The women in the thalidomide/topotecan arm:


-- Had a 47 percent overall response rate compared to 21 percent in the
control arm; and

-- Had a two month improvement in disease free survival compared to the
control arm.


While there was a trend toward an improvement in overall survival
(19 months compared to 15 months in the control arm) the results were not
statistically significant in this trial.


"The results of this study suggest that new molecules under development
that act as immune modulators and anti-angiogenic agents, like thalidomide,
should be studied in women with ovarian cancer in combination with traditional
cytotoxic chemotherapy," said Dr. Downs. "While the development of new
chemotherapy options has improved survival for women diagnosed with this
disease, there is clearly a need for new, effective chemotherapy options."


According to the American Cancer Society ovarian cancer is the leading
cause of death from gynecologic malignancy and the fifth most common cause of
cancer death in women in the United States.















The study, "A Prospective Randomized Trial of Thalidomide with Topotecan
Compared to Topotecan Alone in Women with Recurrent Epithelial Ovarian,
Primary Peritoneal or Fallopian Tube Carcinoma," was partially funded by
Celgene Corporation and conducted by Levi S. Downs Jr., M.D., University of
Minnesota, Minneapolis, MN; Patricia L. Judson, M.D., University of Minnesota,
Minneapolis, MN; Peter A. Argenta, M.D., University of Minnesota, Minneapolis,
MN; Rahel Ghebre, M.D., University of Minnesota, MN; Matthew P. Boente, M.D.,
MN Oncology Hematology PA, Edina, MN; William A. Nahhas, M.D., Wright State
University Miami Valley Hospital, Dayton, OH; Samir Z. Abu-Ghazaleh, M.D.,
Dakota Midwest Cancer Institute, Sioux Falls, SD; M. Dwight Chen, M.D., Center
for Gynecologic Oncology and Pelvic Surgery, Los Gatos, CA; and Linda F.
Carson, M.D., University of Minnesota, Minneapolis, MN.


The 2006 Annual Meeting on Women's Cancer is the premier educational and
scientific event for physicians and health care professionals involved in the
field of gynecologic oncology and is being held March 22-26 at the Palm
Springs Convention Center in Palm Springs, California.


About SGO


The SGO is a national medical specialty organization of physicians who are
trained in the comprehensive management of women with malignancies of the
reproductive tract. Its purpose is to improve the care of women with
gynecologic cancer by encouraging research, disseminating knowledge which will
raise the standards of practice in the prevention and treatment of gynecologic
malignancies and cooperating with other organizations interested in women's
health care, oncology and related fields. The Society's membership is
primarily comprised of gynecologic oncologists, as well as other related
medical specialists such as, medical oncologists, radiation oncologists and
pathologists. SGO members provide multidisciplinary cancer care including
chemotherapy, radiation therapy, supportive care and surgery. More
information on the SGO can be found at sgo.


Society of Gynecologic Oncologists

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