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RI Hospital first in country to enroll patient in new study for recurrent chest wall breast cancer

July 21, 2009

PROVIDENCE -- Rhode Island Hospital is one of only four sites across the country to participate in a new clinical trial called the DIGNITY Study. The study will investigate the effectiveness of a chemotherapeutic agent, ThermoDox, used in conjunction with mild hyperthermia (a form of heat therapy) for treating recurrent chest wall breast cancer.

Recurrent chest wall (RCW) breast cancer is a return of breast cancer on the chest wall, most commonly presenting in the skin overlying the mastectomy scar, affecting approximately 20,000 to 30,000 women each year in the United States. Following a mastectomy, RCW disease will usually present as a small lump in the mastectomy scar or under the skin of the chest or abdominal area. It may be visible or can be felt under the skin, and often goes undetected for some time as it may be mistaken for a leftover stitch or scar tissue from the mastectomy surgery. A significant number of women who are diagnosed with RCW disease frequently cannot be treated with further surgery, radiation or chemotherapy because their available treatment options have been exhausted. As a result, these women often face a poor prognosis.

Rhode Island Hospital is the only hospital in New England to participate in the DIGNITY study that will test 100 patients nationally with an encapsulated chemotherapeutic agent called ThermoDox combined with hyperthermia treatment. ThermoDox is a heat-activated version of an approved and frequently used oncology drug for the treatment of a wide range of cancers, including breast cancer.

Rhode Island Hospital was the first to enroll and treat a patient. That patient has undergone the first three of a 6-cycle course of treatment. Brigid O'Connor, MD, PhD, a radiation oncologist at Rhode Island Hospital, is the principal investigator for the trial in Rhode Island.

According to O'Connor, "We treated our first patient recently and she tolerated the procedure well. I am excited to see her response to this new treatment." She continues, "The rapid development of ThermoDox is warranted so we can provide these women who are experiencing recurrent chest wall cancer with a better treatment for this devastating disease. We look forward to the outcomes of this trial in the hope of gaining increased local tumor control and improved quality of life for our patients."

To be eligible for participation in the trial, patients must have a confirmed diagnosis of RCW disease, had prior radiation to their chest wall and received two chemotherapy regimens.

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