MCG is taking part in an international study that adds Interferon gamma 1-b to the standard treatment protocol for women with late-stage ovarian cancer, says Dr. Sharad Ghamande, a principal investigator. Dr. Michael S. Macfee, chief of the MCG Section of Gynecologic Oncology, is a sub-investigator on the study.
Experience with Interferon gamma 1-b in laboratory studies and previous clinical trials indicates that the drug may significantly increase the five-year survival rate for these women.
"We are hopeful that the addition of Interferon gamma 1-b will offer women with this disease an improvement over the standard therapy we have to offer today," Dr. Ghamande says.
Ovarian cancers are fortunately rare: a woman's lifetime risk is about 1.4 percent for the more than 30 types of ovarian cancer.
Increased risk of the most common type is linked to prolonged ovulation and increasing age. This epithelial ovarian cancer – the target of the new study at MCG – first occurs in the lining of the ovaries, the reproductive glands that produce and store eggs for potential fertilization. The rapidly advancing cancer readily spreads from the ovary, staying on surface tissue as it moves throughout the pelvis into the abdominal cavity and intestines. "Little cells go off and attach themselves to the bowels, the undersurface of the diaphragm, throughout the abdominal cavity." Dr. Ghamande says.
Standard treatment begins with surgery to remove as much disease as possible; in fact surgery is needed to make a definitive diagnosis, Dr. Ghamande says. Surgery also enables doctors to stage the tumor for prognosis.
Soon afterward, a six-week course of chemotherapy is initiated, a combination of the chemotherapeutic agents paclitaxel (Taxolâ) paired with cisplatin (Platinolâ) or carboplatin (Paraplatinâ).
Rapidly progressing ovarian cancer is actually very sensitive to chemotherapy, Dr. Ghamande says. But even in the best scenarios, where after surgery and chemotherapy, patients appear free of disease, the insidious cancer often returns. "The reality is the five-year survival rate in patients with stage 3C ovarian cancer is about 20 to 25 percent," Dr. Ghamande says. "The reason is, a couple of years down the line, the women come back with recurrent disease and you start all over again. They probably had some microscopic disease that you cannot detect."
Another unfortunate fact is that most typically, epithelial ovarian cancer is diagnosed at this late stage of disease. One reason is that there is no good screening test, such as the Pap smear for cervical cancer. Often women present with nondescript symptoms such as early satiety, abdominal bloating and pain. Some show up for the first time in an emergency room with difficulty breathing and a study of their fluid-filled lungs detects cancer cells. "Probably 70 percent of the patients we see for the first time have disease which already has spread all over the abdomen," Dr. Ghamande says. Even women with a strong family history who are followed closely every six months – with pelvic exams, tumor marker studies and transvaginal ultrasounds – can be free of disease on one exam and have extensive problems by the next, he says.
That is where Interferon gamma 1-b may help, by stimulating a component of the immune system called macrophages, cells adept at identifying and eliminating abnormal cells.
For the next three years, centers across the world, such as MCG, will enroll a total of 800 women with late-stage disease. Some will get standard therapy and others will get the standard therapy along with Interferon gamma 1-b.
The goals are longer disease-free periods and, ultimately, better long-term survival coupled with better quality of life, Dr. Ghamande says, noting that the most common side effects include localized redness at the injection site and flulike symptoms.
A previous clinical trial in Austria illustrated the potential of the interferon addition: women who received Interferon gamma 1-b responded better to initial treatment and had longer progression-free intervals than those who received standard chemotherapy alone. That study followed women only for three years because it had to be halted when Taxol received FDA approval for ovarian cancer and was found to be superior to cyclophosphamide, one of the chemotherapeutic agents used in the study, Dr. Ghamande says.
He hopes the new study will offer similar improvements for his patients. "I am very enthused with this study," he says.
In fact, to ensure that the latest treatments under evaluation are available to all patients who seek treatment for cancers of the reproductive system from the MCG Section of Gynecologic Oncology, the section recently became an affiliate member of the National Cancer Institute's Gynecologic Oncology Group, which gives the doctors and their patients access to all NCI-sponsored clinical trials.
For more information about the ovarian cancer study, call study coordinator Nora McClendon at
706-721-5557.