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| |  SGO MEETING: Adding Chemotherapy To Radiation Therapy Increases Cervical Cancer Survival SAN FRANCISCO, CA -- March 22, 1999 -- Women with early-stage cervical cancer who undergo surgery are at increased risk for cancer recurrence if the pelvic lymph nodes have tested positive for metastatic cancer. Radiation therapy has been used to treat these patients. Previous studies revealed that the therapy decreased recurrence rates but did not improve long-term survival. Now, 10 medical researchers from across the nation have released their findings that indicates adding chemotherapy to radiation therapy improves overall survival rate for women with cervical cancer. Dr. William Peters III, MD will presented the research results yesterday at the 30th annual meeting of the Society of Gynecologic Oncologists (SGO). A radical hysterectomy with pelvic lymphadenectomy is the recommended surgical treatment for women diagnosed with early stage carcinoma. Patients who have lymph nodes that test positive or parametrial involvement are thought to be of high-risk for cancer recurrence; accordingly, radiation therapy is employed. Patients having the surgical treatment with no involvement of the lymph nodes or parametrium have a five year survival rate of 80 percent to 90 percent. When the risk of recurrence rises, the five-year survival rate drops to 50 percent to 70 percent. Radiation therapy has been shown to decrease recurrence rates in the pelvis but has had no impact on long-term survival. Previous studies have shown that combining cisplatin and 5-Fluorouracil (chemotherapeutic agents effective in the treatment of some carcinomas) demonstrated some positive activity in patients with advanced cervical cancer. Additionally, both agents are radiation sensitizers and concurrent use of these chemotherapies with pelvic radiation appeared to have a significant effect on tumour cell kill. This suggested to researchers that adding chemotherapy (cisplatin and 5-Fluorouracil) to standard pelvic radiation therapy would improve disease free survival and overall survival in patients at high risk for relapse after primary radical hysterectomy. Patients with clinical stage IA, IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy and who had positive lymph nodes and/or microscopic involvement of the parametrium, were eligible for this study. The study subjects were randomised to receive radiation therapy or radiation therapy plus chemotherapy. The patients in each group received radiation treatments of 4930 cGY in 29 fractions to a standard pelvic field. For those receiving the chemotherapy, treatment began on Day 1 of the radiation therapy and consisted of bolus cisplatin 70 mg/m2 and 96-hour (four day) continuous infusion of 5-Fluorouracil 1000 mg/m2 per day. The second cycle began on Day 22; third and fourth cycles of chemotherapy were scheduled following completion of radiation, to begin on Days 43 and 64, respectively. Between 1991 and 1996, 268 patients were enrolled in this study. Twenty-five were deemed ineligible leaving 243 subjects (127 in the chemotherapy plus (CT+RT) and 116 in the Radiation Therapy only (RT) groups). In the CT+RT group, five patients refused chemotherapy, four patients refused chemotherapy and radiation therapy, and one was not treated due to surgical complications. In the RT group, three patients refused radiation therapy and one was not treated as a result of physician discretion. Patients receiving chemotherapy plus radiation had a progression-free survival that was statistically significantly improved. The researchers found that the estimated four-year survival for patients receiving both therapies was 80 percent. For radiation-therapy only patients, the corresponding rate was 63 percent. The research team believes that this Phase III study establishes the feasibility and efficacy of providing both chemotherapy and radiation therapy following a radical hysterectomy.
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