Embargoed until February 9, 1998

Contact: Johanna Spangenberg
Phone: (703) 527-7424

Contact: Barbara Halpern
Phone: (202) 332-7353

NEWS ROOM: February 6-11, 1998
Walt Disney World Dolphin
Orlando, Florida (407) 560-2675

RADIOTHERAPY, SUPPLEMENTING CONVENTIONAL TREATMENTS, IS FOUND TO BE EFFECTIVE IN PREVENTING RECURRENCE OF CERVICAL CANCER

ORLANDO, FL -- Women will decrease their chances for a recurrence of cervical cancer and possible death after a radical hysterectomy and pelvic lymphadenectomy (excision of lymph nodes from the pelvic area), if they receive supplemental radiotherapy. This is the conclusion of a seven year prospective and randomized study designed to evaluate the risks and benefits of radiotherapy aimed at reducing recurrence of cervical cancer and mortality.

This new medical research was conducted by the Gynecologic Oncology Group, representing 45 academic institutions and medical centers. Alexander Sedlis, MD, Professor, Department of Obstetrics and Gynecology, State University of New York Downstate Medical Center, Brooklyn, NY, presents the Group's research results on February 9, 1998, before the 29th Annual Meeting of the Society of Gynecologic Oncologists (SGO) at the Walt Disney World Dolphin Resort, Orlando, FL, February 7-11, 1998.

Co-authors of the study include Brian N. Bundy, Ph.D., Deputy Director of Statistics, Gynecologic Oncology Group, Cancer Research Scientist IV, Roswell Park Cancer Institute, Buffalo, NY; Marvin Z. Rotman, MD, Professor and Chairman, Department of Radiation Oncology, State University of New York Health Science Center at Brooklyn, Brooklyn, NY; Samuel S. Lentz, MD, Associate Professor of Obstetrics and Gynecology, Section on Gynecologic Oncology, Bowman Gray School of Medicine, Winston-Salem, NC; Laila I. Muderspach, MD, Assistant Professor, Obstetrics and Gynecology, University of Southern California School of Medicine, Los Angeles, CA; and Richard D. Zaino, MD, Professor of Pathology, The Milton S. Hershey Medical Center of Pennsylvania State University, Hershey, PA.

Background: A large-size tumor, deep stromal penetration (invasion into underlying tissue) and capillary space involvement increase the risk of cancer recurrence and death in women with stage 1B cervical cancer who are treated only with a radical hysterectomy and excision of lymph nodes from the pelvic area.

These conditions, known clinically as large tumor diameter (LTD), deep stromal penetration (DSP), and capillary lymphatic spaces (CLS), have all recently been recognized as risk factors due to their documented association with increased cancer recurrence and mortality. In fact, previous studies conducted by the Gynecologic Oncology Group revealed that the presence of these risk factors can increase the probability of cancer recurrence by 69 percent.

Women with lymph node metastases have traditionally been treated with radiotherapy. This post-operative treatment was found to reduce pelvic recurrence rate but had no impact on survival. As an extension of this, a supposition was made that for patients with other high risk factors for recurrence, adjuvant (or supplemental) radiotherapy would also be beneficial. To better establish this approach as a standard of care, a prospective study was launched in 1981 to investigate whether radiotherapy benefits Stage I cervical cancer patients treated by conventional radical hysterectomy and pelvic lymphadenectomy, all at risk because of LTD, DSP, and CLS, but excluding those with lymph node metastases.

Methodology: 277 patients were recruited from participating institutions if they had at least two of the following risk factors: greater than one-third stromal invasion, CLS, and large tumor diameter. They were randomly assigned to two groups, radiotherapy (Rt) or no further treatment (NFT). The distribution of age, race, performance status, cell type, tumor size, and stromal penetration was balanced between the two groups; however, there was a significantly higher number of patients with CLS who received no further treatment which was compensated for by the large number of women with larger tumor size and deeper penetration receiving Rt. Of the patients receiving radiotherapy, 88 percent received the prescribed dose of radiation therapy.

Patients were evaluated by physical examination, blood counts, blood chemistries, and chest x-rays, every three months for the first two years of follow-up, and every six months during the subsequent years. Renal sonogram, IVP or CT scans with contrast were performed at six months and then yearly.

Results and Conclusions: Of the 277 eligible patients, 137 were randomly assigned to radiotherapy and 140 to "no further treatment." Key findings included:

· Cancer recurred in 60 of the patients from the entire study group; 39 of the recurrences were among the NFT group, 21 among those receiving treatment. When adjusting for all risk factors, the recurrence rate was reduced by 44 percent in patients receiving radiotherapy.

· Thirty of the NFT group are now deceased, 25 from cancer, where as in the Rt group, there were only 18 deaths, with 15 from cancer. This means there was a 36 percent decrease in mortality among patients receiving radiotherapy treatment.

· Sixty-eight patients in the treatment group had adverse effects and complications because of the radiotherapy.

The study's results strongly indicate that these women with cervical cancer and these risk factors should be treated with postoperative radiotherapy following their radical hysterectomy and lymph node dissection.

The Society of Gynecologic Oncologists (SGO) is a professional society of physicians who specialize in gynecologic oncology. SGO is the only U.S. based medical organization dedicated to the prevention, detection and cure of female cancers. Gynecologic oncologists are cancer specialists trained in all the effective forms of treatment of gynecologic cancers (surgery, radiation therapy, chemotherapy and experimental treatments) as well as the biology and pathology of gynecologic cancers. The organization is comprised primarily of gynecologic oncologists as well as medical oncologists, radiation therapists and pathologists all of whom have a primary professional commitment to the treatment of women with gynecologic malignancies including those of the ovaries, endometrium, uterus, cervix vagina, vulva and trophoblastic disease.

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Editor's Note: For a complete copy of the complete manuscript or to schedule an interview with Dr. Sedlis contact Johanna Spangenberg (703) 527-7424

The Informatics Committee of the Society of Gynecologic Oncologists (SGO) has led the development of the Women's Cancer Network under the direction of Drs. Mitchell Morris and Ivor Benjamin. For more information vist the following web site http://www.wcn.org