FOR RELEASE: On Receipt ALBANY, N.Y., February 22, 1999 -- Researchers at Albany Medical Center, working with scientists at other major centers and the National Cancer Institute, have learned that the mortality rate of invasive cervical cancer can be reduced by up to 50 percent by treating patients using a combination of radiation and platinum-based chemotherapy.
"This is exciting news that will dramatically change the way cervical cancer is treated," said Henry Keys, M.D., director of the Cancer Center of Albany Med, and principal investigator of one study that led to the new findings. "It may be one of the largest changes in mortality seen in any clinical trial involving cancer therapy," he said. Until now, the standard treatment for invasive cervical cancer has been surgery or radiation alone.
The discovery of a new treatment combination is considered so significant that the National Cancer Institute, which funded the research, is issuing a "Clinical Announcement" to thousands of physicians around the country suggesting that "strong consideration be given" to combining radiation and cisplatin-based chemotherapy in treating cervical cancer. Cisplatin, which is a chemotherapy agent given through an intravenous infusion, works as a potent sensitizer, making the radiation more effective. The New England Journal of Medicine plans to publish articles on the discovery in an April issue, but the journal also IS releasing the information today on its web site (www.nejm.org) so that physicians can review it as soon as possible.
Five separate clinical trials -- all studying women at various stages of the disease -- concluded that chemotherapy using a drug called cisplatin combined with radiation is more effective than radiation alone or radiation combined with other chemotherapy agents such as hydroxyurea and 5-fluorouracil, also known as 5-FU.
Nearly 2,000 women participated in the studies between 1986 and 1997. The trials were available to a variety of patients, including women whose disease was confined to the cervix and women whose cancer had spread to other pelvic tissues. The study did not include women whose cancer had spread outside the pelvis or women whose cancer was detected early enough that surgery or radiation alone was an effective and proven treatment.
A total of 55 women from the Capital Region of New York participated in two of the studies (GOG 85 and GOG 123). Dr. Keys served as principal investigator of the Gynecologic Oncology Group -- Protocol 123 (GOG 123) study involving women with large tumors confined to the cervix.
The study, conducted between 1992 and 1997, involved 368 patients nationwide who were randomly and "blindly" divided into two groups. Half of the patients received radiation with cisplatin chemotherapy and half received radiation alone. The course of radiation included five weeks of X-ray treatments followed by a two- to three-day hospital stay during which a radioactive implant was placed in the cervical area for two- to three-days before being removed. For the group receiving the combination therapy, cisplatin was administered via an intravenous solution once a week on an outpatient basis for up to six doses of the drug.
The three-year survival rate for women treated with the combination therapy was 83 percent compared to 74 percent who received radiation alone. Ten women from the Capital Region were involved in GOG 123, but because of the way the study was conducted, no information is available regarding whether they received the combination or radiation alone. In addition to Albany Medical Center, other participating study centers included Johns Hopkins, the Cleveland Clinic and Duke University.
In the late 1980's, Dr. Keys and John Malfetano, M.D., director of gynecologic oncology at the Albany Medical College, and the institution's principal investigator with the national Gynecologic Oncology Group, were among the first in the country to recognize the potential of cisplatin in combination with radiation when treating high risk cervical cancer patients. "We discovered that it is the most active drug against this particular kind of cancer," said Dr. Malfetano.
"As significant as our study findings are, the bigger issue is why we are still seeing so many patients with invasive cervical cancer in 1999," said Dr. Keys. "It is a largely preventable disease because precancerous and cancerous changes in the cervix can be easily detected through annual pelvic exams and pap tests," he said. If detected early, the disease is almost 100 percent curable.
Albany Medical Center is the only academic health sciences center in the 25 counties of northeastern New York and western New England. The Medical Center incorporates the 651-bed Albany Medical Center Hospital, one of upstate New York's largest teaching hospitals; the Albany Medical College, which was founded in 1839 as one of the nation's first private medical schools; the Albany Medical Center Faculty Group Practice, staffed by 350 full-time clinical faculty members of the Medical College; and the Albany Medical Center Foundation, Inc., one of the largest fund-raising organizations in the region.
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For more information, contact Gregory J. McGarry, director of public relations, or Paige Sheehan, public relations specialist, at 518-262-3421.
The full study can be viewed at www.nejm.org after 10 a.m. (eastern standard time) Monday, Feb. 22.
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