© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 6, 500-501,
March 17, 1999
© 1999 Oxford University Press
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New Standard of Care for Cervical Cancer Sets Stage For Next Questions
New data have resolved one of the major questions in cervical cancer treatment, as thousands of oncologists learned last month in a special mailing from the National Cancer Institute. NCI's "Clinical Announcement" — only the fifth such mailing in the Institute's history — advised physicians that concurrent radiation and chemotherapy with the drug cisplatin significantly extended survival in patients with invasive cervical cancer.
The finding sets the stage for further trials, which will aim to define the optimal form of chemotherapy and/or biological therapy to accompany radiation.
Up to now, surgery and/or radiation alone has been considered the standard of care for locally or regionally invasive cervical cancer. Three years ago, a cervical cancer consensus conference at the National Institutes of Health considered the issue of concurrent chemoradiation but concluded there was no evidence that it should be used in standard practice.
What changed the picture were new, very similar findings from five different multi-institutional, randomized studies (see sidebar). Across the five trials, groups who received cisplatin-based chemoradiation had a risk of dying 30% to 50% below that of control groups, who received radiation alone or radiation with hydroxyurea.
The remarkably similar results of the five trials were an important factor in the decision to issue the clinical announcement, said NCI's Edward Trimble, M.D., who guided development of the announcement. "The consistency of the data on reduced relative risk is impressive," he said, "particularly because there were many differences among the trials in stage of disease and in dose and schedule of treatment."
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Patients in these trials had diagnoses that ranged from disease that was minimally invasive and still confined to the cervix to that which had invaded adjacent organs in the pelvis. All did better on cisplatin-based chemoradiation than on the other regimens.
That the new findings should and would change the standard of care seemed a common view among experts. In statements, both NCI director Richard Klausner, M.D., and a principal investigator on one of the studies, Mitchell Morris, M.D., of the University of Texas M. D. Anderson Cancer Center, Houston, suggested that the combined treatment would become the new standard therapy.
Gillian Thomas, M.D., at the University of Toronto, chair of the Cervix and Vulva Committee of the Gynecologic Oncology Group, agreed: "Platinum-based chemoradiation should now be considered standard of care," she said.
Thomas also pointed out that the new standard will help shape future trials. One question still to be resolved, for example, is how much cisplatin should be given and when. "We still need to optimize the schedule and dose," Thomas said.
Another major issue is whether other chemotherapy drugs could improve survival even further. GOG, which is one of NCI's clinical trial consortiums, is considering a trial that would compare chemoradiation with weekly cisplatin to chemoradiation with a continuous infusion of 5-fluorouracil, according to Trimble. He said there is preliminary data suggesting that 5-FU may be as good as or better than cisplatin when combined with radiation. Also under consideration is a trial combining another platinum-based drug, oxaliplatin, with radiation therapy.
Future trials may also look at the new standard in combination with some of the biologic therapies now in development, said Thomas. "We can use this approach as a platform for investigating innovative strategies, such as anti-angiogenesis agents and human papillomavirus treatment vaccines," she said.
The text of the Clinical Announcement is available on NCI's Web site for clinical trials (cancertrials.nci.nih.gov). It can also be obtained from NCI's CancerFax service (call 301-496-7406 from a fax machine and use document code 400262 when prompted).
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