Investigators testing new treatment for breast cancer
Cancer investigators at Vanderbilt University Medical Center are participating in a clinical trial to determine the best method of treating a specific type of breast cancer.
The current standard treatment for patients with ductal carcinoma in situ (DCIS) is surgical removal of the tumor followed by radiation therapy. VUMC investigators are now studying whether radiation therapy is necessary to adequately treat certain low-risk forms of the disease.
"This trial is going to prove which cases are amenable to local excision alone and which need radiation after removal of the tumor," said Dr. David L. Page, professor of Pathology and Preventive Medicine.
The study, sponsored by the Eastern Cooperative Oncology Group, will include more than 100 cases treated at dozens of medical centers over the course of several years.
The trial seeks patients with low-risk DCIS breast tumors because it is believed that these tumors may be treated effectively without the use of radiation.
"When we do clinical trials we are using the best medical care available and trying to take treatment methods to the next step," said Page.
The new treatment regimen, if proven effective, would also reduce the cost and time commitment involved for the patient.
"If a patient really does not benefit from radiation it would be great if we could spare them the side effects, complications, and inconvenience associated with this treatment," said Dr. Mark C. Kelley, assistant professor of Surgery in the department of Surgical Oncology.
"However, we must show that the risk of recurrence with surgery alone in these selected cases is as low as we think it will be before proceeding with the next step, which is a randomized study."
DCIS is a type of tumor that varies in severity from case to case. Aside from the size of the tumor ‹ which can range from just a few millimeters to several centimeters ‹ the risk rating of the tumor depends on its grade and margins.
The grade of the tumor, or level of abnormality found in the cells, is determined after removal by examining thinly sliced sections of the tumor.
The margins of the tumor refer to its edges, which should be sharply defined and not have cancer cells in the normal tissue.
If the pathologist sees that the tumor has features that suggest a low risk of reccurence, the patient can be enrolled in the study.
"If you believe you can excise the tumor and not use radiation to follow up, it becomes exquisitely important that everyone agrees on the diagnosis," said Page.
In a recent issue of the Journal of the National Cancer Institute, an editorial written by Page; Dr. Jean F. Simpson, associate professor of Pathology; Dr. Roy A. Jenson, associate professor of Pathology and Cell Biology; and William D. Dupont, Ph.D., professor of Preventive Medicine, suggests that during clinical trials central review of DCIS tumors by pathologists is very important, especially considering the diverse types of abnormalities in these tumors.
The editorial accompanies a paper suggesting that 26 pathologists agree almost perfectly in their assessment of 30 breast tissue specimens between benign and malignant.
The paper also suggests that if pathologists agree so thoroughly, central review in clinical trials may be unnecessary in the diagnosis of cancer alone, but Page and co-authors document the need for the determination of special assignments for DCIS.