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Analysis: Lumpectomy without radiation?

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By Ed Susman
San Antonio (UPI) Dec 18, 2006
Doctors said Monday that treating certain breast-cancer patients with surgery alone -- or without standard courses of radiation -- resulted in a low 6-percent risk of the cancer returning within five years.

"For some women, that level of risk may be acceptable," Lorie Hughes, clinical associate professor of medicine at Emory University in Atlanta, told United Press International.

However, Hughes said that going without radiation is certainly not for everyone. "We know that radiation reduces the risk of recurrence in women with ductal carcinoma in situ (DCIS) by about 50 percent.

"We also are aware there are many women who have lumpectomy -- or breast-conserving therapy -- and then do not go through with radiation. We constructed our study to determine what their risk of recurrence was and what factors could reduce that risk," she said.

In a presentation to the more than 8,000 attendees at the 29th annual San Antonio Breast Cancer Symposium, Hughes said the most critical part of the decision tree for women with ductal carcinoma in situ was the grade of the tumor, or whether the small nodule in the breast was low or moderate in aggressiveness, versus highly aggressive.

Other factors include the size of the tumor and how successful the surgeon was in providing wide margins around the tumor in performing the surgery.

"But the key to this study is meticulous pathological assessment of the tumor tissue," Hughes said. In her study, Hughes and colleagues enrolled 606 women with low-risk cancer to undergo lumpectomy -- in which only the cancer and some surrounding tissue are excised from the breast as opposed to a mastectomy in which the entire breast is removed -- and to forgo routine radiation.

In women with low-risk to intermediate-risk grade cancer, the recurrence rate was 6.1 percent in which the cancer reappeared in the breast where surgery was performed. Cancer occurred in 3.7 percent of the women in the opposite breast.

"I think we can say that if these women would have had radiation, these rates would have been halved," she said. There was no group of women who underwent radiation in this study because, Hughes said, several other studies had confirmed and re-confirmed the benefits of radiation.

She said the goal of the researchers in the Eastern Cooperative Oncology Group and the North Central Cancer Treatment Group was not to revisit the effectiveness of radiation, but to give doctors facts and figures to discuss with women who were considering avoiding radiation after surgery.

Richard Elledge, associate professor of medicine at Baylor College of Medicine in Houston, noted that DCIS represents about 20 percent of the 200,000 breast-cancer diagnoses each year. Most often the small cancers are detected during screening mammograms.

"The value of this study is that it gives doctors some numbers to discuss with their patients," he told UPI. "It adds to our knowledge and gives us some evidence when discussing options." He cautioned that the results only represent five years, and the 10-year figures will also be important to analyze.

"I think that a 6.1 percent recurrence rate is acceptable," Hughes said.

However, in a group of 105 women with high-risk cancer, the recurrence rate was 14 percent without radiation. "That is not an acceptable rate," she said.

Most of the women with high-risk cancer did not enter the study. Doctors had hoped to enroll 600 women in that high-risk part of the trial too, but Hughes suggested that the women and their doctors were too fearful of the high-risk situation to proceed without radiation.

The average age of the women in the study was 60 years. Overall, five-year survival was about 95 percent. The study was funded by the U.S. National Cancer Institute. The patients will continue to be followed for another five years, doctors said.

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Analysis: Ketek least of Sanofi's problems
Washington (UPI) Dec 18, 2006
A Food and Drug Administration advisory committee's recommendation that use of Sanofi-aventis' antibiotic Ketek should be limited due to liver failure concerns may have little financial impact because the company has already absorbed much of that damage.







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