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Thursday, June 23, 2011

Loma Linda Clinical Trial Shows Positive Steps in Breast Cancer Treatment

A less invasive form of radiation treatment, currently being researched by Loma Linda University, is offering breast cancer patients hope they might be spared from intense side effects.

The Phase II study involved using a proton beam to deliver radiation directly to the site of a tumor in the breast. By focusing the beam on the location, rather than the whole breast, doctors were able to eliminate remaining cancerous cells without many of the side effects that are encountered by breast cancer patients.


“The concept here is we shouldn’t be radiating tissue that doesn’t need to be radiated, and unless there’s a benefit to radiating any part of the body, then we shouldn’t be doing it,” said Dr. David Bush, vice-chairman of the Department of Radiation Medicine at the medical center, and one of the study’s principal investigators.


The study followed 50 breast cancer patients who had small tumors that had not spread further into the body. Each of the patients had the tumor removed, and then were subjected to the proton therapy, instead of standard chemotherapy.

The results were overwhelmingly positive according to the study, which will be published in the upcoming issue of the peer-reviewed scientific journal, Clinical Breast Cancer.


More than 90 percent of the study’s participants remained cancer free following therapy, and the overall survival rate was 96 percent.


While the rate of success was impressive, doctors and patients were pleased that the treatment came with a lessening of side effects, which can include rib fractures, secondary cancers or long-term heart problems due to radiation.


“When you subject those treatments to trials, follow these patients rigorously over long periods of time, you actually find a significant number of very important side effects,” said Dr. Mark Reeves, the director of the Loma Linda University cancer center. “Much more so than when you’re just looking at the results anecdotally in individual patients. And so following over a period of time and in a rigorous way, you do see significant side effects from this, and again that is one of the things that was strikingly apparent in this trial is that the side effects were much less than would be expected.”


For one patient, Vicki Ramirez, being able to participate in the study meant avoiding a full mastectomy. She had had an aortic valve replaced in her heart some 15 years ago, and after her cancer diagnosis, her cardiologist recommended the procedure in an effort to avoid the strain on her heart.


Instead, she was able to have the proton therapy without any side effects, and minimal interruption of her daily activities.


“I went to work in the morning, took my lunch hour and came here, and did it and went back to work, and I felt fine,” she said.


With the success of the first trial, doctors are working to expand the program. Another 100 patients have been enrolled, and a third phase in being planned, which may include women with larger tumors.


“The current guidelines that are in use for patients who might be eligible for partial breast treatment in this fashion are still being established,” Bush said. “What we’ve done with the new trial is taking some members of the group that have been thought to be, perhaps, borderline candidates for this kind of treatment and use it in those situations so we can gather more data to see what the results actually are. We’re hoping we can use the second trial to be able to know whether we can safely extend the invitation for this kind of treatment into that group of patients.”

For Ramirez, who has now been cancer free for five years, the treatment has been a blessing.


“Thank God for Doctor Bush, and thank God for this trial.”

As reported in: http://lomalinda.patch.com/articles/loma-linda-clinical-trial-shows-positive-steps-in-breast-cancer-treatment