California asked to investigate new breast cancer treatment

A new radiation treatment for early-stage breast cancers, used at Sutter and dozens of other U.S. hospitals, is drawing criticism from three California patient advocacy groups, part of a heated global debate in the breast cancer community.

Concerned that the treatment’s long-term results are unproved and might be pushed on women patients who are too young, the groups have asked state Attorney General Kamala Harris to investigate how the treatment option is advertised and explained to breast cancer patients.

Intraoperative radiation therapy, or IORT, is a relatively new radiation therapy for breast cancer patients who undergo a lumpectomy, or removal of a small tumor. (It’s not used in whole-breast mastectomies.) It’s considered a more efficient, less costly and potentially less damaging form of radiation for older women with low-risk breast cancers.

Unlike traditional radiation therapy, which can require up to six weeks of daily trips to treatment centers, IORT is a single, concentrated dose delivered directly into the tumor cavity while the patient is still on the surgery table. Typically, it’s recommended for post-menopausal women ages 55 and older with nonaggressive, small-tumor, early-stage breast cancers.

“We’re not saying it’s bad. We’re saying people need to be informed,” said Liz Helms, president and CEO of California Chronic Care Coalition, which represents 30 consumer groups for those with chronic health conditions. The coalition is one of three nonprofit groups that asked the Attorney General’s Office to investigate the increased use and advertising practices of what they call an “inferior treatment option.” The other groups are the Fresno-based California Health Collaborative and Carrie’s Touch, a Sacramento nonprofit focused on African American women with breast cancer.

They cite research studies that show a twofold increase in breast cancer recurrence among IORT patients, compared with women who underwent traditional, post-surgery radiation. Another cause of concern were recent TV news reports about a Chicago breast cancer patient who was treated with IORT at age 20. Generally, younger women with breast cancer are considered to have more aggressive cancers that need to be treated with higher-dose radiation and possibly chemotherapy.

“We want full disclosure of the treatment and a comparison with full-breast radiation. Breast cancer isn’t something we can fool around with,” said Helms, who said her best friend died of breast cancer in her 50s.

Helms’ letter, which was also signed by two radiation oncology professors from the University of Michigan and Tufts Medical Center, said that manufacturers of the radiation devices “are marketing IORT ahead of science, and the manipulated data is putting breast cancer patients at risk.” They asked the Attorney General’s Office to look into regulating the advertising of IORT and help ensure that patients are made aware of higher breast cancer recurrence rates when considering their treatment options.

The Attorney General’s Office confirmed that it had received the letter but declined to comment.

Some hospitals, like Kaiser Permanente and UC Davis, have chosen not to adopt IORT for breast cancer, largely because long-term data on recurrence rates aren’t available.

Not for all women

In a highly cited clinical trial of breast cancer patients, known as the TARGIT-A study, the five-year recurrence rate of localized cancer (occurring in the same breast) was about twofold: 3.3 percent for IORT patients, compared with 1.3 percent for those undergoing traditional, external radiation.

“Granted, these are low recurrence rates, but we need to proceed with caution,” said Dr. Jyoti Mayadev, a breast cancer specialist and assistant professor in the UC Davis radiation oncology department. “At this point, it’s a promising treatment option for some selected patients.”

The American Cancer Society also has looked closely at the use of IORT.

“My interpretation is that it appears to be a reasonable approach to treatment that would benefit certain women within certain parameters,” said Len Lichtenfeld, deputy chief medical officer for the American Cancer Society in Atlanta. But, he cautioned, “It has to be the right patients,” who are fully informed about the limitations of “what we do know and what we don’t know” about IORT’s long-term effects and recurrence rates.

Compared with standard, external radiation of the whole breast, “We don’t have all the information to say with certainty that (IORT) is an equivalent therapy,” Lichtenfeld said.

In Sacramento, Sutter Hospital began offering IORT in 2012 for women ages 50 and older, as part of its suite of breast cancer treatment options, said Dr. Gregory Graves, who said he’s done about 100 IORT treatments for a carefully screened group of breast cancer patients.

Graves said patients who meet a “very tight criteria list” (including their age, size of tumor and family history) discuss with a radiation oncologist all their options, including conventional whole breast radiation. “They do have a very thorough, in-depth discussion of the options,” he said.

As for operating on younger patients, “I’d never consider it for a 20-year-old. In my opinion, no reputable hospital would offer it to someone that young,” Graves said.

So far, Sutter says its first 24 months of results, as reported to the Cleveland Clinic, which is gathering U.S. data on IORT procedures, show that cancer recurrence rates are similar to those of standard, external radiation therapy. “In carefully selected patients, we haven’t seen an increase in recurrence,” said Graves. “It doesn’t prove it’s a better treatment; it says it’s as good.”

‘Red hot’ debate

In the May issue of the International Journal of Radiation Oncology, the editors presented what they called an “unprecedented” reaction from researchers and breast cancer physicians on the effectiveness of IORT. Based on the conflicting opinions, IORT is “either a very serious threat or a quantum leap forward,” the journal noted. Ultimately, more data “will resolve this debate but for now ... It is ‘red hot.’ ”

One of the first California hospitals to use IORT for breast cancer was at UC San Francisco, which began offering the radiation therapy about 10 years ago.

Dr. Michael Alvarado, associate professor of surgery at the UCSF Comprehensive Cancer Center, said the three groups who wrote the Attorney General’s Office “have the right idea” about ensuring that patients are informed of treatment benefits and risks but have “gone at it the wrong way – potentially leading to women not having this excellent choice of therapy.”

Alvarado, who calculates he’s done about 200 IORT procedures, said part of the problem is that data results can be misconstrued. He said critics often cite the TARGIT-A clinical trial that found a twofold increase comparing breast cancer recurrence rates of more than 3,000 women who had IORT treatment vs. those who went through traditional, post-surgery, external radiation.

According to Alvarado, however, the trial lumped together two types of IORT therapy: women who received IORT while still in surgery and those whose doctors waited and reopened their incision to deliver the radiation. The cancer recurrence among those with post-surgery IORT radiation were not favorable and that practice has been dropped by most physicians, he noted. When the results from post-surgery IORT are eliminated, the recurrence rate for whole breast, post-surgery radiation vs. IORT radiation was 1.1 percent vs. 2.1 percent – “and not statistically significant,” he said.

As for concerns that IORT is being inappropriately recommended to women whose age or type of cancer make a recurrence more likely, Alvarado said the focus should be on doctors, not the treatment itself. “If unsuitable patients are being offered this treatment, then you should investigate the physicians (who) are using it inappropriately. That is the real problem.”

This story was originally published July 17, 2015 at 5:01 PM with the headline "California asked to investigate new breast cancer treatment."