SACRAMENTO, Calif.--(BUSINESS WIRE)--Two leading advocacy groups representing patients throughout California urge chief law enforcement officer, Attorney General Kamala Harris, to act on her commitment to protect consumer rights and to investigate increased use and advertising of a controversial and experimental breast cancer treatment option: Intra-Operative Radiation Therapy (IORT).
Letters sent by the California Chronic Care Coalition (CCCC) and the California Health Collaborative (CHC) to Attorney General Harris request an investigation and regulations around advertising IORT. The letters were also sent to members of the California Senate and Assembly Health Committees as well as members of the Senate and Assembly Business & Professions Committees.
“Treatment centers offering IORT should ensure that patients are educated about the risks associated with this treatment option, however big or small those risks may be,” said Liz Helms, president and CEO of the CCCC. “Without full patient communication and disclosure, consumers cannot make an informed decision on what the best care is for them. This is critical when someone is diagnosed with cancer.”
IORT is an adjuvant therapy that has been branded as equivalent to whole breast radiation therapy, using a technique that decreases the total dose and amount of tissue being treated, delivered at the actual time of the lumpectomy. Yet clinical studies evaluating the efficacy of IORT concluded the radiation treatment increases local cancer recurrence rates two-fold, compared to traditional radiation options such as whole breast treatments.
“Recent news stories are positioning IORT as a preferred choice,” said Dr. David Wazer, chief of the departments of radiation oncology at Rhode Island Hospital in Providence and Tufts Medical Center in Boston and professor and chairman of the department of radiation oncology at both Tufts University and Brown University. “I am concerned by the claim that IORT is a viable treatment option. The interpretation of the scientific data evaluating IORT is highly contested among leading medical researchers and the results from clinical trials raise considerable doubts as to its safety and efficacy. Patients who choose treatment with IORT should be informed that whole breast external beam radiation therapy (EBRT) is an alternative treatment that has a much longer track record with unequivocally documented long-term effectiveness and safety.”
Two studies of IORT raise large concerns regarding this modality being offered as a proven treatment option. Clinical trial TARGIT-A studied 3,451 patients with very limited follow-up and found a 3.3 percent local recurrence rate for IORT patients versus a 1.3 percent recurrence rate for EBRT patients – a 2.5-fold increase. Clinical trial ELIOT studied 1,305 patients and found a 4.4 percent local recurrence for IORT versus a 0.4 percent recurrence for EBRT patients – an 11-fold increase. In TARGIT-A, the issue of immature follow-up data is compounded by a failure to use standard statistical methods to adjust for patients with a short follow-up, thereby underestimating the relapse risk of patients surviving longer periods of time.
“Current evidence would suggest that IORT is an inferior treatment option that needs much further study before being represented as the new standard,” said Dr. Wazer.
Jack Cuzick, Ph.D., director at Wolfson Institute of Preventive Medicine and head of the Centre for Cancer Prevention in London, was the chairman of the data monitoring committee for the IORT clinical trial TARGIT-A before the committee was disbanded. Dr. Cuzick mirrors Dr. Wazer’s sentiments on the trial’s outcome and has expressed serious concerns about the findings being misrepresented elsewhere.
“The TARGIT-A trial is a good example of trying to make data fit a pre-existing hypothesis; there are several major deficiencies in the analysis … the TARGIT-A trial remains inconclusive and intraoperative radiotherapy using TARGIT remains an experimental treatment,” wrote Cuzick in a letter to The Lancet.
“Of great concern to our organization is the fact that patients choosing this treatment option are not being made aware of the risks associated with this therapy and that potential recurrence rates are more than twice as high as conventional breast cancer treatment options,” said Stephen Ramirez, chief executive officer of the CHC. “Even more concerning is the lack of consensus among the physician community about the efficacy of this treatment option. If there are any concerns or risks, patients deserve to be informed.”
Carrie’s TOUCH, a Sacramento-based breast cancer advocacy organization, supports the CCCC and CHC initiative to properly inform patients.
“As a breast cancer survivor and patient advocate, it is absolutely critical for patients to understand all the facts and risks associated with their treatment options,” said Reverend Tammie Denyse, founder and president of Carrie’s TOUCH. “Without this information, women are not able to make informed decisions about their health care. Regardless of which treatment option they choose, patients are entitled to know all the information up front.”
This issue has also reached an international spotlight. A group of 14 physicians wrote the following comment in the British Medical Journal:
“We believe that the premature and market-driven global implementation of [IORT] represents a serious deviation from huge collaborative efforts over the past decades striving to establish evidence-based best practice for patients with early breast cancer … We are stating the simple fact that the data analyses presented so far do not allow one to conclude that TARGIT-A is non-inferior to standard therapy within a margin tight enough to reassure breast cancer patients that the added convenience of intra-operative radiotherapy is worth the possible added risks.”
About California Chronic Care Coalition
The California Chronic Care Coalition (CCCC) is a unique alliance of more than 30 leading consumer health organizations and provider groups that engage policy makers, industry leaders, providers and consumers to improve the health of Californians with chronic conditions. CCCC envisions a system of care that is accessible, affordable and of a high quality that emphasizes prevention, coordinated care and the patient’s wellness and longevity. http://www.chroniccareca.org/
About California Health Collaborative
The California Health Collaborative (Collaborative) is a nonprofit 501(c)3 organization committed to enhancing the quality of life and health of the people of California, particularly the underserved and underrepresented. Founded in 1982 and headquartered in Fresno, California, the Collaborative has offices in Chico, Merced, Oakland, Sacramento, and San Bernardino serving residents in 50 out of the 58 California counties. Guided by its mission of "changing lives by improving health and wellness," the Collaborative implements an array of health promotion and disease prevention programs, public health surveillance systems and a variety of capacity-building and networking activities. http://www.healthcollaborative.org/