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African-American women are less likely than white women to receive radiation therapy after a lumpectomy, the standard of care for early stage breast cancer, according to a new study by researchers at The University of Texas M. D. Anderson Cancer Center.

The study, the largest of its kind, was presented today in advance of the American Society of Clinical Oncology (ASCO) Breast Cancer Symposium, and is the first national study to examine such racial disparities in radiation therapy. Led by Grace Li Smith, M.D., Ph.D., a postdoctoral fellow in M. D. Anderson’s Department of Radiation Oncology, the researchers reviewed the Medicare records of more than 37,000 patients diagnosed with early stage breast cancer in 2003.

“Although there have been smaller studies of racial disparities in breast cancer care, no prior research has examined the differences across the nation in the rates of radiation therapy after lumpectomy between whites and blacks,” said Smith, the study’s first author. “The national Medicare database, because it’s so comprehensive, allowed us to determine the extent to which racial disparities in radiation therapy affected patients across the country.”

For the retrospective cohort study, Smith and her M. D. Anderson colleagues used Medicare claims to examine the treatment history of women aged 66 and older diagnosed in 2003 with early stage, newly diagnosed breast cancer. Of the 37,305 women who underwent a lumpectomy for their breast cancer, 34,024 were white and 2,305 were black. Overall, 74 percent of the white women received radiation therapy after their lumpectomy; in contrast, 65 percent of the black breast cancer patients received the same treatment.

“The use of radiation after lumpectomy is considered to be the standard of care for women with invasive breast cancer, as clinical trials have demonstrated that it both reduces the chance of recurrence and improves the chance of survival,” said Thomas Buchholz, M.D., professor in the Department of Radiation Oncology and the study’s senior author. “While there are some breast cancer patients, such as those over age 70, with significant co-morbidities for whom radiation would not be appropriate, this discrepancy remained consistent when specifically looking at patients under the age of 70.”

Perhaps the most unexpected aspect of the study, said Smith, was the magnitude of the disparity in specific areas of the country: the Pacific West, 72 (whites) vs. 55 percent (blacks); East South Central, 72 (whites) vs. 57 percent (blacks), and the Northeast, 70 (whites) vs. 58 percent (blacks).

However, in some parts of the country - the Mountain West (76 percent vs. 74 percent) and the North Central Midwest (74 percent vs. 72 percent) - there was virtually no discrepancy in radiation rates between whites and blacks. That level of geographic non-disparity was also surprising and of great benefit for further research, said Smith.

“Until further research is conducted, we may only speculate about the underlying reasons why black and white women are not receiving radiation at the same rate. We don’t know if fewer black women are receiving radiation simply because it is not offered to them, because they decline the treatment, or perhaps because they are unable to complete a whole course of treatment due to other health problems. These questions will be important subjects of future study. As a medical community, we need to identify and eliminate any obstacle prohibiting all women from receiving necessary care for their breast cancer.”

Smith’s plans for follow up research include evaluating the difference in radiation rates results in a difference in mortality. She also plans to investigate whether radiation patterns correlate with other illnesses secondary to breast cancer care, and if there are disparities in other types of cancer treatment.

Smith hopes that results from the study may prompt physicians and patients to work together to overcome some of the barriers to treatment.

“Physicians may be able to help patients identify specific barriers to their care and may be able to be influential in helping patients overcome such obstacles,” said Smith. “Or, if there are concerns or misconceptions about radiation treatment, patients themselves may play a role by becoming educated about the value of radiation after lumpectomy and helping to disseminate this information into their communities.”

In addition to Smith and Buchholz, other authors of the all-M. D. Anderson study include: Tina Shih, Ph.D., associate professor in the Department of Biostatistics; Ying Xu, M.D., senior statistical analyst, Division of Quantitative Sciences; Sharon Giordano, M.D., associate professor in the Department of Breast Medical Oncology; Benjamin Smith, M.D., adjunct assistant professor in the Department of Radiation Oncology; George Perkins, M.D., associate professor in the Department of Radiation Oncology; Welela Tereffe, M.D., assistant professor in the Department of Radiation Oncology; Wendy Woodward, M.D., Ph.D., assistant professor in the Department of Radiation Oncology.

The research was supported by a grant from the Department of Defense Breast Cancer Research Program, BC062438.

By Angela Cullen

Sept. 4 (Bloomberg) — Merck KGaA, the German maker of the Erbitux cancer treatment, is teaming up with Belgian biotechnology company Ablynx NV to develop medicines to fight tumors and immune disorders.

Family-controlled Merck will pay its partner 10 million euros upfront to use Ablynx’s so-called nanobodies, a new class of proteins that have the immune-defense properties of antibodies, the companies said in a statement today.

Under the terms of the agreement, Darmstadt-based Merck and Ghent-based Ablynx will share the research and development costs equally, and Ablynx will be eligible to receive half of the profits resulting from the collaboration. Ablynx also has an option to exit the programs, in which case it would get a reduced profit share or as much as 325 million ($471 million) in goal-related fees.

To contact the reporter on this story: Angela Cullen in Frankfurt at acullen8@bloomberg.net

Heart experts today played down fears that an anti-cholesterol drug could cause cancer.

A study, published in the New England Journal of Medicine, linked Inergy, a combination of two statins, to an increased risk of developing cancer.

But the British Heart Foundation (BHF) advised patients to continue taking the drug until hard evidence suggested otherwise. It said other studies had found no evidence of such a risk.

About 300,000 prescriptions for Inergy, which includes simvastatin and a newer drug called ezetimibe, have been dispensed in England and Wales over the past two years.

The National Institute for Health and Clinical Excellence (Nice), which advises which treatments should be available on the NHS, approved wider use of the drug in November for patients with high levels of cholesterol.

But the study by doctors at Ulleval University Hospital in Oslo raised doubts about its effectiveness.

The researchers found that over four years there were 105 cases of cancer among patients on Inergy, compared with 70 in the placebo group.

The trial found an increase in a variety of cancers, including skin cancer and prostate cancer.

The US Food and Drug Administration has launched an investigation into the drug.

However, the BHF sought to reassure patients, saying drug regulators would act quickly if hard evidence of risk emerged.

Dr Mike Knapton, the charity’s director of prevention and care, said patients concerned about the risk should speak to their GPs.

He pointed to a study by researchers at Oxford University that combined three studies of the drug and found no increased risk of cancer.

But he called for closer study of patients using Inergy.

“At the moment it’s not clear if there is a risk,” he said. “It would be a disaster if, on one hand, a drug which benefits patients gets shelved. On the other hand, we don’t want to give large numbers of patients a drug which has an increased risk of cancer associated with it.”

Knapton said the data from the big trials of the drug were encouraging but the evidence of its efficacy was “not yet conclusive”.

“Because one study did show a cancer risk, it is crucial that others continue and are monitored closely to definitively confirm or refute any link.

“People should be reassured that drug regulators will act quickly if robust evidence of risk to patient health appears.

“If you have been prescribed ezetimibe you should continue to take it. If you have concerns about side-effects of this or other medication, you should talk to your doctor to weigh up the risks and benefits.”

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