Survival Rate Lengthened by Drug Duo

Story first reported from seattletimes.com

Women with metastatic breast cancer treated with a combination of two estrogen-blocking drugs survived more than six months longer than those treated with just one of the drugs or one followed by the other, according to a study involving nearly 700 women.

It's the first time such improvement in overall survival has been seen in trials of first-line hormonal therapy for hormone-receptive metastatic breast cancer, the study authors said.

"We're finding a lot of other ways of treating these estrogen-receptor-positive breast cancers that don't include chemotherapy," said co-author Dr. Julie Gralow, director of breast medical oncology at Seattle Cancer Care Alliance.

Such hormone-targeting therapy is a key focus in breast-cancer research, in part because it avoids the toxic effects of chemotherapy, Gralow said. However, she cautioned, these first results need to be repeated and verified by other researchers and may only apply to a subgroup of women with this type of breast cancer.

The report, from the University of Michigan-based research group SWOG, one of five cooperative groups that comprise the National Cancer Institute's National Clinical Trials Network, was published Wednesday in the New England Journal of Medicine.

The SWOG Statistical Center is based at Fred Hutchinson Cancer Research Center; and co-authors also include Dr. William Barlow, professor of biostatistics at the University of Washington.

The two drugs, anastrozole (brand name Arimidex) and fulvestrant (brand name Faslodex), are both called endocrine therapies because they work through action on a hormone — in this case, estrogen. About three-quarters of women with breast cancer and metastatic breast cancer have tumors that are responsive to estrogen, Gralow said. Anastrozole inhibits estrogen synthesis, while fulvestrant works on estrogen receptors.

The combination therapy increased the median survival of the women in the trial by 6.4 months compared with those who took only anastrozole. The combination also lengthened by 1.5 months the time before patients' disease progressed. More than 40 percent of the women in anastrozole-only group switched to fulvestrant when their disease progressed.

Although at this point metastic breast cancer isn't cured with such endocrine therapies, Gralow said researchers are making a lot of progress in this area.

"We're trying to get away from toxic, nonspecific therapies, like chemotherapy, and better understand how we can affect the estrogen receptors and its pathways and get even better results than with chemo, with fewer side effects. That's where we're going in treating breast cancer."

About 700 women with metastatic breast cancer were enrolled in the study. Gralow said she was surprised to find that nearly 40 percent of them had received no treatment for breast cancer before coming in for evaluation of a breast lump and being informed their cancer had already spread.

"When I first saw that I didn't believe it," Gralow said. While such late diagnosis is common in the rest of the world, she said, it's troubling to see so many women from this country whose breast cancer was not caught in the early stages.

"That means there are a lot of those patients out there," she said.

For the study, having such a large percentage of previously untreated patients may mean the results would not hold for women who had received estrogen-blocking drugs in the past, Gralow said. "What the results mostly relate to is a patient who is just starting endocrine therapy for the first time," she said.

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University of Michigan, Blue Cross Blue Shield of Michigan Collaborating to Cut Rehospitalizations

Ann Arbor

The University of Michigan and Blue Cross Blue Shield of Michigan are backing a statewide initiative meant to cut back on hospital readmissions that occur for up to 1 in 5 patients.

The campaign, called Project BOOST, is meant to help mitigate the risk of complications that could land high-risk patients back in the hospital after being discharged. Focusing on improving the discharge process at hospitals, it is a model that has been used around the country.

The goal of the program is to help reduce unexpected and preventable readmissions for the health and quality of life of patients, said Scott Flanders, U-M's director of the hospital medicine program and president of the society of hospital medicine. Often when a patient is discharged from the hospital, follow up tests and care with a primary care physician is recommended. In the pass-off, patients can fall through the cracks.

Reducing cost is also a major factor driving the project.

According to Blue Cross Blue Shield of Michigan data on a majority of its patients, about 1 in 10 patients discharged from the hospital are readmitted within the month.

Even when adjusting for readmissions unrelated to the original problem or planned readmissions, at least 6.4 percent of discharge patients return to the hospital with unexpected and potentially preventable problems. That represents an opportunity to imrpove quality and save up to about $75 million every year, said Tom Leyden, a manager in clinical programs with Blue Cross Blue Shield.

And according to national Medicare data, about 20 percent of senior patients discharged from the hospital unexpectedly return within the month, costing more than $17 billion nationally each year, according to a statement.

"It's substantial," Leyden said. "That's a lot of patients who come back in for healthcare professional services  who shouldn't really have to."
Reviewing the way hospitals discharge patients is important because not every patient is equal at discharge, Flanders said.

Some get new medications to take every day or get new regimens and may get confused about how to best take care of themselves. Steps like identifying who the highest risk patients are and targeting them for more intensive support after discharge could help reduce their chances of being readmitted, Flanders said.

Solutions for these patients include having a health professional take extra time to explain medication instructions and having a patient or caregiver verbally "teach back" what they were instructed to do. It can also includes follow-up phone calls and direct communication with a patient's primary care physician. The steps could be the difference that keeps a patient's medical issue from returning in a serious enough way to land him or her back in the hospital, Flanders said.

For example, he said, when a patient is hospitalized and treated for congestive heart failure, it means the heart is not pumping as well as it should, and fluid can build up and needs to be addressed by a doctor.

"But if patients go home and don't rigidly adhere to instructions on taking medications and salt intake, then the fluid can build up again," Flanders said. "If a patient is telling a primary care doctor they can't breath again, they can make changes … so (the patient doesn't) end up in the hospital again."

In the coming weeks, 15 hospitals will be chosen across the state to participate in the program. By May, programs will begin to be set up, and healthcare data migration training will be offered to staff. The University of Michigan is leading the effort with the Society of Hospital Medicine.