Surgery deaths drop nationwide in U.S. for high-risk surgeries, according to study

ScienceDaily (June 2, 2011) — Surgery death rates have dropped nationwide over the past decade, according to a University of Michigan Health System study that reveals cancer surgeries have seen the most dramatic improvement in safety.

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The U-M study in this week's New England Journal of Medicine shows surgery mortality dropped substantially for eight different high-risk surgeries performed on 3.2 million Medicare patients from 1999 to 2008.

More patients are surviving open heart surgery and replacement of diseased aortic valves, but research shows high volume hospitals and their expertise drove a 67 percent decline in deaths for pancreatectomy, a 37 percent decline in deaths from cystectomy, surgery to remove the bladder, and a 32 percent drop in esophagectomy mortality.

"Patients should take solace in knowing that all high-risk surgeries have become safer in the last decade," says lead author Jonathan F. Finks, M.D., clinical assistant professor of surgery at the U-M Health System. "In cancer surgery, in particular, mortality has dropped in large part because more patients are having their surgery in safer, higher volume hospitals."

One of the more interesting findings by the U-M's Center for Healthcare Outcomes and Policy is that hundreds of low-volume U.S. hospitals stopped doing high-risk cancer surgery.

For example, the number of Medicare patients needing surgery to treat pancreatic cancer increased by 50 percent, but the number of hospitals performing the surgeries decreased by 25 percent, from 1,308 hospitals to 978.

As a result, the volume of surgeries a hospital may do in a year rose from five cases of pancreatectomies a year to 16.

There have been numerous efforts in the United States to concentrate selected operations at high volume hospitals.

The Leapfrog group, a consortium of large corporations and public agendas that purchase health care largely for their employees, has been among the most prominent advocates of volume-based referrals. In 2000, it placed a minimum volume standard on hospitals for several surgical procedures to guide where employees get medical care.

The U-M analysis shows volume-based referrals have been successful for certain surgeries, but the effort to make surgery safer takes more than one fix, authors say.

"For some procedures, however, strategies such as operating room checklists, outcomes measurement programs, and quality improvement collaboratives are likely to be more effective than volume-based referral," says John Birkmeyer, M.D., professor of surgery and director of the U-M Center for Healthcare Outcomes and Policy.

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No tie found between PTEN and response to breast cancer drug herceptin, according to new study

ScienceDaily (June 3, 2011) — Contrary to what many oncologists had thought, a tumor suppressor protein known as PTEN does not reduce the effectiveness of the breast cancer drug herceptin, according to a study by Mayo Clinic and North Central Cancer Research Group (NCCTG) investigators.

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The study, which looked at tumors from 1,802 patients enrolled in the NCCTG N9831 clinical trial, found that patients with HER2-positive breast cancer and had either a loss of PTEN functioning or normal PTEN activity did equally well when herceptin was added to chemotherapy to prevent breast cancer recurrence.

The researchers presented their findings during the American Society of Clinical Oncology Annual Meeting in Chicago.

"This is the largest study to date evaluating PTEN's presence or loss in the context of antiHER2 therapy, and we found no connection," says the study's lead investigator, oncologist Edith Perez, M.D., director of the Breast Clinic at Mayo Clinic in Jacksonville, Fla., and the Serene M. and Frances C. Durling Professor. "Our research team is very pleased to be able to test an important question in treatment of breast cancer and arrive at a definitive answer."

The researchers stained the samples for PTEN expression and linked that data with disease-free survival. They found that PTEN status did not impact disease-free survival significantly; there was only a slightly greater benefit of adding herceptin for patients with PTEN-tumors.

Preclinical studies and some small patient studies had suggested that tumors with loss of PTEN expression would not benefit from herceptin, Dr. Perez says. As a result, investigators were considering using PTEN biomarkers in clinical studies as a test of herceptin resistance, and patients who tested positive for PTEN loss might then be offered other therapies, or invited to participate in clinical trials.

"We have all been interested in biomarkers that predict for benefit to antiHER2 therapy," Dr. Perez says, "but PTEN is not one that we should pursue further, based on our rigorous analysis."

The tumor samples examined in the study came from NCCTG N9831, a phase III randomized, multicenter clinical trial that tested adjuvant herceptin given with, or following, chemotherapy with paclitaxel, compared with chemotherapy alone.

The study was funded by the National Cancer Institute, the National Institutes of Health and Genentech. The study includes 16 co-authors; nine are from the Mayo Clinic campuses in Florida, Minnesota, and Arizona.

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