Mayo Clinic Makes Strides in Quality Improvement

Tuesday, October 17, 2006

ROCHESTER, Minn. — Through a prospective quality assessment, researchers at Mayo Clinic Cancer Center have shown that instituting a standardized protocol for surgical management of endometrial cancer results in improved surgical staging and increased detection of paraaortic nodal disease. Andrea Mariani, M.D., presented these findings today, Oct. 17, at the 2006 International Gynecologic Cancer Society biennial meeting in Santa Monica, Calif.

Surgeons strive to get the best possible outcomes for their patients, taking into account individual situations, but it is difficult to establish best-quality practices on numerous one-time bases. "Without guidelines, if a surgeon is not sure how much surgery or treatment is necessary, he or she may not proceed as aggressively as might be warranted, resulting in less than satisfactory results for the patient," says Karl Podratz, M.D., Ph.D., Mayo Clinic gynecologic oncologist and lead investigator of the study. "We wanted to eliminate the uncertainty, thus improving the overall quality of our patient care."

Mayo's gynecologic oncologists, when looking at ways to improve quality of care for endometrial cancer patients, retrospectively examined more than a decade of surgical data, in a population of approximately 1,100 patients, showing that a lymphadenectomy was performed only on 65 percent of those patients now considered at risk for lymph node invasion. Moreover, only 38 percent of these had systematic pelvic and paraaortic nodes removed. Of these, the average numbers of pelvic and paraaortic nodes dissected were 19 and 7.1 respectively, with 20 percent and 9 percent of those documented as positive for endometrial cancer.

Using this information, the team developed a protocol to assist in surgical decision making, thereby lessening uncertainty and instituting the best available evidence to guide patient care. "We assumed that if we followed a specific set of guidelines, we would do the appropriate surgery every time," says Dr. Mariani. "Additionally, we expected that we'd be able to detect the metastatic tumors more often, with better overall outcomes for patients."

Endometrial and other uterine cancers will account for about 7,350 deaths in the United States this year, reports the American Cancer Society. Treatment following surgery depends in large part on the severity (stage) of the disease. If surgeons do not have correct staging information, they do not know the severity of the disease and cannot ensure the most effective postoperative treatment. Moreover, failing to remove the nodes when otherwise indicated can potentially leave cancer behind. For women without cancer in the nodes, in an effort to 'catch' the possible remaining nodal cancer, unnecessary treatments may be instituted, say the researchers. Surgeons and oncologists need the right information to make decisions concerning additional treatment, and Mayo's protocol was designed to assist in helping them to get that information.

Because they use an aggressive approach for cancer surgery, Mayo's team developed a protocol to define when not to move forward with a lymphadenectomy. In January 2004, they instituted a surgical management protocol that allowed omission of node removal only for patients with specific low-risk features, with all other patients automatically receiving a lymphadenectomy.

In this prospective study of 288 patients treated from 2004 through 2005 using the new protocol, 90 percent of patients considered at risk received a lymphadenectomy, with 93 percent of these having systematic pelvic and paraaortic nodes removed. The average number of dissected nodes was 35.9 and 16.1 respectively, with 19 percent and 13 percent of those being positively documented as cancerous.

When node-positive patients only were assessed, 39 percent of the patients in the retrospective group had documented positive paraaortic nodes compared to 62 percent in the prospective group, leading the team to conclude that often paraaortic disease had been previously overlooked. The researchers concluded that using a standardized protocol improved results for individual surgeons and the overall group in terms of better accuracy in surgical staging and increased detection of paraaortic nodal disease.

"Contrary to some public opinion about standardized protocols overlooking individualized medicine, in this instance it improved patient care," says Dr. Podratz.

In addition to finding improvements in staging and disease detection, the investigators hope that they will also see overall survival rates increase for Mayo's endometrial cancer patients. An ongoing analysis is looking at whether instituting the protocol has improved survival.

Other Mayo researchers involved with the surgical part of the study included William Cliby, M.D.; Bobbie Gostout, M.D.; Monica Jones, M.D.; Sean Dowdy, M.D.; Timothy Wilson, M.D.; C. Robert Stanhope, M.D.; and Gary Keeney, M.D.

Learn more information about womens cancer/women's cancer research at Mayo Clinic at cancercenter.mayo.edu (opens in new window). Find out more about endometrial cancer treatment at www.mayoclinic.org/uterine-cancer.

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