CHICAGO—Symptoms experienced by women that are more severe or frequent than expected and of recent occurrence warrant further diagnostic investigation because they are more likely to be associated with both benign (non-cancerous) and malignant (cancerous) ovarian masses, according to a study in the June 9 issue of the Journal of the American Medical Association (JAMA).

"Ovarian cancer has often been called the 'silent killer' because symptoms are not thought to develop until advanced stages when chance of cure is poor," the authors provide as background information in the article. The authors looked at previous research which found that "80 percent to 90 percent of women with early stage disease will report symptoms for several months prior to diagnosis." The authors continue, "Identification of early symptoms may have important clinical implications because 5-year survival for early stage disease is 70 percent to 90 percent compared with 20 to 30 percent for advanced-stage disease."

In this study, Barbara A. Goff, M.D., from the University of Washington School of Medicine, Seattle, and colleagues compared the frequency, severity, and duration of symptoms between women with ovarian masses (n=128) and women in the control group who visited two primary care clinics (n=1,709). The women were asked to complete an anonymous survey of symptoms experienced over the past year (July 2001 - January 2002). Severity of symptoms was rated on a 5-point scale, duration was recorded, and frequency was indicated as number of episodes per month.

"In the clinic population, 72 percent of women had recurring symptoms with a median (mid-point) number of two symptoms. The most common were back pain (45 percent), fatigue (34 percent), bloating (27 percent), constipation (24 percent), abdominal pain (22 percent), and urinary symptoms [urgency/frequency] (16 percent)," the researchers found. "Comparing ovarian cancer cases to clinic controls resulted in an [increased] odds ratio of 7.4 for increased abdominal size; 3.6 for bloating; 2.5 for urinary urgency; and 2.2 for pelvic pain. Women with malignant masses typically experienced symptoms 20 to 30 times per month and had significantly more symptoms of higher severity and more recent onset than women with benign masses or controls. The combination of bloating, increased abdominal size, and urinary symptoms was found in 43 percent of those with cancer but in only 8 percent of those presenting to primary care clinics."

CHICAGO—New findings from a long-term study of men with early-stage, initially untreated prostate cancer suggests that the risk of progression to more aggressive and lethal disease increases significantly in the long-term, according to a study published in the June 9 issue of the Journal of the American Medical Association (JAMA).

According to background information in the article, without understanding the natural history of prostate cancer diagnosed at an early, localized stage, patient counseling and clinical management are difficult. The challenge is to maximize the possibilities for survival without extensive overtreatment. Even without initial treatment, only a small proportion of all patients with cancer diagnosed at an early clinical stage die from prostate cancer within 10 to 15 years following diagnosis. However, little is known about disease progression and risk of death beyond 10 to 15 years of watchful waiting.

Jan-Erik Johansson, M.D., Ph.D., of Örebro University Hospital, Örebro, Sweden, and colleagues analyzed survival following "watchful waiting" in 223 patients from central Sweden with early-stage, initially untreated prostate cancer. There was a mean observation period of 21 years.

The researchers found that after complete follow-up, 39 (17 percent) of all patients experienced generalized disease. "Most cancers had an indolent [slow to develop] course during the first 10 to 15 years," the authors write. "However, further follow-up from 15 (when 49 patients were still alive) to 20 years revealed a substantial decrease in cumulative progression-free survival (from 45.0 percent to 36.0 percent), survival without metastases (from 76.9 percent to 51.2 percent) and prostate cancer-specific survival (from 78.7 percent to 54.4 percent). The prostate cancer mortality rate increased from 15 per 1000 person-years during the first 15 years to 44 per 1000 person-years beyond 15 years of follow-up."

CHICAGO—Racial and ethnic minorities, women, and the elderly were less likely to enroll in cancer clinical trials than whites, men, and younger patients, according to a study in the June 9 issue of the Journal of the American Medical Association (JAMA).

According to background information provided by the authors, "Ten years have passed since Congress responded to concerns about unequal access to clinical trials and enacted the National Institutes of Health (NIH) Revitalization Act, which encouraged representation of women and minority patients in NIH-sponsored research. Ensuring broad access to research studies has subsequently been an important aim of national research policy."

Vivek H. Murthy, M.D., M.B.A., and colleagues from the Yale University School of Medicine, New Haven, Conn., analyzed data from participants in therapeutic nonsurgical National Cancer Institute (NCI) Clinical Trial Cooperative Group breast, colorectal, lung, and prostate cancer clinical trials in 2000 through 2002. In a separate analysis, the ethnic distribution of patients enrolled in 2000 through 2002 was compared with those enrolled in 1996 through 1998. The study focused on those four types of cancer trials because they were the four most common causes of cancer-related deaths during the study period.

"From 1996 through 2002, 75,215 patients were enrolled in NCI-sponsored cooperative group nonsurgical treatment trials for breast, lung, colorectal, or prostate cancers. Approximately 3.1 percent of trial participants were Hispanic, 85.6 percent were white, 9.2 percent were black, 1.9 percent were Asian/Pacific Islanders, and 0.3 percent were American Indians/Alaskan Natives," the researchers report. "Trial participants represented approximately 1.7 percent of the total number of incident [new] cancer cases diagnosed during the 2000 through 2002 study period. When all four cancer types were considered in aggregate, Hispanics and blacks were underrepresented," the authors write.

"There was a strong relationship between age and enrollment fraction [number of trial enrollees divided by the estimated U.S. cancer cases in each subgroup], with trial participants 30 to 64 years of age representing 3.0 percent of incident cancer patients in that age group, in comparison to 1.3 percent of 65 - to 74-year-old patients and 0.5 percent of patients 75 years of age and older. … Although the total number of trial participants increased during our study period, the representation of racial and ethnic minorities decreased. In comparison to whites, after adjusting for age, cancer type, and sex, patients enrolled in 2000 through 2002 were 24 percent less likely to be black." The researchers also found that men were more likely than women to enroll in colorectal and lung cancer trials.

"Our study also demonstrates that elderly patients, both minorities and whites, were strikingly underrepresented compared with their younger counterparts. Although the elderly accounted for approximately one third of participants in breast, lung, colorectal, or prostate cancer trials, they accounted for approximately two thirds of patients for these four cancer types," the researchers note.

The researchers point out that several barriers may exist among minority groups to enrollment in clinical trials. "Past and ongoing patterns of discrimination have also resulted in decreased trust in the health care system in general among minority patients. Minorities are more likely to express concerns about exploitation, dishonesty regarding risks of experimental treatment, and motivations of researchers. Other studies have suggested that minority patients may be less likely than whites to be offered trial participation."

CHICAGO—A model has been created that can help determine the risk of death within six months for nursing home patients with advanced dementia, according to a study in the June 9 issue of the Journal of the American Medical Association (JAMA).

Accurately estimating the life expectancy of persons with advanced dementia is difficult and hinders palliative care, according to background information in the article. Prognostic information is important in guiding end-of-life decision-making and, in the United States, for determining hospice eligibility. Medicare beneficiaries must have an estimated life expectancy of less than 6 months to be eligible for hospice. A small proportion of patients admitted to hospice have dementia, in part because of the difficulty in predicting survival. Accurate prognostic tools have not been developed.

Susan L. Mitchell, M.D., M.P.H., of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, and colleagues identified factors associated with the risk of death in 6 months in newly admitted nursing home residents with advanced dementia and created a practical risk score to predict survival in this population.

The study included all Medicare or Medicaid licensed nursing homes in New York and Michigan. Participants had advanced dementia and were admitted to New York nursing homes between June 1, 1994, and December 30, 1998 (n = 6,799), and to Michigan nursing homes from October 1, 1998, through July 30, 2000 (n = 4,631). The risk score was derived in the New York population and validated in the Michigan population. The patient characteristics that were evaluated are routinely collected in nursing homes in the United States and some other countries as part of the Minimum Data Set.

The variables that were found to have prognostic value and were included in the final model were: Activities of Daily Living score of 28, male sex, cancer, the need for oxygen therapy, congestive heart failure, shortness of breath, no more than 25 percent of food eaten at most meals, an unstable condition, bowel incontinence, bedfast, older than 83 years, and not awake most of the day. Patients that had more of these variables (higher risk score) had a higher risk of death within six months.

TOO FEW ADULT CANCER PATIENTS ENROLLING IN CLINICAL TRIALS - PARTICULARLY PATIENTS OF COLOR, WOMEN AND THE ELDERLY