Characteristics of women with gynecologic cancer who enter clinical trials.

OBJECTIVE: To determine if differences exist between gynecologic cancer patients who participate in clinical trials and those who do not. STUDY DESIGN: Two hundred thirty-six subjects with gynecologic cancer diagnosed between 1997 and 2001 were identified. Multiple clinical and demographic factors, including clinical trial enrollment, postoperative treatment and related complications, were recorded. RESULTS: Fifty-four women with gynecologic cancer were enrolled to National Cancer Institute-approved clinical trials, while 182 were not enrolled. Differences between those 2 groups in age, ethnicity, primary residence and related complications were not significant. Subjects enrolled had more blood tests, imaging studies and adjuvant therapy than those not enrolled. Endometrial (p = 0.014) and ovarian (p < 0.001) cancer patients with inadequate initial surgery were less likely to enter clinical trials. Endometrial (p = 0.012) and ovarian (p = 0.001) patients who had a gynecologic oncologist as the initial surgeon were more likely to enter clinical trials. CONCLUSION: The most important factor affecting clinical trial participation appears to be the patients' level of familiarity with the physician-investigator who describes the trial. Earlier involvement of gynecologic oncologists in patient care and/or facilitating access to clinical trials by nongynecologic oncologists should increase patient enrollment.

A pilot study of bone density loss in menopausal women treated with chemotherapy for cancer.

GOALS OF WORK: To estimate the incidence and severity of bone loss in menopausal women diagnosed with cancer who receive treatment with chemotherapy. Also, to evaluate the use of bone loss prevention agents in this population. PATIENTS AND METHODS: A total of 25 postmenopausal women with newly diagnosed cancers who received chemotherapy for a minimum of six cycles were enrolled in this pilot study. All subjects underwent baseline bone mineral density (BMD) testing of the lumber spine (LS), left hip (LH), and femoral neck (FN). Of the 25 women, 22 also underwent follow-up BMD testing at 6 months. MAIN RESULTS: The median age of the subjects was 61 years (range 41-76 years) and the median age of menopause was 50 years (range 34-55 years). Of the 25 subjects, 9 used at least 1 g oral calcium daily, 4 used alendronate, 2 used raloxifene, and 1 used oral estrogen. The mean BMDs (g/cm2) with standard deviation above or below the mean for young adult women at baseline were: LS 0.996 (-0.5 SD), LH 0.876 (-0.5 SD), and FN 0.760 (-0.7 SD). The following values were obtained at 6 months: LS 0.965 (P<0.001), LH 0.847 (P<0.001), and FN 0.739 (P=0.009). CONCLUSIONS: Menopausal women diagnosed with cancer appear to have a high incidence of baseline bone loss, with significant additional loss during treatment. Use of agents for prevention/treatment of bone loss in this group is infrequent. A prospective, controlled analysis is indicated to determine the optimal utility of bone densitometry testing and osteoporosis prevention strategies in this population.

The predictive value of cytologic testing in women with the human immunodeficiency virus who have low-grade squamous cervical lesions: a substudy of a randomized, phase III chemoprevention trial.

OBJECTIVE: The purpose of this study was to determine whether the progression of low-grade squamous intraepithelial lesions of the cervix in women with the human immunodeficiency virus can be predicted reliably by standard cytologic testing. STUDY DESIGN: As part of a previously reported trial, 288 biopsy specimens were collected from 117 women with the human immunodeficiency virus. These specimens underwent central and local interpretation, which were compared and correlated with cytologic results. Ninety-two subjects had matched cytologic/histologic pairs at study termination, which were compared to determine whether cytologic testing was predictive of progression. RESULTS: Of the central histologic interpretations, 26 of 288 interpretations (9%) differed from local results, 97 of 246 cytologic/histologic pairs (39%) were discordant, and 21 subjects had progression to high-grade squamous intraepithelial lesions by histologic evidence. Cytologic testing showed high-grade squamous intraepithelial lesions in 4 of 21 specimens (sensitivity, 19%). The remaining cytologic specimens were either low-grade squamous intraepithelial lesions or were normal. CONCLUSION: This substudy of pathologic results from a randomized clinical trial suggests that, although the risk of progression of low-grade squamous intraepithelial lesions is low, follow-up cytologic testing is unreliable. Colposcopic evaluation with directed biopsies should be continued.

Hospice utilization by male and female cancer patients in an end-of-life transition program.

OBJECTIVE: to determine if there were sex differences in patients' use of hospice services in a regional cancer center in Texas from 1998 to 2000. METHODS: A quality-of-life program for patients with cancer that included an end-of-life component was initiated in 1998 at a regional cancer center. The records of 1057 female and 986 male cancer patients who died from 1998 to 2000 were reviewed. Data on demographics, use of hospice care, length of stay, and location at time of referral were collected and analyzed. RESULTS: Hospice utilization increased in women (47% v 64%; p<.001) and men (53% v 66%; p<.001) who died of cancer from 1998 to 2000. Length of stay (LOS) in hospice did not change for women, but decreased significantly for men over that time (31 days v 14 days, p<.001). The number of men with stays of 14 days or less increased significantly (30% v 53%, p<.001). Subjects whose LOS were less than 14 days were more likely to be hospital inpatients at time of referral. CONCLUSIONS: The institution of a targeted end-of-life program was associated with increased utilization of hospice services in women with cancer at this regional cancer center. Length of stay in hospice was longer for women than men, and more men had very short (less than 14 day) stays. Hospice referrals from outpatient settings were associated with longer LOS.