A phase II trial of 17-allylamino-17-demethoxygeldanamycin in patients with hormone-refractory metastatic prostate cancer.

PURPOSE: 17-Allylamino-17-demethoxygeldanamycin (17-AAG) is a benzoquinone ansamycin antibiotic with antiproliferative activity in several mouse xenograft models, including prostate cancer models. A two-stage phase II study was conducted to assess the activity and toxicity profile of 17-AAG administered to patients with metastatic, hormone-refractory prostate cancer. EXPERIMENTAL DESIGN: Patients with at least one prior systemic therapy and a rising prostate-specific antigen (PSA) were eligible. Patients received 17-AAG at a dose of 300 mg/m2 i.v. weekly for 3 of 4 weeks. The primary objective was to assess the PSA response. Secondary objectives were to determine overall survival, to assess toxicity, and to measure interleukin-6, interleukin-8, and maspin levels and quality of life. RESULTS: Fifteen eligible patients were enrolled. The median age was 68 years and the median PSA was 261 ng/mL. Patients received 17-AAG for a median number of two cycles. Severe adverse events included grade 3 fatigue (four patients), grade 3 lymphopenia (two patients), and grade 3 back pain (two patients). The median PSA progression-free survival was 1.8 months (95% confidence interval, 1.3-3.4 months). The 6-month overall survival was 71% (95% confidence interval, 52-100%). CONCLUSIONS: 17-AAG did not show any activity with regard to PSA response. Due to insufficient PSA response, enrollment was stopped at the end of first stage per study design. The most significant severe toxicity was grade 3 fatigue. Further evaluation of 17-AAG at a dose of 300 mg/m2 i.v. weekly as a single agent in patients with metastatic, hormone-refractory prostate cancer who received at least one prior systemic therapy is not warranted.

Breast cancer risk assessments comparing Gail and CARE models in African-American women.

The Gail model has been used to predict invasive breast cancer risk in women using risk factors of age, age at menarche, age at first live birth, number of first-degree relatives with breast cancer, and number of previous benign breast biopsies. However, this model underestimates breast cancer risk in African-American women. The Contraceptive and Reproductive Experience (CARE) model has been developed to replace the Gail model in predicting breast cancer risk in African-American women. In a sample of 883 women who participated in the breast cancer screening program at Howard University Cancer Center, we compared the breast cancer risk estimates from the Gail model and the CARE model. The mean 5-year breast cancer risk was 0.88% (Range: 0.18-6.60%) for the Gail model and 1.29% (Range: 0.20-4.50%) for the CARE model. Using the usual cutoff-point of 1.67% or above for elevated risk, there is a significant difference in the proportion of women with elevated breast cancer risk between the Gail and the CARE models (McNemar's test, p < 0.0001). For both models, there was a significant mean risk difference between those with and without a family history of breast cancer (Wilcoxon rank-sum test, p < 0.0001). Our results confirm the need for validation of the Gail model in African-Americans and diversity in research. Although these findings are not perfect and perhaps not definitive, they are additive in the discussions during counseling and risk assessment in African-Americans. Furthermore, these findings will be complemented by new technologies such as genomics in refining our ability to assess risk.

Breast Cancer Prognosis for Young Patients.

BACKGROUND/AIMS: Breast cancer (BCa) prognostication is a vital element for providing effective treatment for patients with BCa. Studies suggest that ethnicity plays a greater role in the incidence and poor prognosis of BCa in younger women than in their older counterparts. Therefore, the goal of this study was to assess the association between age and ethnicity on the overall final prognosis. MATERIALS AND METHODS: Nottingham Prognostic Index (NPI) was used to analyze BCa prognosis using Howard University Cancer Center Tumor Registry and the National Cancer Institute's Surveillance, Epidemiology, and End Results BCa datasets. Patients were grouped according to their predicted prognosis based on NPI scheme. RESULTS: There was no correlation between the younger patients compared to their older counterparts for any of the prognostic clusters. The significance of ethnicity in poorer prognosis for younger age is not conclusive either. CONCLUSION: An extended prognostic tool/system needs to be evaluated for its usefulness in a clinical practice environment.

African American women with breast cancer and their spouses' perception of care received from physicians.

Several studies have been conducted which have examined the communication patterns and interpersonal relationships among minority patients and their physicians. These studies suggest that there are differences in the care received from physicians based on the racial and cultural background of the patient. However, little is known about the interpersonal relationships and communication patterns of AA couples coping with a breast cancer diagnosis and their physicians. This report presents the outcomes of a qualitative study undertaken to examine the perceptions of breast cancer care rendered by physicians to African American couples. The AA couples involved in the study reported that the care they received was compassionate, competent, comprehensive and comparable to other women. Each of these qualities was identified by as being essential to quality patient care.

Enrollment of African Americans onto clinical treatment trials: study design barriers.

PURPOSE: African Americans have the highest cancer mortality rates and poorest survival and are more often uninsured and underinsured compared with other ethnic groups. Minority participation in clinical trials has traditionally been low, with reports ranging from 3% to 20%. The present study systematically assesses 235 consecutively diagnosed African American cancer patients regarding recruitment onto cancer treatment clinical trials at Howard University Cancer Center between January 1, 2001, and December 31, 2002. Our intent is to determine the rate-limiting factors associated with enrolling African Americans onto clinical trials at a historically black medical institution. PATIENTS AND METHODS: Two hundred thirty-five consecutively diagnosed African American cancer patients were assessed for participation in clinical trials at Howard University Hospital and Cancer Center. The study population comprised 165 women and 70 men. RESULTS: The overall eligibility rate was 8.5% (20 of 235 patients); however, among those eligible, the enrollment rate (ie, enrollment among the eligible population) was 60.0% (12 of 20 patients). Comorbidities rendered 17.1% of the patient population ineligible for the trials. Advanced disease stage, associated with poor performance status, premature death, and short life expectancy, made an additional 10% of the patient population ineligible. Respiratory failure, HIV positivity, and anemia accounted for 37.8% of the comorbidities in this population. Cardiovascular diseases and renal insufficiency represented 16.2% of the comorbidities. CONCLUSION: It was evident that study design exclusion and inclusion criteria rendered the majority of the study population ineligible. Among African Americans, comorbidity is a major issue that warrants considerable attention.

African American couples merging strengths to successfully cope with breast cancer.

PURPOSE/OBJECTIVES: To explore the process of coping with breast cancer among African American women and their spouses. DESIGN: Exploratory, qualitative study using grounded theory methods. SETTING: Large metropolitan area in the mid-Atlantic United States. SAMPLE: 12 African American couples (N = 24). METHODS: African American women and their spouses were asked to complete a background data sheet and participate in a face-to-face semistructured interview. Qualitative data were audiotaped and transcribed verbatim. Themes were identified using the constant comparative method. Quantitative data were analyzed with descriptive statistics. MAIN RESEARCH VARIABLES: The process of coping with breast cancer among African American couples. FINDINGS: The basic social concern was living through and beyond a breast cancer diagnosis. The core variable was merging strengths to cope with and survive a breast cancer diagnosis. Six main categories emerged to describe how African American couples actively worked together to cope with a breast cancer diagnosis: walking together, praying together, seeking together, trusting together, adjusting together, and being together. CONCLUSIONS: African American couples described the importance of combining their strengths and working together as a couple to cope with a breast cancer diagnosis. IMPLICATIONS FOR NURSING: Nurses must understand the importance of developing culturally sensitive and culturally relevant interventions to assist African American couples with effectively coping with a breast cancer diagnosis. When providing care to African American couples, nurses should incorporate the six categories of walking, praying, seeking, trusting, adjusting, and being together to help couples cope with the various phases of the breast cancer experience.