The role of biomarkers in cancer clinical trials.

OBJECTIVES: To review strategies to incorporate biomarkers into screening studies, and prevention and therapeutic clinical trials. DATA SOURCES: Published research articles. CONCLUSION: The incorporation of biomarkers into cancer clinical trials has been an important advancement in the last two decades of cancer research and has been critical to increasing our understanding of cancer across the spectrum from early lesions to frank cancers. While the incorporation of biomarkers into studies may increase the significance of the results, they also increase cost and a burden on research subjects. IMPLICATIONS FOR NURSING PRACTICE: It is important for nurses to have an understanding of both the science and the implications of the biomarkers.

Structuring survivorship care: discipline-specific clinician perspectives.

INTRODUCTION: Several models for survivorship care are prominent within the cancer literature; however, there is little empirical research that examines what oncology clinicians perceive to be the best approach to caring for cancer survivors, what services survivorship programs should include, and how prepared they feel to care for cancer survivors. METHODS: An IRB approved web-based survey of all clinical staff was conducted at a NCI designated comprehensive cancer center with a 49.8% response rate (N = 377). Data were summarized using frequencies and relative frequencies, and pairwise tests of statistical significance were utilized to evaluate differences between clinician type groups. RESULTS: Overall, the largest proportion of respondents preferred a disease-specific survivorship model (37.6%). This preference was specifically observed in oncology physicians and nurses. When asked where specific survivorship services should be provided, respondents indicated a preference for services directly related to survivors' medical treatment (i.e. information about late effects) to be delivered in a disease-specific survivorship clinic, and ancillary services (i.e. nutrition and fertility counseling) to be housed in a centralized comprehensive survivorship clinic. Physicians felt that they have significantly more information, training, and resources to care for cancer survivors than did oncology nurses. DISCUSSION/CONCLUSION: These results indicate that oncology clinicians prefer a combination of survivorship care delivery models where continuing medical needs are met in disease-specific clinics, and comprehensive wellness services are offered in a centralized comprehensive survivorship clinic. Results also suggest that planning for survivorship initiatives should include additional resources, education, and training for clinical staff. IMPLICATIONS FOR CANCER SURVIVORS: These findings underscore the need for a universally accepted definition of cancer survivorship, and support a model for delivering care to cancer survivors that is a blend of the disease-specific and comprehensive survivorship programs.

Clinical research site infrastructure and efficiency.

Increasing efficiency in the clinical trials development process ensures a vibrant clinical trials system that makes best use of resources, and keeps pace with scientific discoveries in the field of cancer research.

The decision to prematurely terminate a trial of R-HuEPO due to thrombotic events.

Recombinant human erythropoietin (r-HuEPO) corrects cancer-related anemia and, thereby, improves quality of life. The purpose of the present study was to measure the impact of erythropoietin on hemoglobin and mood state in patients with metastatic breast cancer and mild anemia (Hgb < 12.0 g/dL). Women were randomized to receive usual care (G1) or usual care plus r-HuEPO (G2). Usual care included transfusions as necessary and fatigue education. R-HuEPO was begun at 40,000U subcutaneously per week. At 4 weeks, the dose was increased to 60,000U if Hgb had not increased > or = 1.0 g/dL. The drug was discontinued at 8 weeks if hemoglobin improvement was < 1.0 g/dL. The study was terminated early (n = 27, G1 = 13, G2 = 14) when 4/14 (28.5%) subjects in G2 developed thrombotic events (deep vein thrombosis [DVT] in 1; DVT plus pulmonary embolism [PE] in 1; DVT plus PE 1 month after drug discontinuation in 1; and brachial vein thrombosis with infected Mediport in 1). In all four patients, Hgb levels were normal at the time of the event. No patient in G1 developed a thrombotic event. There were no significant differences in demographic characteristics or current chemotherapy regimen in G1 vs. G2. The decision to terminate the trial was made after considerable deliberation. The increased incidence of thrombotic events in the r-HuEPO (G2) arm of this study exceeds that in prior studies in this population and prior r-HuEPO trials. This may relate to the administration of r-HuEPO in this high-risk population, but the small sample size and possible predisposing risk factors preclude definitive conclusions.