A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment (P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them (P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

Case report and literature review on Good's syndrome, a form of acquired immunodeficiency associated with thymomas.

Thymoma is an uncommon and slow-growing neoplasm that usually presents with mass-associated respiratory symptoms, superior vena cava syndrome or parathymic syndromes. We present a patient with thymoma and hypogammaglobulinemia who had recurrent sinopulmonary infections and diarrhea, recognized to be Good's syndrome. A 75-year old male with thymoma was admitted in our institution due to severe dehydration secondary to a 2-week history of non-bloody watery diarrhea refractory to anti-motility medications. His condition started 3 years ago when he had repeated outpatient visits and hospital admissions either from diarrhea or respiratory tract infections. Workup was essentially unremarkable except for low serum IgM and IgG, lymphocytopenia, and a low absolute CD4 T cell count of 94. A diagnosis of Good's syndrome was made. Patients with Good's syndrome usually have low to absent B cells in the peripheral blood, hypogammaglobulinemia, and cell-mediated immunity defects. Immunologic investigations, T cell subsets, B cell, and quantitative immunoglobulins should be considered a part of diagnostic search in patients with thymoma with recurrent infections or diarrhea. Thymectomy has favorable effects on other parathymic syndromes but is ineffective in improving immunologic deficiencies in this syndrome. Immunoglobulin replacements have been reported to decrease infections, reduce hospitalizations, and decrease antibiotic use in these patients. Clinical outcomes depend on the severity of infections, associated hematologic and autoimmune diseases rather than the thymoma itself.

Final results of a prematurely discontinued Phase 1/2 study of eniluracil with escalating doses of 5-fluorouracil administered orally in patients with advanced hepatocellular carcinoma.

PURPOSE: Eniluracil (EU) is a potent dihydropyrimidine (DPD) inhibitor, which improves the oral bio-availability of 5-fluorouracil (5-FU) and may overcome fluoropyrimidine (FP) resistance in hepatocellular carcinoma (HCC). Based on preclinical evidence, we aimed at studying a new dosing schedule for the combination with sequential administration, a lower dose of EU and higher doses of 5-FU than previously investigated. METHODS: Patients with a diagnosis of hepatocellular carcinoma were eligible for this Phase 1/2 study. The primary endpoint for the Phase 1 was the determination of dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of oral 5-FU when given 14 h after oral EU 5 mg, weekly for 3 out of 4 weeks. The starting dose of 5-FU was 20 mg, followed by 30 mg and 80 mg. Secondary endpoints were anti-tumor activity, pharmacokinetics, and DPD activity in peripheral blood mononuclear cells. RECIST was used for assessment of efficacy and NCI CTC-AE version 3.0 for describing toxicity. RESULTS: Nine patients enrolled in the trial. Median age was 53 years. All patients were Asian (one from Hawaii, 8 from Singapore). Prior treatment was as follows: liver surgery, 2 patients; chemo-embolization, 2 patients; thalidomide, 3 patients; adriamycin, 3 patients. Patients received a median of 2 cycles (range, 1-14) of therapy. No DLTs were seen up to the 80-mg 5-FU cohort. Out of 3 patients in the 80-mg cohort, one had pancytopenia. One patient at the 20-mg cohort had stable disease that lasted for 14 months. CONCLUSION: EU, at a 5.0-mg weekly dose, was well tolerated. There was no evidence of dose-related safety effects. This trial did not define the MTD for oral 5-FU. No objective responses by RECIST were noted but one patient had stable disease and a decrease of 28% in the sum of the largest diameters of her target lesions. The study was terminated early because of CNS-related toxicities noted in the single higher dose levels in a companion study, AHX-03-104.

Prognostic factors and utility of scoring systems in patients with hematological malignancies admitted to the intensive care unit and required a mechanical ventilator.

RATIONALE: Mortality of patients with hematological malignancy requiring mechanical ventilation is high. Neither early prognostic indicators nor scoring systems that discriminate survivors from non-survivors to aid in end-of-life decision making have been identified. OBJECTIVE: To assess the outcomes, prognostic factors, and scoring systems of acute respiratory failure requiring endotracheal intubation in the intensive care unit (ICU) in patients with hematological malignancies. METHODS: Retrospective cohort study in the medical ICU of a tertiary hospital. Thirty-three critically ill patients with hematological malignancies requiring mechanical ventilation were analyzed for demographic data, ICU survival, type of malignancy state of disease, reasons for hospitalization and ICU admission, peripheral blood parameters and scoring systems (APACHE II, SOFA, SAPS II, and MODS) during ICU stay All recorded variables were evaluated for prognostic relevance by univariate and multivariate analyses. MEASUREMENTS AND RESULTS: Overall ICU mortality was 74%. Univariate analysis revealed statistically significant differences in red blood cell count, hemoglobin, mean arterial pressure, coagulation studies, as well as the presence of oliguria, multi-organ failure, vasopressor requirement, pneumonia, blood product requirement. APACHE II, SOFA, and SAPS II scales also revealed similar statistical significance in outcome. However, multivariate analysis did not reveal any independent prognostic factors statistically. Among these, hemoglobin level appears to be the strongest trend (p = 0.0577) for survival. CONCLUSIONS: Mortality of patients with hematological malignancies requiring mechanical ventilation remains high. No single independent risk factor for ICU mortality was identified with multivariate logistic regression analysis. Prognostic scoring systems do not yield adequately reliable information to be used exclusively for end-of-life decision making in individual patients.