Randomised phase II study of siltuximab (CNTO 328), an anti-IL-6 monoclonal antibody, in combination with mitoxantrone/prednisone versus mitoxantrone/prednisone alone in metastatic castration-resistant prostate cancer.

PURPOSE: This open-label phase II trial assessed mitoxantrone/prednisone (M/P) with and without siltuximab (CNTO 328), an anti-interleukin-6 chimeric monoclonal antibody, for patients with metastatic castration-resistant prostate cancer who received prior docetaxel-based chemotherapy. METHODS: Part 1 assessed the safety of biweekly siltuximab 6 mg/kg plus M 12 mg/m(2) every 3 weeks and P. Part 2 assessed efficacy and safety of siltuximab plus M/P versus M/P alone. The primary end-point was progression-free survival (PFS). Progression was defined as progressive disease per Response Evaluation Criteria in Solid Tumours (RECIST), or ≥ 3 new skeletal lesions with clinical deterioration or without deterioration confirmed by repeated bone scan. Rising prostate-specific antigen was not considered progression. RESULTS: Siltuximab plus M/P was well tolerated in Part 1 (n=9). In Part 2, 48 and 49 patients received siltuximab plus M/P or M/P alone, respectively. Enrolment was prematurely terminated by the Independent Data Monitoring Committee since an apparent imbalance in patient baseline characteristics (favoring the M/P only arm) made it unlikely that the study could achieve its primary efficacy end-point. Median PFS was 97 days with siltuximab combination and 228 days with M/P alone (hazard ratio, 1.72; P=0.043). Use of a novel non-validated PFS definition may have contributed to this result. Abnormal laboratory assessments were more frequent with the combination. Infection and febrile neutropenia rates were similar between groups. Greater C-reactive protein suppression was achieved during siltuximab combination treatment compared with M/P alone (P=0.0003). CONCLUSION: While siltuximab plus M/P appeared well tolerated, improvement in outcomes was not demonstrated.

Motor vehicle crashes and positive toxicology screens in adolescents and young adults.

The purpose of this study was to identify and describe the outcome of motor vehicle crashes for adolescents and young adults with positive toxicology screens. A retrospective design was used to collect data for 134 subjects ranging in age from 15 to 25 at an urban Level II trauma center. Outcomes related to sex, age, injury-severity score, length of stay, and hospital cost were analyzed using multiple regression, and the relationship was significant (p < .0001). Spearman's correlation analysis resulted in a significant relationship between survival outcome, injury severity, discharge, and hospital cost (p < .05).

Gender and racial differences in mathematical performance.

The authors examined gender and racial differences in mathematics performance among 5th- and 8th-grade students in the United States. Math performance was assessed by scores on the math-concepts and math-computation sections of the California Achievement Test (CTB/McGraw-Hill, 1986) given at the end of the previous year. There were no significant gender differences, but in both grades, the White students scored significantly higher than the Black students. The racial differences were more pronounced in the scores for concepts than in the scores for computation. Responses to a parent questionnaire showed significant relationships between parents' self-reported math anxiety, parents' most advanced math course, and parents' education level in relation to the child's math performance. Differences in these relationships suggest that, although parents' beliefs and attitudes about math influence their child's math performance, the relationship is complex and may vary with race.