Statistical considerations for confirmatory clinical trials for similar biotherapeutic products.

For the purpose of comparing the efficacy and safety of a Similar Biotherapeutic Product (SBP) to a Reference Biotherapeutic Product (RBP), the "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)" issued by the World Health Organisation (WHO), states that equivalence or non-inferiority studies may be acceptable. While in principle, equivalence trials are preferred, non-inferiority trials may be considered if appropriately justified, such as for a medicinal product with a wide safety margin. However, the statistical issues involved in the design, conduct, analysis and interpretation of equivalence and non-inferiority trials are complex and subtle, and require that all aspects of these trials be given careful consideration.

Psoriasin (S100A7) expression is associated with poor outcome in estrogen receptor-negative invasive breast cancer.

Purpose: Psoriasin (S100A7) is highly expressed in preinvasive ductal carcinoma in situ of the breast and persistent expression occurs in some invasive carcinomas. This study explores the clinical significance of psoriasin in relation to patient survival in invasive breast cancer.

Experimental Design: We examined psoriasin expression by immunohistochemistry in a cohort of 122 estrogen receptor-negative invasive ductal carcinomas.

Reduced expression of the small leucine-rich proteoglycans, lumican, and decorin is associated with poor outcome in node-negative invasive breast cancer.

Purpose: To examine the prognostic significance of lumican and decorin, two abundant small leucine-rich proteoglycans in breast tissue stroma.

Experimental Design: Lumican and decorin expression was examined in a cohort of 140 invasive breast carcinomas by Western blot analysis. All cases were axillary lymph node-negative and treated by adjuvant endocrine therapy.