Tumor thickness should be considered in the management planning of patients with early oral tongue carcinoma.

Human papillomavirus (HPV) infection strongly correlates with the development of anal intraepithelial neoplasias and carcinomas; however, few studies have characterized the distribution of the specific subtypes of the virus in the varying grades of dysplasia. This report characterizes the distribution of HPV 16/18 in surgical specimens with anal intraepithelial neoplasia (AIN) I-III and histological variants of anal carcinoma. A total of 111 anal surgical specimens with no dysplasia (10), AIN I-III (53), and anal carcinomas (48) were evaluated for the presence of high-risk HPV infection and subtyped by nested PCR or the Invader Assay. High-risk virus types were detected in progressively greater number of anal intraepithelial lesions from 56% in low grade to 88% in high grade. Type 16 was the prevalent subtype and was noted in 28% of low grade and 68% of high-grade lesions. Moderate dysplasias showed type 16 in 20%, a prevalence similar to that in low-grade lesions. The non-16/18 subtypes of the virus predominated and were present in 50% of the cases. Most (89%) squamous carcinomas were associated with high-risk viruses, 68% with type 16, a prevalence similar to that noted in highgrade dysplasia. Non-16/18 subtypes were encountered more frequently in squamous carcinomas from immunodeficient individuals (57% cases) as compared with immunocompetent individuals (18% cases). The similarity in the prevalence of type 16 in high-grade dysplasia and squamous carcinomas suggests that anal intraepithelial lesion III is the true precursor of squamous carcinoma and warrants aggressive management. Anal intraepithelial lesions II showed a virus distribution that was similar to low-grade dysplasia. In addition, a subset of these that were associated with type 16 or 18 showed progression, whereas those associated with non-16/18 subtypes regressed, thereby raising the possibility of conservative management for these lesions.

The current development paradigm for biosimilars required by regulators in highly regulated jurisdictions is derived from the development of novel drugs and is unnecessarily burdensome and inefficient. It requires the accumulation of data from analytical, nonclinical (including in vivo studies in some jurisdictions), and clinical studies (including powered efficacy studies in most cases); this paradigm is known as ‘totality of evidence’ (ToE) and does not admit a conclusion of biosimilarity from analytical data alone. The record of biosimilar approvals in these jurisdictions shows that no biosimilar candidate that has been found highly similar to its reference in analytical and pharmacokinetic studies has failed to be approved. We propose a new paradigm (‘confirmation of sufficient likeness’, CSL) that emphasizes the demonstration of analytical resemblance between the biosimilar candidate and its reference, and permits the conclusion of biosimilarity upon this basis. CSL does not entail bridging studies between reference products, in vivo nonclinical studies, or powered efficacy studies and is, therefore, substantially more efficient than ToE while maintaining equivalent scientific rigor. Such efficiency will contribute to the attractiveness as well as the sustainability of biosimilars as a therapeutic modality.

Primary lymphomas of the breast are rare and predominately of B-cell phenotype. Anaplastic large cell lymphoma is a T-cell lymphoma that accounts for only 3% of all non-Hodgkin lymphomas. We present a rare case of primary anaplastic large cell lymphoma of the breast in association with a silicone breast implant capsule in a healthy 40-year-old woman. The patient had bilateral breast implants placed at 21 years of age and presented with painful bilateral breast contractures and associated breast asymmetry. Histology, immunohistochemistry, and T-cell gene rearrangement studies were supportive of a CD 30-positive ALK-1 negative anaplastic large cell lymphoma. This case represents the 14th reported case of primary breast lymphoma in association with breast prosthesis. Of interest is that 11 of these cases were T-cell lymphomas with 8 specifically of the CD30-positive anaplastic large cell lymphoma type. This rare case highlights the importance of histologic examination of breast capsule specimens.

Background: The objectives were to evaluate the effectiveness of an infection control bundle in controlling the meticillin resistant Staphylococcus aureus (MRSA) transmission in residential care homes for the elderly (RCHEs) in Hong Kong. Methods:This was a two-arm cluster randomised controlled trial. Infection control bundles focused on hand hygiene (HH), environmental hygiene, and modified contact precautions were applied to the intervention arm. Nasal swabs from residents; staff HH compliance and effectiveness; and environmental hygiene were assessed by microbiological sampling or observation at the baseline and quarterly after the intervention.Results: A total of 2776 residents from 36 RCHEs were recruited. The overall MRSA prevalence was 20.4% (95% confidence interval, 18.9%-21.9%). The intervention elicited an immediate effect of 2.4% absolute decrease in the prevalence and 3.7% in the intra-facility transmission, though the difference between the two arms was insignificant. Staff HH compliance increased substantially from 5.9% to 45.6% post-intervention (p < 0.001). Conclusions:We initiated the infection control culture into the RCHEs and gained their acceptance. However, this behavioural change takes time to emerge. Our study shows that relying on the bundle alone could not bring sustainable MRSA reduction. Administrative control for strengthening infection control infrastructure is important for continuous compliance and improvement.