Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.

Purpose: As prostate-specific membrane antigen (PSMA) positron emission tomography (PET) becomes increasingly available in the United States, the greater sensitivity of the technology in comparison to conventional imaging poses challenges for clinical trials. The NCI Clinical Imaging Steering Committee (CISC) PSMA PET Working Group was convened to coordinate the identification of these challenges in various clinical scenarios and to develop consensus recommendations on how best to integrate PSMA PET into ongoing and upcoming National Clinical Trials Network (NCTN) trials.

Methods: NCI CISC and NCI Genitourinary Steering Committee members and leadership nominated clinicians, biostatisticians, patient advocates, and other imaging experts for inclusion in the PSMA PET Working Group.

Current status of clinical trials in head and neck cancer 2014.

Introduction: The last few years have seen significant increase in the number of available clinical trials in head and neck cancer. It has been difficult to stay abreast of these efforts because multiple cooperative groups and institutions are engaged in their recruitment. This review presents the state of the art of available clinical trials organized around major research themes.

Total knee arthroplasty after high tibial osteotomy: a registry-based case-control study of 1,036 knees.

Introduction: Total knee arthroplasty (TKA) after high tibial osteotomy (HTO) is a technically demanding procedure, and concerns have been raised that previous HTO might compromise the outcome of TKA. The aims of the study were to assess the survivorship of TKA after HTO and to determine whether the survivorship is similar to that of primary TKA without previous HTO.

Materials And Methods: Using the Finnish Arthroplasty Register and the National Hospital Discharge Register, we extracted the data of 1,036 patients [mean age 64.

Assessing non-cancer-related health status of US cancer patients: other-cause survival and comorbidity prevalence.

With advances in prevention, screening, and treatment, cancer patients are living longer; hence, non-cancer-related health status will likely play a larger role in determining their life expectancy. In this study, we present a novel method for characterizing non-cancer--related health status of cancer patients using population-based cancer registry data. We assessed non-cancer-related health status in the context of survival from other causes of death and prevalence of comorbidities.

Mortality as an indicator of patient safety in orthopaedics: lessons from qualitative analysis of a database of medical errors.

Background: Orthopaedic surgery is a high-risk specialty in which errors will undoubtedly occur. Patient safety incidents can yield valuable information to generate solutions and prevent future cases of avoidable harm. The aim of this study was to understand the causative factors leading to all unnecessary deaths in orthopaedics and trauma surgery reported to the National Patient Safety Agency (NPSA) over a four-year period (2005-2009), using a qualitative approach.

Metal-on-metal bearings, inflammatory pseudotumours and their neurological manifestations.

Metal-on-metal bearings have become more popular for hip arthroplasty in younger patients in the last 15 years. We present a review of the neurological consequences relating to such bearing surfaces illustrated by an appropriate case report. The mechanisms of increased metal ion production and pseudotumour formation are discussed.

Free fibular graft reconstruction following resection of chondrosarcoma in the first metacarpal.

Chondrosarcoma is most frequently present in the pelvis and long bones and rarely seen in the bones of the hand. Traditionally the treatment of choice for involvment of the hand is ray amputation, however this causes significant functional deficit if there is thumb involvement. There are limited cases in literature of resection of thumb chondrosarcoma with restoration of function.

A severe case of multisystem sarcoidosis complicated by aspergillosis and aspergillomas.

The authors present an atypical case of multisystem sarcoidosis presenting at a late stage with severe lupus pernio sarcoidosis skin lesions and stage IV pulmonary sarcoidosis complicated by semi-invasive chronic necrotising aspergillosis and aspergillomas. Lepromatous leprosy, tuberculosis and active atypical mycobacterial infection had to be ruled out en route to reaching the final diagnoses. His case presented us with a management dilemma, specifically concerning treatment of his sarcoidosis with corticosteroid and other immunosuppressive agents, as these risked aggravating his active invasive fungal disease.

FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphoma.

On October 6, 2006, the U.S. Food and Drug Administration granted regular approval to vorinostat (Zolinza(R); Merck & Co.

Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphoma.

Purpose: To discuss vorinostat approval for treatment of cutaneous manifestations of advanced cutaneous T-cell lymphoma (CTCL).

Experimental Design: Data from 1 single-arm, open-label, multicenter pivotal trial and 11 other trials submitted to support the new drug application for vorinostat in the treatment of advanced primary CTCL were reviewed. The pivotal trial assessed responses by changes in overall skin disease score using a severity-weighted assessment tool (SWAT).

Blood neutrophil activation markers in severe asthma: lack of inhibition by prednisolone therapy.

Background: Neutrophils are increased in the airways and in induced sputum of severe asthma patients. We determined the expression of activation markers from circulating neutrophils in severe asthma, and their supressibility by corticosteroids.

Methods: We compared blood neutrophils from mild, moderate-to-severe and severe steroid-dependent asthma, and non-asthmatics (n = 10 each).

Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen.

Purpose: To present the basis of the decision of the Food and Drug Administration to grant accelerated approval for letrozole for extended adjuvant treatment of early-stage breast cancer in postmenopausal women after completion of adjuvant tamoxifen.

Experimental Design: The Food and Drug Administration reviewed the data from the MA17 trial, a single, multinational, randomized, double-blind, and placebo-controlled trial, submitted by the applicant to support the proposed new indication.

Results: MA17 consisted of a core study and Lipid and Bone Mineral Density safety substudies.