Aromatase inhibitor therapy: toxicities and management strategies in the treatment of postmenopausal women with hormone-sensitive early breast cancer.

Aromatase inhibitors (AIs) have been shown to reduce the risk of breast cancer recurrence and are widely used today as adjuvant therapy in women with early stage endocrine-responsive breast cancer. Aromatase inhibitors may be prescribed as initial hormonal therapy, sequentially following 2-3 years of tamoxifen, or as extended adjuvant therapy (following 5 years of tamoxifen). Aromatase inhibitors are generally well tolerated; however, certain side effects, particularly arthralgia/musculoskeletal symptoms and gynecologic effects, may result in poor adherence to treatment. Patients receiving adjuvant therapy with an AI should be counseled regarding possible side effects and the importance of completing treatment. Interventions to ameliorate side effects should be individualized based on symptoms, comorbid conditions, and pre-existing therapies. In addition, bone and cardiovascular health should be monitored during AI therapy. Prompt therapeutic management of common side effects associated with AIs may provide patients with the opportunity to receive the full benefit of their adjuvant hormonal treatment while minimizing toxicity.

Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member Companies.

OBJECTIVE: The Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey was conducted to evaluate the use of technology and websites associated with the medical information (MI) departments of 27 biopharmaceutical companies in the United States. METHODS: The e-survey was administered to phactMI™ members between December 2017 and February 2018 and included closed and open-ended questions with 7 distinct categories: existence of a MI website, content type available following a search query, website functions, search engine optimization (SEO), website traffic, internal communications/analytics, and additional technology capabilities. RESULTS: Survey findings noted that 20 companies own a MI-specific website through which MI services are provided to healthcare providers (HCPs). When asked about the dissemination of MI content through varying formats, survey results indicated Portable Document Format (PDF) to be the most common (18/27), followed by videos (8/27), presentations (5/27), infographics (3/27), and Hypertext Markup Language (3/27). Many companies have a responsive design website (19/25), webform (24/25), and a 1-800 number (22/25) for MI services. Few companies have a live chat (10/25) or a chatbot (1/25) and 9 of 25 said that content is searchable on Google™. Although website traffic varied among companies, a significant driver of this appeared to be whether the site is indexed. CONCLUSION: While most of the member companies have a MI website, there is significant room for improvement in content formats available as part of a search. Traditional website features, such as search functionality and webform, are commonly available on websites; however, newer technologies, such as chatbot and live chat, are less featured. Across most member companies, there is also a need for improvement in increasing website traffic, Google™ indexing, and SEO.

A Canadian multi-centre, open-label long-term study of Pegvisomant treatment in refractory acromegaly.

PURPOSE: Acromegaly is a rarely diagnosed condition with potentially serious complications including accelerated heart disease and reduced survival. After a mean interval of nearly 9 years from onset of disease, a significant proportion of patients are diagnosed with invasive adenomas precluding complete surgical resection. Furthermore, strict normalization of the growth hormone (GH) target insulin-like growth factor I (IGF-I) cannot always be achieved by adjunctive medical therapy with somatostatin analogues. Here we report the results of a Canadian multi-centre study open-label, dose-titrated long-term study examining safety and efficacy outcomes of a growth hormone receptor antagonist, pegvisomant in 19 patients with refractory acromegaly. METHODS: Previously pegvisomant-treated and treatment-naïve refractory acromegalic patients at least 18 yr of age were eligible (n=19). Patients received open-label daily subcutaneous injections of pegvisomant adjusted according to IGF-I levels. Safety and IGF-I levels were assessed every 4 to 6 wk. Baseline and follow-up visits at 3-month intervals also included administration of the Signs and Symptoms of Acromegaly Questionnaire. This study is registered with ClinicalTrials.gov, NCT00151437. RESULTS: We show that, in escalating doses, pegvisomant results in age-adjusted normalization of IGF-I in nearly all such patients. This IGF-I normalization occurred early on and was maintained throughout the study period of 27 months (IGF-I standard deviation score (SDS), mean +/- SE: 1.66 +/- 0.36, P=0.0003 vs baseline), with a nadir at 18 months (IGF-I SDS, mean +/- SE: 1.50 +/- 0.38, P=0.0010 vs baseline). IGF-I control was also accompanied by measurable improvements in disease-associated symptoms and without radiographic evidence of pituitary tumour progression. Overall, the safety profile of pegvisomant therapy in this patient population was found to be satisfactory and suitable for a long-term treatment. CONCLUSION: Our findings provide support for the long-term safety and efficacy of the GH receptor antagonist pegvisomant in achieving IGF-I control in patients with refractory acromegaly.

US Medical Information Websites Benchmarking: How Is the Industry Fairing in Usability?

OBJECTIVES: This study of 23 US-based biopharmaceutical medical information (MI) websites was conducted to assess usability and identify best practices and areas of potential improvement. METHODS: In this systematic review, websites were evaluated from June 22-November 1, 2016, and awarded points based on content, functionality, and navigation (maximum score of 42). Low-, mid-, and high-range usability scores were ≤13, 14-27, ≥28, respectively. RESULTS: Mean scores were 7 of 17, 4 of 10, and only 5 of 15 criteria for content, functionality, and navigation. The mean usability score across all websites was 15 of 42 criteria. Larger companies generally had a higher mean usability score. A minor trend was also observed with regard to usability score and industry size (r2 = 0.3). Only 2 websites scored high, whereas 13 scored in the mid- and 8 in the lower range of usability. Overall, websites scored low when pertaining to presence of novel content type, search engine optimization, presence of social media, and MI services offered. Overall site architecture, presence of self-certification, and mobile compatibility scored fairly well across the industry. CONCLUSION: The majority of websites scored in the low to midrange, which suggests an industry-wide opportunity for improvement. In order to meet the evolving needs of health care professionals, MI websites need to be optimized for content, navigation, and functionality. Ensuring MI websites are discoverable through search engines and improving the level of MI services offered was also deemed to be important features to incorporate into a given MI website optimization strategy.

Canadian anaplastic lymphoma kinase study: a model for multicenter standardization and optimization of ALK testing in lung cancer.

INTRODUCTION: Fluorescence in situ hybridization (FISH) is currently the standard for diagnosing anaplastic lymphoma kinase (ALK)-rearranged (ALK+) lung cancers for ALK inhibitor therapies. ALK immunohistochemistry (IHC) may serve as a screening and alternative diagnostic method. The Canadian ALK (CALK) study was initiated to implement a multicenter optimization and standardization of laboratory developed ALK IHC and FISH tests across 14 hospitals. METHODS: Twenty-eight lung adenocarcinomas with known ALK status were used as blinded study samples. Thirteen laboratories performed IHC using locally developed staining protocols for 5A4, ALK1, or D5F3 antibodies; results were assessed by H-score. Twelve centers conducted FISH using protocols based on Vysis' ALK break-apart FISH kit. Initial IHC results were used to optimize local IHC protocols, followed by a repeat IHC study to assess the results of standardization. Three laboratories conducted a prospective parallel IHC and FISH analysis on 411 consecutive clinical samples using post-validation optimized assays. RESULTS: Among study samples, FISH demonstrated 22 consensus ALK+ and six ALK wild type tumors. Preoptimization IHC scores from 12 centers with 5A4 and the percent abnormal cells by FISH from 12 centers showed intraclass correlation coefficients of 0.83 and 0.68, respectively. IHC optimization improved the intraclass correlation coefficients to 0.94. Factors affecting FISH scoring and outliers were identified. Post-optimization concurrent IHC/FISH testing in 373 informative cases revealed 100% sensitivity and specificity for IHC versus FISH. CONCLUSIONS: Multicenter standardization study may accelerate the implementation of ALK testing protocols across a country/region. Our data support the use of an appropriately validated IHC assay to screen for ALK+ lung cancers.

Referral source, symptoms, and severity at diagnosis of ocular hypertension or open-angle glaucoma in various practices.

OBJECTIVE: To evaluate the severity of glaucoma at presentation and the relationship to referral source and presenting symptoms. DESIGN: Prospective, multicentre, cross-sectional, study. PARTICIPANTS: Patients newly diagnosed with ocular hypertension (OH) or open-angle glaucoma (OAG). METHODS: Eligible subjects underwent comprehensive ocular examinations, including medical histories and presenting symptoms. The referral source was also documented. Patients were classified as OH or mild, moderate, or advanced OAG. The proportion of subjects in each disease category was determined and compared for differences in demographics, ocular findings, referral sources, and presenting symptoms. RESULTS: We enrolled 404 subjects; 113 (28%) were diagnosed as having OH and 291 (72%) as having OAG. In the OAG group 151 (52%) had mild, 79 (27%) moderate, and 61 (21%) advanced disease at initial diagnosis. The majority of the referrals were from optometrists (82%), followed by family physicians (7%) and ophthalmologists (7%). Referral patterns and presenting symptoms were significantly different for advanced disease as compared to the other severity levels (p = 0.03 and p 0 .003, respectively). In more than half of the patients, the referral was made because of an abnormality noted by the referring source in an asymptomatic subject. Visual symptoms noted by the subject were more common in advanced OAG (23%) as compared to OH (9%), mild (4%), and moderate (9%) OAG. CONCLUSIONS: Nearly half of the patients with OAG had moderate or advanced disease at the time of initial diagnosis. Although optometrists were responsible for the majority of the referrals, the proportion was significantly less for advanced disease. These results raise the possibility of suboptimal detection services for glaucoma.

Comparison of newly diagnosed ocular hypertension and open-angle glaucoma: ocular variables, risk factors, and disease severity.

Purpose. To describe the distribution of ocular variables, risk factors, and disease severity in newly diagnosed ocular hypertension (OH) or open-angle glaucoma (OAG). Methods. Eligible subjects underwent a complete history and examination. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) obtained from multiple logistic regression models were used to compare OAG to OH and advanced to early/moderate OAG. Results. 405 subjects were enrolled: 292 (72.1%) with OAG and 113 (27.9%) with OH. 51.7% had early, 27.1% moderate, and 20.9% advanced OAG. The OR for OAG versus OH was 8.19 (P < 0.0001) for disc notch, 5.36 (P < 0.0001) for abnormal visual field, 1.45 (P = 0.001) for worsening mean deviation, 1.91 (P < 0.0001) for increased cupping, 1.03 for increased age (P = 0.030), and 0.36 (P = 0.010) for smoking. Conclusions. Increased age was a risk for OAG, and smoking decreased the risk of OAG compared to OH. Almost half of the OAG subjects had moderate/advanced disease at diagnosis.