Positive spillover effects of prescribing requirements: increased cardiac testing in patients treated with trastuzumab for HER2+ metastatic breast cancer.

BACKGROUND: Cardiotoxicity is a concern in patients on trastuzumab therapy, and cardiac function assessment is a recommended practice. In 2006, trastuzumab was publically subsidised for human epidermal growth factor receptor-2 early stage breast cancer with a requirement for cardiac testing prior to and during treatment. AIM: To investigate the spillover effects of this requirement on testing rates in metastatic patients treated with trastuzumab where no monitoring requirements are applied. METHODS: We examined cardiac testing (echocardiography or multiple-gated acquisition scan) in 3779 women with metastatic breast cancer receiving trastuzumab between December 2001 and February 2010 and used interrupted time-series analyses to estimate changes in testing rates. The main outcome measures were the proportion of eligible patients, by quarter, receiving a cardiac function test pretreatment and during trastuzumab therapy. RESULTS: Only 21% of women had a cardiac function test pretreatment, and 47% were tested at some point during the first year of trastuzumab therapy. The introduction of mandatory cardiac testing for early breast cancer was associated with an immediate 8% increase (95% confidence interval, 2-14%) in pretreatment cardiac testing and an immediate 7% increase (95% confidence interval, 4-10%) in testing during therapy in metastatic patients. Testing rates during therapy increased steadily from early 2005, coinciding with the release of interim results from several trastuzumab trials reporting cardiac-safety outcomes. CONCLUSION: The introduction of mandatory cardiac testing for early stage disease spilled over to the metastatic setting. While deviation from guidelines may be warranted in some cases, this study suggests underutilisation of cardiac testing among patients treated with trastuzumab in the metastatic setting.

The quality of web-based oncology guidelines and protocols: how do international sites stack up?

BACKGROUND: The Internet is a popular medium for disseminating information relevant to oncology practitioners. Despite the widespread use of web-based guidelines and protocols, the quality of these resources has not been evaluated. This study addresses this gap. METHODS: The Appraisal of Guidelines for Research and Evaluation (AGREE-II) instrument was used to assess the quality of breast and sarcoma guidelines and protocols according to six independent domains. The oncology resources were selected from eight websites developed for healthcare settings in North America, the United Kingdom, Europe, and Australia. RESULTS: Mean quality scores across domains were highly variable for both guidelines (29-73%) and protocols (31-71%). Guidelines scored highly in terms of articulating their Scope and Purpose (72.6 ± 11.2%) but poorly with respect to Applicability in clinical practice (29.0 ± 17.3%). Protocols scored highly on Clarity of Presentation (70.6 ± 17.6%) but poorly in terms of the processes used to synthesise underlying evidence, develop, and update recommendations (30.8 ± 20.0%). CONCLUSION: Our evaluation provides a quick reference tool for clinicians about the strengths and limitations of oncology resources across several major websites. Further, it supports resource developers in terms of where to direct efforts to enhance guideline and protocol development processes or the communication of these processes to end-users.

The efficacy of HER2-targeted agents in metastatic breast cancer: a meta-analysis.

BACKGROUND: The addition of HER2-targeted agents to standard treatment has been shown to improve outcomes for HER2 positive metastatic breast cancer patients. We undertook a meta-analysis to evaluate the efficacy of HER2-targeted therapy in addition to standard treatment in metastatic breast cancer patients. PATIENTS AND METHODS: Eligible trials were randomised controlled trials (RCTs) comparing the addition of HER2 therapy to standard treatment (hormone or chemotherapy) reporting overall survival (OS), time to progression (TTP), progression-free survival (PFS) and/or response rates. RESULTS: Eight trials comprising 1848 patients were eligible for inclusion. HER2-targeted agents were trastuzumab and lapatinib and therapeutic partners were taxanes (4 RCTs), anthracyclines (1), capecitabine (2), anastrozole (1) and letrozole (1). The addition of HER2-targeted agents improved OS [hazard ratios (HR) 0.78; 95% confidence interval (CI) 0.67-0.91], TTP (HR 0.56; 95% CI 0.48-0.64), PFS (HR 0.63; 95% CI 0.53-0.74) and overall response rate (relative risk 1.67; 95% CI 1.46-1.90). CONCLUSIONS: Our meta-analysis confirms the benefit of adding HER2-targeted therapy to standard treatment in HER2 positive metastatic breast cancer. Compared with OS, TTP, PFS and ORR overestimate treatment benefit. Trials in our meta-analysis differed in terms of partner drug or HER2 agents, yet delivered comparable outcomes.

Drug information for consumers: should it be disease or medication specific? Results of a community survey.

OBJECTIVE: To investigate the information-seeking behaviour of medicine users. METHODS: A telephone survey and follow-up in-depth interviews of a random sample of the adult population in the Hunter Region, NSW, Australia. The survey sought information on medicine use, information seeking, and satisfaction and understanding of the information received. In-depth interviews examined the barriers and facilitators of information seeking. RESULTS: Seven hundred and eighty-six people completed the telephone survey and 58 completed the follow-up interviews. Over half (51%) of the medicine users sought information, primarily to 'manage' their medicines, such as how to use the medicine. Over 30% of the questions asked by users related to 'therapeutic choices', such as how well the medicine worked for a particular condition. Doctors and pharmacists were the most frequent sources of information. A small proportion (10%) reported a potential unmet need for medicines information by indicating they would have liked to ask a question, but did not, or were dissatisfied with the information they received. Barriers to information seeking included perceptions that health care professionals were 'too busy', and that they were unwilling to provide information. CONCLUSIONS: Physicians and pharmacists continue to play an important role in providing consumers with medicines information. Although the reported level of unmet need was low, a significant proportion identified needs relating to information on therapeutic choice, rather than 'classical' drug information. IMPLICATIONS: Medicines-related information for the public should include advice on comparative performance of drugs, and be provided within the wider framework of general health information.

Safety issues in herbal medicine: implications for the health professions.

The use of herbal medicines in Australia is widespread. A number of factors make assessment of adverse effects associated with these products more complex than for pharmaceuticals. Problems have resulted from contamination with heavy metals and adulteration with prescription drugs in overseas herbal products. A classification is proposed for adverse effects associated with herbal medicines, and medical practitioners are encouraged to include use of these preparations in a patient's drug history and in reports of suspected adverse drug reactions. It may be necessary to develop a separate database to promote adverse drug reaction reporting for herbal medicine and the wider field of complementary and alternative medicine.