Comparing the clinical trial efficacy versus real-world effectiveness of treatments for multiple myeloma: a population-based study.

Not available.

Developing Organizational Requirements to Standardize Delivery and Improve Quality of Acute Leukemia Care in Ontario.

Acute leukemia is a rapidly progressive cancer of the blood and bone marrow that requires a high degree of complex, specialized, resource-intensive clinical and supportive care. The aging Canadian population has introduced an unprecedented demand on the health care system for a variety of illnesses, including acute leukemia. The purpose of this work was to develop organizational requirements for service providers delivering care for patients aged 18 years and older with acute leukemia within a single-payer health care system in Ontario. This initiative was intended to support streamlining high-quality health care across Ontario. We worked collaboratively with an expert panel to conduct a review of the literature to synthesize the organizational requirements for delivering acute leukemia care. A total of 229 requirements were developed. The requirements were categorized into themes including (1) facility requirements, including infrastructure, data management, safety, policies and procedures; (2) availability of clinical services and service complexity; (3) personnel, including roles, responsibilities, and ongoing education; (4) patient care; (5) quality management; (6) clinical research; and (7) laboratory services. These requirements will act as a framework for the provision of service, complexity of care, safety, accessibility, and quality care across all levels from the patient, organization, and system perspectives. This framework will help support person-centred care, emphasizing providing care close to home, while optimizing the use of specialized resources. Moving forward, Ontario Health (Cancer Care Ontario) will continue to work with acute leukemia service providers in the province to determine compliance and focus improvement efforts in priority areas.

A structured oral chemotherapy teaching tool to improve adherence in adults with multiple myeloma: A pilot randomized controlled trial.

INTRODUCTION: Many of the newer treatments for adults with newly-diagnosed and relapsed multiple myeloma (MM) are orally administered. Adherence is a challenge, and little is known about strategies to optimize adherence. MATERIALS AND METHODS: Forty-seven patients initiating orally-administered anti-myeloma therapy were enrolled and randomized in a pilot study to receive either standard of care teaching or the Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool (MOATT), a structured teaching tool. Adherence was measured electronically with a Medication Event Monitoring System (MEMS) cap. Optimal adherence was defined as an adherence rate of ≥90% over the six months study duration. Patients completed surveys regarding cancer therapy satisfaction and self-efficacy for medication management at one month and six months following the initiation of treatment in both arms. RESULTS: The mean adherence of patients over six months was 86.9%; 43.9% of the cohort were classified as non-adherent using the 90% threshold of adherence. Mean adherence was similar among standard of care teaching (87.9%) versus the MOATT intervention tool (85.6%) as was cancer therapy satisfaction and self-efficacy for medication management. DISCUSSION: In our pilot, the MOATT tool was not found to be feasible or acceptable. There were no preliminary differences noted between standard of care teaching versus the structured MOATT teaching tool with regards to overall adherence rates, cancer therapy satisfaction, or self-efficacy in medication management. Overall adherence rates were suboptimal in our study. Future research should work to identify aspects of educational interventions which are effective, and investigate different strategies which can be used to supplement patient education and potentially optimize medication adherence in patients with MM.

The CDK inhibitor AT7519M in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma. A Phase II study of the Canadian Cancer Trials Group.

AT7519M is a small molecule inhibitor of cyclin-dependent kinases 1, 2, 4, 5, and 9 with in vitro activity against lymphoid malignancies. In two concurrent Phase II trials, we evaluated AT7519M in relapsed or refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) using the recommended Phase II dosing of 27 mg/m2 twice weekly for 2 of every 3 weeks. Primary objective was objective response rate (ORR). Nineteen patients were accrued (7 CLL, 12 MCL). Four CLL patients achieved stable disease (SD). Two MCL patients achieved partial response (PR), and 6 had SD. One additional MCL patient with SD subsequently achieved PR 9 months after completion of AT7519M. Tumor lysis syndrome was not reported. In conclusion, AT7519M was safely administered to patients with relapsed/refractory CLL and MCL. In CLL, some patients had tumor reductions, but the ORR was low. In MCL, activity was noted with ORR of 27%.

Are oral bisphosphonates effective in improving lumbar bone mineral density in breast cancer survivors with osteopenia or osteoporosis?

OBJECTIVE: Breast cancer survivors with osteoporosis or osteopenia are commonly encountered in primary care and gynaecology practices. Our objective was to determine whether treatment with oral bisphosphonates (alendronate or cyclic etidronate) was more effective than calcium with vitamin D in improving lumbar spine bone mineral density (BMD) within one year in breast cancer survivors. METHODS: Breast cancer survivors with at least one year of clinical follow-up were identified from the prospective observational Canadian Database of Osteoporosis and Osteopenia (CANDOO). Analysis of covariance was used to examine the effects of bisphosphonate therapy on change in lumbar spine BMD at one year compared with the effects of calcium with vitamin D (analysis adjusted for baseline L2-L4 BMD, current tamoxifen use, number of prevalent vertebral fractures [VFs], and time since diagnosis of breast cancer, and age). RESULTS: Eighteen patients took calcium and vitamin D, 25 took cyclic etidronate, and 27 took oral alendronate. Adjusted one-year BMD increases for alendronate and cyclic etidronate compared to calcium and vitamin D were as follows: alendronate 4.53% (95% confidence interval [CI] 1.26%, 7.81%, P = 0.008), and cyclic etidronate 1.85% (-1.55%, 5.25%, P = 0.280). BMD increases were significantly greater in patients with prevalent VF compared to those without VF (P = 0.025). In contrast, time since diagnosis of breast cancer was significantly associated with a decrease in BMD (P = 0.002). We were unable to detect any effect of current tamoxifen use, baseline lumbar spine BMD, or age on changes in BMD at one year. CONCLUSION: Treatment with alendronate was associated with significantly greater improvements in lumbar spine BMD within one year in breast cancer survivors when compared with treatment with cyclic etidronate or calcium and vitamin D.

An evaluation of age-related differences in quality of life preferences in patients with non-Hodgkin's lymphoma.

Health related quality of life is an important outcome measure. With aging, patients may experience changes in physical, socioeconomic and psychological functioning. This pilot study examined whether age influences the level of importance that patients with non-Hodgkin's lymphoma assign to questions addressing aspects of traditional quality of life domains. A questionnaire assessing six domains (physical, appearance, toxicity, social, financial, psychological) with 29 items was given to 76 outpatients with non-Hodgkin's lymphoma. Each question asked how important the content of the item was to the individual. Mean item scores were compared between patients aged < 65 and > 65 years. Reliability ranged from 0.57 (social domain) to 0.83 (physical domain). Test-retest reliability for the entire questionnaire was 0.63. Although there was a suggestion that older patients scored the items relating to faith, appearance to others, intimacy and toxicity trade-offs differently than younger patients, when accounting for multiple comparisons in this study, no apparent differences were seen in any of the items between age groups. It appears that in this group of patients with lymphoma, age does not obviously influence the preferences of patients for items contained in quality of life assessment.