Cost-effectiveness analysis of a randomized study comparing radiosurgery with radiosurgery and whole brain radiation therapy in patients with 1 to 3 brain metastases.

BACKGROUND: In this study, we compare 2 treatment options and determine cost-effectiveness and cost-utility. METHODS: We carried out a decision analysis populated with data from patients with brain metastasis in a concurrent trial randomized to either stereotactic radiosurgery (SRS) and observation or SRS and whole brain radiation therapy. Outcomes included actual life years saved (LYS), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). Costs used were from the healthcare perspective and utilities were captured through a time-trade-off method, using 10-year, 5-year, and 1-year time horizons. One-way sensitivity analyses were carried out to determine robustness of the decision analysis model. RESULTS: Compared with SRS and whole brain radiation therapy, SRS and observation not only had a higher average cost ($74,000 vs $119,000, respectively) but also a higher average effectiveness (0.60 LYS vs 1.64 LYS, respectively) with an ICER of $44,231/LYS or $41,783/QALY (with utilities captured using a 10-year horizon). Slightly higher ICER estimates were achieved with utilities captured using the other time horizons ($43,280/QALY and $44,064/QALY, respectively). Sensitivity analysis showed that the following variables had the highest impact on the ICER: probability of no recurrence in recursive-partitioning analysis class 2 after SRS and observation; probability of being alive after SRS and observation in recursive-partitioning analysis class 2 and being treated for recurrence. CONCLUSIONS: Compared with other interventions in the $50,000 to $100,000/QALY cost-effectiveness range, the application of SRS and observation, with subsequent neurosurgical management of recurrences, is shown to be a reasonable treatment modality for brain metastases.

Evaluation of medication compliance in patients on antidepressants at an outpatient tertiary cancer center setting.

OBJECTIVE: The purpose is to evaluate antidepressant compliance in a cancer population at a tertiary cancer center and to determine if there are covariates of importance in predicting the level of compliance in the study population. METHODS: Patients who received at least three prescriptions covering parts of each month for a continuous 6-month period with at least one of the months being in 2006 from a tertiary cancer center were identified as the prevalent population of interest for this retrospective study. Data collected included demographics, cancer and co-morbid diagnoses, and compliance to antidepressant medication using medication possession ratio (MPR) by patient, medication class, and individual agents. Analysis was conducted using descriptive statistics, analysis of variance, and logistic regression (using MPR ≥ 80 as cutoff). RESULTS: The study population included 297 patients with demographics showing 69% female, 71% Caucasian, a mean age of 52.94 (SD: 12.42), and an average 403 days of follow-up. The MPR for the total study population was 0.87 with 78% of the population having an MPR of ≥ 80% and 22% having an MPR of less than 80%. While there was no significant difference in MPR by different pharmaceutical classes, there were significant differences in the MPR by specific agents (p = 0.02), with nortriptyline having the lowest MPR of 0.79 and doxepin, fluoxetine, mirtazapine, and venlafaxine all having MPR over 0.90. There was also a trend toward a difference in MPR between Caucasians versus non-Caucasians, p = 0.055. CONCLUSION: There appears to be relatively good compliance to antidepressant medications in the study population.

Disparities in outpatient antidepressant prescribing patterns and determinants of resource utilization at a tertiary care cancer center.

Our objective was to assess the prevalence of use of different classes of antidepressants, prescribing patterns, and determinants of exposure to specific types of antidepressants and resource utilization at a comprehensive cancer center from 2001 to 2006. Data were collected from the institution's outpatient pharmacy database and cross-referenced with the institution's electronic medical record system. Data collected included demographic characteristics, cancer diagnosis, comorbidities, prescribing physician and service, type and number of antidepressant prescriptions, and resource utilization. Significant differences in the usage and prescribing patterns of the type of antidepressants were found in the analysis by gender and ethnicity, with women seeing a psychiatrist more often than men (P = 0.001) and Caucasians receiving more selective serotonin reuptake inhibitors (SSRIs) than other ethnic groups (P = 0.002). In terms of resource utilization, men had significantly more hospital admissions (P < 0.0001) and emergency room visits (P = 0.004) than women, whereas non-Caucasian ethnic groups had more emergency room visits (P < 0.0001) and clinic visits (P = 0.001) than Caucasians. Further investigation of men and non-Caucasians in the screening, evaluation, and treatment of depression is necessary to confirm disparities and evaluate their possible causes.

Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates.

INTRODUCTION: Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. The incidence and risk factors associated with this disorder have not been clearly defined. MATERIALS AND METHODS: We conducted a retrospective analysis of 4019 patients treated with intravenous bisphosphonates between 1996 and 2004. Our goals were to estimate the frequency, understand the clinical presentation, and identify risk factors associated with ONJ development. RESULTS: Sixteen of 1338 patients with breast cancer (1.2%) and 13 of 548 patients with multiple myeloma (2.4%) developed ONJ. The median dose and duration of treatment with pamidronate or zoledronic acid were significantly higher in patients with ONJ (p < 0.0001). Multivariate Cox proportional hazards regression analysis identified treatment with zoledronic acid (hazards ratio [HR], 15.01; 95% CI: 2.41-93.48; p = 0.0037), treatment with pamidronate followed by zoledronic acid (HR, 4.00; 95% CI: 0.86-18.70; p = 0.078), and dental extractions (HR, 53.19; 95% CI: 18.20-155.46; p < 0.0001) as significant risks for ONJ in breast cancer. In multiple myeloma, dental extractions (HR, 9.78; 95% CI: 3.07-31.14; p = 0.0001) and osteoporosis (HR, 6.11; 95% CI: 1.56-23.98; p = 0.0095) were significant risk factors while controlling for bisphosphonate therapy. Thirteen of 29 patients were followed for a median of 17.1 mo (range, 7-67 mo); lesions healed in 3 patients during this period. CONCLUSIONS: ONJ is an uncommon but long-lasting disorder that occurs mainly in breast cancer and multiple myeloma patients treated with intravenous bisphosphonates. High cumulative doses of bisphosphonates, poor oral health, and dental extractions may be significant risk factors for ONJ development. ONJ resolved in 23% of patients with conservative therapy.

Outcomes of patients with prostate cancer receiving zoledronic acid or pamidronate for prevention of skeletal-related events.

STUDY OBJECTIVE: To determine the relative effectiveness of two bisphosphonates--pamidronate and zoledronic acid--for preventing skeletal-related events (SREs) in patients with prostate cancer metastatic to bone. DESIGN: Retrospective cohort study. SETTING: Large, tertiary care cancer center. PATIENTS: One hundred thirty-seven patients with a diagnosis of prostate cancer who received either pamidronate or zoledronic acid between January 1, 1998, and December 31, 2004, were identified in the electronic medical records; 24 of these patients met all prespecified eligibility criteria, and 105 patients met relaxed eligibility criteria. MEASUREMENTS AND MAIN RESULTS: Using a binary logistic regression model, we explored the effect of the bisphosphonate received on development of an SRE. Whether the patient was receiving chemotherapy as of the date of first receipt of a study drug, the number of bisphosphonate doses received, time since the diagnosis of prostate cancer, and the number of previous SREs were included as covariates. The odds ratio for developing an SRE after receiving zoledronic acid was 0.80 (95% confidence interval 0.08-7.50) compared with the reference group that received pamidronate. This difference did not reach statistical significance (p=0.84). Because of the limited number of patients who met all prespecified eligibility criteria, various post hoc analyses were performed in the 105 patients with use of relaxed eligibility criteria. None provided definitive evidence of the superiority of one agent versus the other. CONCLUSION: No definitive evidence of a difference in the efficacy for preventing the development of an SRE was found between pamidronate and zoledronic acid, although a smaller-than-expected sample size impairs the interpretability of this finding. In the absence of additional research, it seems reasonable to assume that no clinically important difference exists between the two agents.

Pharmacoeconomics in oncology.

Healthcare costs in the USA continue to rise faster than the consumer price index. Nothing demonstrates this more vividly than the double-digit increases posted for the cost of the drug treatment of the oncology patient. A factor that will compound this cost is the expansion in the oncology patient population that will occur as the population ages. Pharmacoeconomics is a discipline that evaluates the relationship between clinical, economic and humanistic outcomes to determine the products and services that maximize the value for each dollar spent. Research in this area is evolving to meet the needs of the individual patient and decision-makers within a payer group, healthcare system, or society. Healthcare interests in countries in Europe, Canada and Australia have already adopted analytical tools and incorporated them into guidelines for drug use. The USA is also moving in this direction now that the Food and Drug Administration is considering requiring studies in pharmacoeconomics in addition to the standard studies of the safety and efficacy of drugs. The importance of this approach to oncology will be seen as policy-makers apply research findings to practice decisions.