Distress: Characterizing What Causes the Thermometer to Shift in Patients with Newly Diagnosed Breast Cancer Attending a Multidisciplinary Clinic.

BACKGROUND: A diagnosis of breast cancer (BC) can result in multifactorial stress. If not addressed, distress can have a negative impact on outcomes. The experience of patients with newly diagnosed BC has not been sufficiently investigated. This study characterizes distress among new patients in a multidisciplinary care (MDC) clinic. The study aimed to determine the degree of distress at presentation, to characterize the sources, and to evaluate the impact of an MDC visit. METHODS: A retrospective review was performed from January 2015 to November 2017. Charts were accessed for demographics, tumor characteristics, and treatment data. Distress scores (DS) and problems as captured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer were completed before evaluation and in a subgroup after an MDC visit. Predictors of severe distress (DS ≥4) were investigated using multivariable logistic regression. The paired t test was used to determine the impact of an MDC visit. RESULTS: The mean initial DS (n = 474) was 4.98. The top four sources of distress were worry, anxiety, fears, and sadness. Age younger than 65 years was significantly associated with a higher DS at presentation (p < 0.003). Among the patients queried before and after MDC (n = 137), a significant reduction in distress was identified (5.58-2.94; p < 0.0005). CONCLUSIONS: Severe distress was found in 66 % of the patients with a recent diagnosis of BC, with younger age related to higher distress scores at presentation. Emotional stressors were the predominant factors accounting for distress. A same-day MDC visit was associated with a significant reduction in DS. These data indicate the importance and feasibility of proactively screening patients. Our research lends support to the value of multidisciplinary evaluation in this setting.

Risk and Economic Burden of Peristomal Skin Complications Following Ostomy Surgery.

PURPOSE: The purpose of this study was to examine the incidence and economic burden of peristomal skin complications (PSCs) following ostomy surgery. DESIGN: Retrospective cohort study based on electronic health records and administrative data stores at a large US integrated healthcare system. SUBJECTS AND SETTINGS: The sample comprised 168 patients who underwent colostomy (ICD-9-CM 46.1X) (n = 108), ileostomy (46.2X) (n = 40), cutaneous ureteroileostomy (56.5X), or other external urinary diversion (56.6X) (n = 20) between January 1, 2012, and December 31, 2014. The study setting was an integrated health services organization that serves more than 2 million persons in the northeastern United States. METHODS: We scanned electronic health records of all study subjects to identify those with evidence of PSCs within 90 days of ostomy surgery and then examined healthcare utilization and costs over 120 days, beginning with date of surgery, among patients with and without evidence of PSCs. Testing for differences in continuous measures between the 3 ostomy groups was based on one-way analysis of variance; testing for differences in such measures between the PSC and non-PSC groups was based on a t statistic, and the χ statistic was used to test for differences in categorical measures. RESULTS: Sixty-one subjects (36.3%) had evidence of PSCs within 90 days of ostomy surgery (ileostomy, 47.5%; colostomy, 36.1%; urinary diversion, 15.0%; P < .05 for differences between groups). Among patients with evidence of PSCs, the mean (SD) time from surgery to first notation of this complication was 26.4 (19.0) days; it was 24.1 (13.2) days for ileostomy, 27.2 (21.1) days for colostomy, and 31.7 (25.7) days for urinary diversion (P = .752). Patients with PSCs were more likely to be readmitted to hospital by day 120 (55.7% vs 35.5% for those without PSCs; P = .011). The mean length of stay for patients readmitted to hospital was 11.0 days for those with PSCs and 6.8 days for those without PSCs (P = .111). The mean total healthcare cost over 120 days was $58,329 for patients with evidence of PSCs and $50,298 for those without evidence of PSCs (P = .251). CONCLUSIONS: Approximately one-third of ostomy patients developed PSCs within 90 days of their surgery. Peristomal skin complications are associated with a greater likelihood of hospital readmission. Our findings corroborate results of earlier studies.

Clinical and Economic Burden of Peristomal Skin Complications in Patients With Recent Ostomies.

PURPOSE: The purpose of this study was to estimate the risk and economic burden of peristomal skin complications (PSCs) in a large integrated healthcare system in the Midwestern United States. DESIGN: Retrospective cohort study. SUBJECTS AND SETTING: The sample comprised 128 patients; 40% (n = 51) underwent colostomy, 50% (n = 64) underwent ileostomy, and 10% (n = 13) underwent urostomy. Their average age was 60.6 ± 15.6 years at the time of ostomy surgery. METHODS: Using administrative data, we retrospectively identified all patients who underwent colostomy, ileostomy, or urostomy between January 1, 2008, and November 30, 2012. Trained medical abstractors then reviewed the clinical records of these persons to identify those with evidence of PSC within 90 days of ostomy surgery. We then examined levels of healthcare utilization and costs over a 120-day period, beginning with date of surgery, for patients with and without PSC, respectively. Our analyses were principally descriptive in nature. RESULTS: The study cohort comprised 128 patients who underwent ostomy surgery (colostomy, n = 51 [40%]; ileostomy, n = 64 [50%]; urostomy, n = 13 [10%]). Approximately one-third (36.7%) had evidence of a PSC in the 90-day period following surgery (urinary diversion, 7.7%; colostomy, 35.3%; ileostomy, 43.8%). The average time from surgery to PSC was 23.7 ± 20.5 days (mean ± SD). Patients with PSC had index admissions that averaged 21.5 days versus 13.9 days for those without these complications. Corresponding rates of hospital readmission within the 120-day period following surgery were 47% versus 33%, respectively. Total healthcare costs over 120 days were almost $80,000 higher for patients with PSCs. CONCLUSIONS: Approximately one-third of ostomy patients over a 5-year study period had evidence of PSCs within 90 days of surgery. Costs of care were substantially higher for patients with these complications.

Cost-effectiveness of adjunctive therapy with atypical antipsychotics for acute treatment of major depressive disorder.

BACKGROUND: While the clinical utility of atypical antipsychotics has been established in patients with major depressive disorder (MDD) who are refractory to antidepressant therapy, their cost-effectiveness is unknown. OBJECTIVE: To examine the cost-effectiveness of aripiprazole, quetiapine, and olanzapine/fluoxetine in adults with MDD who are refractory to antidepressant therapy. METHODS: Using techniques of decision analysis, we estimated expected outcomes and costs over 6 weeks in adults with MDD receiving (1) aripiprazole 2-20 mg/day and antidepressant therapy; (2) quetiapine 150 mg/day or 300 mg/day and antidepressant therapy; (3) the fixed-dose combination of olanzapine 6, 12, or 18 mg/day with fluoxetine 50 mg/day; or (4) antidepressant therapy alone. Cost-effectiveness was assessed in terms of the cost per additional responder at 6 weeks, defined as the ratio of the difference in the cost of MDD-related care over 6 weeks versus antidepressant therapy alone to the difference in the number of patients achieving clinical response by 6 weeks. We estimated the model using data from Phase 3 clinical trials of atypical antipsychotics along with other secondary data sources. RESULTS: With antidepressant therapy alone, the estimated clinical response rate at 6 weeks was 30%. Aripiprazole, quetiapine 150 mg/day, quetiapine 300 mg/day, and olanzapine/fluoxetine were estimated to increase clinical response at 6 weeks to 49%, 34%, 38%, and 45%, respectively. Costs of MDD-related care over 6 weeks were estimated to be $192 for antidepressant therapy, $847 for aripiprazole, $541 for quetiapine 150 mg/day, $672 for quetiapine 300 mg/day plus antidepressant therapy, and $791 for olanzapine/fluoxetine. Costs per additional responder (vs antidepressant therapy) over a 6-week period were estimated to be $3447 for aripiprazole, $8725 for quetiapine 150 mg/day, $6000 for quetiapine 300 mg/day, and $3993 for olanzapine/fluoxetine. CONCLUSIONS: Atypical antipsychotics substantially increase clinical response at 6 weeks. Cost per additional responder is lower for aripiprazole than for quetiapine or olanzapine/fluoxetine.

Clinical and economic outcomes for patients with health care-associated Staphylococcus aureus pneumonia.

While the increasing importance of methicillin-resistant Staphylococcus aureus (MRSA) as a pathogen in health care-associated S. aureus pneumonia has been documented widely, information on the clinical and economic consequences of such infections is limited. We retrospectively identified all patients admitted to a large U.S. urban teaching hospital between January 2005 and May 2008 with pneumonia and positive blood or respiratory cultures for S. aureus within 48 h of admission. Among these patients, those with suspected health care-associated pneumonia (HCAP) were identified using established criteria (e.g., recent hospitalization, admission from nursing home, or hemodialysis). Subjects were designated as having methicillin-resistant (MRSA) or methicillin-susceptible (MSSA) HCAP, based on initial S. aureus isolates. Initial therapy was designated "appropriate" versus "inappropriate" based on the expected susceptibility of the organism to the regimen received. We identified 142 patients with evidence of S. aureus HCAP. Their mean (standard deviation [SD]) age was 64.5 (17) years. Eighty-seven patients (61%) had initial cultures that were positive for MRSA. Most ( approximately 90%) patients received appropriate initial antibiotic therapy (86% for MRSA versus 91% for MSSA; P = 0.783). There were no significant differences between MRSA and MSSA HCAP patients in mortality (29% versus 20%, respectively), surgery for pneumonia (22% versus 20%), receipt of mechanical ventilation (60% versus 58%), or admission to the intensive care unit (79% versus 76%). Mean (SD) total charges per admission were universally high ($98,170 [$94,707] for MRSA versus $104,121 [$91,314]) for MSSA [P = 0.712]). Almost two-thirds of patients admitted to hospital with S. aureus HCAP have evidence of MRSA infection. S. aureus HCAP, irrespective of MRSA versus MSSA status, is associated with significant mortality and high health care costs, despite appropriate initial antibiotic therapy.

Cost-effectiveness of tacrolimus ointment versus pimecrolimus cream in adults with atopic dermatitis.

BACKGROUND: Tacrolimus 0.1% and pimecrolimus 1.0% are used for short-term and noncontinuous treatment of atopic dermatitis (AD) in patients unresponsive to conventional therapies. OBJECTIVE: To assess the cost-effectiveness of tacrolimus versus pimecrolimus in adults with AD. METHODS: Using a Markov cohort model, the authors projected clinical and economic outcomes over six weeks in adults receiving tacrolimus versus pimecrolimus. Cost-effectiveness was assessed in terms of the ratio of the expected cost of AD-related care to the expected number of days with resolved AD. RESULTS: Patients receiving tacrolimus had an estimated 4.9 fewer days with active AD over six weeks (30.0 versus 34.9 for pimecrolimus). Expected costs (per patient) of AD-related care also were lower for tacrolimus patients ($501.27 versus $546.14, respectively). LIMITATION: While pimecrolimus is indicated for use solely in patients with mild-to-moderate AD, the trial on which this study was based included some patients with severe AD. CONCLUSION: In adults with AD, tacrolimus 0.1% may yield better clinical outcomes and lower costs of care than pimecrolimus 1.0%.

Trends in US hospital admissions for skin and soft tissue infections.

Using data from the 2000-2004 US Healthcare Cost and Utilization Project National Inpatient Sample, we found that total hospital admissions for skin and soft tissue infections increased by 29% during 2000-2004; admissions for pneumonia were largely unchanged. These results are consistent with recent reported increases in community-associated methicillin-resistant Staphylococcus aureus infections.

Three-Dimensional Bioabsorbable Tissue Marker Placement is Associated with Decreased Tumor Bed Volume Among Patients Receiving Radiation Therapy for Breast Cancer.

PURPOSE: BioZorb® (Focal Therapeutics, Aliso Viejo, CA) is an implantable 3-dimensional bioabsorbable marker used for tumor bed volume (TBV) identification during postoperative radiation therapy (RT) planning. We aimed to calculate and compare RT TBVs between two cohorts managed with and without the device. METHODS AND MATERIALS: Data from patients with breast cancer who were treated at Rhode Island Hosptial, Providence RI between May 1, 2015 and April 30, 2016 were retrospectively reviewed and grouped based on 3-dimensional bioabsorbable marker placement. Pathology reports were used to calculate tumor excision volume (TEV) after breast conservation. Specifically, the three dimensions provided were multiplied to generate a cubic volume, defined as TEV. TBV was calculated using treatment volumes generated with Philips Pinnacle3 treatment planning software (Andover, MA). Linear regression analyses assessed the relationship between excised TEV and TBV. T tests compared the slopes of the best fit lines for plots of TEV versus TBV. RESULTS: In this retrospective case-control study, 116 patients undergoing breast RT were identified; of whom 42 received a 3-dimensional bioabsorbable marker and 74 did not. The mean TEVs were 102.7 cm3 with the device and 103.2 cm3 without the device, and the mean TBVs for the same groups were 27.5 cm3 and 40.1 cm3, respectively. The TBV standard errors for patients who did and did not receive 3-dimensional bioabsorbable markers were 23.739 and 38.685, respectively. The t tests found the slopes of the lines of best fit for these cohorts to be statistically significantly different (P = .001), with smaller TBVs achieved with 3-dimensional bioabsorbable marker placement. CONCLUSIONS: When comparing TBVs between patients contemporaneously treated with or without a 3-dimensional bioabsorbable marker, device placement was associated with statistically significantly smaller TBVs in the setting of similar TEVs.

Valsartan versus lisinopril or extended-release metoprolol in preventing cardiovascular and renal events in patients with hypertension.

PURPOSE: The objective of this study was to compare cardiovascular and renal events in patients with hypertension receiving the angiotensin II-receptor blocker valsartan versus those receiving the angiotensin-converting-enzyme lisinopril or the beta-blocker metoprolol succinate in an extended-release formulation. METHODS: A retrospective study was conducted using a health insurance claims database spanning the period from January 1997 through December 2003 and representing approximately 40 million members enrolled in over 70 health plans across the United States. Study subjects included all persons in the database with two or more outpatient prescriptions for valsartan, lisinopril, or extended-release metoprolol and two or more prior claims with a diagnosis of hypertension. Those with a history of major cardiovascular or renal events (diagnosis of myocardial infarction, stroke, heart failure, ventricular arrhythmias, or cardiac arrest; coronary revascularization procedure; diagnosis of renal failure; or dialysis or kidney transplantation) or using other antihypertensive medications except diuretics during the 12 months before treatment with valsartan, lisinopril, or extended-release metoprolol were excluded. Risks of major cardiovascular or renal event during follow-up were analyzed using Cox proportional hazards regression. RESULTS: A total of 29,357 antihypertensive patients were identified who initiated therapy with valsartan (n = 6,645), lisinopril (n = 17,320), or extended-release metoprolol (n = 5,392). In multivariate analyses, therapy with valsartan was associated with a significantly lower risk of a major cardiovascular or renal event versus extended-release metoprolol (heart rate [HR], 0.70; 95% confidence interval [CI], 0.56-0.87; p = 0.0015). Patients receiving valsartan had a nominally lower risk of a major cardiovascular or renal event than those receiving lisinopril, although this difference was not statistically significant (HR, 0.89; 95% CI, 0.74-1.07; p = 0.1987). CONCLUSION: Results of this observational study suggest that the use of valsartan may reduce the risk of major cardiovascular and renal events compared with extended-release metoprolol.

Role of ultrasound-guided axillary fine-needle aspiration in the management of invasive breast cancer.

BACKGROUND: Previous studies from Women & Infants' Hospital have reported the accuracy of ultrasound-guided fine-needle aspiration biopsy examination of axillary lymph nodes (USFNAB) for locally advanced breast cancer. The aim of this article is to report our further experience with USFNAB in staging the axilla and determining its affect on management decisions. METHODS: We performed a retrospective review of prospectively collected data between January 1998 and June 2005. RESULTS: A total of 220 patients underwent USFNAB for breast cancer. Of these, 52 were excluded. Of the 168 remaining patients, 79 had positive and 89 had negative USFNAB results. A total of 107 (63%) patients underwent primary surgery and 61 (37%) patients underwent neoadjuvant chemotherapy. In these patients, the sensitivity and specificity of USFNAB was 35% and 96% for T1, and 67% and 100% for T2, respectively. CONCLUSIONS: The high specificity of USFNAB could safely eliminate sentinel lymph node biopsy examination before axillary lymph node dissection, particularly in T2 lesions.

Risk of venous thromboembolism among hospitalized medically ill patients.

PURPOSE: The 90-day risk of venous thromboembolism (VTE) among medically ill patients admitted to a hospital was estimated and is discussed. SUMMARY: Patients aged > or =40 years who were hospitalized between January 1, 1998, and June 30, 2002, for reasons other than traumatic injury, labor and delivery, mental disorder, or VTE and who did not undergo surgery were identified in a large U.S. healthcare claims database. Patients receiving anticoagulants in the 90-day period preceding hospital admission were excluded. We estimated the percentage of study subjects who developed clinical deep-vein thrombosis (DVT) or pulmonary embolism (PE) within 90 days of hospital admission using Kaplan-Meier methods. We also estimated hazard ratios (HRs) for potential risk factors for VTE using univariate and stepwise multivariate Cox proportional hazards regression models. Among 92,162 study subjects, 1468 (1.59%) developed clinical DVT or PE within 90 days of hospital admission; 18% of these events occurred postdischarge. In multivariate analyses, significant risk factors for clinical VTE included: 1) history of cancer (HR, 1.67; 95% confidence interval [CI], 1.45-1.93); 2) history of VTE within six months of index admission (HR, 6.14; 95% CI, 4.74-7.96); 3) operating room procedure within 30 days of index admission (HR, 1.81; 95% CI, 1.47-2.24); 4) peripheral artery disease during index admission (HR, 1.68; 95% CI, 1.28-2.21); and 5) heart failure during index admission (HR, 1.72; 95% CI, 1.52-1.95). CONCLUSION: The risk of clinical VTE among medically ill patients admitted to a hospital, although less than that of patients undergoing major surgery, is not negligible. Patients with a history of recent VTE or surgery, those who are admitted to the intensive care unit, those with an admitting diagnosis of heart failure, and those with active cancer are at especially high risk of VTE and deserve increased consideration for prophylaxis.

Changing patterns of failure of head and neck cancer.

BACKGROUND: With the increased use of neoadjuvant therapy for advanced stage squamous cell carcinoma of the head and neck, we have observed an apparent change in the pattern of failure from predominantly locoregional sites to distant metastases. We reviewed the patterns of failure in cancers of the oral cavity, oropharynx, and larynx at our institution during the last decade. OBJECTIVE: To determine whether there has been a significant change in the patterns of recurrence from the historical locoregional failure to distant sites, and whether this change is associated with the increased use of multimodality therapy. METHODS: We reviewed cancer registry data on patients with squamous cell carcinoma of the head and neck diagnosed between January 1, 1988, and December 31, 1999. Sites included the oral cavity and oropharynx (including the tongue, floor of mouth, retromolar trigone, gingiva, tonsil, and lip) and larynx. RESULTS: Among 432 patients with squamous cell carcinoma of the head and neck, 280 (65%) had oral cavity and oropharyngeal cancers, and 152 (35%) had laryngeal cancers. Overall, 19% developed locoregional recurrence, and 8% developed distant failure. Although locoregional failure for oral cavity and oropharyngeal squamous cell carcinoma decreased from 26% to 16% from 1988-1993 to 1994-1999, distant failure increased significantly from 3% to 8%. During these periods, multimodality therapy was used in 62% of oral cavity and oropharyngeal cancers, and this rate remained essentially unchanged. For laryngeal cancer, locoregional and distant failure remained stable at 18% and 9%, respectively. In these laryngeal cancers, the use of multimodality therapy decreased from 60% to 46%, but this difference was not statistically significant (P =.43). CONCLUSIONS: Although locoregional control in oral cavity and oropharyngeal cancers has improved significantly with the use of multimodality therapy, the incidence of distant failure has doubled. In laryngeal squamous cell carcinoma, the patterns of failure have not changed significantly.

Can dialysis patients be accurately identified using healthcare claims data?

BACKGROUND: While health insurance claims data are often used to estimate the costs of renal replacement therapy in patients with end-stage renal disease (ESRD), the accuracy of methods used to identify patients receiving dialysis - especially peritoneal dialysis (PD) and hemodialysis (HD) - in these data is unknown. METHODS: The study population consisted of all persons aged 18 - 63 years in a large US integrated health plan with ESRD and dialysis-related billing codes (i.e., diagnosis, procedures) on healthcare encounters between January 1, 2005, and December 31, 2008. Using billing codes for all healthcare encounters within 30 days of each patient's first dialysis-related claim ("index encounter"), we attempted to designate each study subject as either a "PD patient" or "HD patient." Using alternative windows of ± 30 days, ± 90 days, and ± 180 days around the index encounter, we reviewed patients' medical records to determine the dialysis modality actually received. We calculated the positive predictive value (PPV) for each dialysis-related billing code, using information in patients' medical records as the "gold standard." RESULTS: We identified a total of 233 patients with evidence of ESRD and receipt of dialysis in healthcare claims data. Based on examination of billing codes, 43 and 173 study subjects were designated PD patients and HD patients, respectively (14 patients had evidence of PD and HD, and modality could not be ascertained for 31 patients). The PPV of codes used to identify PD patients was low based on a ± 30-day medical record review window (34.9%), and increased with use of ± 90-day and ± 180-day windows (both 67.4%). The PPV for codes used to identify HD patients was uniformly high - 86.7% based on ± 30-day review, 90.8% based on ± 90-day review, and 93.1% based on ± 180-day review. CONCLUSIONS: While HD patients could be accurately identified using billing codes in healthcare claims data, case identification was much more problematic for patients receiving PD.

A prospective study of prognostic factors for recurrence in early oral tongue cancer.

BACKGROUND: Tongue cancer is one of the common cancers in head and neck region. Cervical node metastasis is the strongest poor prognostic factor. Other prognostic factors were also said to be of significance. Our aim was to find out the significant prognostic factors of tumor aggressiveness in Indian perspective. MATERIAL AND METHODS: Sixty cases of early cancer of oral tongue with clinically non palpable neck nodes were managed by upfront surgery. Surgeries performed for the primary tumor were 'wide excision' or 'hemiglossectomy' along with neck dissection. Patients were then given post-operative radiotherapy according to standard guidelines. They were analyzed using a detailed proforma. Three patients were lost to follow-up rest all patients were followed. RESULTS: Recurrence was seen in 11 out of 60 patients (18.3%), in an average follow-up period of about 28 months. Among those who recurred, one patient had both nodal and local recurrence, 2 patients had nodal only (regional) recurrence and rest 8 patients had local recurrence. The prognostic factors that significantly affected the recurrence were endo-phytic disease, depth of invasion, lymphatic invasion, muscle invasion, healthy margin and adjuvant radiotherapy. CONCLUSION: The risk factors for recurrence in early lesions of oral tongue are - Cervical nodal metastasis, Lymphatic permeation, Depth of disease - 6 mm or more, poorly differentiated tumor, Endophytic (infiltrative) disease, Young age at presentation and Muscle invasion. In early tongue lesions, that are node negative, selective node dissection (SND) including level 1, 2, 3 and 4, is a viable option for neck to decrease the morbidity of MND.

Adherence and persistence with non-nucleoside reverse transcriptase inhibitor-based antiretroviral regimens.

OBJECTIVE: The objective of this study was to examine adherence and persistency in HIV patients initiating first-line combination antiretroviral therapy (cART) with a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen. METHODS: Using US health insurance records, the authors identified all persons aged ≥ 18 years with HIV, who began NNRTI-based cART between 1 January 2003 and 30 September 2009. They examined adherence using proportion of days covered (PDC), and non-persistency based on evidence of discontinuation, switching or augmentation. Differences in non-adherence (1 - PC) and non-persistency were compared over 12 months, between three treatment groups: i) efavirenz, emtricitabine and tenofovir as a fixed-dose combination ('EFV/FTC/TDF'); ii) EFV-based regimens other than EFV/TDF/FTC, with ≥ 2 NRTIs ('EFV + ≥ 2 NRTIs'); and iii) nevirapine-based regimens with ≥ 2 NRTIs (NVP + ≥ 2 NRTIs). RESULTS: There were 1874 patients receiving EFV/FTC/TDF, 893 receiving EFV + ≥ 2 NRTIs and 207 receiving NVP + ≥ 2 NRTIs. Adherence was lower for both EFV + ≥ 2 NRTIs and NVP + ≥ 2 NRTIs than for EFV/FTC/TDF (rate ratio (RR) = 1.57 and 2.01, respectively; both p < 0.01), while non-persistency was higher (hazard ratio (HR) = 1.56, p < 0.01 and 1.70, p < 0.01, respectively). CONCLUSION: Adherence and persistency may differ between NNRTI-based regimens; additional analyses are needed to understand the reasons for these differences.

Cost-effectiveness of zoledronic acid plus endocrine therapy in premenopausal women with hormone-responsive early breast cancer.

PURPOSE: The aim of this study was to estimate the cost-effectiveness of adding zoledronic acid 4 mg intravenously every 6 months to endocrine therapy in premenopausal women with hormone receptor-positive early breast cancer from a US health care system perspective. MATERIALS AND METHODS: A Markov model was developed to predict disease progression, mortality, and costs of breast cancer care for premenopausal women with hormone receptor-positive early breast cancer receiving up to 3 years of (1) endocrine therapy (goserelin plus tamoxifen or anastrozole); or (2) endocrine therapy plus zoledronic acid. Model parameters were obtained from ABCSG-12 (Austrian Breast and Colorectal Cancer Study Group Trial-12) and the literature. The incremental cost per quality-adjusted life year (QALY) gained with zoledronic acid was calculated under 2 scenarios: (1) benefits of zoledronic acid persist to maximum (7 years) follow-up in ABCSG-12 ("trial benefits") or (2) benefits persist until death ("lifetime benefits"). RESULTS: Adding zoledronic acid to endocrine therapy was projected to yield a gain of 0.41 life years (LYs) and 0.43 QALYs assuming trial benefits and 1.34 LYs and 1.41 QALYs assuming lifetime benefits. Assuming trial benefits, the incremental cost per QALY gained with zoledronic acid was $9300. Assuming lifetime benefits, zoledronic acid was estimated to increase QALYs and reduce costs. Cost per QALY gained was