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Chemotherapy plus G-CSF (C+G) and G-CSF alone are two of the most common methods used to mobilize CD34(+) cells for autologous hematopoietic SCT (AHSCT). In order to compare and determine the real-world outcomes and costs of these strategies, we performed a retrospective study of 226 consecutive patients at 11 medical centers (64 lymphoma, 162 multiple myeloma), of whom 55% of lymphoma patients and 66% of myeloma patients received C+G. Patients with C+G yielded more CD34(+) cells/day than those with G-CSF alone (lymphoma: average 5.51 × 10(6) cells/kg on day 1 vs 2.92 × 10(6) cells/kg, P=0.0231; myeloma: 4.16 × 10(6) vs 3.69 × 10(6) cells/kg, P0.00001) and required fewer days of apheresis (lymphoma: average 2.11 vs 2.96 days, P=0.012; myeloma: 2.02 vs 2.83 days, P=0.0015), although nearly all patients ultimately reached the goal of 2 × 10(6) cells/kg. With the exception of higher rates of febrile neutropenia in myeloma patients with C+G (17% vs 2%, P0.05), toxicities and other outcomes were similar. Mobilization with C+G cost significantly more (lymphoma: median $10,300 vs $7300, P0.0001; myeloma: $8800 vs $5600, P0.0001), although re-mobilization adds $6700 for drugs alone. Our results suggest that although both C+G and G-CSF alone are effective mobilization strategies, C+G may be more cost-effective for patients at high risk of insufficient mobilization.

In many jurisdictions, cost-effectiveness analysis (CEA) plays an important role in determining drug coverage and reimbursement and, therefore, has the potential to impact patient access. Health economic guidelines recommend the inclusion of future costs related to the intervention of interest within CEAs but provide little guidance regarding the definition of 'related'. In the case of CEAs of therapies that extend the lives of patients with chronic kidney disease (CKD) on dialysis but do not impact the need for or the intensity of dialysis, the determination of the relatedness of future dialysis costs to the therapy of interest is particularly ambiguous. The uncertainty as to whether dialysis costs are related or unrelated in these circumstances has led to inconsistencies in the conduct of CEAs for such products, with dialysis costs included in some analyses while excluded in others. Due to the magnitude of the cost of dialysis, whether or not dialysis costs are included in CEAs of such therapies has substantial implications for the results of such analyses, often meaning the difference between a therapy being deemed cost effective (in instances where dialysis costs are excluded) or not cost effective (in instances where dialysis costs are included). This paper explores the issues and implications surrounding the inclusion of dialysis costs in CEAs of therapies that extend the lives of dialysis patients but do not impact the need for dialysis. Relevant case studies clearly demonstrate that, regardless of the clinical benefits of a life-extending intervention for dialysis patients, and due to the high cost of dialysis, the inclusion of dialysis costs in the analysis essentially eliminates the possibility of obtaining a favourable cost-effectiveness ratio. This raises the significant risk that dialysis patients may be denied access to interventions that are cost effective in other populations due solely to the high background cost of dialysis itself. Finally, the paper presents a case for excluding dialysis costs in CEAs of therapies that extend the lives of patients receiving dialysis but do not impact the need for dialysis. The argument is founded on the following: (i) health economic guidelines imply that dialysis costs are unrelated to such therapies and therefore should not be included in CEAs of such therapies; (ii) the high cost and cost-effectiveness ratio associated with dialysis place an unreasonable and insurmountable barrier to demonstrating the cost effectiveness of such therapies, particularly since the decision to fund dialysis has already been made; and (iii) current clinical and reimbursement practices include the use of such therapies for patients with CKD receiving dialysis. We conclude that the exclusion of dialysis costs in such cases is methodologically correct given current health economic guidelines and is consistent with current practices regarding the treatment of dialysis patients.

There is limited information regarding the cost-effectiveness of sevelamer for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis in the UK. Using a UK National Health Service (NHS) perspective and final results of the Dialysis Clinical Outcomes Revisited (DCOR) study, an evaluation was performed to determine the cost-effectiveness of sevelamer compared to calcium-based phosphate binders for the first-line treatment of hyperphosphatemia in CKD patients on dialysis.A Markov model was developed to estimate life years, quality-adjusted life years (QALYs), costs, incremental cost per life year (LY) gained, and QALY gained. Treatment-specific overall survival up to 44 months, hospitalizations, and resource utilization were derived from the DCOR study. Survival was extrapolated to a lifetime horizon using Weibull regression analysis. Unit costs and utility estimates specific to the UK were obtained from the published literature. Sub-group analyses were conducted based on data reported from the DCOR study for increasing age cut-points. Outcomes and costs were modeled for a lifetime horizon.In the base case analysis, the use of sevelamer resulted in a gain of ∼0.73 LYs and 0.44 QALYs per patient (discounted at 3.5% per year). Total per-patient costs were higher for sevelamer, resulting in an incremental cost of £22,157 per QALY gained and £13,427 per LY gained (in £2009). Increasingly favorable cost per QALY ratios were observed with increasing age cut-points, ranging from £15,864 for patients ≥45 to £13,296 for patients ≥65 years of age. Results were most sensitive to assumptions regarding overall survival and the inclusion of dialysis costs. Key limitations of the analysis included the use of non-UK trial data for survival and hospitalizations, and the exclusion of quality-of-life impacts associated with hospitalization.In CKD patients receiving dialysis, treatment of hyperphosphatemia with sevelamer offers good value for money compared with calcium-based binders.

Objective.To assess whether use of oral vancomycin for treatment during an outbreak of Clostridium difficile infection (CDI) was associated with increased rates of colonization with vancomycin-resistant enterococci (VRE)..Design.A retrospective analysis of hospital databases.Setting.The Jewish General Hospital in Montreal, Quebec, Canada.Methods.We collected data regarding VRE colonization and CDI from November 1, 2000, through September 30, 2007, during which policies of preferential oral metronidazole or vancomycin treatment were implemented to control an outbreak of CDI. Four periods were considered: period 1, the preoutbreak period when metronidazole was used; period 2, the CDI outbreak period when metronidazole was used; period 3, the postoutbreak period when vancomycin was used; and period 4, the postoutbreak period when metronidazole was used.Results.A total of 2,412 cases of CDI and 425 cases of VRE colonization were identified. The rate of CDI increased significantly during period 2 and decreased to preoutbreak levels during period 3. The rate of VRE also increased during period 2 and decreased during the first 18 months of period 3. A clonal outbreak of cases of VRE (VanA) colonization was observed toward the end of period 3 and into period 4. Excluding the period of the clonal outbreak, there was a strong correlation between the number of cases of CDI and VRE colonization (r = 0.736; P = .001) and a negative association between VRE colonization and vancomycin use (r = —0.765; P = .04).Conclusions.Increased vancomycin use was not associated with an increase in VRE colonization over a 2-year period. Restriction of vancomycin use during CDI outbreaks because of the fear of increasing VRE colonization may not be warranted.

Background and objectives People with CKD stages 3–5 and on dialysis (5D) have dramatically increased mortality, which has been associated with hyperphosphatemia in many studies. Oral phosphate binders are commonly prescribed to lower serum phosphate. We conducted an updated meta-analysis of the noncalcium–based binder (non-CBB) sevelamer versus CBBs in CKD stages 3–5D. Design, setting, participants, & measurements Randomized, controlled trials comparing sevelamer with CBBs were identified through MEDLINE and the Cochrane Central Register of Controlled Trials. Patient-level outcomes included all-cause mortality, cardiovascular events and mortality, hospitalization, and adverse effects. Intermediate outcomes included vascular calcification and bone changes. Biochemical outcomes included serum phosphate, calcium, parathyroid hormone, lipids, and hypercalcemia. We conducted and reported this review according to Cochrane guidelines. Results We included 25 studies to March 31, 2015 with 4770 participants (88% on hemodialysis). Patients receiving sevelamer had lower all–cause mortality (risk ratio [RR], 0.54; 95% confidence interval [95% CI], 0.32 to 0.93), no statistically significant difference in cardiovascular mortality (n=2712; RR, 0.33; 95% CI, 0.07 to 1.64), and an increase in combined gastrointestinal events of borderline statistical significance (n=384; RR, 1.42; 95% CI, 0.97 to 2.08). For biochemical outcomes, patients receiving sevelamer had lower total serum cholesterol (mean difference [MD], −20.2 mg/dl; 95% CI, −25.9 to −14.5 mg/dl), LDL-cholesterol (MD, −21.6 mg/dl; 95% CI, −27.9 to −15.4 mg/dl), and calcium (MD, −0.4 mg/dl; 95% CI, −0.6 to −0.2 mg/dl) and a reduced risk of hypercalcemia (RR, 0.30; 95% CI, 0.19 to 0.48). End of treatment intact parathyroid hormone was significantly higher for sevelamer (MD, 32.9 pg/ml; 95% CI, 0.1 to 65.7 pg/ml). Serum phosphate values showed no significant differences. Conclusions Patients with CKD stages 3–5D using sevelamer have lower all–cause mortality compared with those using CBBs. Because of a lack of placebo-controlled studies, questions remain regarding phosphate binder benefits for patients with CKD stages 3–5 and not on dialysis.

PURPOSE To assess the cost-effectiveness of treatment strategies that utilize first-line latanoprost compared to those based on initial beta-blocker therapy in patients with open-angle glaucoma (OAG) or ocular hypertension (OH) in France. METHODS The study was based on a decision-analytic model that was populated with data from a retrospective chart review. A hypothetical cohort of patients newly diagnosed with OAG and/or OH was assessed over a period of 2 and 3 years. For each treatment strategy 10,000 patients were assumed. RESULTS First-line latanoprost therapy was significantly more effective than initial treatment with a beta-blocker, providing more days of intraocular pressure (IOP) control primarily due to its longer time until initial treatment failure. Latanoprost's higher acquisition cost was largely offset by reductions in costs associated with surgical procedures. The additional cost for latanoprost was estimated at approximately 41 Euro and 27 Euro over 2 and 3 years, respectively. The incremental cost per day of IOP control when latanoprost was used as first-line strategy compared to the first-line beta-blocker strategy was 0.82 Euro and 0.36 Euro over 2 and 3 years, respectively. CONCLUSIONS These results provide compelling evidence that first-line latanoprost therapy can provide superior clinical outcomes at a small additional cost in actual clinical practice.

In patients with significant mitral regurgitation (MR) at high risk of mortality and morbidity from mitral valve surgery, transcatheter mitral valve repair with the MitraClip System is associated with a reduction in MR and improved quality-of-life and functional status compared with baseline. The objective was to evaluate the cost-effectiveness of MitraClip therapy compared with standard of care in patients with significant MR at high risk for mitral valve surgery from a Canadian payer perspective.A decision analytic model was developed to estimate the lifetime costs, life years, quality-adjusted life years (QALYs), and incremental cost per life year and QALY gained for patients receiving MitraClip therapy compared with standard of care. Treatment-specific overall survival, risk of clinical events, quality-of-life, and resource utilization were obtained from the Endovascular Valve Edge-to-Edge REpair High Risk Study (EVEREST II HRS). Health utility and unit costs (CAD $2013) were taken from the published literature. Sensitivity analyses were conducted to explore the impact of alternative assumptions and parameter uncertainty on results.The base case incremental cost per QALY gained was $23,433. RESULTS were most sensitive to alternative assumptions regarding overall survival, time horizon, and risk of hospitalization for congestive heart failure (CHF). Probabilistic sensitivity analysis showed MitraClip therapy to have a 92% chance of being cost-effective compared with standard of care at a willingness-to-pay threshold of $50,000 per QALY gained.Key limitations include the small number of patients included in the EVEREST II HRS which informed the analysis, the limited data available to inform clinical events and disease progression in the concurrent comparator group, and the lack of a comparator group from a randomized control trial.MitraClip therapy is likely a cost-effective option for the treatment of patients at high risk for mitral valve surgery with significant MR.

To determine the cost effectiveness of sevelamer vs calcium carbonate in patients with chronic kidney disease and not on dialysis (CKD-ND) from the perspective of the National Health Service (NHS) in the UK.A Markov decision analytic model was developed to estimate (1) total life years (LYs), quality-adjusted life years (QALYs), and costs for patients treated with sevelamer or calcium carbonate; and (2) incremental costs per LY gained (LYG) and per QALY gained for sevelamer vs calcium carbonate. Data informing probability transitions to all-cause death and dialysis inception in CKD-ND patients were taken directly from the INDEPENDENT-CKD study and were extrapolated beyond the 3-year clinical trial using Weibull regression analysis. Estimates of health utility and costs (in £2011) were derived from the published literature.Over a lifetime horizon, sevelamer treatment resulted in a gain of 2.05 LYs and 1.56 QALYs per patient, an increase of £37,282 in total costs per patient vs calcium carbonate (3.5% discount), and a per-patient cost of £18,193/LYG and £23,878/QALY gained. Results were robust to alternative assumptions in key parameters; results were most sensitive to alternative assumptions regarding the mean daily dose of sevelamer, impact of sevelamer on dialysis initiation, cost of dialysis, and health utility estimates. The probabilistic sensitivity analysis showed that sevelamer was cost-effective vs calcium carbonate in 93% of simulations at a willingness-to-pay threshold of £30,000/QALY gained.While the model simulated a real-world clinical setting, this analysis was subject to limitations common to all decision analytic models, in that it used a mix of data sources and relied on several assumptions. Not all variables that impact real-world outcomes and costs were included in this model.Sevelamer is a cost-effective option compared to calcium carbonate for the first-line treatment of hyperphosphatemia in CKD-ND patients in the UK.

The avoidance of hospitalizations and the maintenance of in-center dialysis sessions in patients receiving dialysis for end-stage renal disease (ESRD) have obvious benefits to patients, dialysis providers and payers. Benefits include better continuity of care, better patient outcomes, improved quality of life, and reduced healthcare expenditures. The objective of this study was to quantify, from the perspective of a dialysis provider in the US, the potential impact of sevelamer versus calcium-based binders (CBBs) on hospitalization days and maintenance of in-center dialysis sessions among hyperphosphatemic dialysis patients.A Microsoft Excel-based model was developed to simulate the number of missed dialysis sessions among three hypothetical cohorts of hyperphosphatemic patients treated with either sevelamer or CBBs. The cohorts were characterized by their size to represent a small, mid-size, or large dialysis organization (75, 30,000, and 120,000 patients, respectively). In any given month, a patient in the model could receive dialysis treatments within the center, experience a hospitalization, or die. Treatment-specific monthly survival rates, hospitalization rates, length of stay, and binder dosages were derived from the Dialysis Clinical Outcomes Revisited (DCOR) study. A dialysis schedule of three treatments per week was assumed. Analyses were conducted for a 1-year time horizon.For a small dialysis center, CBBs were associated with an increased number of missed in-center dialysis treatments (447) compared to sevelamer (395). Thus, sevelamer use avoided 52 missed in-center dialysis sessions during 1 year of treatment compared to CBBs. The magnitude of sevelamer's impact on maintaining in-center dialysis treatments increased with the size of the dialysis organization; for a mid-size dialysis organization sevelamer use avoided 20,571 missed in-center dialysis sessions and for a large dialysis organization sevelamer use avoided 82,286 missed in-center dialysis sessions.Treatment of hyperphosphatemic dialysis patients with sevelamer relative to CBBs was associated with a reduction in the number of missed in-center dialysis treatments across small, mid-size, and large dialysis organizations. This reduction could contribute to improved patient outcomes via undisrupted delivery of care within the dialysis clinic. The use of sevelamer versus CBBs could also result in an increased number of reimbursement payments to dialysis clinics and providers by avoiding missed in-center dialysis sessions due to hospitalization.

Recent results of the U.S. Oncology Adjuvant Trial 9735 demonstrated significant disease-free survival and overall survival benefits for docetaxel and cyclophosphamide (tc) compared with doxorubicin and cyclophosphamide (ac) in the adjuvant treatment of operable invasive breast cancer. Based on clinical data from the 9735 study, we evaluated the lifetime cost-effectiveness of tc compared with ac from the perspective of the Canadian publicly funded health care system. A Markov model was developed to estimate the incremental cost per quality-adjusted life-year gained and per life-year gained. Monthly survival and risk of disease recurrence up to 7 years were obtained directly from the overall survival and disease-free survival curves in the 9735 study, life-years beyond 7 years were estimated using the average life expectancy of age-matched women in the general Canadian population. Canadian-specific resource utilization and unit costs (in 2008 Canadian dollars) were applied to estimate costs for chemotherapy administration, chemotherapy-related toxicities, recurrence, and adverse events. Health-utility scores and decrements used in the calculation of quality-adjusted life-years were derived from the literature. The lifetime cost per quality-adjusted life-year gained was $8,251 for tc compared with ac, and the cost per life-year gained was $6,842. The results were robust across a range of sensitivity analyses. Cost-effectiveness, combined with efficacy and an acceptable safety profile, support the adoption of tc as an alternative to ac in Canadian clinical practice for the adjuvant treatment of operable early breast cancer.

The cost-effectiveness of oxaliplatin in combination with 5-fluorouracil/leucovorin (5fu/lv)&mdash, the folfox regimen&mdash, was compared with that of 5fu/lv alone as adjuvant therapy for patients with stage iii colon cancer, from the perspective of the Cancer Care Ontario New Drug Funding Program. In the mosaic (Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer) trial, the folfox regimen significantly improved disease-free survival. The mosaic trial formed the basis of the present analysis. Extrapolated patient-level data from the mosaic trial were used to model patient outcomes from treatment until death. Utilities were obtained from the literature. Resource utilization data were derived from the mosaic trial and supplemented with data from the literature. Unit costs were obtained from the Ontario Ministry of Health and Long-Term Care, the London Health Sciences Centre, and the literature. Lifetime incremental cost-effectiveness ratios for folfox compared with 5fu/lv were CA$14,266 per disease-free year, CA$23,598 per life-year saved, and CA$24,104 per quality adjusted life-year (qaly) gained, discounting costs and outcomes at 5% per annum. These results were stable for a wide range of inputs, only utility values associated with relapse seemed to influence the cost-effectiveness ratios observed. With an incremental cost of CA$24,104 per qaly gained, folfox is a cost-effective adjuvant treatment for stage iii colon cancer. Compared with 5fu/lv alone, this regimen offers better clinical outcomes and provides good value for money.

Purpose To facilitate future glaucoma model development and to provide guidance for decision-makers evaluating them, we provide an overview of an innovative glaucoma model and highlight important modeling considerations. Considerations The considerations that were addressed include: disease outcome that is both relevant and meaningful to current clinical practice; diversity in treatment options and practices; incorporation of therapy discontinuation; and consideration of the variability in patient response to treatment. Model scope A state-transition, Monte Carlo simulation model was developed to simulate the management and treatment of patients with glaucoma and/or ocular hypertension. The model examines strategies involving sequential use of up to 6 pharmacologic interventions. Transitions are based on the monthly probability that a patient is no longer "successfully maintained" on therapy, which can be a consequence of lack of intraocular pressure control, adverse events, lack of compliance, or lack of persistence. Outputs of the model include months on each treatment, frequency of therapy switches, days of intraocular pressure control, frequency of ophthalmologist visits, frequency of surgery, and glaucoma-related costs. The model allows the user to specify country-specific treatment strategies, survival on therapy, surgical rates, practice patterns, and costs. Concept application The model presented offers insights into accommodating patient and clinician variability through the use of persistence distributions. It will facilitate future glaucoma model development and provide insight for decision-makers who must evaluate model-based analyses of the economic value of glaucoma interventions.

Background: The purpose of this study was to characterize current patterns of treatment of glaucoma and ocular hypertension and to examine the effect of those patterns on intraocular pressure (IOP) control and persistence on therapy. Methods: A retrospective chart review was conducted at 3 ophthalmology practices in Alberta. Data were collected for patients who had begun therapy for newly diagnosed primary open-angle glaucoma or ocular hypertension between May 1, 1998, and Sept. 30, 1999 (phase 1), and for patients who had begun second-line therapy after initial therapy with a β-blocker had failed (phase 2). Data were collected for a minimum of 24 months for phase 1 and a minimum of 18 months for phase 2. Results: We included 115 patient charts in phase 1 and 93 in phase 2. In each phase, the patients for whom latanoprost had been prescribed in unfixed combination with a β-blocker had the greatest mean percentage reduction in IOP at month 24, and the patients for whom latanoprost had been prescribed alone or in combination with a β-blocker were more likely to still be on initial therapy at month 24;the difference in persistence on therapy was statistically significant only in phase 1 ( p = 0.001). The mean number of switches in therapy was smaller in phase 1 than in phase 2 in all therapy groups. Interpretation: Compared with other first- and second-line forms of therapy, treatment with latanoprost, alone or in combination with a β-blocker, was associated with greater reductions in IOP, better therapeutic persistence, fewer therapy switches and fewer ophthalmologist visits over a 2-year period.

In their response to our paper on unrelated medical costs [1], van Baal et al. [2] confirm that our paper identifies inherent problems with many national pharmacoeconomic guidelines regarding the consideration of ‘unrelated’ medical costs. In their article, the authors do not offer an opinion on the interpretation of unrelated healthcare costs as they relate to our dialysis example; instead, they conclude that the only logical solution is to change pharmacoeconomic guidelines to include all medical costs, ‘‘whether they are ‘related’ or ‘unrelated’, ‘direct’ or ‘indirect’’’ [2]. Although we are pleased that our article has contributed to the ongoing debate over the appropriateness of excluding unrelated future health costs, we suggest that such theoretical debates must be considered ‘unrelated’ or at least tangential to the objective of our original paper [1]. The objective of our paper was to determine the appropriate handling of dialysis costs in economic analyses of therapies that may extend the life of a dialysis patient, but are not meant to replace or modify the need for chronic, expensive dialysis treatments—given existing guidelines. It is argued by van Baal et al. [2] that excluding dialysis costs ignores the real opportunity costs of prolonging the lives of dialysis patients. We do not disagree that improved survival of high-cost dialysis patients represents a real opportunity cost to the healthcare system; however, exclusion of such costs in our example is entirely consistent with current pharmacoeconomic guidelines and clinical practice. As such, it provides cost-effectiveness ratios that are most comparable to other products considered for reimbursement. In our paper [1], we discuss the following

Abstract 4048 Introduction: Chemotherapy + GCSF mobilization and GCSF alone are the most common mobilization regimens for autologous stem cell transplant (ASCT). We examined the benefits and limitations of both regimens in terms of mobilization success, predictability and costs. Methods: A retrospective, multi-center chart review was conducted of multiple myeloma (MM) and lymphoma patients mobilized between January 1, 2006 and December 31, 2007 for ASCT. Patients were excluded if they were mobilized with plerixafor (Mozobil®) or enrolled in a clinical trial of mobilization regimens. Data collected included demographics, disease and treatment history, mobilization regimen, blood counts, aphaeresis, remobilization, cells transplanted, time to engraftment and resource use. Stem cell collection practices and related clinical outcomes were analyzed separately for patients that were mobilized with chemotherapy + GCSF vs. GCSF alone. Resource use was evaluated using US unit cost data. Results: Data were collected for 227 consecutive patients from 11 centers (143 patients that received a chemotherapy + GCSF mobilization regimen and 84 patients who received GCSF alone). Total cells collected were significantly higher in the chemotherapy + GCSF mobilization group compared to GSF alone (18.6 × 106/kg vs.7.0 × 106/kg, p Even with fewer aphaeresis days and re-mobilizations, the cost total cost of mobilization, remobilization and aphaeresis with chemotherapy + GCSF was higher than GCSF alone ($19,614 vs. 16,852; p=0.003). Higher chemotherapy + GCSF costs were driven by the costs of chemotherapy, and extra days of GCSF. Chemotherapy + GCSF was also harder to predict in terms of timing the first day of aphaeresis. In patients receiving GCSF alone, the majority (95%) of first day aphaeresis occurred between Monday and Wednesday with the remaining 5% occurring on a Thursday or Friday. In contrast, chemotherapy + GCSF mobilizations resulted in 74.1% of first day aphaeresis occurring between Monday and Wednesday, 12.6% on Thursday and Friday and a further 13.3% occurring on a Saturday or Sunday. Discussion: Significant differences in mobilization success, costs and predictability were observed between patients that received chemotherapy + GCSF and those that received GCSF alone. While a chemotherapy + GCSF mobilization regimen may provide better mobilization and collection, there is a trade-off in terms of predictability, time to collection, costs and rate of febrile neutropenia. However, as chemotherapy + GCSF may be used for the treatment of the underlying malignancy; its use may not be completely comparable to GCSF mobilization alone. Disclosures: Grima: Cornerstone Research Group Inc.: Employment, Equity Ownership. Holmberg:Genzyme: Membership on an entity's Board of Directors or advisory committees, Research Funding; Millenium: Research Funding; Otsuka: Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding; Celgene: Research Funding. Fung:Genzyme: Consultancy, Honoraria, Speakers Bureau. Brown:Cornerstone Research: Employment. Horwitz:Genzyme: Honoraria, Research Funding. Bernard:Cornerstone Research: Employment, Equity Ownership. Shaughnessy:Genzyme: Consultancy, Honoraria, Research Funding, Speakers Bureau; Millenium: Honoraria, Speakers Bureau; Otsuka: Honoraria, Speakers Bureau.

Abstract 1925 After mobilization, the timing of aphaeresis can be highly variable, often depending on rise in peripheral blood stem cell levels. Some centers that conduct autologous stem cell transplant (ASCT) do not conduct aphaeresis for stem cell collection on weekends. We examined stem cell collection practices and related outcomes in centers that do and do not conduct weekend aphaeresis. Methods: A retrospective, multi-center chart review was conducted of multiple myeloma (MM) and lymphoma patients mobilized between January 1, 2006 and December 31, 2007 for ASCT. Patients were excluded if they were mobilized with plerixafor (Mozobil®) or were enrolled in a clinical trial of mobilization regimens. Data collected included demographics, disease and treatment history, mobilization regimen, blood counts, aphaeresis, remobilization, cells transplanted, time to engraftment, and resource use. Stem cell collection practices and related clinical outcomes were analyzed separately for sites that did and did not conduct weekend aphaeresis. Results: Data were collected for 292 consecutive patients in the different centers (91 patients from 4 sites that performed weekday only aphaeresis and 201 patients from 7 sites who performed aphaeresis on weekends and weekdays). Weekday only aphaeresis sites were more likely to conduct GCSF alone mobilization compared to weekend sites (42% vs. 21%, p Discussion: Significant differences in the management of patients were observed between sites that conduct and don't conduct weekend aphaeresis. Weekday only aphaeresis sites used a more regimented collection schedule with most collections starting on a Monday, potentially missing the “peak” day of cell collection. Sites that conducted weekend aphaeresis used a more cell-count based approach and were more likely to monitor peripheral blood stem cell counts. Collection success appears to be superior with the cell-count based approach that includes greater use of chemo-mobilization, cell count monitoring and weekend collection. Disclosures: Chao: Genzyme: Research Funding. Bernard:Cornerstone Research: Employment, Equity Ownership. Fung:Genzyme: Consultancy, Honoraria, Speakers Bureau. Grima:Cornerstone Research Group Inc.: Employment, Equity Ownership. Holmberg:Genzyme: Membership on an entity's Board of Directors or advisory committees, Research Funding; Millenium: Research Funding; Otsuka: Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding; Celgene: Research Funding. Brown:Cornerstone Research: Employment. Horwitz:Genzyme: Honoraria, Research Funding. Shaughnessy:Genzyme: Consultancy, Honoraria, Research Funding, Speakers Bureau; Millenium: Honoraria, Speakers Bureau; Otsuka: Honoraria, Speakers Bureau. Tricot:Otsuka: I have an ongoing clinical study supported by Otsuka.

Abstract #6105 Background: Extended 7-year follow-up of the US Oncology Adjuvant Trial 9735 demonstrated that docetaxel plus cyclophosphamide (TC) as adjuvant treatment of operable invasive breast cancer significantly improves disease-free survival (DFS) and overall survival (OS) compared to doxorubicin plus cyclophosphamide (AC). DFS was 81% vs. 75%, respectively (p = 0.033) and OS was 87% vs. 82%, respectively (p = 0.032). A lifetime cost-effectiveness analysis of TC versus AC was conducted from a Canadian (province of Ontario) government payer perspective, based on head-to-head clinical data from Trial 9735. Methods: Survival and monthly risk of disease recurrence of women with early stage breast cancer (base case typifying those entered into the trial) was estimated up to 7 years using OS and DFS data from Trial 9735. Survival was extrapolated to lifetime using life expectancy estimates from the Canadian general population. Canadian resource utilization and unit costs were applied to estimate the costs of chemotherapy (including drug and administration costs), chemotherapy-related toxicities and disease recurrence. Quality of life (utility) weights for health states and events, used in the calculation of quality-adjusted life years (QALYs), were derived from the literature. Total costs, life years and QALYs were calculated for a lifetime horizon. Results: Life years and QALYs were higher for TC patients compared to AC patients, due primarily to longer survival and fewer recurrences for patients receiving TC. The predicted life expectancy of patients receiving TC and AC was 14.64 and 14.02 years, respectively. Mean total lifetime disease-related costs were $12,840 with TC and $8,579 with AC; the difference in costs was driven by higher drug acquisition costs for TC. Cost per life year gained (TC vs. AC) was $6,842 and cost per QALY gained was $8,251, discounting costs and outcomes at 5% per year. Base case results were most sensitive to assumptions regarding time horizon. In a sensitivity analysis conducted with a 7-year time horizon (the time frame of the clinical trial), cost per life year gained was $36,120 and cost per QALY gained was $43,248. In additional one-way sensitivity analyses conducted with a lifetime horizon and alternative assumptions regarding survival extrapolation, utility estimates, costs and discount rate, cost per life year gained remained between $2,982 and $7,538 and cost per QALY gained remained between $3,600 and $9,090. Conclusion: In patients with early stage, operable, invasive breast cancer, adjuvant treatment with TC provides gains in terms of life years and QALYs compared to AC and results in favourable cost-effectiveness ratios that should be acceptable in most jurisdictions. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6105.

A patient-level meta-analysis of 5 randomized trials including 4,896 patients found that the XIENCE™ cobalt chromium everolimus drug-eluting stent (DES) significantly improved cardiovascular (CV) outcomes compared with bare metal stents (BMS) (Valgimigli et al., 2014). Using these results, a cost