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Weycker D.,Policy Analysis Inc. PAI | Barron R.,Amgen Inc. | Edelsberg J.,Policy Analysis Inc. PAI | Kartashov A.,Policy Analysis Inc. PAI | Lyman G.H.,Duke University
Breast Cancer Research and Treatment | Year: 2012

Chemotherapy is widely used to treat early stage breast cancer (ESBC). Reductions and delays in dose administered-e.g., due to advanced age or febrile neutropenia (FN)-are generally believed to increase risk of disease progression and reduce survival. Little is known about incidence of reduced chemotherapy dose intensity among women with ESBC in the current era of US clinical practice. This study employed a retrospective cohort design and electronic medical records from >65 community oncology/hematology clinics in >35 states (2004-2010). The study population comprised adult women who received myelosuppressive chemotherapy for ESBC (stages I-IIIA). For each such woman, each unique cycle of chemotherapy within their first observed course was identified. Incidence of chemotherapy dose delays (7 days for any drug in 1 cycles), chemotherapy dose reductions (15% for any drug in 1 cycles), and low chemotherapy relative dose intensity (RDI <85% over the course) relative to published reference standards were descriptively analyzed for the seven most-frequently planned regimens in the study database. A total of 2,228 women (70% of the subjects who received chemotherapy for ESBC and met other selection criteria) initiated 1 of the 7 most-frequently planned regimens. Mean age of subjects was 54 years and 69% received primary prophylaxis against FN with a colony-stimulating factor. Incidence of dose delays, dose reductions, and low RDI was 31, 24, and 26%, respectively; low RDI typically was due to premature treatment discontinuation. For patients (n = 626) receiving the most common regimen (dose-dense AC-T: doxorubicin/cyclophosphamide, Q2 × 4 cycles, paclitaxel or docetaxel, Q2 × 4 cycles), incidence of dose delays, dose reductions, and low RDI was 42, 29, and 32%, respectively. In the current era of US clinical practice, chemotherapy dose delays and dose reductions are common among women with ESBC receiving frequently used myelosuppressive dose-dense, as well as conventional, chemotherapy regimens. © 2012 Springer Science+Business Media, LLC.


Shea K.M.,Boston University | Weycker D.,Policy Analysis Inc. PAI | Stevenson A.E.,Boston University | Strutton D.R.,Pfizer | Pelton S.I.,Boston University
Vaccine | Year: 2011

We hypothesized that following the introduction of PCV7, the exchange of vaccine serotypes (VST) for non-vaccine serotypes (NVST) in the nasopharynx has resulted in fewer episodes of pneumococcal acute otitis media (AOM) due to the reduced capacity for common NVST strains to cause disease. We modeled the change in the proportion of children colonized with S. pneumoniae who would develop pneumococcal AOM that would occur due to serotype replacement, and projected the future impact of PCV13. Our model is based on observed changes in the nasopharyngeal pneumococcal serotype distribution from the pre- to post-PCV7 era, and an estimated capacity of each serotype to produce pneumococcal AOM given colonization; the latter was derived by dividing serotype-specific disease prevalence by serotype-specific carriage prevalence in the same population. Our results indicate a 12% (95% CI 0.5-26) decline in the number of AOM episodes attributable to S. pneumoniae in children less than 3 years of age between 2000 and 2007 due to the combined effects of PCV7 vaccine efficacy and vaccine-induced serotype replacement, and predicts that PCV13 will further decrease pneumococcal AOM an additional 27% (95% CI 13-40) from 2007 to 2013. Evaluation of changes in VST disease revealed a 91% (95% CI 83-97) decrease in PCV7-VST AOM from 2000 to 2007, and predicted an additional 65% (95% CI 57-74) decrease in PCV13-VST AOM from 2007 to 2013. Our model indicates that following vaccination, nasopharyngeal replacement of VST by NVST has led to a decrease in the amount of pneumococcal AOM despite a consistent rate of S. pneumoniae colonization, and that pneumococcal AOM may continue to decrease as pneumococcal serotypes with greater capacity to cause disease are replaced by less locally invasive serotypes. © 2011 Elsevier Ltd.


Hagiwara M.,Policy Analysis Inc. PAI | Delea T.E.,Policy Analysis Inc. PAI | Chung K.,Amgen
Journal of Medical Economics | Year: 2014

Background: Patients with bone metastases secondary to breast cancer are pre-disposed to skeletal-related events (SREs), including spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiotherapy to bone (RT). Objective: To document current patterns of healthcare utilization and costs of SREs in patients with breast cancer and bone metastases. Methods: This was a retrospective, observational study using the Thomson MedStat MarketScan Commercial Claims and Encounters database from 9/2002 to 6/2011. Study subjects included all persons with claims for breast cancer and for bone metastases, and 1 claims for an SRE. Unique SRE episodes were identified based on a gap of at least 90 days without an SRE claim, and classified by treatment setting (inpatient or outpatient) and SRE type (SCC, PF, SB, or RT). Results: Of 17,266 patients with breast cancer and bone metastases, 9142 (53%) had one or more SRE episodes. Among 5809 patients who met all other criteria, there were 7617 SRE episodes over mean (SD) follow-up of 17.2 (15.2) months. The percentage of episodes that required inpatient treatment ranged from 11% (RT) to 76% (SB). On average, inpatient SCC episodes (n=83 episodes) were most costly; while outpatient PF episodes (n=552 episodes) were least costly. Of the total SRE costs (mean [SE] $21,072 [$36,462]/episode), 36% were attributable to outpatient RT (n=5265 episodes) and 31% to inpatient PF (n=838 episodes). Limitations: The administrative claims data used in this study may lack sensitivity and specificity for identification of clinical events and may not be generalizable to other populations. Also, for some SRE episode categories, the number of events was small and cost estimates may lack precision. Conclusion: In patients with breast cancer and bone metastases, SREs are associated with high costs and hospitalizations. © 2014 All rights reserved.


Hagiwara M.,Policy Analysis Inc. PAI | Delea T.E.,Policy Analysis Inc. PAI | Cong Z.,Amgen Inc. | Chung K.,Amgen Inc.
Supportive Care in Cancer | Year: 2014

Purpose: Cancer patients with bone metastases (BMets) are predisposed to skeletal complications. Bone-targeted therapies such as denosumab or intravenous bisphosphonates (IVBs) reduce the risk of these complications. This study characterized patterns of IVB use in these patients in the USA. Methods: This was a retrospective, observational study using the Truven Health MarketScan Commercial and Medicare databases (2002-2011). Subjects with ≥1 claims of diagnosis of breast, lung, or prostate cancer (BC, LC, or PC) and ≥1 claims of BMets diagnosis were included. The date of first BMet diagnosis claim was the "index date." Key exclusion criteria were diagnosis of other primary cancer, receipt of IVB, or <6 months continuous enrollment pre-index. Cumulative incidence of treatment initiation, interruption, and discontinuation were estimated. Proportions of IVB claims with chemotherapy administered on the same day and with renal monitoring within 2 weeks prior were summarized. Multivariate regressions assessing factors associated with IVB initiation were conducted. Results: Cumulative incidence of IVB initiation at 12 months post-index was greatest for BC followed by PC and LC, and it declined with age in all tumor types, e.g., in BC from 62 % at age <50 years to 47 % at age ≥75 years. At 12 months, IVB treatment interruption ranged from 16 % (LC) to 31 % (PC), with discontinuation ranging from 46 % (BC) to 83 % (LC). Conclusions: IVBs are used more frequently in patients with BMets secondary to BC than PC or LC. Many patients interrupt or discontinue IVB therapy within 12 months of initiation potentially impacting effectiveness. © 2013 Springer-Verlag Berlin Heidelberg.


Hagiwara M.,Policy Analysis Inc. PAI | Delea T.E.,Policy Analysis Inc. PAI | Saville M.W.,Amgen | Chung K.,Amgen
Prostate Cancer and Prostatic Diseases | Year: 2013

Background:Patients with bone metastases secondary to prostate cancer are predisposed to skeletal-related events (SREs), including spinal cord compression, pathological fracture, surgery to bone and radiotherapy to bone. The objective of this study was to document current patterns of healthcare utilization and costs of SREs in patients with prostate cancer and bone metastases.Methods:This was a retrospective, observational study using the Thomson MedStat MarketScan Commercial Claims and Encounters database from September 2002 to June 2011. Study subjects included all persons with claims for prostate cancer and for bone metastases, and one or more claims for an SRE. Unique SRE episodes were identified based on a gap of at least 90 days without an SRE claim, and classified by treatment setting (inpatient or outpatient) and SRE type (spinal cord compression, pathological fracture, surgery to bone or radiotherapy).Results:Of 3919 patients with prostate cancer and bone metastases, 2090 (53%) had one or more SRE episodes. Among 1237 patients who met all other criteria, there were 1623 SRE episodes over a mean (s.d.) follow-up of 16.1 (12.9) months. The percent of episodes that required inpatient treatment ranged from 14% (radiotherapy) to 82% (surgery to bone). On average, inpatient episodes with surgery to bone (n=36 episodes) were most costly (mean (s.e.) 88 838 (11 830)/episode), whereas outpatient episodes with surgery to bone (n=8 episodes) were least costly (mean (s.e.) 4749 (1690)/episode). Of the total SRE costs (mean (s.e.) 20 984 (951)/episode), 41% were attributable to outpatient radiotherapy (n=1169 episodes), 23% to inpatient radiotherapy (n=184 episodes), and 19% to inpatient treatment of pathological fractures (n=101 episodes).Conclusions:In patients with prostate cancer and bone metastases, SREs are associated with high costs and hospitalizations. © 2013 Macmillan Publishers Limited. All rights reserved.

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