Aim: With the aggregation of real-world data in healthcare, opportunities for outcomes research are growing. In this study, we summarize published literature examining comparative effectiveness research (CER), treatment patterns, quality of life (QoL) and costs in HER2 -negative and triple-negative (TN) metastatic breast cancer (mBC). Methods: PubMed (2010–January 2016) and four conferences (2013–January 2016) were searched using MeSH/keywords, including mBC, QoL, morbidity and therapeutics. Studies relating to CER, treatment patterns, QoL, costs or treatment appropriateness in US patients with HER2 -negative/TN mBC were included in the review. Results: Of 1782 identified records, 33 studies met full inclusion criteria: seven related to CER, 18 to treatment patterns, one to treatment appropriateness/navigation, two to QoL and five to costs. Studies varied in objectives, designs and outcomes. Study designs included retrospective chart reviews (52%), retrospective secondary database analyses (27%), economic models (12%), physician surveys (6%) and patient surveys (3%). 25 studies reported results on HER2 -negative mBC, six on TN mBC and two on both subtypes. The most common end points examined were treatment patterns, overall survival and progression-free survival. Conclusion: Outcomes research in HER2 -negative mBC in the USA was limited, specifically among TN patients, indicating an opportunity for further research in this high unmet need population. Endpoints and treatment options varied, thus, it is difficult to draw summary conclusions about these studies. Outcomes research examining real-world data in mBC has increased in recent years, and may continue to grow with the implementation of new policy programs.
e15741 Background: In independent phase III trials, both nab-P+G and FFX demonstrated superiority over G as 1L MPAC tx. Limited data exist on real world effectiveness and costs of nab-P+G v FFX. This study compared median time to tx discontinuation (TTD) and costs between the two cohorts. Methods: A retrospective study was conducted with MedAssets’ de-identified US hospital data. Patients (pts) ≥ 18 yo diagnosed with MPAC between 04/13 and 02/15, completing ≥ 1 cycle of nab-P+G or FFX as 1L, and with ≥ 6 months of data were included. Primary endpoints were median TTD and total costs. Supportive care use and costs were also examined. Between group comparisons used Kaplan-Meier (TTD) and ANOVA (costs). Multivariable general linear regression with gamma distributions were used for costs. Results: A total of 89 pts received nab-P+G, while 61 received FFX. nab-P+G pts were older (age ≥ 70: 31.5% v 11.5%; p < 0.05) compared to FFX, though Charlson Comorbidity Indices were similar (nab-P+G = 8.8, FFX = 9.0). More nab-P+G pts were treated in teaching (56% v 49%) and < 200 bed facilities (27% v 21%), but these differences were not significant. Median TTD did not differ significantly between nab-P+G (120 days) and FFX (98 days; p = 0.77). Median costs per month of tx were lower in nab-P+G pts ($12,192 v $18,743, p < 0.01). More FFX pts used GCSF (66.7% v 22.5%, p < 0.01), while more nab-P+G pts used blood products (BP) (30.0 v 10.4%, p < 0.05). Monthly GCSF and antiemetic costs were lower in nab-P+G pts ($1,584 v $4,793, p < 0.05; $595 v $1,351, p < 0.05). Multivariable analysis confirmed higher total costs (IRR = 1.4, p < 0.01), GCSF costs (IRR = 2.5, p < 0.05) and antiemetic costs (IRR = 6.4, p < 0.01) in FFX pts. No significant differences were seen in BP costs between cohorts. Monthly inpatient costs were lower for nab-P+G ($510 v $3,503, p < 0.01) but not significant (p = 0.18) when controlling for baseline variables. Conclusions: While median TTD was similar between nab-P+G and FFX cohorts, pts treated with FFX had higher total costs driven in part by use of GCSF, antiemetics, and inpatient visits.
Open vial vaccine wastage in multi-dose vials is a major contributor to vaccine wastage. Although switching from 10-dose vials to 5-dose vials could reduce wastage, a higher total cost could be triggered because smaller vials cost more to purchase and store.This study drew field data of daily session sizes in local vaccination facilities from Bangladesh, India (Uttar Pradesh), Mozambique, and Uganda, and used Akaike Information Criteria to determine the best fit statistical distribution across various clinic types. These distributions were input to estimate the vaccine wastage using Lee's (2010) model. Inactivated polio vaccine (IPV) immunization was simulated to compare the costs over ten years with 10-dose vials versus 5-dose vials.By switching from 10- to 5-dose vials, the observed open vial wastage rate due to vial size preference and session size for IPV was reduced from 0.25 to 0.11 in Bangladesh, 0.17 to 0.08 in India (Uttar Pradesh), 0.13 to 0.06 in Mozambique, and 0.09 to 0.04 in Uganda, respectively. The cost savings realized from lower IPV wastage did not offset the higher costs of procurement and storage costs associated with smaller dose presentation.While our model showed that switching from 10-dose vials to 5-dose vials of IPV reduced open vial wastage, it was not cost-saving.
The combination chemotherapy regimens of nab-paclitaxel plus gemcitabine (nab-p + G) and FOLFIRINOX (FFX) have each demonstrated improved survival compared with gemcitabine monotherapy in clinical trials for metastatic pancreatic cancer; however, limited comparative data exist.The objective of this study was to compare patient characteristics and clinical outcomes including time to treatment failure and overall survival in patients with metastatic pancreatic cancer receiving first-line chemotherapy in the community.We conducted a retrospective, multi-site, observational cohort study of patients with metastatic pancreatic cancer receiving first-line nab-p + G, FFX, or gemcitabine monotherapy between April 2013 and October 2015, using data from the iKnowMed electronic health record database. Patients on clinical trials or with other cancer diagnoses were excluded. Time to treatment failure and overall survival were assessed by Kaplan-Meier methods.Four hundred and eighty-six patients met selection criteria, 255 nab-p + G, 159 FFX, and 72 gemcitabine patients. Median age was 61, 68, and 73 years for FFX, nab-p + G, and gemcitabine patients, respectively (p < 0.01 for nab-p + G vs. FFX). Eastern Cooperative Oncology Group performance status of 0-1 was 91% for FFX, 77% for nab-p + G, and 68% for gemcitabine patients (p < 0.01 for nab-p + G vs. FFX). For the nab-p + G vs. FFX cohorts, respectively, time to treatment failure was 3.7 vs. 4.3 months (log-rank p = 0.25); and OS was 9.8 vs. 11.4 months (log-rank p = 0.38). Among patients with Eastern Cooperative Oncology Group performance status 0-1, time to treatment failure was 4.2 vs. 4.3 months (log-rank p = 0.47); and overall survival was 12.1 vs 11.4 months (log-rank p = 0.68).The nab-p + G patients were older and had worse performance status than FFX patients. Time to treatment failure and overall survival were not observed to be significantly different in first-line nab-p + G and FFX patients. Results were similar after stratifying by performance status.
The economic burden of metastatic pancreatic cancer (mPC) is substantial while treatment options are limited. Little is known about the treatment patterns and healthcare costs among mPC patients who initiated first-line gemcitabine plus nanoparticle albumin-bound paclitaxel (nab-P + G) and FOLFIRINOX.The MarketScan® claims databases were used to identify adults with ≥2 claims for pancreatic cancer, 1 claim for a secondary malignancy, completed ≥1 cycle of nab-P + G or FOLFIRINOX during 4/1/2013 and 3/31/2015, and had continuous plan enrollment for ≥6 months pre- and 3 months after the first-line treatment. Duration of therapy, per patient per month (PPPM) costs of total healthcare, mPC-related treatment, and supportive care were measured during first-line therapy.550 mPC patients met selection criteria (nab-P + G, n = 294; FOLFIRINOX, n = 256). There was no difference in duration of therapy (p = 0.60) between nab-P + G and FOLFIRINOX. Compared with FOLFIRINOX, patients with nab-P + G had higher chemotherapy drug costs but lower treatment administration costs and supportive care costs (all p < 0.01).Patients treated with nab-P + G (vs FOLFIRINOX) had similar treatment duration but lower costs of outpatient prescriptions, treatment administration and supportive care. Lower supportive care costs in the nab-P + G cohort were mainly driven by lower utilization of pegfilgrastim and anti-emetics.
433 Background: Both nab-P+G and FFX demonstrated superior overall survival (OS) over gemcitabine monotherapy for the treatment of PDAC; but there is no real-world effectiveness and utilization study of nab-P+G vs. FFX. The objective of this study is to compare real-world treatment patterns of patients receiving nab-P+G vs. FFX as first-line treatment for advanced PDAC. Methods: A retrospective cohort study was performed using fully de-identified data from a nationally representative electronic medical record platform of 1,300 community oncology physicians. Patients diagnosed with PDAC between September 2013 and October 2014 who received either nab-P+G or FFX as 1st line therapy were included in the analysis. We calculated median time to treatment discontinuation (TTD) and database persistence (DP), a proxy for OS, using the Kaplan Meier method, and assessed supportive care usage with Poisson regression. Results: 202 (out of 851) patients met eligibility criteria (nab-P+G, n = 122; FFX, n = 80). Patients on nab-P+G were older than patients on FFX (mean age 67.0 v 61.4; p < 0.01), but other baseline characteristics were comparable. TTD (3.4 v 3.8 mos) and DP (8.6 v 8.6 mos) were not statistically different for nab-P+G and FFX, respectively. The rate of AE-related discontinuation was similar in patients on nab-P+G and FFX (18% v 21%); however patients on nab-P+G utilized less doses of granulocyte-colony stimulating factor (GCSF) agents (2.0 v 4.4; p < 0.01), but needed more doses of erythropoietin-stimulating agents (ESA) (0.9 v 0.1; p < 0.01) and steroids (7.9 v 5.8; p < 0.01) per 100 days. Conclusions: TTD and DP for patients with advanced PDAC did not differ significantly between nab-P+G and FFX, although supportive care medications differed. Patients treated with nab-P+G required fewer doses of GCSF and more doses of ESA and steroids, though AEs leading to discontinuation was not statistically different. Management of chemotherapy related toxicities may incur substantial burden on the U.S. healthcare system, especially if an alternative therapy exists with similar clinical outcomes.
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