Real-world data on usage of scalp cooling for chemotherapy associated alopecia in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18739-e18739
Author(s):  
Nicole Olivia Williams ◽  
Richard Paxman ◽  
Emma Thornhill ◽  
Mahmoud Kassem ◽  
Michael Grimm ◽  
...  

e18739 Background: Hair loss is a well-known side effect of chemotherapy. The Paxman Hair Loss Prevention System, a scalp cooling device, has been shown to be effective in reducing chemotherapy induced alopecia in patients receiving chemotherapy (Nangia, JAMA, 2017). The National Comprehensive Cancer Network and the European Society for Medical Oncology guidelines have recommended scalp cooling as category 2A and 2B options, respectively. Methods: The real world use of scalp cooling using the Paxman device, as documented by orders through the Paxman Hub during the years of 2017-2020 was summarized. Descriptive statistics were used to summarize demographics and utilization. Results: Data from 6649 patients who used scalp cooling were reviewed. Patients with breast cancer were the most common users of scalp cooling (78%, n=5197) followed by gynecology (12%, n=775), gastrointestinal (3%, n=201), lung (1%, n=81) and genitourinary (1%, n=52). The majority of patients were between the ages of 45-65 (55%), followed by 65-74 (18%), older than 75 (5%), and 25-44 (2%). Average number (#) of cycles of cooling completed was 6.53 (range of average # of cycles 4.50-12). Scalp cooling with this device was commonly used in 39 out of 50 states. Conclusions: This is the largest report of scalp cooling usage in the real world setting in the USA, including scalp cooling usage in older adults. Uptake of scalp cooling across various cancers has not been uniform and this deserves further study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16249-e16249
Author(s):  
Salwan Al Mutar ◽  
Muhammad Shaalan Beg ◽  
Eric Hansen ◽  
Andrew J. Belli ◽  
Maegan Vaz ◽  
...  

e16249 Background: The difference between the FOLFIRINOX and gemcitabine/nab-paclitaxel (GnP) regimens’ clinical trial designs limit the ability to generate cross-study comparisons. Therefore, there is a significant need to understand the impact of various demographic and clinical characteristics on the effectiveness of these systemic therapies in the real-world treatment setting. This study seeks to compare the real-world outcomes of patients with metastatic pancreatic cancer treated with frontline FOLFIRINOX or GnP. Methods: Patients with primary metastatic pancreatic cancer who received first-line (1L) FOLFIRINOX or GnP were identified in the COTA real-world database. The COTA database is a de-identified database of real-world data (RWD) derived from the electronic health records of healthcare providers in the United States. Real-world overall response rate (rwORR) was calculated as the proportion of patients achieving complete response (CR) or partial response (PR). Overall survival (OS) was calculated using the Kaplan-Meier method and multivariate analyses utilized Cox proportional hazards. Results: The overall qualified cohort (n=236) was stratified by 1L FOLFIRINOX (n=109) or GnP (n=127). Select patient characteristics are shown in table. Patients treated with 1L FOLFIRINOX showed greater rwORR as compared to those treated with GnP (68.8% vs. 55.9%, p=0.04). Additionally, patients treated with 1L FOLFIRINOX had longer median OS (14.4 vs 11.4 mos, respectively). In univariate analysis, patients treated with GnP had a greater chance of mortality (HR: 1.3, 95% CI: 1.0, 1.8, p=0.05). This relationship strengthened in multivariate analysis (GnP treated HR: 1.6, 95% CI: 1.1, 2.1, p=0.01). Conclusions: Due to lack of enrollment of representative patients in clinical trials and in the absence of a comparative clinical trial, real-world experience with chemotherapy regimens provide critical insights on the outcome of treatments. In our cohort, patients treated with frontline GnP had a significantly greater chance of mortality as compared to patients treated with frontline FOLFIRINOX. The FOLFIRINOX cohort also showed greater rwORR. Future research will continue to expand on treatment patterns in subsequent lines of therapy, as well as emerging therapy types, in order to better understand the optimal treatment sequence in metastatic pancreatic cancer.[Table: see text]


2021 ◽  
pp. 401-413
Author(s):  
Michelle H. Lerman ◽  
Benjamin Holmes ◽  
Daniel St Hilaire ◽  
Mary Tran ◽  
Matthew Rioth ◽  
...  

PURPOSE This study tested whether a composite mortality score could overcome gaps and potential biases in individual real-world mortality data sources. Complete and accurate mortality data are necessary to calculate important outcomes in oncology, including overall survival. However, in the United States, there is not a single complete and broadly applicable mortality data source. It is further likely that available data sources are biased in their coverage of sex, race, age, and socioeconomic status (SES). METHODS Six individual real-world data sources were combined to develop a high-quality composite mortality score. The composite score was benchmarked against the gold standard for mortality data, the National Death Index. Subgroup analyses were then conducted to evaluate the completeness and accuracy by sex, race, age, and SES. RESULTS The composite mortality score achieved a sensitivity of 94.9% and specificity of 92.8% compared with the National Death Index, with concordance within 1 day of 98.6%. Although some individual data sources show significant coverage gaps related to sex, race, age, and SES, the composite score maintains high sensitivity (84.6%-96.1%) and specificity (77.9%-99.2%) across subgroups. CONCLUSION A composite score leveraging multiple scalable sources for mortality in the real-world setting maintained strong sensitivity, specificity, and concordance, including across sex, race, age, and SES subgroups.


2019 ◽  
Vol 147 (5) ◽  
pp. 1429-1445 ◽  
Author(s):  
Yuchu Zhao ◽  
Zhengyu Liu ◽  
Fei Zheng ◽  
Yishuai Jin

Abstract We performed parameter estimation in the Zebiak–Cane model for the real-world scenario using the approach of ensemble Kalman filter (EnKF) data assimilation and the observational data of sea surface temperature and wind stress analyses. With real-world data assimilation in the coupled model, our study shows that model parameters converge toward stable values. Furthermore, the new parameters improve the real-world ENSO prediction skill, with the skill improved most by the parameter of the highest climate sensitivity (gam2), which controls the strength of anomalous upwelling advection term in the SST equation. The improved prediction skill is found to be contributed mainly by the improvement in the model dynamics, and second by the improvement in the initial field. Finally, geographic-dependent parameter optimization further improves the prediction skill across all the regions. Our study suggests that parameter optimization using ensemble data assimilation may provide an effective strategy to improve climate models and their real-world climate predictions in the future.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tae-Hwan Kim ◽  
Hun Do Cho ◽  
Yong Won Choi ◽  
Hyun Woo Lee ◽  
Seok Yun Kang ◽  
...  

Abstract Background Since the results of the ToGA trial were published, trastuzumab-based chemotherapy has been used as the standard first-line treatment for HER2-positive recurrent or primary metastatic gastric cancer (RPMGC). However, the real-world data has been rarely reported. Therefore, we investigated the outcomes of trastuzumab-based chemotherapy in a single center. Methods This study analyzed the real-world data of 47 patients with HER2-positive RPMGC treated with trastuzumab-based chemotherapy in a single institution. Results With the median follow-up duration of 18.8 months in survivors, the median overall survival (OS) and progression-free survival were 12.8 and 6.9 months, respectively, and the overall response rate was 64%. Eastern Cooperative Oncology Group performance status 2 and massive amount of ascites were independent poor prognostic factors for OS, while surgical resection before or after chemotherapy was associated with favorable OS, in multivariate analysis. In addition, 5 patients who underwent conversion surgery after chemotherapy demonstrated an encouraging median OS of 30.8 months, all with R0 resection. Conclusions Trastuzumab-based chemotherapy in patients with HER2-positive RPMGC in the real world demonstrated outcomes almost comparable to those of the ToGA trial. Moreover, conversion surgery can be actively considered in fit patients with a favorable response after trastuzumab-based chemotherapy.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 57-57
Author(s):  
Robert M. Rifkin ◽  
Lisa Herms ◽  
Chuck Wentworth ◽  
Anupama Vasudevan ◽  
Kimberley Campbell ◽  
...  

57 Background: Biosimilars have potential to reduce healthcare costs and increase access in the United States, but lack of uptake has contributed to lost savings. Filgrastim-sndz was the first FDA-approved biosimilar, and much can be learned by evaluating its uptake. In February 2016, the US Oncology Network converted to filgrastim-sndz as its short-acting granulocyte colony-stimulating factor (GCSF) of choice for prevention of febrile neutropenia (FN) following myelosuppressive chemotherapy (MCT). To understand utilization and cost patterns, this study analyzes real-world data of GCSFs within a community oncology network during the initial period of conversion to the first biosimilar available in the US. Methods: This descriptive retrospective observational study used electronic health record data for female breast cancer (BC) patients receiving GCSF and MCT at high risk of FN. Patient cohorts were defined by first receipt of either filgrastim or filgrastim-sndz during the 410 days before and after biosimilar conversion. Healthcare resource utilization (HCRU) and costs for GCSF and complete blood counts (CBC) were collected at GCSF initiation through the earliest of 30 days following end of MCT, loss to follow up, death, or data cutoff. Results: 146 patients were identified: 81 (55.5%) filgrastim and 65 (44.5%) filgrastim-sndz. No directional differences existed in baseline characteristics between the cohorts. Higher proportions of filgrastim-sndz patients received dose-dense MCT (33.8% vs 22.2%). Time trends show an initial spike in HCRU and cost for filgrastim-sndz patients after formulary conversion, which subsequently decreased and converged to that of the filgrastim cohort after 12 months. When aggregated, the overall median total administration counts, per patient per month (PPPM) and dosage, were marginally higher for filgrastim-sndz (5 vs 3; 2.9 vs 1.4; 1920 vs 1440 mcg, respectively). Median PPPM costs were higher for filgrastim-sndz ($803 vs $545). Median CBC utilization and costs were higher for filgrastim-sndz (2.8 vs 2.5; $28 vs $23, respectively). Conclusions: This study provides insight into real-world HCRU and cost patterns after formulary conversion to a biosimilar for BC patients receiving MCT and GCSF. As a descriptive study, causal inferences cannot be made and an underlying effect from index chemotherapy cannot be excluded. Convergence of HCRU and costs after 12 months suggests that overall results may be driven by behavior at initial formulary switch. Since filgrastim-sndz was the first US biosimilar approved, the uptake may be indicative of an experience with biosimilar acceptance in general. Future real-world studies of biosimilars must consider inconsistent utilization and practice trends during the time frame directly following formulary conversion.


2021 ◽  
Author(s):  
Ravi Thadhani ◽  
Joanna Willetts ◽  
Catherine Wang ◽  
John Larkin ◽  
Hanjie Zhang ◽  
...  

AbstractBackgroundSARS-CoV-2 is primarily transmitted through aerosolized droplets; however, the virus can remain transiently viable on surfaces.ObjectiveWe examined transmission within hemodialysis facilities, with a specific focus on the possibility of indirect patient-to-patient transmission through shared dialysis chairs.DesignWe used real-world data from hemodialysis patients treated between February 1st and June 8th, 2020 to perform a case-control study matching each SARS-CoV-2 positive patient (case) to a non-SARS-CoV-2 patient (control) in the same dialysis shift and traced back 14 days to capture possible exposure from chairs sat in by SARS-CoV-2 patients. Cases and controls were matched on age, sex, race, facility, shift date, and treatment count.Setting2,600 hemodialysis facilities in the United States.PatientsAdult (age ≥18 years) hemodialysis patients.MeasurementsConditional logistic regression models tested whether chair exposure after a positive patient conferred a higher risk of SARS-CoV-2 infection to the immediate subsequent patient.ResultsAmong 170,234 hemodialysis patients, 4,782 (2.8%) tested positive for SARS-CoV-2 (mean age 64 years, 44% female). Most facilities (68.5%) had 0 to 1 positive SARS-CoV-2 patient. We matched 2,379 SARS-CoV-2 positive cases to 2,379 non-SARS-CoV-2 controls; 1.30% (95%CI 0.90%, 1.87%) of cases and 1.39% (95%CI 0.97%, 1.97%) of controls were exposed to a chair previously sat in by a shedding SARS-CoV-2 patient. Transmission risk among cases was not significantly different from controls (OR=0.94; 95%CI 0.57 to 1.54; p=0.80). Results remained consistent in adjusted and sensitivity analyses.LimitationAnalysis used real-world data that could contain errors and only considered vertical transmission associated with shared use of dialysis chairs by symptomatic patients.ConclusionsThe risk of indirect patient-to-patient transmission of SARS-CoV-2 infection from dialysis chairs appears to be low.Primary Funding SourceFresenius Medical Care North America; National Institute of Diabetes and Digestive and Kidney Diseases (R01DK130067)


2021 ◽  
Vol 21 (2) ◽  
pp. 252-264
Author(s):  
Nicholas Ross Smith ◽  
Ruairidh J. Brown

There is much pessimism as to the current state of Sino-American relations, especially since the onset of the COVID-19 pandemic in January 2020. Such pessimism has led to some scholars and commentators asserting that the Sino-American relationship is on the cusp of either a new Cold War or, even more alarmingly, something akin to the Peloponnesian War (via a Thucydides Trap) whereby the United States might take pre-emptive measures against China. This article rejects such analogizing and argues that, due to important technological advancements found at the intersection of the digital and fourth industrial revolutions, most of the real competition in the relationship is now occurring in cyberspace, especially with regards to the aim of asserting narratives of truth. Two key narrative battlegrounds that have raged since the onset of the COVID-19 pandemic are examined: where was the origin of the COVID-19 pandemic? and who has had the most successful response to the COVID-19 pandemic?. This article shows that Sino-American competition in cyberspace over asserting their narratives of truth (related to the COVID-19 pandemic) is fierce and unhinged. Part of what is driving this competition is the challenging domestic settings politicians and officials find themselves in both China and the United States, thus, the competing narratives being asserted by both sides are predominately for domestic audiences. However, given that cyberspace connects states with foreign publics more intimately, the international aspect of this competition is also important and could result in further damage to the already fragile Sino-American relationship. Yet, whether this competition will bleed into the real world is far from certain and, because of this, doomsaying via historical analogies should be avoided.


1987 ◽  
Vol 8 (x) ◽  
pp. 251-261
Author(s):  
Richard C. Rockwell

This essay sets forth the thesis that social reporting in the United States has suffered from an excess of modesty among social scientists. This modesty might be traceable to an incomplete model of scientific advance. one that has an aversion to engagement with the real world. The prospects for social reporting in the United States would be brighter if reasonable allowances were to be made for the probable scientific yield of the social reporting enterprise itself. This yield could support and improve not only social reporting but also many unrelated aspects of the social sciences.


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