Systematic literature review of the real-world burden and use of chemotherapies for treatment of advanced or recurrent endometrial carcinoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17571-e17571
Author(s):  
Qi Zhao ◽  
Rachel Hughes ◽  
Ishaaq Altaf-Haroon ◽  
Emma Schiller ◽  
Ananth Kadambi
Keyword(s):  
Adjuvant Chemotherapy ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Real World ◽  
Systemic Therapy ◽  
Observational Studies ◽  
The Real ◽  
Real World Evidence ◽  
Platinum Based Chemotherapy ◽  
Prior Systemic Therapy

e17571 Background: Women diagnosed with advanced or recurrent endometrial cancer (EC) have a poor prognosis, with a 5-year survival of only 15% to 17%. While a multi-modality approach is often used for newly diagnosed EC including platinum-based chemotherapy, there are no definitively approved standard treatment options for advanced or recurrent EC following prior systemic therapy (FPST). The real-world evidence surrounding the effectiveness of chemotherapies in this setting is not well characterized. We conducted a systematic literature review to attempt to fill this evidence gap. Methods: Systematic searches were run in Embase, MEDLINE, and the Cochrane Library to identify English-language publications from January 2000 to July 2020. Additional hand searches of 5 key conferences held from 2018 to 2020 were also conducted. The review included observational studies reporting the clinical effectiveness, safety, or treatment patterns of pharmacological treatments in adult women with advanced or recurrent EC. Results: Seventy-seven observational studies met the inclusion criteria, of these 63 studies reported on the effectiveness of chemotherapies. While 57 studies described adjuvant chemotherapy use, 6 described use of chemotherapies FPST, including 1 study in the second line or later. Only one of these 6 studies reported a sample size greater than 100 patients. Chemotherapy FPST included paclitaxel/carboplatin (3 studies), doxorubicin (2 studies), etoposide (1 study), or any platinum-based chemotherapy (1 study). Shorter median overall survival (OS) was observed in patients with treatment-free intervals (TFI) < 6 months from prior systemic therapy (5.5-11.3 months; 2 studies) compared to those with TFI > 6 months (13.0-27.0 months; 3 studies). Similarly, shorter median progression-free survival (PFS) was seen in patients with TFI < 6 months from prior systemic therapy (2.0-3.2 months; 2 studies) vs. those with TFI > 6 months (6.0-10.0 months; 3 studies). Conclusions: Women with advanced or recurrent EC have poor OS and PFS with current chemotherapy regimens, especially for those with TFI < 6 months. The time at recurrence from prior systemic therapy seems to correlate with the outcomes of subsequent treatment. Novel efficacious treatment strategies are required to improve patients’ outcomes in the FPST setting. While extensive real-world evidence exists for patients with EC receiving adjuvant chemotherapy, real world data is limited for use of chemotherapy in advanced or recurrent setting, warranting further research in larger samples of patients.

scholarly journals A Systematic Literature Review of Real-World Evidence in Post-Transplant Lymphoproliferative Disorder

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5839-5839 ◽  
Author(s):  
Hairong Xu ◽  
Anna Forsythe ◽  
Arie Barlev ◽  
Nazia Rashid ◽  
Crystal Watson
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Real World ◽  
Lymphoproliferative Disorder ◽  
Survival Outcomes ◽  
Employment Equity ◽  
The Real ◽  
Post Transplant ◽  
Real World Evidence ◽  
Equity Ownership

Abstract Introduction: Recipients of solid-organ transplant (SOT) or allogeneic hematopoietic stem cell transplantation (HCT) have an increased risk of cancers from Epstein-Barr virus (EBV), specifically lymphomas due to immunosuppression. Post-transplant lymphoproliferative disorder (PTLD) is a disease with a range of clinical presentations, including that of an aggressive lymphoma, that occurs after transplantation. PTLD occurs rarely after transplantation and is associated with poor survival outcomes. Publications on the clinical evidence for PTLD are scarce; therefore, a systematic literature review (SLR) was conducted to better understand the real-world evidence in PTLD. Methods: An SLR was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, with the scope defined in terms of Population, Intervention Comparators, Outcomes and Study design (PICOS) criteria. Studies were identified based on a systematic search using key biomedical literature databases: EMBASE, MEDLINE, and Cochrane. The literature search was conducted on July 19, 2018 and included studies published between database inception in January 1, 1959 and July 19, 2018. Relevant congress abstracts published between January 2015 and June 2018 were also identified. The PICOS-based inclusion and exclusion criteria were used to review identified citations. To ensure inclusion of all relevant evidence, no treatment limitations were imposed; however, the study designs were limited to prospective and retrospective observational studies. Case reports were included regardless of sample size. Two independent reviewers screened all citations and full-text articles; any discrepancies were resolved by a third independent reviewer. Data from included studies were extracted into a pre-defined template, and results were summarized using the PRISMA flow diagram. Results: A total of 447 articles were identified that met the SLR criteria: 350 SOT, 70 HCT, and 27 that included both SOT and HCT. Among 97 studies of PTLD post HCT, 81 involved allogeneic HCT, 2 involved autologous HCT, and 14 did not report the type of HCT. Of the 376 identified studies with PTLD post-SOT, the most prevalent SOTs involved were: kidney (193 studies), heart (126 studies), liver (91 studies), lung (84 studies), pancreas (43 studies), and intestine (25 studies). Data on the risk of PTLD, treatment patterns for PTLD, and utilization and survival outcomes following PTLD were reported in 334, 331, and 210 studies, respectively. There was notable clinical and methodological heterogeneity among studies. For example, there was variability in the study populations: 114 were adult populations, 136 were pediatric populations, and 197 did not specify age. Most of the studies were retrospective (419 studies) versus prospective (28 studies), and most were single-center studies (340 studies) versus multicenter studies/registries (98 studies), limiting the generalizability of the results. In addition, the sample sizes were small among most PTLD studies, with fewer than 50 patients in 376 studies, 50-100 patients in 9 studies, and more than 100 patients in 46 studies. The clinical and methodological heterogeneity noted above may explain the large variations in reported risk of PTLD in both HCT and SOT. Among adult SOT patients, the risk of developing PTLD was 0.2% to 11.5%, while among pediatric SOT patients, the risk was 0.3% to 25.0%. Among adults with HCT, the risk of developing PTLD was 1.0 to 20.0%, while among pediatric patients with HCT, the risk was 1.3% to 23.5%. Conclusions: To the best of our knowledge, this is the first comprehensive SLR to examine the published real-world evidence in patients with PTLD. Our SLR reveals important differences with respect to methodology and reporting of real-world published studies assessing the current landscape in PTLD. Additional large, high-quality studies employing more rigorous study methodology are required to understand the current landscape of PTLD in the real-world setting. Disclosures Xu: Atara Biotherapeutics, Inc: Employment, Equity Ownership. Forsythe:Novartis: Consultancy. Barlev:Atara Biotherapeutics, Inc: Employment, Equity Ownership. Watson:Atara Biotherapeutics, Inc: Employment, Equity Ownership.

scholarly journals Technological Ecosystems in Care and Assistance: A Systematic Literature Review

Sensors ◽  
2019 ◽  
Vol 19 (3) ◽  
pp. 708 ◽  
Author(s):  
Samuel Marcos-Pablos ◽  
Francisco García-Peñalvo
Keyword(s):  
Systematic Review ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Real World ◽  
The Real ◽  
Software Ecosystems ◽  
Medical Standards ◽  
Technological Ecosystems ◽  
Complex Relationships ◽  
Published Research

Applying the concepts of technological ecosystems to the care and assistance domain is an emerging field that has gained interest during the last years, as they allow to describe the complex relationships between actors in a technologically boosted care domain. In that context, this paper presents a systematic review and mapping of the literature to identify, analyse and classify the published research carried out to provide care and assistance services under a technological ecosystems’ perspective. Thirty-seven papers were identified in the literature as relevant and analysed in detail (between 2003–2018). The main findings show that it is indeed an emerging field, as few of the found ecosystem proposals have been developed in the real world nor have they been tested with real users. In addition, a lot of research to date reports the proposal of platform-centric architectures developed over existing platforms not specifically developed for care and services provision. Employed sensor technologies for providing services have very diverse natures depending on the intended services to be provided. However, many of these technologies do not take into account medical standards. The degree of the ecosystems’ openness to adding new devices greatly depends on the approach followed, such as the type of middleware considered. Thus, there is still much work to be done in order to equate other more established ecosystems such as business or software ecosystems.

scholarly journals 1390. Effectiveness of M-M-R® II in outbreaks - a systematic literature review of real-world observational studies

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S704-S705
Author(s):  
Se Li ◽  
Barbara J Kuter ◽  
Elvira Schmidt ◽  
Elizabeth Richardson ◽  
Louise P Saldutti ◽  
...  
Keyword(s):  
High School Students ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Real World ◽  
Observational Studies ◽  
Grey Literature ◽  
Post Exposure Prophylaxis ◽  
School Students ◽  
Material Support ◽  
The Us

Abstract Background M-M-R® II was approved in the US in 1978 and has been used globally for over 40 years. Widespread use of M-M-R® II has resulted in important declines in incidence, morbidity, and mortality of measles, mumps, and rubella in the US and other countries. While vaccine immunogenicity and efficacy were established in multiple placebo-controlled trials of each vaccine component, there are limited studies on vaccine effectiveness (VE) of M-M-R® II. This systematic literature review was conducted to summarize the VE of M-M-R® II from real-world observational studies. Methods The literature search was conducted in Medline and Embase (through May 2019), and grey literature sources (through July 2019). All publications and findings in English language were screened by two independent reviewers. The study characteristics and VE results were extracted for each study. Results Ten full-text publications related to VE of M-M-R® II were all identified from outbreak investigations and mainly in the US (n=8, sample size=318 - 20,496). For measles outbreaks (n=4), VE ranged from 71% to 96% in different age groups. Among high school students, VE of ≥1-dose of M-M-R® II was 94-96%. Among young adolescents, the incremental VE of ≥2-dose vs. 1-dose was 94.1%. When M-M-R® II was used as post-exposure prophylaxis within 72 hours of exposure during an outbreak, the VE was 83.4% among children 6 months to 19 years old. In another study among infants 6-14 months old, VE was 71% against laboratory-confirmed measles. Among mumps outbreaks, the VE of 1-dose, 2-dose, and ≥1-dose M-M-R® II compared to unvaccinated was 83-84%, 80-89%, 83-86% respectively. Three studies evaluating the effectiveness of a third dose of M-M-R® II showed an incremental mumps VE of 60-88% for 3-dose vs. ≤ 2-dose. One study found that individuals who had received a 2nd dose of M-M-R® II ≥13 years (vs. &lt; 13 years) before the outbreak had higher risk for contracting mumps. No study reported VE of M-M-R® II in a rubella outbreak. Conclusion M-M-R® II was found to be effective against measles and mumps during outbreaks. More effectiveness studies are warranted to further address questions on the relationship of VE and time since vaccination as well as the effectiveness of a third dose of M-M-R® II for measles or mumps outbreak control. Disclosures Se Li, PhD, Merck & Co., Inc. (Employee, Shareholder) Barbara J. Kuter, PhD, MPH, Merck (Other Financial or Material Support, Former employee) Elvira Schmidt, MSc, Certara (Employee of Certara, paid contractor to Merck) (Employee, Other Financial or Material Support) Elizabeth Richardson, BS, Merck Sharp & Dohme Corp. (Employee) Louise P. Saldutti, PhD, Mercfk & Co., Inc (Employee) Neumann Monika, Information Specialist, Certara (Employee, Employee of Certara, who was paid contractor to Merck.) Linnea Koller, n/a, Merck (Employee, Other Financial or Material Support, Employee of Certara who was paid contractor to Merck) Manica Agrawal, n/a, Certara (Employee)Merck (Grant/Research Support) Manjiri D. Pawaskar, PhD, Merck & Co., Inc (Employee, Shareholder)

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