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.

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 Treatment Patterns for Patients with Post-Transplant Lymphoproliferative Disorder Who Fail Rituximab after Allogeneic Hematopoietic Stem Cell Transplantation: Findings from a Systematic Literature Review

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4777-4777
Author(s):  
Hairong Xu ◽  
Crystal Watson ◽  
Shan Ashton Garib ◽  
Anna Forsythe ◽  
Arie Barlev
Keyword(s):  
Literature Review ◽  
Sample Size ◽  
Systematic Literature Review ◽  
Treatment Patterns ◽  
Second Line ◽  
First Line ◽  
Employment Equity ◽  
Post Transplant ◽  
Allogeneic Hct ◽  
Equity Ownership

Abstract Introduction: Post-transplant lymphoproliferative disorder (PTLD) is a well-recognized disease after allogeneic hematopoietic stem cell transplantation (HCT) and is one of the most common post-transplant malignancies. In most cases, PTLD is associated with Epstein-Barr Virus (EBV) infection. The management of PTLD remains a challenge, with no approved treatments for patients. Clinical practice treatment guidelines recommend rituximab as first-line therapy for PTLD post-allogeneic HCT; however, treatment options for PTLD patients who fail rituximab are not clearly defined. We conducted a systematic literature review of the published literature to better understand treatment patterns for patients with PTLD who fail rituximab post-allogeneic HCT in a real-world setting. Methods: The systematic literature review was performed following 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. Using extensive search terms for the indication and study designs, studies were identified 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. No treatment limitations were imposed to ensure inclusion of all relevant evidence; 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 69 studies were identified that described patients with PTLD post-allogeneic HCT. The majority (61 studies) were retrospective chart reviews, of which 54 studies were single-center studies. Forty-eight studies reported data on treatment of patients with PTLD. Among these, 5 studies included data prior to 2000, 33 studies included data from 2000-2010, and 26 studies included data from 2010-2016. The sample size for PTLD patients was between 1 and 144 patients, with only one study of > 100 patients. First-line therapy in PTLD included rituximab (41 studies), various chemotherapy regimens (15 studies), and lymphocyte infusion (10 studies). Nine studies reported treatment for patients who failed first-line rituximab (13-67% of PTLD patients); the number of patients with second-line treatments ranged from 2-10 across studies. Second-line treatments varied greatly across studies and included cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP, n=1); rituximab plus CHOP (R-CHOP, n=1-2); cyclophosphamide, etoposide/cytarabine (VP16/ARA-C, n=1); rituximab plus cyclophosphamide (n=1); rituximab plus high-dose cytarabine (n=1); chemotherapy unspecified (n=2-4), and lymphocyte infusion (n=3-5). Only 2 studies reported treatment outcomes in rituximab-refractory patients. One study (N=62, second-line n=10, median age 49 years) reported no complete or partial remission in the chemotherapy group; 60% had complete remission in the lymphocyte infusion group. The second study (N=12, second-line n=3, mean age 5 years) reported complete remission in 1 patient with lymphocyte infusion as second-line treatment. Conclusions: This systematic literature review demonstrates that data on treatment patterns for PTLD patients who failed rituximab post-allogeneic HCT are limited (9 studies with a sample size ≤ 10). Published data suggest that the percentage of patients who fail rituximab vary greatly (13-67%), there is no consistent standard of care for PTLD patients who fail rituximab, and outcomes are poor. There continues to be a significant unmet need among PTLD patients who fail rituximab, and further studies are needed to better understand rituximab response rates in the real-world setting. Disclosures Xu: Atara Biotherapeutics, Inc: Employment, Equity Ownership. Watson:Atara Biotherapeutics, Inc: Employment, Equity Ownership. Forsythe:Novartis: Consultancy. Barlev:Atara Biotherapeutics, Inc: Employment, Equity Ownership.

scholarly journals Younger Patients Are Impacted By Post-Transplant Lymphoproliferative Disorder: Findings from a Systematic Literature Review of Real-World Evidence

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5841-5841
Author(s):  
Crystal Watson ◽  
Hairong Xu ◽  
Anna Forsythe ◽  
Shan Ashton Garib ◽  
Arie Barlev
Keyword(s):  
Literature Review ◽  
Sample Size ◽  
Study Design ◽  
Real World ◽  
Lymphoproliferative Disorder ◽  
Pediatric Patients ◽  
Employment Equity ◽  
Younger Patients ◽  
Cancer Statistics ◽  
Equity Ownership

Abstract Introduction: Transplant recipients younger than 18 years old are believed to have a 2- to 4-fold higher risk of developing post-transplant lymphoproliferative disorder (PTLD) than adult transplant patients. Within the pediatric group, there is evidence to suggest an increased risk of PTLD in younger children. We conducted a systematic literature review (SLR) to estimate the weighted mean age (WMA) at PTLD diagnosis and describe patient demographics in the real-world setting. 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. Using the sample size from the selected studies, the WMA for each relevant subgroup was determined and was compared to the average age at the time of diagnosis for other cancers reported in SEER Cancer Statistics (2011-2015; https://seer.cancer.gov/csr/). Results: A total of 447 studies fulfilled the search criteria: 114 adult studies, 136 pediatric studies with varied definitions (< 16, < 18 or < 21 years old), and 197 that did not specify inclusion by age. Seventy studies enrolled only PTLD patients after allogeneic hematopoietic stem cell transplantation (HCT). Among these studies, 17 included pediatric patients with a WMA of 12.5 years, 10 included adult patients with a WMA of 40.2 years, and 41 had no age restriction with a WMA of 34.4 years. For pediatric patients, the risk of post-HCT PTLD was 1.3-23.5% and the time from transplant to PTLD was 0.9-6.0 months. There was only one pediatric HCT study (N=4; mean age, 9 years), which reported median survival of 27.6 months. A total of 350 studies only enrolled PTLD patients after solid-organ transplant (SOT). Among these studies, 115 included pediatric patients with a WMA of 6.6 years, 98 included adult patients with a WMA of 46.9 years, and 136 had no age restriction with a WMA of 38.6 years. Among the pediatric SOT studies, the risk of PTLD was 0.3-25.0%, the time from transplant to PTLD was 1.4-92.8 months, and the reported survival was 0.9-37.2 months. The average age of lymphoma patients at cancer diagnosis according to the SEER Cancer Statistics database was 65 years. Conclusions: This SLR of published real-world studies demonstrates that the WMA at PTLD diagnosis (for studies with no age restrictions: 34.4 years for HCT and 38.6 years for SOT) is substantially lower than the reported average age at diagnosis for lymphomas (65 years), irrespective of study design and inclusion criteria. PTLD greatly impacts the pediatric population, with a quarter of HCT studies and a third of SOT studies focusing on this population. Currently, there is no indicated treatment for this ultra-rare disease with poor prognosis, indicating a clear unmet need for patients with PTLD that disproportionately affects younger patients. Disclosures Watson: Atara Biotherapeutics, Inc: Employment, Equity Ownership. Xu:Atara Biotherapeutics, Inc: Employment, Equity Ownership. Forsythe:Novartis: Consultancy. Barlev: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.

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