scholarly journals 1077P Treatment outcomes in patients (pts) with melanoma brain metastases (MBM) undergoing systemic therapy: A systematic literature review (SLR) and meta-analysis (MA) of real-world evidence (RWE)

2021 ◽  
Vol 32 ◽  
pp. S892-S893
Author(s):  
G.V. Long ◽  
H.A. Tawbi ◽  
N. Meyer ◽  
B. Breznen ◽  
C. Vyas ◽  
...  
2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17571-e17571
Author(s):  
Qi Zhao ◽  
Rachel Hughes ◽  
Ishaaq Altaf-Haroon ◽  
Emma Schiller ◽  
Ananth Kadambi

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.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5839-5839 ◽  
Author(s):  
Hairong Xu ◽  
Anna Forsythe ◽  
Arie Barlev ◽  
Nazia Rashid ◽  
Crystal Watson

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.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Sibbing ◽  
D Paek ◽  
M Del Aguila ◽  
S Girotra ◽  
T Cuisset

Abstract Introduction The ischemic benefit of ticagrelor over clopidogrel seen in randomized trials has not been fully reproduced in real world cohorts. The discrepancy between these two treatments may be influenced by differences in prescribing. Purpose To provide insights in patient care for patients with high levels of comorbidities. Methods A systematic literature review and meta-analysis were conducted to compare clinical outcomes for clopidogrel vs. ticagrelor in real-world populations with acute coronary syndrome. MEDLINE and Embase were searched from inception to January 2018. Pairwise meta-analyses were performed using unadjusted random-effects models for both outcomes and patient characteristics to test for differences. Heterogeneity was assessed using the I2 statistic. Results The search identified 17 studies for analysis from 1,771 publications (TOTAL N=66,198; CLO N=54,175; TIC N=12,023). Clopidogrel-treated patients were more likely to have diabetes (33% vs. 24%), hypertension (59% vs. 47%), hyperlipidaemia/dyslipidaemia (45% vs. 39%), and prior stroke/transient ischemic attack (TIA) (8% vs. 5%). A slightly higher risk of myocardial infarction (MI) was observed for clopidogrel (4.5% vs. 3.5%; OR 1.29 [1.15–1.46]) and included clopidogrel patients had significantly more comorbidities (Figure 1). No statistical difference between clopidogrel and ticagrelor was found for risk of MACE, defined as the composite of cardiovascular (CV) death, MI or stroke, (13.6% vs. 10.1%; OR 1.41 [95% confidence interval 0.93–2.14]), despite clopidogrel patients having significantly more diabetes and hypertension (p≤0.01). Similarly, the risks of CV death (2.3% vs. 2.1%; OR 1.11 [0.58–2.13]), stroke (1.2% vs. 1.1%; OR 1.11 [0.56–2.17]), and stent thrombosis (1.3% vs. 1.0%; OR 1.34 [0.88–2.06]) were not statistically differentiable, despite clopidogrel patients having significantly more hyperlipidaemia in studies analysed for CV death (p<0.05); significantly more diabetes, hypertension, peripheral arterial disease (PAD), hyperlipidaemia, and prior stroke/TIA in studies analysed for stroke (p<0.05); and significantly more hyperlipidaemia and prior stroke/TIA in studies analysed for stent thrombosis (p<0.01). There were no significant differences in all bleeding events (major or minor, as defined by study) (2.0% vs. 2.7%; OR 0.74 [0.54–1.00]) or major bleeding (2.9% vs. 2.7%; OR 1.07 [0.85–1.33]). Included clopidogrel patients had significantly more diabetes, hypertension, PAD, and prior stroke/TIA (p<0.05). Significant heterogeneity (I2 >60%) was observed for MACE, CV death, stroke and bleeding. Figure 1. Comorbidities in MI Conclusion This analysis suggests clopidogrel-treated patients had more comorbidities than ticagrelor-treated patients, which may introduce a bias with negative impact on their outcomes. Despite this circumstance, with the exception of MI, this analysis showed no statistical difference in efficacy and safety between clopidogrel and ticagrelor. Acknowledgement/Funding This analysis was funded by Sanofi.


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