Real-world outcomes of ponatinib in treatment of advanced gastrointestinal stromal tumors (GIST) after tyrosine kinase inhibitor (TKI) failure.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e22508-e22508 ◽  
Author(s):  
Michael C. Heinrich ◽  
Lisa McGarry ◽  
David Kerstein ◽  
Hui Huang
Keyword(s):  
Real World ◽  
Kinase Inhibitor ◽  
Unmet Need ◽  
Rapid Progression ◽  
Phase 2 ◽  
Duration Of Treatment ◽  
Real World Data ◽  
Study Results ◽  
Starting Dose ◽  
Exon 11

e22508 Background: Imatinib is standard front-line treatment for advanced KIT+ GIST. For patients whose tumors progress on imatinib, sunitinib is indicated, followed by regorafenib for those with disease progression on both imatinib and sunitinib. Patients refractory to 2 prior TKIs typically experience rapid progression (median PFS: 4.8 mos for regorafenib; 0.9 mos for placebo [Demetri Lancet 2013]), and with failure of all approved TKIs, unmet need remains high. The oral TKI ponatinib, approved for TKI-refractory CML and Ph+ ALL, has shown activity in heavily-pretreated (76% with ≥4 prior regimens) advanced KIT+ GIST patients in a Phase 2, single-arm study (Heinrich ASCO 2015) at starting dose of 45 mg/day: clinical benefit rate (CBR = CR + PR + SD for ≥16 wks) of 37% and median PFS of 4.3 mos were observed in 30 patients with KIT exon-11-mutant GIST and CBR of 14% and median PFS of 2.0 mos in 15 patients whose GIST lacked a KIT exon 11 mutation. Methods: To examine real-world outcomes, we retrospectively identified patients receiving ponatinib off-label for GIST (ICD-9 171.5x, 171.9x) between 01Jan2014 and 31Dec2016 from sole-source US specialty-pharmacy records. Using patient, physician and pharmacy dispensing data, patient characteristics, treatment setting and dosing were noted, and duration of treatment (DOT) was examined using Kaplan-Meier techniques. Results: We identified 26 probable GIST patients receiving ponatinib over this 2-year period: 58% male; median age 57.5 yrs. Where reported, all received prior TKIs, but data for prior lines of therapy were incomplete. Most (69%) were treated in an academic setting, and the most frequent starting dose was 45 mg (77%). DOT ranged from < 1 to > 19 mos, with an estimated median DOT of 3.8 mos. At 3 mos, 61% of patients were estimated to remain on ponatinib, and at 6 mos, 34%. Conclusions: Available real-world data show that patients treated with ponatinib for TKI-refractory GIST had a median DOT of almost 4 mos, with 1/3 remaining on therapy for > 6 mos. Using DOT as a surrogate for PFS, these results are consistent with Phase 2 study results, and suggest ponatinib may have activity in patients who have exhausted other treatment options.

Treatment duration and response of advanced renal cell carcinoma (aRCC) patients (pts) who have completed first-line (1L) treatment (tx): Results from a cross-sectional real-world study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 643-643
Author(s):  
Giovanni Zanotti ◽  
Ruth Kim ◽  
Stan Krulewicz ◽  
Jennifer P. Hall ◽  
Andrea Leith ◽  
...  
Keyword(s):  
Real World ◽  
Kinase Inhibitor ◽  
Unmet Need ◽  
Stage Iv ◽  
Complete Response ◽  
Cross Sectional Survey ◽  
Real World Data ◽  
Cross Sectional ◽  
Therapeutic Landscape ◽  
The Us

643 Background: In 2019, there was an estimated 73,820 new cases of kidney cancers in the US. The tx landscape for aRCC is changing rapidly. Recently approved txs for 1L aRCC include new targeted agents and immuno-oncology (IO) therapies. We examine outcomes for pts who completed 1L tx. Methods: Real-world data were drawn from the RCC Disease Specific Programme; a cross-sectional survey administered to US oncologists, nephrologists and urologists. Physicians completed pt record forms (PRFs) for up to the next 8 consulting aRCC pts receiving drug tx, from February - September 2019, plus additional optional PRFs for pts receiving/who had received either 1L tx of nivolumab/ipilimumab combination or cabozantinib, where these pts were available. Results: Physicians (n=82) provided data on 687 pts; 230 had progressed from 1L tx and were on 2L tx at time of data collection. Of those receiving 2L tx, 61% male; mean age was 66.4 years (SD=11.0); 43% stage IV at diagnosis. At 1L, 72% (n=165) had received tyrosine kinase inhibitor (TKI) monotherapy; 16% (n=37) IO+IO, 3% (n=7) TKI+IO and 9% (n=20) other regimens. Mean 1L duration was 10.3 months (SD=9.4) and mean time to 2L initiation was 13.7 months (SD=21.1). 1L treatment responses were: 6% complete response, 21% partial response, 16% stable disease, and the remainder relapsed/progressed (44%) or unknown response (13%). Most common 2L regimens were TKI (37%) or IO (34%) monotherapy. 47% of 1L TKI monotherapy pts received 2L IO monotherapy. 86% of 1L IO+IO pts received 2L TKI monotherapy. Conclusions: Some pts with aRCC progress to 2L; many experience poor clinical outcomes with 1L txs, highlighting high unmet need in 1L for more efficacious txs. Optimal tx strategy (and sequencing) continues to evolve. Approval of IO+TKI therapies, approved during the fieldwork period, has broadened the therapeutic landscape for 1L aRCC. Whilst the proportion of 1L pts receiving IO+TKI therapies is still low, the adoption of these in 1L is likely to transform the management of aRCC. Further research is needed to determine the optimum tx sequence in these pts with high unmet need.

scholarly journals Pazopanib in Patients with Osteosarcoma Metastatic to the Lung: Phase 2 Study Results and the Lessons for Tumor Measurement

2022 ◽  
Vol 2022 ◽  
pp. 1-9
Author(s):  
Paul Frankel ◽  
Chris Ruel ◽  
An Uche ◽  
Edwin Choy ◽  
Scott Okuno ◽  
...  
Keyword(s):  
Doubling Time ◽  
Kinase Inhibitor ◽  
Common Adverse Event ◽  
Phase 2 ◽  
Primary Analysis ◽  
Tumor Doubling Time ◽  
Metastatic Osteosarcoma ◽  
Phase 2 Study ◽  
Study Results ◽  
Slow Growing

Background. This single-arm, multicenter, phase 2 study evaluated the safety and antitumor activity of pazopanib in patients with unresectable, pulmonary metastatic osteosarcoma. Patients and Methods. Patients with pulmonary metastatic osteosarcoma unresponsive to chemotherapy were eligible. Patients who received prior tyrosine kinase inhibitor therapy were excluded. Pazopanib at 800 mg once daily was administered for 28-day cycles. Tumor responses were evaluated by local radiology assessment 1 month prior to and after initiation of treatment to calculate tumor doubling time and after every even numbered cycle. The primary endpoints were progression-free survival at 4 months, concomitant with a demonstrated 30% increase in tumor doubling time relative to the pretreatment growth rate. Results. 12 patients (7 female) were enrolled. The study was terminated prematurely due to withdrawal of financial support by the sponsor. 8 subjects were eligible for the primary analysis, whereas 4 patients were in a predefined exploratory “slow-growing” cohort. In the “fast-growing” cohort, 3 of the 8 patients (37.5%) eligible for first-stage analysis were deemed “success” by the preplanned criteria, adequate to proceed to second-stage accrual. In addition, 1 of the 4 patients in the “slow-growing” cohort experienced a partial remission. Grade 1-2 diarrhea was the most common adverse event, and grade 3 events were infrequent. Conclusion. This study illustrates a novel method of demonstrating positive drug activity in osteosarcoma by increasing tumor doubling time, and this is further supported by a partial response in a patient with “slow-growing” disease. This trial is registered with NCT01759303.

scholarly journals Valuing new medicines in the early 21:st century

2017 ◽  
Vol 5 (1) ◽  
pp. 7-22
Author(s):  
Katarina Steen Carlsson ◽  
Bengt Jönsson
Keyword(s):  
Health Care ◽  
Clinical Practice ◽  
Real World ◽  
Patent Protection ◽  
New Technologies ◽  
New Technology ◽  
Treatment Strategies ◽  
Real World Data ◽  
Study Results ◽  
Pricing And Reimbursement

What is the actual value of new medicines? The answer to this question is the key to rational use of new technologies in health care and for design of appropriate incentives for innovation. In this paper we present methods, data and study results for valuing new medical technologies in a life cycle perspective, relevant for development of a new approach to contract and payment for innovation that can replace present systems for pricing and reimbursement.   Focus is on value in clinical practice, and on the data needs and methods needed for the development of outcome-based payment systems that balances risks and rewards for innovation in health care. We provide an overview of studies from the Swedish context on the value of new medicines introduced in the treatment of diabetes, cancer, cardiovascular disease and rheumatoid arthritis. These studies using national health data and quality registers emphasise the importance of continuing efforts to collect relevant data for assessment of value after a medicine reaches the market and starts to be used in clinical practice. It is only when medicines are used in clinical practice that the benefits for real-world patient populations can be identified, measured and valued. Analyses of real-world data will also assist further development and tailoring of treatment strategies to optimize the value of the new technology. While an effective patent system rewards innovation for a limited period of time, many innovations may continue to provide value to society long after patent protection, and these values must be included in the assessment of value of innovation.

scholarly journals Exploring Predictors of Response to Dacomitinib in EGFR-Amplified Recurrent Glioblastoma

2020 ◽  
pp. 593-613
Author(s):  
Andrew S. Chi ◽  
Daniel P. Cahill ◽  
David A. Reardon ◽  
Patrick Y. Wen ◽  
Tom Mikkelsen ◽  
...  
Keyword(s):  
Gene Amplification ◽  
Clinical Benefit ◽  
Kinase Inhibitor ◽  
Growth Factor Receptor ◽  
Genetic Alterations ◽  
Recurrent Glioblastoma ◽  
Rapid Progression ◽  
Duration Of Treatment ◽  
Egfr Gene ◽  
Predictors Of Response

PURPOSE Despite the high frequency of EGFR genetic alterations in glioblastoma (GBM), EGFR-targeted therapies have not had success in this disease. To improve the likelihood of efficacy, we targeted adult patients with recurrent GBM enriched for EGFR gene amplification, which occurs in approximately half of GBM, with dacomitinib, a second-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that penetrates the blood-brain barrier, in a multicenter phase II trial. PATIENTS AND METHODS We retrospectively explored whether previously described EGFR extracellular domain (ECD)–sensitizing mutations in the context of EGFR gene amplification could predict response to dacomitinib, and in a predefined subset of patients, we measured post-treatment intratumoral dacomitinib levels to verify tumor penetration. RESULTS We found that dacomitinib effectively penetrates contrast-enhancing GBM tumors. Among all 56 treated patients, 8 (14.3%) had a clinical benefit as defined by a duration of treatment of at least 6 months, of whom 5 (8.9%) remained progression free for at least 1 year. Presence of EGFRvIII or EGFR ECD missense mutation was not associated with clinical benefit. We evaluated the pretreatment transcriptome in circulating extracellular vesicles (EVs) by RNA sequencing in a subset of patients and identified a signature that distinguished patients who had durable benefit versus those with rapid progression. CONCLUSION While dacomitinib was not effective in most patients with EGFR-amplified GBM, a subset experienced a durable, clinically meaningful benefit. Moreover, EGFRvIII and EGFR ECD mutation status in archival tumors did not predict clinical benefit. RNA signatures in circulating EVs may warrant investigation as biomarkers of dacomitinib efficacy in GBM.

scholarly journals Validity of social media for assessing treatment patterns in oncology patients: a case study in melanoma

JAMIA Open ◽  
2019 ◽  
Vol 2 (4) ◽  
pp. 416-422
Author(s):  
Laura McDonald ◽  
Varun Behl ◽  
Vijayarakhavan Sundar ◽  
Faisal Mehmud ◽  
Bill Malcolm ◽  
...  
Keyword(s):  
Social Media ◽  
Confidence Intervals ◽  
Real World ◽  
Unmet Need ◽  
Data Access ◽  
Treatment Patterns ◽  
Patient Treatment ◽  
Real World Data ◽  
The Real ◽  
Third Line

Abstract There is a need to understand how patients are managed in the real world to better understand disease burden and unmet need. Traditional approaches to gather these data include the use of electronic medical record (EMR) or claims databases; however, in many cases data access policies prevent rapid insight gathering. Social media may provide a potential source of real-world data to assess treatment patterns, but the limitations and biases of doing so have not yet been evaluated. Here, we assessed whether patient treatment patterns extracted from publicly available patient forums compare to results from more traditional EMR and claims databases. We observed that the 95% confidence intervals of proportions of treatments received at first, second, and third line for advanced/metastatic melanoma generated from unstructured social media data overlapped with 95% confidence intervals from proportions obtained from 1 or more traditional EMR/Claims databases. Social media may offer a valid data option to understand treatment patterns in the real world.

Real-world evidence of male breast cancer (BC) patients treated with palbociclib (PAL) in combination with endocrine therapy (ET).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1055-1055 ◽  
Author(s):  
Cynthia Huang Bartlett ◽  
Jack Mardekian ◽  
Michelle Yu-Kite ◽  
Matthew James Cotter ◽  
Sindy Kim ◽  
...  
Keyword(s):  
Real World ◽  
Randomized Clinical Trials ◽  
Treatment Guidelines ◽  
Healthcare Providers ◽  
First Line ◽  
Duration Of Treatment ◽  
Real World Data ◽  
The Real ◽  
Real World Evidence ◽  
Line Setting

1055 Background: The rarity of BC in men limits the feasibility of randomized clinical studies in this population. Treatment guidelines recommend that men with BC be treated similarly to postmenopausal women. PAL, a cyclin-dependent kinase 4/6 inhibitor, is used in men with metastatic BC (mBC) in real-world clinical practice, presenting an opportunity to utilize real-world evidence to enable healthcare providers to assess novel agents in this space. Methods: Two parallel approaches were taken. In the first approach, pharmacy and medical claims data from IQVIA Inc were retrospectively analyzed to describe the treatment patterns and duration of PAL + ET (aromatase inhibitor or fulvestrant) compared to ET in men with mBC. The second approach was a retrospective analysis of data derived from electronic health records in the Flatiron Health database to understand real-world clinical response to PAL + ET vs ET alone. Median duration of treatment (mDOT) was estimated by the Kaplan-Meier method. Results: Between Feb 2015 and Apr 2017, 12.9% (147/1139 [IQVIA dataset]) of men receiving treatment for mBC were prescribed PAL + ET for any line of therapy. The mDOT in the first-line setting was numerically longer in the PAL cohort (n=37) compared with the non-PAL cohort (n=214; 8.5 vs 4.3 mo, respectively). In particular, mDOT in the first-line setting was longer with PAL + letrozole (LET; n=26) than with LET alone (n=63; 9.4 vs 3.0 mo, respectively). In the Flatiron Health dataset between Feb 2015 and July 2017, the real-world maximum response rate in the PAL + ET cohort across all lines of therapy in the mBC setting (n=12) was 33.3% (2 complete responses [CR], 2 partial responses [PR]) vs 12.5% (0 CR, 1 PR) for the ET alone cohort (n=8). Conclusions: The real-world data sources used in this study support that men with mBC derive clinical benefit from the addition of PAL to ET. Given the challenges of conducting randomized clinical trials in men with mBC, noninterventional, real-world evidence data appear to be useful to delineate the benefit of such therapies in this setting. Funding: Pfizer.

Nivolumab in second or third line setting for the treatment of metastatic renal cell carcinoma (mRCC): The real-world experience from Guy’s Hospital.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 624-624
Author(s):  
Ha Mo Linh Le ◽  
Debra Hannah Josephs ◽  
Simon Chowdhury ◽  
Sarah Maria Rudman ◽  
Deborah Enting
Keyword(s):  
Real World ◽  
Progression Free Survival ◽  
Duration Of Treatment ◽  
Real World Data ◽  
Optimal Sequence ◽  
Entire Cohort ◽  
Visceral Metastases ◽  
Third Line ◽  
Grade 3 ◽  
Line Setting

624 Background: Nivolumab (Nivo) has been approved by the FDA for patients (pts) with mRCC who have received prior VEGF tyrosine kinase inhibition based on the Checkmate 025 study. However following various new anti-angiogenic therapies licensed over the past decade, optimal sequence of treatments in mRCC remains unknown. Methods: This is a retrospective review of mRCC pts who received nivo at Guy’s Hospital. Pts were divided based on treatment line setting. Clinical characteristics, response rate (RR), progression free survival (PFS), duration on treatment and safety are reported. Results: Between March 2016 and April 2018, 50 pts with mRCC received nivo, 25 as second line (2L) and 25 as third line treatment or beyond (3L+). In 2L setting, median age was 62 years and 68% were male. 76% had a nephrectomy, with a majority of clear cell (cc) histology (92%). 96% of pts had visceral metastases. 88% received pazopanib in the first line setting (1L). Median age for pts in 3L+ was 60 years and 88% were male. 60% had a nephrectomy and 80% had cc histology. 96% had visceral metastases. Pazopanib was given in 72% in 1L. RR was 28% and 16% in 2L and 3L+ respectively. Median duration of treatment was 4.3 months in 2L and 2.2 months in 3L+, with 11 patients (22%) still on treatment. Median follow-up time was 12.4 months in 2L and 9 months in 3L+. Median PFS was 4.8 months and 3.7 months respectively in 2L and 3L+ groups. Median OS was not reached in either group. Adverse events leading to treatment discontinuation occurred in 7 pts (14%). 5 pts experienced grade 3/4 toxicities (colitis, pneumonitis, hepatitis, arthritis and nephritis), with 4 pts in 3L+. Overall 22 pts received subsequent treatments: 8/25 (32%) had cabozantinib (cabo) and 4/25 (16%) were treated with axitinib following nivo given in 2L. For pts who received nivo in the 3L+ setting 7/25 (28%) received cabo and 2/25 (8%) had axitinib as subsequent therapy. Conclusions: Our real world data supports the efficacy and safety of nivo following VEGF inhibition for pts with mRCC. Nivo was associated with a trend towards superior clinical responses in the 2L setting. For the entire cohort no new safety signals were reported.

Real-world dosing, management, and clinical outcomes of patients (pts) with metastatic pancreatic adenocarcinoma (mPDAC) treated with liposomal irinotecan.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16780-e16780
Author(s):  
Laith I. Abushahin ◽  
Paul Cockrum ◽  
Andy Surinach ◽  
Bruce Belanger
Keyword(s):  
Real World ◽  
Relative Survival ◽  
The United States ◽  
Duration Of Treatment ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Starting Dose ◽  
The Us ◽  
Liposomal Irinotecan ◽  
To Receive ◽  
Dose Reductions

e16780 Background: Pancreatic cancer remains one of the most lethal cancers in the United States (US) with a 5-year relative survival of 10%. Liposomal irinotecan is a topoisomerase inhibitor indicated, in combination with 5-fluorouracil and leucovorin, for pts with mPDAC following disease progression on gemcitabine-based therapy. This study examines the real-world use and therapeutic management of pts with mPDAC treated with liposomal irinotecan. Methods: This retrospective observational study utilized the Flatiron Health EHR-derived de-identified database from over 280 cancer clinics in the US. Data were analyzed for adult pts with mPDAC treated with liposomal irinotecan based regimens between Nov 2015 and Oct 2019. Pts were categorized into two starting dose groups: 70mg/m2 and < 65mg/m2. Pt characteristics, overall survival (OS), duration of treatment (DOT), and impact of dose reductions (DR, reduction ≥ 7mg/m2) were assessed among pts who received ≥3 cycles of treatment (tx). Results: Of the 532 pts (median age: 69y, IQR: 62-75) included in the study, 95 (18%) had an ECOG score of 2+ at tx initiation. Of the 184 pts (69y, 42 – 84) that did not receive 3 cycles of tx, 47 (25%) had an ECOG score of 2+ and 83 (45%) had two or more prior lines of tx. 348 pts (69y, 43 – 85) received ≥3 cycles of tx. 116 (33%) pts had two or more prior lines of tx, 209 (60%) had an ECOG score of 0-1, 48 (14%) had an ECOG score of 2+, and 91 (26%) had missing scores. 220 (63%) initiated tx at 70mg/m2 and 128 (37%) initiated at < 65mg/m2. 83 (38%) 70mg/m2 and 26 (20%) < 65mg/m2 pts experienced a DR during tx. 43 (52%) and 14 (54%) of the DRs occurred within the first 6 wks of tx in the 70mg/m2 and < 65mg/m2 cohorts, respectively. Median DOT was 12.6 weeks for 70mg/mg2 and 9.1 wks for < 65mg/m2 pts; DOT was longer among pts with a DR: 19.0 wks and 16.1 wks, respectively. Median OS (mOS) was 7.2 months (95% CI: 6.2 – 8.1) and 6.2 mos (5.0 – 7.4) for pts receiving 70mg/m2 and < 65mg/m2, respectively. mOS for pts with a DR was 8.9 mos (7.3 – 10.8) and 7.7 mos (5.0 – 14.9) for pts receiving 70mg/m2 and < 65mg/m2, respectively. mOS for pts with no DR was 6.0 mos (4.8 – 7.2) and 6.0 mos (4.7 - 7.2) for those receiving 70mg/m2 and < 65mg/m2, respectively. Conclusions: In this descriptive study among pts who were able to receive ≥3 cycles of liposomal irinotecan and remain on tx for ≥4 wks, DRs were effective in extending DOT and OS, independent of starting dose. The longest DOT and OS were observed in the pts who received 70mg/m2 with DRs. Pts who received 70mg/m2 and < 65mg/m2 had similar OS in the absence of DRs.

scholarly journals Real World data for Health and Technology assessment in Brazil: an unmet need

2015 ◽  
Vol 18 (3) ◽  
pp. A85
Author(s):  
E. Minowa ◽  
A. Piedade ◽  
G. Julian
Keyword(s):  
Technology Assessment ◽  
Real World ◽  
Unmet Need ◽  
Real World Data ◽  
World Data

scholarly journals The Impact of COVID-19 on Gastric Cancer Surgery: A Single-center Retrospective Study Based on Real-world Data

2020 ◽  
Author(s):  
Yu-xuan Li ◽  
Chang-zheng He ◽  
Yi-chen Liu ◽  
Peng-yue Zhao ◽  
Xiao-lei Xu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Cancer Surgery ◽  
Real World Data ◽  
Gastric Cancer Surgery ◽  
World Data ◽  
Study Results ◽  
Gastric Cancer Patients ◽  
The Impact

Abstract Background ： A respiratory epidemic defined as coronavirus disease 2019 ( COVID-19 ) is becoming unstoppable and has been declared a pandemic. Patients with cancer are more likely to develop COVID-19. Based on our experience during the pandemic period, we propose some surgery strategies for gastric cancer patients under the COVID-19 situation. Methods ： We defined the ‘COVID-19’ period as occurring between 2020-01-20 and 2020-03-20. All the enrolled patients were divided into two groups, pre-COVID-19 group (PCG) and COVID-19 group (CG). A total of 109 patients with gastric cancer were enrolled in this study. Results ： The waiting times before admission increased by 4 days in CG(PCG:4.5 [IQR: 2, 7.8] vs. CG:8.0 [IQR: 2,20]; P = 0.006). More patients had performed chest CT scan besides abdominal CT before admission during COVID-19 period(PCG:22[32%]vs. CG:30[73%], p=0.001). After admission, during COVID period, the waiting time before surgery was longer(3[IQR: 2,5] vs. 7[IQR: 5,9]; P < 0.001),more laparoscopic surgery were performed(PCG: 51[75%] vs. CG: 38[92%],p=0.021), and hospital stay after surgery was longer (7[IQR: 6,8] vs.9[IQR:7,11] ; P < 0.001). The total cost of hospitalization increased during COVID period, (9.22[IQR:7.82,10.97] vs. 10.42[IQR:8.99,12.57]; p=0.006). Conclusion ： Since no data is available yet on the impact of COVID-19 on gastric cancer patients,our own experience with COVID-19 in gastric cancer surgery has hopefully provided an opportunity for colleagues to reflect on their own service and any contingency plans they have to tackle the crisis. Keywords: gastric cancer; coronavirus disease 2019; COVID-19; retrospective analysis; real-world data.

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