Real-world Setting Research Articles

Large-scale, prospective observational study of regorafenib in Japanese patients with advanced gastrointestinal stromal tumors in a real-world clinical setting.

Regorafenib improves overall survival (OS) of patients with advanced progressive gastrointestinal stromal tumors (GISTs) after standard chemotherapy in phase III trials in the 3rd-line setting. This large-scale, prospective observational study evaluated the safety and effectiveness of regorafenib in Japanese patients with GIST in a real-world clinical setting. Patients with GIST received oral regorafenib at a maximum daily dose of 160 mg for weeks 1-3 of each 4-week cycle (dose could be modified at investigator's discretion). The primary objective was to assess safety, particularly significant adverse drug reactions (ADRs), as well as the frequency of occurrence of ADRs, hand and foot syndrome (HFS), discontinuation of treatment due to disease progression and adverse events. A Cox proportional hazards model was used to evaluate associations between OS or time to treatment failure (TTF) and baseline characteristics or HFS. Between August 2013 and March 2021, 143 evaluable patients were enrolled. ADRs occurred in 90.2% of patients and led to treatment discontinuation in 28.3%. The most frequent ADRs were HFS, hypertension, and liver injury. The overall response rate was 11.3% and disease control rate 56.5% (RECIST) based on investigators' assessments. Median OS was 17.4 months (95% CI 14.24-23.68). Median TTF was 5.3 (95% CI 4.0-6.5) months. Improved OS and TTF responses occurred in patients with an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1. The outcomes in this real-world study were consistent with those seen in clinical trials. No new safety concerns were identified. https://clinicaltrials.gov, identifier NCT01933958.

Concomitant use of lansoprazole and ceftriaxone is associated with an increased risk of ventricular arrhythmias and cardiac arrest in a large Japanese hospital database

To determine whether concomitant use of ceftriaxone and oral or intravenous lansoprazole increases the risk of ventricular arrhythmia and cardiac arrest in the real-world setting in Japan. The data analyzed were obtained from the JMDC hospital-based administrative claims database for the period April 2014 to August 2022. Patients who received a proton pump inhibitor (PPI) while receiving ceftriaxone or sulbactam/ampicillin were identified. The frequency of ventricular arrhythmia and cardiac arrest was analyzed according to whether oral or intravenous PPI was concomitant with ceftriaxone or sulbactam/ampicillin. Estimates of the incidence of ventricular arrhythmia and cardiac arrest were then compared among the groups, using the Fine-Gray competing risk regression model. The results showed that the risk of ventricular arrhythmia and cardiac arrest was significantly higher with concomitant ceftriaxone and oral lansoprazole (hazard ratio 2.92, 95% confidence interval 1.99-4.29, P<0.01) or intravenous lansoprazole (hazard ratio 4.57, 95% confidence interval 1.24-16.80, P=0.02) than with concomitant sulbactam/ampicillin and oral or intravenous lansoprazole. Oral and intravenous lansoprazole may increase the risk of ventricular arrhythmia and cardiac arrest in patients who are receiving ceftriaxone.

Playing with data differently: engaging with autism and gender through participatory arts/music and a performative framework for analysis.

There are increasing demands for Participatory Arts-Based (PAB) programs involved in health research to better evidence outcomes using robust quantitative evaluation methodologies taken from science, such as standardized questionnaires, to inform commissioning and scale-up decisions. However, for PAB researchers trying to do this, barriers arise from fundamental interdisciplinary differences in values and contexts. Researchers are required to navigate the tensions between the practice-based evidence produced by the arts and the evidence-based practice sought by psychologists. Consequently, there is a need for interdisciplinary arts-science collaborations to produce alternative methods of evaluation that are better aligned to PAB approaches, and which combine systematic rigor with a sensitivity to the values, contexts and strengths of this approach. The current article centers on the development of an alternative transdisciplinary analytic tool, the Participatory arts Play Framework (PP-Framework), undertaken as part of an arts-psychology collaboration for a UK AHRC-funded PAB research project: Playing A/Part: Investigating the identities and experiences of autistic girls. We present details of three stages in the development of the PP-Framework: 1. preliminary emergence of the framework from initial video analysis of observational data from participatory music and sound workshops run for 6 adolescent autistic girls (aged 11-16); 2. identification and application of modes of engagement; and 3. further testing of the framework as an evaluation tool for use in a real-world setting, involving professional musicians engaged in delivery of a creative music project at a center for homeless people. The PP-Framework maps types of participation in terms of performative behaviors and qualities of experience, understood as modes of play. It functions as a vehicle for analyzing participant engagement, providing a tool predicated on the processes of working in creative participatory contexts while also being sensitive to the esthetic qualities of what is produced and capable of capturing beneficial changes in engagement. It offers a conceptual approach for researchers to undertake observation of participatory arts practices, taking account of embodied engagement and interaction processes. It is informed by understandings of autistic performativity and masking in conjunction with an ecological understanding of sense making as being shaped by environments, social relations and sensing subjectivity. The framework has the potential to be a bi-directional tool, with application for both practitioners and participants.

Use of pre-operative 3D planning software for revision shoulder arthroplasty: clinical experience data from a survey in a real-world setting

BackgroundPreoperative 3D planning is routinely used in primary shoulder arthroplasty, while specific challenges in the revision setting make such approaches more cumbersome and less accessible. Recently, an established preoperative planning software (Blueprint; Stryker, Tornier SA, Montbonnot-Saint-Martin, France) was expanded to offer a capability for planning of revision and complex primary shoulder arthroplasty cases. The aim of this study was to survey experienced surgeons on their perception of the new software feature for preoperative 3D planning in the setting of revision shoulder arthroplasty. MethodsAn observational survey was conducted from January 2022 to October 2022 among orthopedic surgeons performing revision shoulder arthroplasty cases. The survey was part of the Early Product Surveillance program, with the primary goal of obtaining observational data from surgical experience in a real-world setting. A two-staged survey process was applied with separate questionnaires to seek voluntary feedback on the preoperative planning phase as well as on the intra-operative evaluation of the software planning features in revision shoulder arthroplasty. ResultsTwenty-five fellowship-trained orthopedic surgeons from the USA and Canada participated in the survey and reported their feedback on 34 revision shoulder arthroplasty cases that were preoperatively planned with use of Blueprint revision planning software. The surgeons were largely in favor of the revision software planning features and confirmed perceived benefits of its use in the preoperative planning stage of revision shoulder arthroplasty cases. Reported benefits in the preoperative planning phase included increased efficiency and improved ease of creating an appropriate surgical plan, as well as increased confidence to execute revision shoulder arthroplasty cases. Surgeons also noted improvements in translation of preoperative planning to intra-operative execution of revision cases, including more appropriate implant selection and improved accuracy of implant placement. ConclusionThe feedback from fellowship-trained shoulder arthroplasty surgeons on the use of the new software feature for preoperative 3D planning of revision shoulder arthroplasty is largely favorable. Further research should be conducted to investigate whether these surgeon-perceived benefits can lead to improved clinical outcomes for patients.

Brief Report: Real-World Eligibility for Clinical Trials in Patients With Extensive-Stage SCLC at a Tertiary Care Center

IntroductionThe CASPIAN and IMpower133 trials revealed a significant survival benefit of chemotherapy plus immunotherapy in patients with extensive-stage SCLC. The current study characterizes the proportion of real-world patients who would have met eligibility for these trials and highlights factors influencing eligibility in the real-world setting. MethodsA retrospective analysis of patient data was conducted for stage IV patients with SCLC treated at the Cancer Centre of Southeastern Ontario, Canada. Trial eligibility was based on criteria used in the IMpower133 and CASPIAN trials. Data were summarized using descriptive statistics. Overall survival was assessed using the Kaplan–Meier method. ResultsOf the 116 patients included, only 12.1% met the overall eligibility criteria for the IMpower133 trial, and 14.7% for the CASPIAN trial. The most common reasons for ineligibility included: Eastern Cooperative Oncology Group (ECOG) 2 or greater (77.5%), inadequate organ function (48%), and the presence of brain metastases at diagnosis (37.3%). Sixty-one patients (59.8%) met two or more major ineligibility criteria. If trial eligibility was expanded to include ECOG 2 patients, an additional 10.3% would have met eligibility. The median overall survival for all-comers was 6.5 months. ConclusionsOnly a small minority of real-world patients with extensive-stage SCLC would have met eligibility for the IMpower133 and CASPIAN trials, with ECOG greater than or equal to 2, inadequate organ function, and brain metastases comprising the most common reasons for trial ineligibility. Future clinical trials should expand the inclusion criteria to better represent real-world patient populations.

HSD104 Semaglutide and Tirzepatide in Type 2 Diabetes: Patient Characteristics and Weight-Related Outcomes in the Real-World Setting

HSD104 Semaglutide and Tirzepatide in Type 2 Diabetes: Patient Characteristics and Weight-Related Outcomes in the Real-World Setting

HSD29 Predicting Psoriasis Area and Severity Index From Physician Global Assessment and Body Surface Area in the Real-World Dermatology Setting

HSD29 Predicting Psoriasis Area and Severity Index From Physician Global Assessment and Body Surface Area in the Real-World Dermatology Setting

Centralized or Onsite Testing? Examining the Costs of Water Quality Monitoring in Rural Africa.

Rural water systems in Africa have room to improve water quality monitoring. However, the most cost-effective approach for microbial water testing remains uncertain. This study compared the cost per E. coli test (membrane filtration) of four approaches representing different levels of centralization: (i) one centralized laboratory serving all water systems, (ii) a mobile laboratory serving all systems, (iii) multiple semi-centralized laboratories serving clusters of systems, and (iv) decentralized analysis at each system. We employed Monte Carlo analyses to model the costs of these approaches in three real-world contexts in Ghana and Uganda and in hypothetical simulations capturing various conditions across rural Africa. Centralized testing was the lowest cost in two real-world settings and the widest variety of simulations, especially those with water systems close to a central laboratory (<36 km). Semi-centralized testing was the lowest cost in one real-world setting and in simulations with clustered water systems and intermediate sampling frequencies (1-2 monthly samples per system). The mobile lab was the lowest cost in the fewest simulations, requiring few systems and infrequent sampling. Decentralized testing was cost-effective for remote systems and frequent sampling, but only if sampling did not require a dedicated vehicle. Alternative low-cost testing methods could make decentralized testing more competitive.

808-P: Impact of Fasting on Adherence to Dosing Instructions and Efficacy of Oral Semaglutide during Ramadan in People with Type 2 Diabetes in Real-World Setting—O-SEMA-Fast Subanalysis

808-P: Impact of Fasting on Adherence to Dosing Instructions and Efficacy of Oral Semaglutide during Ramadan in People with Type 2 Diabetes in Real-World Setting—O-SEMA-Fast Subanalysis

803-P: How Effective Is Weight Loss by Oral Semaglutide on Glycemic Control in a Real-World Setting?

803-P: How Effective Is Weight Loss by Oral Semaglutide on Glycemic Control in a Real-World Setting?

1692-P: Prevalence, Characteristics, and Clinical Burden among Patients with Overweight or Obesity and Established ASCVD in a U.S. Real-World Setting

1692-P: Prevalence, Characteristics, and Clinical Burden among Patients with Overweight or Obesity and Established ASCVD in a U.S. Real-World Setting

A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry

BackgroundAdvances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction. ObjectiveThe purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months. MethodsThe Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system. ResultsThe device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28–0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13–0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%–86.4%) in patients paced >90%. ConclusionThe Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.

Evaluating the ability of convolutional neural networks for transfer learning in Pinus radiata cover predictions

The species Pinus radiata is highly invasive in native forests in Chile, drastically affecting the functioning and structure of ecosystems. Hence, it is imperative to develop robust approaches to detect P. radiata invasions at different scales. Models based on convolutional neural networks (CNN) have proven to be a promising alternative to detect plant invasions in high-resolution remote sensing data, such as those obtained by drones. However, studies have been limited in their spatial variability and their assessments of transferability or transfer learning to new sectors, hindering the ability to use these models in a real-world setting. We train models based on CNN architectures using unpiloted aerial vehicle data and evaluate their ability to transfer learning outside the training domain using regression approaches. We compared models trained with low spatial variability (mono-site) with those with high spatial variability (multi-site). We further sought to maximize the transference of learning outside the training domain by searching among different architectures and models, maximizing the evaluation in an independent data set. The results showed that transfer learning is better when multi-site models with higher spatial variability are used for training, obtaining a coefficient of determination R2 between 60% and 87%. On the contrary, mono-site models present a wide variability of performance attributed to the dissimilarity of information between sites, limiting the possibilities of using these models for extrapolations or model generalizations. We also obtained a significant difference between within-domain generalization using test data versus transfer learning outside the training domain, showing that testing data alone cannot depict such discrepancy without further data. Finally, the best models for transfer learning on new data domains often do not agree with those selected by the standard training/validation/testing scheme. Our findings pave the way for deeper discussions and further investigations into the limitations of CNN models when applied to high-resolution imagery.

Implications of therapy interruption on monthly migraine days and modified migraine disability assessment in patients treated with erenumab for chronic and episodic migraine: SQUARE study interim results

BackgroundThere are limited real-world data in Switzerland examining the impact of erenumab, a fully human IgG2 monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, on migraine-related quality of life.ObjectiveThis 18-month interim analysis of 172 patients with episodic or chronic migraine from the SQUARE study provides first prospective insights on the impact of mandatory erenumab treatment interruption, following Swiss-reimbursement requirements, in a real-world clinical setting in Switzerland.FindingsRecruited patients receiving 70 or 140 mg erenumab underwent treatment interruption on average 11.2 months after therapy onset with a mean duration of 4 months. There were sustained improvements in mean monthly migraine days (MMD) and migraine disability (mMIDAS) during initial treatment with erenumab. Treatment interruption was associated with a temporary worsening of condition. Symptoms ameliorated upon therapy reuptake reaching improvements similar to pre-break within 3 months.ConclusionsTreatment interruption was associated with a temporary worsening of condition, which improved again after therapy restart.

Hepatitis C (HCV) Reinfection and Risk Factors among Clients of a Low-Threshold Primary Healthcare Service for People Who Inject Drugs in Sydney, Australia.

Hepatitis C (HCV) reinfection studies have not focused on primary healthcare services in Australia, where priority populations including people who inject drugs (PWID) typically engage in healthcare. We aimed to describe the incidence of HCV reinfection and associated risk factors in a cohort of people most at risk of reinfection in a real-world community setting. We conducted a secondary analysis of routinely collected HCV testing and treatment data from treatment episodes initiated with direct-acting antiviral (DAA) therapy between October 2015 and June 2021. The overall proportion of clients (N = 413) reinfected was 9% (N = 37), and the overall incidence rate of HCV reinfection was 9.5/100PY (95% CI: 6.3-14.3). Reinfection incidence rates varied by sub-group and were highest for Aboriginal and/or Torres Strait Islander people (20.4/100PY; 95% CI: 12.1-34.4). Among PWID (N= 321), only Aboriginality was significantly associated with reinfection (AOR: 2.73, 95% CI: 1.33-5.60, p = 0.006). High rates of HCV reinfection in populations with multiple vulnerabilities and continued drug use, especially among Aboriginal and Torres Strait Islander people, highlight the need for ongoing regular HCV testing and retreatment in order to achieve HCV elimination. A priority is resourcing testing and treatment for Aboriginal and/or Torres Strait Islander people. Our findings support the need for novel and holistic healthcare strategies for PWID and the upscaling of Indigenous cultural approaches and interventions.

Real-World Experience with Isavuconazole in Allogeneic Stem Cell Transplantation in Spain

Invasive fungal infections (IFI) pose a significant complication after hematopoietic stem cell transplantation (HSCT). Isavuconazole (ISV) is a new generation azole with a favourable adverse effect and interaction profile approved for the treatment of invasive aspergillosis and mucormycosis. We analyzed the indications, effectiveness, adverse event profile and drug interaction management of ISV in the real-world setting in adults who received allogeneic-HSCT (allo-HSCT) within the Spanish Group of HSCT and Cell Therapy (GETH-TC). We conducted a multicenter retrospective study of all consecutive adult allo-HSCT recipients (≥18 years) who received ISV either for IFI treatment or prophylaxis, from December 2017 to August 2021, in 20 centers within the Spanish Group of Hematopoietic Stem Cell Transplantation and Cell Therapy (GETH-TC). A total of 166 adult allografted patients who received ISV from 2017 to 2021 were included. Median age was 48 years with 43% females. In 81 (49%) patients, ISV was used for treatment of IFI, and in 85 (51%) for prophylaxis. Median duration of ISV administration for IFI treatment was 57 days (range 31-126) and 86 days (range 33-196) for prophylaxis. Most frequent indication for treatment was invasive aspergillosis (78%), followed by mucormycosis (6%). Therapeutic success (45%) was the most frequent reason for ISV withdrawal. In the prophylaxis group, the resolution of IFI risk factors was the most frequent reason for withdrawal (62%). Six (7%) breakthrough IFI were reported. The majority of patients (80%) presented pharmacologic interactions. Twenty-one patients (13%) reported adverse events related to ISV, mainly liver biochemistry abnormalities, which led to ISV withdrawal in 7 patients (4%). ISV was effective and well tolerated for IFI treatment and prophylaxis, with a manageable interaction profile.

Just-in-Time Adaptive Intervention for Stabilizing Sleep Hours of Japanese Workers: Microrandomized Trial.

Sleep disturbance is a major contributor to future health and occupational issues. Mobile health can provide interventions that address adverse health behaviors for individuals in a vulnerable health state in real-world settings (just-in-time adaptive intervention). This study aims to identify a subpopulation with vulnerable sleep state in daily life (study 1) and, immediately afterward, to test whether providing mobile health intervention improved habitual sleep behaviors and psychological wellness in real-world settings by conducting a microrandomized trial (study 2). Japanese workers (n=182) were instructed to collect data on their habitual sleep behaviors and momentary symptoms (including depressive mood, anxiety, and subjective sleep quality) using digital devices in a real-world setting. In study 1, we calculated intraindividual mean and variability of sleep hours, midpoint of sleep, and sleep efficiency to characterize their habitual sleep behaviors. In study 2, we designed and conducted a sleep just-in-time adaptive intervention, which delivered objective push-type sleep feedback messages to improve their sleep hours for a subset of participants in study 1 (n=81). The feedback messages were generated based on their sleep data measured on previous nights and were randomly sent to participants with a 50% chance for each day (microrandomization). In study 1, we applied hierarchical clustering to dichotomize the population into 2 clusters (group A and group B) and found that group B was characterized by unstable habitual sleep behaviors (large intraindividual variabilities). In addition, linear mixed-effect models showed that the interindividual variability of sleep hours was significantly associated with depressive mood (β=3.83; P=.004), anxiety (β=5.70; P=.03), and subjective sleep quality (β=-3.37; P=.03). In study 2, we found that providing sleep feedback prolonged subsequent sleep hours (increasing up to 40 min; P=.01), and this effect lasted for up to 7 days. Overall, the stability of sleep hours in study 2 was significantly improved among participants in group B compared with the participants in study 1 (P=.001). This is the first study to demonstrate that providing sleep feedback can benefit the modification of habitual sleep behaviors in a microrandomized trial. The findings of this study encourage the use of digitalized health intervention that uses real-time health monitoring and personalized feedback.

Outcome of Patients with Locally Advanced Rectal Cancer Pursuing Non-Surgical Strategy in National Cancer Database

Background: Survival data on patients with locally advanced rectal cancer (LARC) undergoing non-operative management (NOM) in a real-world setting are lacking. Methods: We analyzed LARC patients from the National Cancer Database with the following features: treated between 2010 and 2020, age 18–65 years, Charlson comorbidity index (CCI) ≤ 1, received neoadjuvant multiagent chemotherapy plus radiation ≥ 45 Gray, and underwent surgery or NOM. Patients were stratified into two groups: (A) clinical T1-3 tumors with positive nodes (cT1-3N+) and (B) clinical T4 tumors, N+/− (cT4N+/−). We performed a comparative analysis of overall survival (OS) with NOM versus surgery by the Kaplan–Meier method and propensity score matching. Additionally, a multivariable analysis explored the association between NOM and OS. Results: NOM exhibited significantly lower OS than surgery in both groups. In cT1-3N+ patients, NOM resulted in a 5-year OS of 73.9% (95% confidence interval [CI] = 69.7–77.6%) versus 84.5% (95% CI = 83.6–85.3%) with surgery (p &lt; 0.001). In the cT4N+/− group, NOM yielded a 5-year OS of 44.5% (95% CI = 37.0–51.8%) versus 72.5% (95% CI = 69.9–74.8%) with surgery (p &lt; 0.001). Propensity score matching and multivariable analyses revealed similar conclusions. Conclusion: Patients with LARC undergoing NOM versus surgery in real-world settings appear to have inferior survival.

Short-, mid- and long-term efficacy of dupilumab in moderate-to-severe atopic dermatitis: a real-world multicentre Italian study of 2576 patients

Abstract Background The efficacy and safety of dupilumab in atopic dermatitis (AD) have been defined in clinical trials but limited real-world evidence on long-term treatment outcomes is currently available to inform clinical decisions. Objectives To describe the long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD. Methods A multicentre, retrospective, dynamic cohort study was conducted to assess long-term effectiveness and safety of dupilumab in patients with moderate-to-severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria [defined as the simultaneous achievement of a 90% reduction in Eczema Area and Severity Index score, itch-numeric rating scale (NRS) score ≤ 1, sleep-NRS score ≤ 1 and Dermatology Life Quality Index ≤ 1] were investigated. Results In total, 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506/2309 (21.9%), 769/1959 (39.3%), 628/1247 (50.4%), 330/596 (55.4%) and 58/106 (54.7%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AEs) were mild and were observed in 373/2364 (15.8%), 166/2066 (8.0%), 83/1291 (6.4%), 27/601 (4.5%) and 5/110 (4.5%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AEs led to treatment discontinuation in &amp;lt; 1% of patients during the evaluated time periods. Conclusions The high long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate-to-severe AD, regardless of clinical phenotype and course (persisting or relapsing) at baseline. Further research will be needed to investigate the effect of T helper cell 2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.

Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence.

Aim: To describe the evolution of regorafenib use, since its approval, in patients with previously treated metastatic colorectal cancer (mCRC) in routine clinical practice in Spain.Methods: We extracted patient characteristics, dosing, safety and efficacy data for the Spanish cohorts of the CORRECT and CONSIGN trials, and the real-world CORRELATE study.Results: The Spanish cohorts represented 10.7-13.8% of the global cohorts. Efficacy and safety in the Spanish cohorts reflected findings from the global cohorts, with evidence of a flexible dosing approach being adopted in routine clinical practice.Conclusion: Regorafenib use in patients with mCRC has evolved in the real-world setting, emphasizing the need for further research evaluating dosing patterns that can optimize clinical outcomes in these patients.Clinical trial registration: The CORRECT trial is registered at ClinicalTrials.gov, number NCT01103323; the CONSIGN trial is registered at ClinicalTrials.gov, number NCT01538680; the CORRELATE study is registered at ClinicalTrials.gov, number NCT02042144.