scholarly journals Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries

2021 ◽  
Vol 11 ◽  
Author(s):  
Katja A. Oppelt ◽  
Josephina G. Kuiper ◽  
Ylenia Ingrasciotta ◽  
Valentina Ientile ◽  
Ron M. C. Herings ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Real World ◽  
European Countries ◽  
Real World Data ◽  
Exclusion Criteria ◽  
The Real ◽  
Randomized Controlled ◽  
Real World Setting ◽  
The Mean ◽  
Colorectal Cancer Patients

Introduction: Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany).Methods: We included CRC patients treated with a biologic in 2010 or 2014 and characterized them regarding age, sex, comorbidities, and absolute survival.Results: Among 4,758 patients, the mean age ranged from 64.8 to 66.8 years, the majority was male, and comorbidities used as exclusion criteria in RCTs were coded in up to 30% of these patients. The proportion of bevacizumab users decreased between 2010 (72–93%) and 2014 (63–85%). In 2014, the absolute 12-month survival in new users was 64% (95% CI 51–77%), 56% (30–80%), and 61% (58–63%) in the Dutch, Italian, and German database, respectively, varying by age and comorbidity.Conclusions: Our study suggests that in the real-world setting, CRC patients treated with biologics are older and less selected regarding comorbidities compared to patients in RCTs, potentially explaining the relatively low 12-month survival we found. Treatment decisions in the real-world setting may require careful evaluation given that the risk-benefit ratio may vary depending on age and co-existing conditions.

Survival impact on regorafenib (REG) and trifluridine/tipiracil hydrochloride (FTD/TPI) for patients with metastatic colorectal cancer: Single institutional experience.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 43-43
Author(s):  
Keigo Chida ◽  
Daisuke Kotani ◽  
Kentaro Sawada ◽  
Yoshiaki Nakamura ◽  
Akihito Kawazoe ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Phase Iii ◽  
First Line ◽  
Standard Chemotherapy ◽  
Exon 2 ◽  
The Real ◽  
Real World Setting ◽  
Tipiracil Hydrochloride

43 Background: Regorafenib (REG) and trifluridine/tipiracil hydrochloride (FTD/TPI) demonstrated overall survival (OS) benefit in patients (pts) with metastatic colorectal cancer (mCRC) in the CORRECT and RECOURSE phase III trials. In Japan, REG and FTD/TPI have been approved in 2013 and 2014, respectively. However, little is known about survival impact on these agents in the real-world setting. Therefore, the aim of this retrospective study was to evaluate the effects of REG and FTD/TPI in pts with mCRC. Methods: We collected medical records from consecutive 1142 pts who had been initiated with first-line chemotherapy for mCRC from 2008 to 2016 at National Cancer Center Hospital East. The survival outcomes were compared between pts from 2008 to 2011 (cohort A) and those from 2012 to 2016 (cohort B). This study excluded pts who have not been refractory or intolerant to standard chemotherapy including fluoropyrimidine, oxaliplatin, irinotecan, and anti-EGFR antibody if KRAS exon 2/ RAS wild-type tumors. Results: A total of 590 pts were analyzed (cohort A; N = 236 and cohort B; N = 354). More patients received at least one of REG or FTD/TPI in cohort B (16.1% vs. 59.9%, p < 0.001). The time from initiation to end of standard chemotherapy was comparable between the two cohort (20.0 vs. 17.5 months, p = 0.266). With a median follow-up period of 34.9 months, salvage-line OS (sOS) after standard chemotherapy was significantly longer in cohort B (4.8 vs. 6.6 months, p = 0.001), while there was only a favorable trend in cohort B in terms of OS from start of first-line treatment (27.3 vs. 28.5 months, p = 0.516). In cohort B, pts who sequentially received both of REG and FTD/TPI showed longest sOS (median, both of REG and FTD/TPI; 11.3 months, either REG or FTD/TPI; 7.0 months, neither REG nor FTD/TPI; 3.1 months). Conclusions: Our study showed that REG and FTD/TPI led to prolongation of sOS in the real-world setting, indicating the importance of strategies which make all active agents available to pts with mCRC.

scholarly journals Role of real-world evidence in informing cancer care: lessons from colorectal cancer

2019 ◽  
Vol 26 (1) ◽  
Author(s):  
A. Batra ◽  
W. Y. Cheung
Keyword(s):  
Colorectal Cancer ◽  
Real World ◽  
Cancer Care ◽  
Clinical Care ◽  
Real World Data ◽  
Cancer Management ◽  
Randomized Controlled ◽  
Real World Evidence ◽  
Research Questions

The term “real-world evidence” (rwe) describes the analysis of data that are collected beyond the context of clinical trials. The use and application of rwe have become increasingly common and relevant, especially in oncology, because there is growing recognition that randomized controlled trials (rcts) might not be sufficiently representative of the entire patient population that is affected by cancer, and that specific clinical research questions might be best addressed by real-world data. In this brief review, our main aim is to highlight the role of rwe in informing cancer care, particularly focusing on specific examples from colorectal cancer. Our hope is to illustrate the ways in which rwe can complement rcts in improving the understanding of cancer management and how rwe can facilitate cancer treatment decisions for real-world patients encountered in routine clinical care.

scholarly journals Establishment of inflammation biomarkers-based nomograms to predict prognosis of advanced colorectal cancer patients based on real world data

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208547 ◽  
Author(s):  
Guifang Guo ◽  
Xiuxing Chen ◽  
Wenzhuo He ◽  
Haohua Wang ◽  
Yixing Wang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Advanced Colorectal Cancer ◽  
Real World Data ◽  
World Data ◽  
Colorectal Cancer Patients

scholarly journals Comparison of Pancreatic Cancer Treatment Outcomes: A Real-World Data Analysis

2020 ◽  
Author(s):  
Jacob Vikström ◽  
Georgii Shangin ◽  
Tommi Viitanen ◽  
Natalja Eigeliene ◽  
Antti Jekunen
Keyword(s):  
Metastatic Disease ◽  
Real World ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Phase Iii ◽  
Real World Data ◽  
World Data ◽  
The Real ◽  
Randomized Controlled ◽  
Study Results

Abstract Background Since the ground-breaking phase III MPACT trial showed clear benefit of gemcitabine-nab-paclitaxel, this regimen has emerged as the standard of care for advanced pancreatic adenocarcinoma (PAC). Prior to this study, few studies have shown how results from randomized controlled trial translate to the real world. This study investigated how patients fared in the real world. Methods This single-centre, retrospective study was conducted in the Vaasa Central Hospital, Finland. 148 patients with PAC (ICD-10 C25) between 1/2011-12/2016 were identified with resectable, locally advanced or metastatic disease. Information about the basic characteristics, treatment regimens and adverse effects (AEs) were extracted from patient files and analysed. Results The median overall survival (OS) was 10.4 months for treated and 2.8 months for untreated patients. For metastatic disease OS was 4.9 months, for locally advanced 9.1 months. Patients who received 3 or more treatment lines had OS 19.1 months, while those who received 2 or 1 line had 11.3 and 6.2 months, respectively. The following grade 2–4 haematologic toxicities occurred: anaemia (n = 19), leukopenia (n = 49), neutropenia (n = 55) and thrombocytopenia (n = 9). Febrile neutropenia occurred 7 times. A total of 12 grade 5 AEs were recorded in 7 patients, and 3 other patients died of unknown complications. Conclusion This study shows that active treatment is worth pursuing in most PAC patients and study results from this real-world data study differ from randomized controlled trials. Special caution should be applied when continuing chemotherapy in patients with ECOG 2 and who are older than 70 years.

Use of cancer immunotherapies in the real-world in the setting of microsatellite instability.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 30-30
Author(s):  
Vineeta Agarwala ◽  
Anala Gossai ◽  
Gaurav Singal ◽  
Claire O'Connell ◽  
Gerald Li ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Microsatellite Instability ◽  
Real World ◽  
Checkpoint Inhibitors ◽  
Clinical Care ◽  
Unknown Primary ◽  
Tumor Type ◽  
Real World Data ◽  
The Real ◽  
Genomic Marker

30 Background: In May 2017, the FDA approved for the first time a cancer therapy (pembrolizumab) for use in patients based on the presence of a genomic marker (microsatellite instability, or MSI) rather than anatomical tumor type. Real-world data on the rates and clinical impact of MSI on treatment selection and response are scant, especially outside of colorectal cancer. Methods: We performed a retrospective study of all patients treated in the Flatiron Health network (>265 oncology practices across the U.S.) between January 2011 and June 2017, and who underwent FoundationOne tumor sequencing as part of routine clinical care. Tumor type was determined by pathologist review of specimens submitted to Foundation Medicine. Data on therapy use was sourced from electronic health records (EHRs). Assessment of MSI was performed from DNA sequencing across the coding regions of >300 genes. Results: Our overall cohort included n=16,020 patients. Among patients in whom MSI status could be assessed (n=12,411), 207 patients had MSI-high tumors. The observed rate of MSI-high was 1.7% across all tumor types combined; tumor-specific rates varied significantly, from 4.9% in colorectal adenocarcinoma to 0.3% in breast and non-small cell lung cancer. The rate of MSI-high was 2.4% in patients with an unknown primary based on specimen review. A total of 1,329 patients received common checkpoint inhibitors (nivolumab, pembrolizumab, atezolizumab). Among the checkpoint-inhibitor treated patients with known MSI status (n=1,175), 14 (1.2%) had MSI-high tumors, and the majority of these patients (n=8) had colorectal cancer. Conclusions: Evidence of MSI-high is rare in real world cancer care settings. Early identification of patients with this biomarker is important in order to efficiently match them to treatment. Further evaluation of the real-world effectiveness of immune checkpoint inhibitors in the MSI-high population is still needed. Because most patients receiving these therapies today do not have high MSI, exploration of additional biomarkers for immunotherapy response is also critical.

scholarly journals Validation of a Mortality Composite Score in the Real-World Setting: Overcoming Source-Specific Disparities and Biases

2021 ◽  
pp. 401-413
Author(s):  
Michelle H. Lerman ◽  
Benjamin Holmes ◽  
Daniel St Hilaire ◽  
Mary Tran ◽  
Matthew Rioth ◽  
...  
Keyword(s):  
Real World ◽  
High Sensitivity ◽  
The United States ◽  
Composite Score ◽  
Data Sources ◽  
Mortality Data ◽  
National Death Index ◽  
Real World Data ◽  
The Real ◽  
Real World Setting

PURPOSE This study tested whether a composite mortality score could overcome gaps and potential biases in individual real-world mortality data sources. Complete and accurate mortality data are necessary to calculate important outcomes in oncology, including overall survival. However, in the United States, there is not a single complete and broadly applicable mortality data source. It is further likely that available data sources are biased in their coverage of sex, race, age, and socioeconomic status (SES). METHODS Six individual real-world data sources were combined to develop a high-quality composite mortality score. The composite score was benchmarked against the gold standard for mortality data, the National Death Index. Subgroup analyses were then conducted to evaluate the completeness and accuracy by sex, race, age, and SES. RESULTS The composite mortality score achieved a sensitivity of 94.9% and specificity of 92.8% compared with the National Death Index, with concordance within 1 day of 98.6%. Although some individual data sources show significant coverage gaps related to sex, race, age, and SES, the composite score maintains high sensitivity (84.6%-96.1%) and specificity (77.9%-99.2%) across subgroups. CONCLUSION A composite score leveraging multiple scalable sources for mortality in the real-world setting maintained strong sensitivity, specificity, and concordance, including across sex, race, age, and SES subgroups.

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