Abstract
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.
Highlights
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
We identified 2,274 CRC patients exposed to biologics in 2010 and 2,484 patients in 2014
After 24 months, the survival probabilities were 32% in the two younger age groups (75 years). This observational population-based study of more than 4,500 CRC patients from three European countries showed that CRC patients treated with biologics in the real-world setting differ substantially from those included in pivotal RCTs of those drugs
Summary
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 aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany). Several randomized controlled trials (RCTs) have shown that biologic drugs, called “biologic” because they are produced by living organisms, may improve survival in patients with advanced colorectal cancer (CRC) [1,2,3,4]. A positive assessment of the risk-benefit ratio and confirmatory results from further RCTs led to the approval by the European Medicines Agency of bevacizumab for the treatment of advanced CRC in 2005 [6]
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