Real‐world, population‐based cohort study of toxicity and resource utilization of second‐line ipilimumab for metastatic melanoma in Ontario, Canada

Author(s):  
Wei Fang Dai ◽  
Jaclyn Beca ◽  
Ruth Croxford ◽  
Wanrudee Isaranuwatchai ◽  
Ines B. Menjak ◽  
...  
BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Wei Fang Dai ◽  
Jaclyn M. Beca ◽  
Ruth Croxford ◽  
Wanrudee Isaranawatchai ◽  
Ines B. Menjak ◽  
...  

Author(s):  
Yen‐Chu Huang ◽  
Meng‐Che Wu ◽  
Yu‐Hsun Wang ◽  
James Cheng‐Chung Wei

2020 ◽  
Author(s):  
Wei Fang Dai ◽  
Jaclyn Beca ◽  
Ruth Croxford ◽  
Wanrudee Isaranawatchai ◽  
Ines B. Menjak ◽  
...  

Abstract Background For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment’s real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments). Methods We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting. Results We identified 329 patients with MM who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27%-41%), 20.6% (15%-27%), and 15.2% (9.6%-21%) for ipilimumab and 17.1% (11%-23%), 7.1% (2.9%-11%), and 4.7% (1.2%-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR=0.62; 95% CI: 0.49-0.78; p <0.0001). Conclusions This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.


2020 ◽  
Author(s):  
Wei Fang Dai ◽  
Jaclyn Beca ◽  
Ruth Croxford ◽  
Wanrudee Isaranawatchai ◽  
Ines B. Menjak ◽  
...  

Abstract Background For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment’s real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments). Methods We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW). Results We identified 329 patients with MM who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27%-41%), 20.6% (15%-27%), and 15.2% (9.6%-21%) for ipilimumab and 17.1% (11%-23%), 7.1% (2.9%-11%), and 4.7% (1.2%-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR=0.62; 95% CI: 0.49-0.78; p <0.0001). Conclusions This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4277-4277
Author(s):  
Hedwig M Blommestein ◽  
Djamila E Issa ◽  
Marjolein Pompen ◽  
Cédric Révil ◽  
Mels Hoogendoorn ◽  
...  

Abstract Abstract 4277 OBJECTIVES: Effectiveness of rituximab maintenance treatment among patients with relapsed follicular lymphoma (FL) has been established in a randomised setting (EORTC20981 trial). Although the golden standard, results might not be generalisable to unselected real-world patient populations. Outcomes research was conducted to calculate real-world cost-effectiveness of second line rituximab maintenance compared to observation in FL patients in the Netherlands. METHODS: Two Dutch population-based registries, PHAROS and HemoBase respectively, collected information on patient characteristics, treatment, and resource utilisation on patients diagnosed with FL in the past 20 years. Patients responding to second line chemotherapy were included in the observation or maintenance group. A Markov model was applied to calculate real-world cost-effectiveness. RESULTS: Although 735 FL patients entered the registries, only 57 and 49 patients were eligible and included in the observation and maintenance group, respectively. Median age was 61 years and similar in both groups. Differences between the groups were found for second line treatment with rituximab (77% and 92% in the observation and maintenance group p<0.05) and years since diagnosis (p<0.01). Besides, the proportion of people with a partial response was higher in the observation group (60%) compared to the maintenance group (33%). The maintenance group showed higher 3-year overall survival (75% versus 63%) and longer time till next treatment (p<0.01). Compared to the trial, our real-world population was older and fewer patients were diagnosed with stage IV FL. Real-world prescription of rituximab was comparable to the trial although cycles were prescribed more frequent. Daily practice data combined with trial efficacy data resulted in cost-effectiveness ratios between € 3,614 and € 5,246 per life year gained and €3,555 and € 5,156 per quality-adjusted life year. CONCLUSIONS: Real-world FL patients were not identical to trial patients emphasising the importance of studying real-world data. Nevertheless, these data also suggest that rituximab is an effective treatment in daily life. However, analysing non-randomised groups is challenging. Careful interpretation is required since observed dissimilarities between the groups suggested the representation of different types of patients. Nevertheless, real-world cost-effectiveness for second line rituximab maintenance was favourable compared to other haematological treatments. Disclosures: Pompen: Roche Netherlands: Employment. Révil:Roche Netherlands: Employment.


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