THE GRETA STUDY- GENERATING REAL-WORLD EVIDENCE ABOUT BEVACIZUMAB TREATMENT OF METASTATIC COLORECTAL CANCER BY LINKING CANCER REGISTRIES AND HEALTHCARE DATABASES IN ITALY
Author(s)
Franchi M1, Caputo A2, Barni S3, De Ceglie MC4, Mazzucco W5, Ricci P6, Tagliabue G7, Tumino R8, Corrao G9
1University of Milano-Bicocca, Milano, Italy, 2Roche S.p.A., Monza, Italy, 3ASST Bergamo Ovest Ospedale di Treviglio, Treviglio, Italy, 4Roche S.p.A, Monza, Italy, 5University of Palermo, Palermo, Italy, 6Health Protection Agency Mantua&Cremona, NHS Italy, Mantova, Italy, 7Fondazione IRCCS National Cancer Institute, Milano, Italy, 8Provincial Health Authority, ASP Ragusa, Ragusa, Italy, 9Università di Milano-Bicocca, Milan, Italy
OBJECTIVES: Based on the results of randomized clinical trials, bevacizumab plus chemotherapy is currently recommended as first-line treatment for metastatic colorectal cancer (mCRC). However, scant real-world data are available about effectiveness of bevacizumab-containing therapy used in patients with mCRC in Italy. The GRETA observational cohort study was designed for comparing overall survival (OS) of mCRC patients treated with first-line bevacizumab plus chemotherapy (B+CT), as compared to CT alone, in the real-world setting of Italian clinical practice, by linking cancer registries and healthcare utilization (HCU) databases. METHODS: Incident mCRC patients were identified during the period 2010-2012 from five population-based cancer registries, representing the 5.4% of the entire Italian population. Cases were linked to Regional HCU databases, in order to obtain the entire pathway of health services provided to each patient. Patients who started a first-line treatment with either B+CT or CT alone were included in the study cohort. A propensity score (PS) method was applied in order to take into account residual confounding. RESULTS: A study cohort of 480 subjects was selected, of which 101 received first-line B+CT and 379 CT alone. The median OS was 22.5 and 14.6 months in patients treated with or without bevacizumab, respectively (p=0.011). The corresponding adjusted hazard ratio (HR) was 0.82 (95% CI 0.62-1.08). The HR resulting from the PS matched analysis was 0.86 (95% CI 0.56-1.33). The gain in median OS was 8.3 months among patients aged less than 70 years (p=0.087) and 4.3 months among those aged 70 years or older (p=0.221). CONCLUSIONS: Despite not statistically significant, the addition of bevacizumab to CT showed a beneficial effect on OS, in the real-world clinical practice of mCRC patients in Italy. The gain in OS is comparable to that from the pivotal trial.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
CN2
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes
Disease
Oncology