The Greta study: generating real-world evidence about bevacizumab treatment of metastatic Colorectal Cancer by linking Cancer registries and healthcare databases in Italy

Risultato della ricerca: Otherpeer review

Abstract

OBJECTIVES: Based on the results of randomized clinical trials, bevacizumab plus chemotherapy is currently recommended as firstline treatment for metastatic colorectal cancer (mCRC). However, scant realworld data are available about effectiveness of bevacizumabcontaining 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 firstline bevacizumab plus chemotherapy (B+CT), as compared to CT alone, in the realworld setting of Italian clinical practice, by linking cancer registries and healthcare utilization (HCU) databases.METHODS: Incident mCRC patients were identified during the period 20102012 from five populationbased 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 firstline 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 firstline 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 0.621.08). The HR resulting from the PS matched analysis was 0.86 (95% CI 0.561.33). 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 realworld clinical practice of mCRC patients in Italy. The gain in OS is comparable to that from the pivotal trial.
Lingua originaleEnglish
Numero di pagine1
Stato di pubblicazionePublished - 2017

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