Introduction:

Clinical trial results with new cancer therapies often differ from the results observed in daily practice. Atezolizumab showed durable responses and a favorable safety profile for patients with advanced urothelial carcinoma refractory to platinum-based chemotherapy in the IMvigor211 trial. This study was conducted to compare patients treated in real clinical practice and IMvigor211 trial regarding baseline characteristics, effectiveness and safety.

Material and methods:

Retrospective, observational study of data collection in a tertiary hospital. Patients receiving atezolizumab between January 10, 2018, and March 5, 2020, were included. Primary endpoints were progression free survival, overall survival and the number of discontinuations due to adverse events.

Results:

Twenty-nine patients were studied with a median follow up of 5.1 months (range 0-21.6). Median age was 75 years in our cohort and 67 years in the IMvigor211 trial. The median progression free survival was 2.7 months (95%CI 1.9-3.5) versus 2.1 months (95%CI 2.1-2.2) in the IMvigor211. The median overall survival was 5.1 months (95% CI 1.9-8.3) versus 8.6 months (95%CI 7.8-9.6) in the IMvigor211. There was a 13.8% of treatment withdrawals due to immune related toxicity compared to 3.5% of patients who discontinued treatment due to the same cause in IMvigor211.

Conclusion:

Patients treated in real clinical practice have less favorable baseline characteristics than patients in the IMvigor211 trial. Results in real clinical practice are similar to those of the clinical trial. Further studies with a longer median follow up and a more significant number of patients would be warranted to confirm these hypotheses.

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