| Sumario: | Simple Summary: Small cell lung cancer accounts for a relatively small share of lung cancer cases, yet is highly lethal, without notable advances in treatment approaches over the past three decades. The recent introduction of immunotherapy as part of the initial chemotherapy regimens has contributed to improving survival, bringing a renewed hope for better patient outcomes. With the approval of atezolizumab for clinical use, however, it is essential to accumulate evidence on its efficacy and safety in real clinical practice. In the present study, we provide real-world evidence from Bulgarian patients receiving atezolizumab as part of their initial treatment for small cell lung cancer. The current data corroborate the notion that this newly introduced regimen delays disease progression to an extent comparable to that reported in the clinical trial that led to atezolizumab approval for small cell lung cancer. Background/Objectives: Small cell lung cancer (SCLC) is a highly metastatic and lethal malignancy. Doublet chemotherapy consisting of a platinum compound and etoposide had remained the standard first-line regimen for decades, particularly for the majority of patients, who are diagnosed with extensive-stage disease. Over the past 5 years, results from the IMpower133 trial led to the approval of anti-PD-L1 agent atezolizumab as part of the first-line regimen for extensive-stage SCLC. The accumulation of real-world evidence on atezolizumab efficacy in this context is essential for corroborating trial results and further improving patient outcomes. Herein, we present real-world evidence from a Bulgarian cohort receiving atezolizumab as part of first-line extensive-stage SCLC treatment, comparing these data to the results of IMpower133. Methods: Data were extracted from the electronic health records of patients receiving atezolizumab plus chemotherapy as first-line treatment for extensive-stage SCLC in the period between 1 January 2022 and 31 December 2024. Analysis was conducted via the Danny Platform, an analytic platform for the integration of real-world evidence using embedded machine learning and LLM algorithms. Patients matching IMpower133 inclusion criteria were included in a group for comparison with trial results. Results: A total of 302 patients were included in the analysis. The real-world progression-free survival (PFS) in our study surpassed that in IMpower133 (7.6 versus 5.2 months), in addition to higher PFS rates beyond six months. A lower Objective Response Rate (ORR) (38.7% versus 65.4%) was noted in our real-world cohort, which we attribute to real-world documentation practices. Conclusions: Real-world evidence regarding PFS and treatment response generally align with the efficacy of adding atezolizumab to first-line extensive-stage SCLC treatment reported in the IMpower133 trial, while reflecting differences that may arise in routine clinical practice.
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