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Atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma with impaired liver function and prior systemic therapy: A practical experience
Evidence-based medicine relies on the results of controlled trials and provides the scientific basis for our medical decision-making. However, in order to conduct studies under the most "controlled" conditions possible, there are inclusion and exclusion criteria that must be met by the participating patients. For the inclusion of patients with liver cancer, these criteria often represent a hurdle for treatment within therapy studies: for example, liver function must not fall below certain threshold values, the type and number of possible previous therapies is not arbitrary, and the general condition of the participants should still be good at the time of the start of therapy.
"Conducting studies under the most controlled conditions possible is important to ensure an objective assessment of the investigational medicinal products. In our everyday clinical work, however, we often see patients who would not fully meet the classic inclusion criteria of clinical trials - and as treating physicians, we are faced with the question of whether and which therapy is appropriate and effective for our patients," explains Anna Saborowski, research group leader and assistant physician in the Clinical Department of Gastroenterology, Hepatology and Endocrinology.
Based on the results of the IMbrave150 study (Finn et al, NEJM 2020, DOI: 10.1056/NEJMoa1915745), the combination of the immune checkpoint inhibitor atezolizumab and the angiogenesis inhibitor bevacizumab has been considered the new standard in the first-line treatment of hepatocellular carcinoma (HCC) since the end of 2020. In the article "Atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma with impaired liver function and prior systemic therapy: a real-world experience" , recently published in the scientific journal "Therapeutic Advances in Medical Oncology ", the group led by Arndt Vogel and Anna Saborowski addresses the question of how the efficacy and safety of the combination therapy of atezolizumab and bevacizumab is presented in a "real" patient collective outside of a clinical trial. Tiago de Castro, assistant physician at the Clinical Department of Gastroenterology, Hepatology and Endocrinology, and first author of the study, together with colleagues from Essen, Mainz, Lübeck, Munich and Vienna, evaluated data from over 140 patients with HCC who received appropriate therapy at the local centers. "The patients who would have met the inclusion criteria of the pivotal study also showed a good treatment response and survival in our retrospective analysis. However, around every second patient had at least one exclusion criterion. Overall survival in this patient group was significantly worse and clinically relevant decompensation of liver function occurred more frequently during treatment," reports Mr. de Castro.
"Overall, our data confirm the effectiveness of the combination approach in everyday clinical practice, but also underline the overriding importance of preserved liver function at the start of treatment," emphasizes Prof. Arndt Vogel, Head of the Gastro-Oncology Day Clinic. For clinicians, the study outlines a "horizon of expectation" for patients with HCC and reinforces the use of combination therapy even in previously treated patients.
To the original article at PubMed
Atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma with impaired liver function and prior systemic therapy: a real-world experience
Evidence-based medicine relies on the results of clinical trials and provides the scientific rationale for medical decision-making. However, in order to conduct studies under the most "controlled" conditions possible, prespecified in- and exclusion criteria must be met by all participating patients. For patients with liver cancer, these criteria often include a sustained liver function, a preserved general health condition and no or only selected prior therapies.
"Studies under controlled conditions are important to ensure comparability of therapeutic options, and new treatment concepts are nowadays usually approved based on data from these trials. Nevertheless, in our daily clinical routine we frequently see patients who would have failed to meet one or more of such criteria - and we, as the treating physicians, are faced with the question of whether the therapy retains effectivity in our patients," explains Anna Saborowski, working group leader and assistant physician in the Department of Gastroenterology, Hepatology and Endocrinology.
Based on the results of the IMbrave150 study (Finn et al, NEJM 2020), the combination of the immune checkpoint inhibitor atezolizumab and the angiogenesis inhibitor bevacizumab has been considered the new standard of care in the first-line treatment of hepatocellular carcinoma (HCC) since 2020. In the article"Atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma with impaired liver function and prior systemic therapy: a real-world experience", recently published in the scientific journal "Therapeutic Advances in Medical Oncology", the group led by Arndt Vogel and Anna Saborowski addresses the question of how the efficacy and safety of atezolizumab in combination with bevacizumab translates to a "real-world" patient population outside of a clinical trial. Tiago de Castro, a resident at the Department of Gastroenterology, Hepatology and Endocrinology, and first author of the study, together with colleagues from Essen, Mainz, Lübeck, Munich and Vienna, evaluated data from more than 140 HCC patients who were treated with the combination therapy in their local centers. "The patients who would have fulfilled the inclusion criteria of the pivotal study also showed a good response to therapy and favorable overall survival in our retrospective analysis. However, approximately one in two patients met at least one exclusion criterion. Overall survival in this group of patients was significantly worse, and clinically relevant decompensation of liver function occurred more frequently," Mr. de Castro reports.
"Overall, our data confirm the effectiveness of the combination approach in clinical practice, but also highlight the overarching importance of a preserved liver function at the time of therapy initiation," emphasizes Prof. Arndt Vogel, Head of the Gastro-Oncology Outpatient Clinic. For clinicians, the study outlines a "horizon of expectation" for real-world patients with HCC and encourages the use of combination therapy also in pre-treated patients.