NEW YORK (Reuters Health) – Patients with unresectable hepatocellular carcinoma report that quality of life, functioning and disease symptoms are improved with atezolizumab plus bevacizumab compared with sorafenib, according to prespecified analyses of an open-label randomized trial.
“The data are important,” Dr. Peter R. Galle told Reuters Health by email, “because they demonstrate that the combination of atezolizumab plus bevacizumab is not only efficacious but also well tolerated with a maintained quality of life. This is of relevance for the frail liver patients who do not tolerate a lot of toxicity.”
This, he added, “has been learned in the past where agents such as linifanib, brivanib, erlotinib and others were found to be too toxic in the context of liver disease and cirrhosis.”
Dr. Galle of University Medical Center Mainz, in Germany, and colleagues analyzed patient-reported outcomes (PROs) from the phase-3 IMbrave150 trial.
They included 309 patients in the atezolizumab-bevacizumab group and 145 patients in the sorafenib group in their analysis, with a median follow-up of 8.6 months. Patients reported outcomes on the European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire for cancer (QLQ-C30) and quality-of-life questionnaire for hepatocellular carcinoma (QLQ-HCC18).
Compared with sorafenib, atezolizumab plus bevacizumab significantly reduced the risk of deterioration on all prespecified EORTC QLQ-C30 generic-cancer-symptom scales, the researchers report in The Lancet Oncology. Among these were appetite loss (hazard ratio, 0.57), diarrhea (HR, 0.23), fatigue, (HR, 0.61) and pain (HR, 0.46). This was also the case in two of three EORTC QLQ-HCC18 disease-specific-symptom scales.
At day one of treatment cycle five (after which attrition in the sorafenib group was at least 59%), the mean EORTC QLQ-C30 score changes from baseline in the combination versus sorafenib groups were markedly less for quality of life, role functioning and for physical functioning.
These data, the researchers conclude, “provide a unique patient perspective on the treatment experience” and “provide further justification for why this combination therapy should become the standard of care for these patients.”
Commenting on the findings by email, Dr. Lorenza Rimassa, co-author an accompanying editorial, told Reuters Health, “Although overall survival in patients with unresectable hepatocellular carcinoma has increased due to the introduction of novel treatment agents, their unique side-effects might mitigate the overall treatment efficacy and perceived benefits.”
Dr. Rimassa, of Humanitas University in Milan, Italy, added, “From a clinical standpoint, the decision as to which patients are candidates for treatment is usually made based on a physician’s subjective assessment of clinical variables. In this respect, seminal studies have already highlighted the need to complement this assessment with patient-reported outcomes, to achieve more accurate predictions of overall survival.”
The current study “provides valuable guidance by introducing a baseline analysis of patient-reported outcomes that identifies patients who are likely to derive benefit from systemic treatment.”
“With additional health-related quality-of-life analyses that will further convey patients’ voices into the prospective investigation level,” he concluded, “a deeper insight is expected to better inform our strategies across the therapeutic landscape for hepatocellular carcinoma.”
The study was funded by F. Hoffmann-La Roche and Genentech. Dr. Galle has relationships with these companies as do a number of other authors, some of whom are employees.
SOURCE: https://bit.ly/3vhc6HK and https://bit.ly/3pQjAAl The Lancet Oncology, online May 27, 2021
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