Patients report no quality-of-life issues with adjuvant regimen for high-risk liver cancer
Click Here to Manage Email Alerts
Key takeaways:
- Atezolizumab plus bevacizumab did not lead to clinically meaningful deterioration in quality of life or function, patient-reported outcomes showed.
- The regimen cut risk for disease recurrence or death by 28%.
CHICAGO — Individuals with high-risk hepatocellular carcinoma undergoing curative-intent procedures did not experience clinically meaningful deterioration in quality of life or function after adjuvant therapy, phase 3 study results showed.
Patient-reported outcomes from the randomized IMbrave050 trial presented at ASCO Annual Meeting suggest that an adjuvant regimen of atezolizumab plus bevacizumab does not negatively affect health-related quality-of-life or functional measures compared with active surveillance among patients with HCC who are at high risk for disease recurrence after surgical resection or ablation.
“Atezolizumab plus bevacizumab may be a practice-changing adjuvant treatment option for patients with high-risk HCC,” Masatoshi Kudo, MD, PhD, professor and chairman of the department of gastroenterology and hepatology at Kindai University Hospital, said during a presentation. “Health-related quality of life and functioning scores between the atezolizumab plus bevacizumab and active surveillance groups were comparable throughout treatment.
Background
Previous results of the IMbrave050 trial, presented at this year’s AACR Annual Meeting, showed adjuvant treatment with atezolizumab (Tecentriq, Genentech) — an anti-PD-L1 antibody — and bevacizumab (Avastin, Genentech), a humanized anti-VEGFR monoclonal antibody, significantly extended RFS compared with active surveillance among patients with high-risk HCC. The combination also exhibited a “generally manageable” safety profile, the investigators wrote.
The findings led researchers to suggest the combination could be a new standard for adjuvant treatment of HCC.
Study investigators wanted to know whether the addition of new therapeutic agents would have an impact on health-related quality of life or function when compared with the standard approach of active surveillance after surgical resection or ablation with curative intent.
Methodology
The IMbrave050 trial included 668 patients with HCC who underwent resection or ablation but remained at high risk for recurrence.
Researchers randomly assigned 334 patients to receive 1,200 mg atezolizumab and 15 mg/kg bevacizumab every 3 weeks for 1 year (17 cycles). The other 334 patients underwent active surveillance for 1 year. The study design permitted crossover to adjuvant atezolizumab plus bevacizumab for patients undergoing active surveillance who experienced confirmed disease progression.
RFS per independent review facility assessment served as the study’s primary endpoint. Secondary exploratory endpoints included changes in global health status/quality of life and measurements of physical, role, emotional and social functioning.
The investigators used IL42–EORTC QLQ-C30 questionnaire assessments at baseline and at every odd treatment or surveillance visit through treatment cycle 17 to evaluate patient-reported outcomes for health-related quality of life and functioning.
Median follow-up was 17.4 months, with a data cutoff date of Oct. 21, 2022.
Key findings, implications
The atezolizumab-bevacizumab regimen reduced risk for recurrence or death by 28% compared with active surveillance (HR = 0.72; 95% CI, 0.56-0.93) among the intent-to-treat population.
Among the study’s safety population, 41% who received adjuvant atezolizumab-bevacizumab experienced grade 3 or grade 4 treatment-related adverse events compared with 13% in the active surveillance arm.
Researchers reported a greater than 93% questionnaire completion rate for the entire study population from baseline through the last treatment cycle.
Investigators reported no clinically meaningful deterioration in health-related quality of life or function during the study period in either treatment group.
Both study groups exhibited similar mean health-related quality of life and functioning scores at baseline, with no clinically meaningful changes in scores through treatment cycle 17.
“IMbrave050 is the first positive phase 3 study in HCC to demonstrate RFS improvement with adjuvant treatment following curative intent resection or ablation,” Kudo said. “This patient-reported outcomes analysis showed that patients started the trial with high baseline scores in both treatment arms for health-related quality-of-life and functioning, and did not experience any clinically meaningful deterioration at any time during the treatment period.”
Perspective
Back to Top
Timothy Kennedy, MD, MBA
HCC is the most common liver malignancy and a major cause of cancer mortality worldwide. Liver resection and ablation are important curative-intent treatment options; however, risk of recurrent cancer reaches 70% to 80% five years after surgical resection or ablation. The purpose of adjuvant therapy is to reduce the rate of recurrence of HCC following surgical resection or ablation. Despite a high risk of recurrent disease in patients with surgically resected or ablated HCC, patients have traditionally been recommended for surveillance given no proven benefit to adjuvant therapy.
The IMbrave150 study previously demonstrated that the combination of atezolizumab and bevacizumab improved survival compared with sorafenib in patients with metastatic or unresectable HCC, establishing this regimen as a standard of care in the advanced setting. IMbrave050 is a landmark study that has established a new standard of care for adjuvant treatment of patients with high-risk HCC who undergo surgical resection or ablation with curative intent.
Although this trial met the primary endpoint of improving recurrence-free survival, OS outcomes are still pending. Currently, there are other several other ongoing phase 3 clinical trials evaluating adjuvant therapy for HCC. Results from these trials will hopefully establish several regimens for adjuvant therapy for resected HCC and pave the way for future trials improving upon these current results.
RWJBarnabas Health
Collapse
Kudo M, et al. Abstract 4002. Presented at: ASCO Annual Meeting; June 2-6, 2022; Chicago.
Click Here to Manage Email Alerts