Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial
Introduction The efficacy of systemic first-line treatments in older adults with unresectable hepatocellular carcinoma (HCC) has not been well-studied. We compared the safety and efficacy of atezolizumab plus bevacizumab vs sorafenib as a first-line treatment in younger vs older patients with unrese...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Karger Publishers
2022-07-01
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| Series: | Liver Cancer |
| Online Access: | https://beta.karger.com/Article/FullText/525671 |
| _version_ | 1811217298016436224 |
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| author | Daneng Li Han Chong Toh Philippe Merle Kaoru Tsuchiya Sairy Hernandez Wendy Verret Alan Nicholas Masatoshi Kudo |
| author_facet | Daneng Li Han Chong Toh Philippe Merle Kaoru Tsuchiya Sairy Hernandez Wendy Verret Alan Nicholas Masatoshi Kudo |
| author_sort | Daneng Li |
| collection | DOAJ |
| description | Introduction The efficacy of systemic first-line treatments in older adults with unresectable hepatocellular carcinoma (HCC) has not been well-studied. We compared the safety and efficacy of atezolizumab plus bevacizumab vs sorafenib as a first-line treatment in younger vs older patients with unresectable HCC.
Methods This global, phase 3, open-label, randomized clinical trial (IMbrave150) recruited patients aged ≥18 years with locally advanced metastatic or unresectable HCC, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and Child-Pugh class A liver function who had not previously received systemic therapy for liver cancer. Patients received either 1200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks or 400 mg sorafenib orally twice daily until loss of clinical benefit or unacceptable toxicity. Primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary outcomes were incidence of adverse events and time to deterioration of patient-reported outcomes (PROs). This subgroup analysis evaluated safety and efficacy endpoints in patients <65 years, ≥65 to <75 years, and ≥75 years.
Results Of 501 patients, 165 patients were randomized to sorafenib and 336 were randomized to atezolizumab plus bevacizumab (175 patients <65 years; 106 patients ≥65 to <75 years; 55 patients ≥75 years). Across all age groups, patients receiving atezolizumab plus bevacizumab had longer median OS (<65: 18.0 vs 12.2 months [HR, 0.57; 95% CI, 0.40-0.82]; ≥65 to <75: 19.4 vs 14.9 months [HR, 0.80; 95% CI, 0.52-1.23]; ≥75: 24.0 vs 18.0 months [HR, 0.72, 95% CI, 0.37-1.41]) and PFS than those receiving sorafenib. Time to deterioration for multiple PROs was delayed for patients receiving atezolizumab plus bevacizumab, including older adults. There were no clinically meaningful differences in toxicity between age groups.
Conclusion Atezolizumab plus bevacizumab is safe and effective in adults <65, ≥65 to <75, and ≥75. Treatment was well-tolerated even in elderly patients. |
| first_indexed | 2024-04-12T06:53:04Z |
| format | Article |
| id | doaj.art-bffb1e2d18d848fc9f8efeb89eb97bb0 |
| institution | Directory Open Access Journal |
| issn | 2235-1795 1664-5553 |
| language | English |
| last_indexed | 2024-04-12T06:53:04Z |
| publishDate | 2022-07-01 |
| publisher | Karger Publishers |
| record_format | Article |
| series | Liver Cancer |
| spelling | doaj.art-bffb1e2d18d848fc9f8efeb89eb97bb02022-12-22T03:43:16ZengKarger PublishersLiver Cancer2235-17951664-55532022-07-0110.1159/000525671525671Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical TrialDaneng LiHan Chong TohPhilippe Merlehttps://orcid.org/0000-0002-8230-394XKaoru Tsuchiyahttps://orcid.org/0000-0003-0436-5915Sairy HernandezWendy VerretAlan NicholasMasatoshi Kudohttps://orcid.org/0000-0002-4102-3474Introduction The efficacy of systemic first-line treatments in older adults with unresectable hepatocellular carcinoma (HCC) has not been well-studied. We compared the safety and efficacy of atezolizumab plus bevacizumab vs sorafenib as a first-line treatment in younger vs older patients with unresectable HCC. Methods This global, phase 3, open-label, randomized clinical trial (IMbrave150) recruited patients aged ≥18 years with locally advanced metastatic or unresectable HCC, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and Child-Pugh class A liver function who had not previously received systemic therapy for liver cancer. Patients received either 1200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks or 400 mg sorafenib orally twice daily until loss of clinical benefit or unacceptable toxicity. Primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary outcomes were incidence of adverse events and time to deterioration of patient-reported outcomes (PROs). This subgroup analysis evaluated safety and efficacy endpoints in patients <65 years, ≥65 to <75 years, and ≥75 years. Results Of 501 patients, 165 patients were randomized to sorafenib and 336 were randomized to atezolizumab plus bevacizumab (175 patients <65 years; 106 patients ≥65 to <75 years; 55 patients ≥75 years). Across all age groups, patients receiving atezolizumab plus bevacizumab had longer median OS (<65: 18.0 vs 12.2 months [HR, 0.57; 95% CI, 0.40-0.82]; ≥65 to <75: 19.4 vs 14.9 months [HR, 0.80; 95% CI, 0.52-1.23]; ≥75: 24.0 vs 18.0 months [HR, 0.72, 95% CI, 0.37-1.41]) and PFS than those receiving sorafenib. Time to deterioration for multiple PROs was delayed for patients receiving atezolizumab plus bevacizumab, including older adults. There were no clinically meaningful differences in toxicity between age groups. Conclusion Atezolizumab plus bevacizumab is safe and effective in adults <65, ≥65 to <75, and ≥75. Treatment was well-tolerated even in elderly patients.https://beta.karger.com/Article/FullText/525671 |
| spellingShingle | Daneng Li Han Chong Toh Philippe Merle Kaoru Tsuchiya Sairy Hernandez Wendy Verret Alan Nicholas Masatoshi Kudo Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial Liver Cancer |
| title | Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial |
| title_full | Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial |
| title_fullStr | Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial |
| title_full_unstemmed | Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial |
| title_short | Atezolizumab Plus Bevacizumab vs Sorafenib for Unresectable Hepatocellular Carcinoma: Results From Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial |
| title_sort | atezolizumab plus bevacizumab vs sorafenib for unresectable hepatocellular carcinoma results from older adults enrolled in the imbrave150 randomized clinical trial |
| url | https://beta.karger.com/Article/FullText/525671 |
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