Title |
Phase II trial of bevacizumab and erlotinib as a second-line therapy for advanced hepatocellular carcinoma
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Published in |
OncoTargets and therapy, February 2016
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DOI | 10.2147/ott.s91977 |
Pubmed ID | |
Authors |
Ahmed O Kaseb, Jeffrey S Morris, Michiko Iwasaki, Humaid O Al-Shamsi, Kanwal Pratap Singh Raghav, Lauren Girard, Sheree Cheung, Van Nguyen, Khaled M Elsayes, Lianchun Xiao, Reham Abdel-Wahab, Ahmed S Shalaby, Manal Hassan, Hesham M Hassabo, Robert A Wolff, James C Yao |
Abstract |
Clinicaltrials.gov #NCT01180959. Early clinical studies of bevacizumab and erlotinib in advanced hepatocellular carcinoma (HCC) have a tolerable toxicity and a promising clinical outcome. We evaluated the efficacy and tolerability of this combination as a second-line therapy for HCC refractory to sorafenib. For this single-arm, Phase II study, we recruited patients with Child-Pugh class A or B liver disease, Eastern Cooperative Oncology Group performance status 0-2, and advanced HCC that was not amenable to surgical or regional therapies and treatment with sorafenib had failed (disease progressed or patient could not tolerate sorafenib). Patients received 10 mg/kg intravenous bevacizumab every 14 days and 150 mg oral erlotinib daily for 28-day cycles until progression. Tumor response was evaluated every two cycles using Response Evaluation Criteria in Solid Tumors. The primary end point was the 16-week progression-free survival rate. Secondary end points included time to progression and overall survival. A total of 44 patients were enrolled and had a median follow-up time of 33.8 months (95% confidence interval [CI]: 23.5 months - not defined). The 16-week progression-free survival rate was 43% (95% CI: 28%-59%), median time to progression was 3.9 months (95% CI: 2.0-8.3 months), and median overall survival duration was 9.9 months (95% CI: 8.3-15.5 months). Grade 3-4 adverse events included fatigue (13%), acne (11%), diarrhea (9%), anemia (7%), and upper gastrointestinal hemorrhage (7%). Bevacizumab plus erlotinib was tolerable and showed a signal of survival benefit in the second-line setting for patients with advanced HCC. Because standard-of-care options are lacking in this setting, further studies to identify predictors of response to this regimen are warranted. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Unknown | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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United States | 1 | 3% |
Unknown | 35 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 5 | 14% |
Student > Ph. D. Student | 4 | 11% |
Student > Doctoral Student | 3 | 8% |
Student > Bachelor | 3 | 8% |
Student > Master | 3 | 8% |
Other | 7 | 19% |
Unknown | 11 | 31% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 14 | 39% |
Nursing and Health Professions | 3 | 8% |
Agricultural and Biological Sciences | 3 | 8% |
Mathematics | 1 | 3% |
Immunology and Microbiology | 1 | 3% |
Other | 3 | 8% |
Unknown | 11 | 31% |