Phase II trial of bevacizumab and erlotinib as a second-line therapy for advanced hepatocellular carcinoma
| العنوان: | Phase II trial of bevacizumab and erlotinib as a second-line therapy for advanced hepatocellular carcinoma |
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| المؤلفون: | James C. Yao, Sheree Cheung, Kanwal Pratap Singh Raghav, Reham Abdel-Wahab, Jeffrey S. Morris, Ahmed S Shalaby, Khaled M. Elsayes, Van Nguyen, Lauren Girard, Lianchun Xiao, Robert A. Wolff, Ahmed Omar Kaseb, Michiko Iwasaki, Humaid O. Al-Shamsi, Hesham M. Hassabo, Manal Hassan |
| المصدر: | OncoTargets and therapy |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Sorafenib, medicine.medical_specialty, erlotinib, Bevacizumab, bevacizumab, Gastroenterology, OncoTargets and Therapy, second-line therapy, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Clinical endpoint, Pharmacology (medical), Survival rate, Original Research, business.industry, hepatocellular carcinoma, targeted therapy, Surgery, Regimen, Oncology, Tolerability, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Erlotinib, business, medicine.drug |
| الوصف: | Ahmed O Kaseb,1 Jeffrey S Morris,2 Michiko Iwasaki,1 Humaid O Al-Shamsi,1 Kanwal Pratap Singh Raghav,1 Lauren Girard,1 Sheree Cheung,1 Van Nguyen,3 Khaled M Elsayes,4 Lianchun Xiao,2 Reham Abdel-Wahab,1,5 Ahmed S Shalaby,1 Manal Hassan,1 Hesham M Hassabo,1 Robert A Wolff,1 James C Yao1 1Department of Gastrointestinal Medical Oncology, 2Department of Biostatistics, 3Department of Pharmacy, 4Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; 5Department of Clinical Oncology, Assiut University Hospital, Assiut, Egypt Trial registry: Clinicaltrials.gov #NCT01180959. Background: 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. Methods: 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. Results: 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: 2.0–8.3months), and median overall survival duration was 9.9 months (95% CI: 8.3–15.5months). Grade 3–4 adverse events included fatigue (13%), acne (11%), diarrhea (9%), anemia (7%), and upper gastrointestinal hemorrhage (7%). Conclusion: 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. Keywords: hepatocellular carcinoma, targeted therapy, bevacizumab, erlotinib, second-line therapy |
| وصف الملف: | text/html |
| تدمد: | 1178-6930 0118-0959 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31590edd8ccc5810ee1d7a916543dedf https://pubmed.ncbi.nlm.nih.gov/26929648 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....31590edd8ccc5810ee1d7a916543dedf |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 11786930 01180959 |
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