Matthew G Fury1, Han Xiao2, Eric J Sherman1, Shrujal Baxi1, Stephanie Smith-Marrone3, Karen Schupak4, Richard Gewanter5, Daphna Gelblum5,6, Sofia Haque7, Heiko Schoder7, Jatin P Shah8, Nora Katabi9, Rachel Kurtzman1, Brynna Lipson1, Lisa Cox1, Nancy Y Lee10, David G Pfister1. 1. Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York. 2. Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center Regional Network Site, Basking Ridge, New Jersey. 3. Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center Regional Network Site, Sleepy Hollow, New York. 4. Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Basking Ridge, New Jersey. 5. Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Commack, New York. 6. Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Rockville Center, New York. 7. Head and Neck Medical Oncology Service, Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York. 8. Head and Neck Medical Oncology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York. 9. Head and Neck Medical Oncology Service, Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York. 10. Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York.
Abstract
BACKGROUND: The purpose of this study was to evaluate the efficacy and tolerability of the addition of 2 monoclonal antibodies, bevacizumab and cetuximab, to 2 cycles of high-dose cisplatin administered concurrently with intensity-modulated radiation therapy (IMRT) for head and neck squamous cell carcinoma (HNSCC). METHODS: Patients with newly diagnosed stage III/IVB (M0) HNSCC received cetuximab (400 mg/m(2) loading dose, followed by 250 mg/m(2) weekly), bevacizumab (15 mg/kg, days 1 and 22), and cisplatin (50 mg/m(2) , days 1, 2, 22, and 23) concurrently with IMRT (70 Gy). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety and tolerability. RESULTS: Among 30 patients enrolled in this study, the primary tumor site was the oropharynx in 24 patients (p16 immunohistochemistry was positive in 17, negative in 1, and not done in 6 of the oropharyngeal tumors). Median age was 57 years (range, 38-77 years) and 27 patients had clinical stage IVA disease. All patients completed the full planned dose of radiation therapy. The most common ≥ grade 3 adverse events were lymphopenia, mucositis (functional), and dysphagia. With a median follow-up of 33.8 months, 2-year PFS was 88.5% (95% confidence interval [CI] = 68.1-96.1) and 2-year OS was 92.8% (95% CI = 74.2-98.1). CONCLUSION: The addition of bevacizumab and cetuximab to 2 cycles of cisplatin, given concurrently with IMRT, was well-tolerated and was associated with favorable efficacy outcomes in this patient population.
BACKGROUND: The purpose of this study was to evaluate the efficacy and tolerability of the addition of 2 monoclonal antibodies, bevacizumab and cetuximab, to 2 cycles of high-dose cisplatin administered concurrently with intensity-modulated radiation therapy (IMRT) for head and neck squamous cell carcinoma (HNSCC). METHODS:Patients with newly diagnosed stage III/IVB (M0) HNSCC received cetuximab (400 mg/m(2) loading dose, followed by 250 mg/m(2) weekly), bevacizumab (15 mg/kg, days 1 and 22), and cisplatin (50 mg/m(2) , days 1, 2, 22, and 23) concurrently with IMRT (70 Gy). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety and tolerability. RESULTS: Among 30 patients enrolled in this study, the primary tumor site was the oropharynx in 24 patients (p16 immunohistochemistry was positive in 17, negative in 1, and not done in 6 of the oropharyngeal tumors). Median age was 57 years (range, 38-77 years) and 27 patients had clinical stage IVA disease. All patients completed the full planned dose of radiation therapy. The most common ≥ grade 3 adverse events were lymphopenia, mucositis (functional), and dysphagia. With a median follow-up of 33.8 months, 2-year PFS was 88.5% (95% confidence interval [CI] = 68.1-96.1) and 2-year OS was 92.8% (95% CI = 74.2-98.1). CONCLUSION: The addition of bevacizumab and cetuximab to 2 cycles of cisplatin, given concurrently with IMRT, was well-tolerated and was associated with favorable efficacy outcomes in this patient population.
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