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Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2019 Dec 01; Vol. 37 (34), pp. 3266-3274. Date of Electronic Publication: 2019 Oct 16. - Publication Year :
- 2019
-
Abstract
- Purpose: We evaluated the addition of bevacizumab, a humanized monoclonal antibody that targets vascular endothelial growth factor, to platinum-based chemotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).<br />Patients and Methods: Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier) recurrent or metastatic SCCHN were randomly assigned to receive a platinum-based chemotherapy doublet with or without bevacizumab 15 mg/kg given intravenously every 3 weeks until disease progression. Chemotherapy could be discontinued after six cycles if a maximum response was achieved.<br />Results: The study randomly assigned 403 patients. Median overall survival (OS) was 12.6 months with bevacizumab plus chemotherapy (BC) and 11.0 months with chemotherapy alone (hazard ratio, 0.87; 95% CI, 0.70 to 1.09; P = .22). At 2, 3, and 4 years, the OS rates were 25.2% v 18.1%, 16.4% v 10.0%, and 11.8% v 6.4% for BC versus chemotherapy, respectively. In an analysis of 365 eligible patients who started treatment, the hazard ratio was 0.82 (95% CI, 0.65 to 1.04; P = .10), with a median OS of 14.2 months on BC v 11.1 months on chemotherapy. Median progression-free survival with BC was 6.0 months v 4.3 months with chemotherapy ( P = .0014). Overall response rates were 35.5% with BC and 24.5% with chemotherapy ( P = .016). There was increased toxicity, including a higher rate of treatment-related grade 3 to 5 bleeding events (6.7% v 0.5%; P < .001) and treatment-related deaths (9.3% v 3.5%; P = .022) with BC versus chemotherapy.<br />Conclusion: The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities. These results encourage biomarker-driven studies of angiogenesis inhibitors with better toxicity profiles in select patients with SCCHN.
- Subjects :
- Aged
Antineoplastic Agents, Immunological adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Bevacizumab adverse effects
Disease Progression
Drug Administration Schedule
Female
Head and Neck Neoplasms mortality
Head and Neck Neoplasms pathology
Humans
Male
Progression-Free Survival
Squamous Cell Carcinoma of Head and Neck mortality
Squamous Cell Carcinoma of Head and Neck secondary
Time Factors
United States
Antineoplastic Agents, Immunological administration & dosage
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Bevacizumab administration & dosage
Head and Neck Neoplasms drug therapy
Neoplasm Recurrence, Local
Squamous Cell Carcinoma of Head and Neck drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 37
- Issue :
- 34
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 31618129
- Full Text :
- https://doi.org/10.1200/JCO.19.00555