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Incorporating bevacizumab into nasopharyngeal treatment safe, feasible
Lee NY. Lancet Oncol. 2011;doi:10.1016/S1470-2045(11)70303-5.
The use of bevacizumab in addition to radiation treatment with intensity-modulated radiation therapy was feasible in patients with nasopharyngeal carcinoma, according to the results of the phase-2 RTOG 0615 trial.
Most patients with nasopharyngeal carcinoma who undergo intensity-modulated radiation therapy (IMRT) have local tumor control rates of 90% or better; however, nasopharyngeal carcinoma has the highest metastases rate of any head and neck cancer, with about 30% of patients developing distant disease.
In this study, the researchers enrolled 46 patients aged 18 years or older with stage IIb-IVb nasopharyngeal carcinoma to determine if the addition of bevacizumab to treatment was safe. Patients were enrolled at 19 centers in North America and Hong Kong. Only 44 were eligible for analysis.
The treatment regimen for patients consisted of three stages.
Patients were given three cycles of bevacizumab (15 mg/kg) and cisplatin (100 mg/m2) on days 1, 22 and 43 of IMRT. They then received three more cycles of bevacizumab and cisplatin (80 mg/m2) on days 64, 85 and 106 after radiation. Finally, three cycles of fluorouracil (1,000 mg/m2 per day) were given on days 64-67, 85-88, and 106-109 after radiation.
Patients underwent a median of 2.5 years of follow-up, during which 9% of patients had locoregional failure and 11% had distant metastases. Fourteen percent of patients died.
The researchers observed no grade-3/grade-4 hemorrhages and no grade-5 adverse events. In addition, there were no deaths within 30 days of treatment completion. Twenty-two percent of patients had grade-1/grade-2 hemorrhage, and 20% had at least one grade-4 blood or bone marrow-related adverse event.
About 75% of patients had grade-3/grade-4 mucositis, 14% had grade-3 radiation dermatitis and 5% had grade-3 late xerostomia.
At median follow-up, the estimated 2-year locoregional progression-free interval was 83.7% and the 2-year distant metastasis-free interval was 90.8%. Two-year PFS was 74.7% and 2-year OS was 90.9%.
The researchers cautioned the results are preliminary and concurrent chemoradiation is still the standard treatment for nasopharyngeal carcinoma. Further research will be needed to identify those patients who may benefit from additional treatment with bevacizumab, they added.
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