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Concomitant use of chemotherapy, bevacizumb safe in NSCLC with treated brain metastases
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Bevacizumab was safe when used in addition to other chemotherapy agents or erlotinib in patients with non-small cell lung cancer and treated brain metastases, according to data from an open-label, multicenter trial.
The study included 115 patients with non-squamous NSCLC who were previously treated for brain metastases. Patients in the first-line setting were assigned to bevacizumab (Avastin, Genetech; 15 mg/kg) every three weeks with platinum-based doublet therapy or erlotinib (Tarceva, OSI).
Second-line patients were assigned to bevacizumab with single-agent chemotherapy or erlotinib until progression or death.
Data were collected until June 23, 2008, at which time 106 patients who received at least one dose of bevacizumab were available for safety evaluation.
The median duration of bevacizumab treatment was 85 days and the median number of cycles was five.
Bevacizumab was discontinued among the 106 patients due to any adverse event (24.5%), bevacizumab-targeted events (7.5%) or disease progression (34.9%).
Among the 106 patients, there were no reports of grade-1 to -5 CNS hemorrhage events (95% CI, 0.0%-3.3%). As of the data cut, eight bevacizumab-targeted events occurred; the only grade-5 event was pulmonary hemorrhage.
One additional death caused by pulmonary hemorrhage occurred six weeks after the data cut. During the planned treatment period, five additional non-targeted grade-5 events occurred (acute renal failure, cerebral edema, cerebral arteriosclerosis, lung cancer and one of unknown cause), leading to death.
According to the researchers, 12 patients died after an adverse event, although all but one death was caused by the underlying cancer.
One grade-4 non-CNS/non-pulmonary hemorrhage occurred; it was not bevacizumab-targeted. Pulmonary embolism was the most common grade-4 event, occurring in seven patients and resulting in the discontinuation of four patients.
“As a result [of the acceptable safety profile demonstrated in this study], the NCCN guidelines for this agent now explicitly permit the use of bevacizumab in otherwise eligible patients with treated brain metastases,” the researchers wrote.
Socinski MA. J Clin Oncol. 2009;doi:10.1200/JCO.2009.22.0616