The addition of bevacizumab to cisplatin and gemcitabine prolongs progression-free survival of patients with advanced non-small cell lung cancer, according to results of a phase III study presented at the annual meeting of the American Society of Clinical Oncology.

The multi-center European trial was conducted in parallel with a US study conducted by the Eastern Cooperative Oncology Group (ECOG): The US trial evaluated addition of bevacizumab to chemotherapy with carboplatin and paclitaxel. The current, European trial added bevacizumab to the regimen used more commonly there, cisplatin plus gemcitabine.

“These findings demonstrate that bevacizumab plus gemcitabine and cisplatin is another effective treatment choice for patients with this disease,” said Christian Manegold, MD, Professor of Medicine at the University of Heidelberg, Germany, and the lead author of the study.

“The study confirms the conclusions of the ECOG study and extends our knowledge about the management f advanced lung cancer.”

The European investigators compared progression-free survival, response to treatment, and incidence of side effects for patients who were randomized to one of three arms: bevacizumab (7.5 mg/kg) plus cisplatin and gemcitabine (345 patients), bevacizumab (15 mg/kg) plus cisplatin and gemcitabine (351 patients), or cisplatin and gemcitabine (347 patients, the control group).

The combination cisplatin plus gemcitabine regimen was given with bevacizumab for a maximum of six cycles; afterward, patients received bevacizumab only until tumor progression was observed.

The magnitude of benefit was comparable between the current study and the earlier, ECOG trial. More patients in the bevacizumab arms responded with tumor shrinkage than patients in the control arm (34 percent for lower-dose bevacizumab, 30 percent for higher-dose bevacizumab vs. 20 percent for control patients).

Duration of tumor response was also longer in the arms that included bevacizumab: 6.1 months for both bevacizumab arms compared with 4.7 months for the control arm.

Incidence of side effects was only slightly higher in the two bevacizumab arms. The most common serious side effect was hypertension (9 percent for higher-dose bevacizumab vs. 6 percent for lower-dose bevacizumab vs. 2 percent for controls). Less common but potentially serious was pulmonary hemorrhage, which occurred in up to 1.5 percent of the lower-dose bevacizumab group, in less than 1.0 percent of the higher-dose group, and in less than 1.0 percent of the control group.

The incidence of fatal side effects was comparable for all three groups: 4 percent for lower-dose bevacizumab, 5 percent for higher-dose bevacizumab, and 4 percent for controls. Overall, no unexpected side effects or other safety issues were identified.