ATLANTAIn the treatment of recurrent or refractory non-small-cell lung cancer (NSCLC), the addition of bevacizumab(Drug information on bevacizumab) (Avastin) to either chemotherapy or erlotinib (Tarceva) was associated with a trend toward improved progression-free and overall survival in a phase II study reported at the 42nd Annual Meeting of the American Society of Clinical Oncology (abstract 7062).
Louis Fehrenbacher, MD, of Kaiser Permanente Northern California, Vallejo, presented the findings of the multicenter, randomized phase II study of 120 NSCLC recurrent or unresectable patients who progressed after prior chemotherapy with a platinum-based regimen. Patients were randomized to chemotherapydocetaxel (Taxotere) or pemetrexed(Drug information on pemetrexed) (Alimta)plus placebo; chemotherapy plus bevacizumab; or bevacizumab plus erlotinib. Patients remained on study until disease progression or through 52 weeks of treatment.
In this exploratory analysis, at a median follow-up of 10 months, both treatment arms containing bevacizumab showed improvements in progression-free and overall survival, compared with chemotherapy alone (see Table). There were no observed differences between the two bevacizumab-containing arms in these endpoints.
As expected, there was a greater incidence of rash and diarrhea in the bevacizumab/erlotinib arm, compared with the other two arms. Bevacizumab did not increase the incidence of neutropenia, which was 24% with chemotherapy alone and 30% with chemotherapy/bevacizumab, and dropped to 10% in the bevacizumab/erlotinib arm. The incidence of grade 3 to 5 hemorrhage in bevacizumab-treated patients was 5.1%, Dr. Fehrenbacher reported.
"No new or unexpected safety signals were noted in the bevacizumab arms. The rate of fatal pulmonary hemorrhage was consistent with previous bevacizumab trials in NSCLC," he said. "The toxicity profile of bevacizumab/erlotinib was favorable when compared with either of the chemotherapy-containing groups."
Dr. Fehrenbacher concluded, "The bevacizumab plus erlotinib combination regimen may represent an alternative to chemotherapy-based treatment in patients with relapsed non-small-cell lung cancer if the results can be confirmed in a fully powered phase III trial."