"All biologic" NSCLC therapy is effective, less toxic

A noncytotoxic combination of erlotinib and bevacizumab appears to be effective and well-tolerated as first-line management of advanced non-small cell lung cancer (NSCLC) in fit elderly patients, according to recent research results.      

In an abstract presented at the annual meeting of the American Society of Clinical Oncology (ASCO), held June 3–7, 2011, in Chicago, Illinois, Fox Chase Cancer Center (Philadelphia, Pennsylvania) medical oncologist Hossein Borghaei, DO, and co-investigators noted that the median age of patients with newly diagnosed NSCLCin the United States is 71 years, with more than 60% of new diagnoses in patients 65 years or older (http://abstract.asco.org/AbstView_102_80606.html).

The researchers sought to explore the efficacy and tolerability of an “all biologic” therapy in treatment-naïve elderly patients with advanced (stage IIIB or IV) NSCLC, as opposed to the standard treatment of two cytotoxic chemotherapeutic agents, which is associated with substantial toxicity.

The 33 participants (median age 74 years) received full-dose erlotinib (150 mg/d) and bevacizumab (15 mg/kg every 3 weeks) in 21-day cycles. With six patients still on therapy at the time of reporting, the estimated median progression-free survival was 6.6 months and estimated median overall survival was 14.1 months. The estimated 1-year overall survival rate was 56.6%.

The most common serious adverse events were grade 3 hypertension in five patients and grade 3 rash in three patients. The following grade 3 toxicities affected one patient each: fatigue, anorexia, neutropenia with infection, bowel perforation, and abnormal blood tests. Two patients had grade 3 diarrhea and one had grade 4 diarrhea. Because of the relatively low toxicity of the erlotinib/bevacizumab regimen, patients can continue chemotherapy well beyond the 4-to-6-cycle limit seen with the more toxic standard regimen.

“Of course, the problem with a phase II trial always is that the patients tend to be a select patient population,” acknowledged Borghaei in a statement detailing his team's findings. “But when you look at the numbers, the patients appear to be benefiting from the treatment. And we don't have a lot of toxicities, like major hair loss or nausea, and we don't have a lot of neutropenia or anemia.”

These results suggest that the erlotinib/bevacizumab combination is effective front-line therapy for fit elderly patients with advanced NSCLC. “We have to wait for the final data and analyze it before we know,” cautioned Borghaei.  “And the big test would be a head-to-head phase III trial with chemotherapy.”

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