August 2, 2009
All-Biologic Regimen Efficacious, Well-Tolerated In Elderly Lung Cancer Patients
Previously untreated non-small cell lung cancer (NSCLC) patients over the age of 70 respond well to a combination of bevacizumab and erlotinib, Fox Chase Cancer Center researchers reported today at the annual meeting of the International Association for the Study of Lung Cancer.
"Based on our initial data, the combination appears to be well tolerated and efficacious, though we'll have to wait and see the final results," says Hossein Borghaei, D.O., medical oncologist at Fox Chase, who led the trial.Elderly patients are often excluded from clinical trials because researchers fear they will have trouble tolerating standard chemotherapy regimens. That leaves open the question of how best to treat these individuals who account for more than half of all NSCLC in the United States.
With that challenge in mind, Borghaei and colleagues designed a trial testing a combination of two molecularly targeted agents in patients 70 years or older. The team reasoned that a combination lacking standard cytotoxic agents may be better tolerated by these patients, potentially without comprising efficacy. "We looked for a regimen that had few side effects, would involve only targeted agents, and had a bit of a track record. This combination was a natural fit," Borghaei says. Several small phase II trials in younger NSCLC patients demonstrated that the combination had anti-tumor activity and a relatively favorable toxicity profile.
Thus far 21 elderly NSCLC patients have enrolled in the Fox Chase trial and 14 are evaluable for response. The median age of the 14 evaluable patients is 78, with a range of 71 to 84 years. Four patients have had partial responses with demonstrable tumor shrinkage and three patients had stable disease by RECIST criteria.
The combination appears safe and well tolerated in this patient population with the most commonly encountered toxicities of clinical relevance being high blood pressure, fatigue, loss of appetite and diarrhea.
"The observed activity of this regimen in this patient population suggests promise and therefore warrants continued investigation," Borghaei says. He also emphasizes that designing a clinical trial just for elderly patients is a novel approach, but one that should be used more in the future given the large proportion of NSCLC patients in this demographic group.
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