(RxWiki News) About 5 percent of the 226,000 lung cancers diagnosed every year in the U.S. have a scrambled ALK gene. Usually people with this type of lung cancer are treated with chemotherapy. Now, another drug has been shown to be more effective.
A phase III trial has found that crizotinib – sold under the brand name of Xalkori – helps to keep advanced ALK-positive non-small cell lung cancer (NSCLC) from progressing more than twice as long as standard chemotherapy.
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"This study is the first head-to-head comparison of crizotinib with standard chemotherapy in this patient group," said lead study author, Alice Shaw, MD, PhD from Massachusetts General Hospital Cancer Center in Boston.
The global trial involves 347 people with ALK-positive non-small cell lung cancer that have already been treated with chemotherapy - pemetrexed or docetaxel.
"In ALK-positive patients who have been previously treated with first-line, platinum-based chemotherapy, crizotinib is superior to standard single-agent chemotherapy in terms of response, progression-free survival and quality of life,” Dr. Shaw said.
People being treated with crizotinib didn’t see their disease get worse (progression-free survival) for a median of 7.7 months compared to 3 months for people receiving standard chemotherapy.
Researchers also saw that Xalkori worked better, with 65 percent of the cancers responding to the medication vs. 20 percent of those treated with chemotherapy.
And while patients taking crizotinib had more side effects, they also reported having a higher quality of life than those undergoing chemotherapy.
The study has not yet been able to analyze how the two drugs compare in terms of lifespan – overall survival.
"It is important to note that there was significant crossover in this study," Dr. Shaw said. "Patients who were randomized to receive chemotherapy and had disease progression were allowed to crossover to receive crizotinib. Hence, the majority of patients on the chemotherapy arm actually did receive crizotinib. This makes determination of overall survival benefit very challenging."
One of the study authors and a member of the PROFILE 1007 trial steering committee, D. Ross Camidge, MD, PhD, told dailyRx News the study shows that “using a targeted agent in a targeted manner , i.e. giving the right drug to the right patient, produces greater clinical benefit than the catch all use of chemotherapy.”
Dr. Camidge, the director of the lung cancer clinical program at University of Colorado Hospital said, “The chemotherapy is still important – it may well be needed at a later date, but this study really emphasizes that if we can get into the habit of testing people early we can make the best decisions for them from the start.”
Dr. Shaw said, “These results establish crizotinib as the standard of care for patients with advanced, previously treated, ALK-positive lung cancer."
Forbes reports that Xalkori will cost $9,600 a month, or $115,000 for patients who take it for a year.
Findings from this ongoing trial were presented at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.