ATLANTA ? Sutent (sunitinib), a tyrosine kinase inhibitor approved for the treatment of advanced renal cell carcinoma and refractory gastrointestinal stromal tumor (GIST), has also hinted at efficacy for recurrent non-small-cell lung cancer (NSCLC).
ATLANTA, June 4 ? Sutent (sunitinib), a tyrosine kinase inhibitor approved for the treatment of advanced renal cell carcinoma and refractory gastrointestinal stromal tumor (GIST), has also hinted at efficacy for recurrent non-small-cell lung cancer (NSCLC).
Six of 63 patients achieved partial response after two cycles of Sutent and 27 patients had stable disease, Mark A. Socinski, M.D., of the University of North Carolina reported at the American Society of Clinical Oncology meeting here.
A majority had a decrease in the size of target lesions, Dr. Socinski said. But for about half of those patients the decrease was less than 30%.
The median age of patients was 61 and two-thirds were men. Sixty-four percent had adenocarcinoma, 22% squamous-cell carcinoma, and 14% had other histology. All patients had failed one to four prior chemotherapy regimens.
The patients were given 50 mg of Sutent daily for four weeks, followed by two weeks off drug. The cycle was repeated for as long as there was clinical benefit.
"Response was observed after the first cycle and confirmed after the second cycle," Dr. Socinski said.
He said the drug was generally well tolerated, but there were three fatal bleeding events, two pulmonary hemorrhages and one cerebral hemorrhage.
"Hemorrhage is a complication of both the disease and therapy," Dr. Socinski said. "In our judgment, one of the pulmonary hemorrhages was related to the progression of disease and the other to treatment." The cerebral hemorrhage was judged to be treatment related.
Other grade 3-4 toxicities included fatigue/asthenia, nausea, vomiting, abdominal pain, and hypertension. "But most patients reported grade 1-2 toxicities," he said.
Dr. Socinski said the results were encouraging "because this is a very difficult group of patients."
He said the trial "establishes [Sutent] as a drug with single agent activity in NSCLC. It is a beachhead for the drug in lung cancer, but many questions remain about moving up the drug to the first-line setting."
At an ASCO press briefing, where the study was discussed, Dr. Socinski said that the trial met its endpoint with a 10% response to Sutent. Later, however, during a presentation at an ASCO plenary session, he said the trial had an unconventional design. A response of at least 15% would be considered "interesting" while less than 5% would be uninteresting. He described the middle ground of 10% as hypothesis-generating.
Bruce E. Johnson, M.D., of the Dana-Farber Cancer Institute in Boston, said that he and other lung cancer specialists are always "happy to have another agent that works," but he cautioned that the data are preliminary.
Dr. Johnson, who moderated the ASCO press briefing, was not involved in the study
Dr. Socinski said that this trial is going forward with a different dosing strategy-Sutent at 37.5 mg daily continuously.