IASLC: Sutent May Have Single-Agent Activity in Recurrent NSCLC

CHICAGO, Nov. 2 -- The tyrosine kinase inhibitor Sutent (sunitinib) has single-agent activity in patients with recurrent and advanced non-small cell lung cancer who have previously been treated with platinum-based regimens.

In an open-label multicenter study, Sutent had an 11.1% confirmed partial-response rate among 63 evaluable patients, "which is comparable to approved agents," reported Mark A. Socinski, M.D., of the University of North Carolina at Chapel Hill at the International Society for the Study of Lung Cancer symposium on malignancies of the chest and head and neck.

His presentation here updated data reported in June at the American Society of Clinical Oncology meeting. In all, 63 patients were given Sutent 40 mg daily for four weeks, followed by two weeks off the drug and 47 patients were given 37.5 mg of Sutent on a continuous dosing schedule in four-week cycles.

Dr. Socinski reported safety data for both regimens and efficacy data for the four-two regimen. He explained that the efficacy data for continuous dosing were not yet mature.

Among the evaluable patients, in addition to the seven who had partial responses, 28 had stable disease, and 11 had disease progression, he said.

The median duration of response was 21.2 weeks, Dr. Socinski said. He concluded that the data justify a "larger randomized trial in this population."

The updated data included information about three deaths, two of which were judged to be study drug-related.

The three deaths occurred in the on-off Sutent arm and all were bleeding events. There were no deaths in the continuous dosing arm.

The first drug-related death was a 62-year-old woman with squamous cell carcinoma who had a pulmonary hemorrhage seven days after her last dose of Sutent and 22 days after her first dose.

The second study drug-related death occurred in a 73-year-old man with adenocarcinoma who developed cerebral hemorrhage seven days after his last dose of Sutent and 21 days after the initial dose. CT revealed a frontal brain metastasis.

The third death was pulmonary hemorrhage in a 77-year-old man with squamous cell carcinoma who died 16 days after the last dose of Sutent and 41 days after the initial dose. This death was assessed as not study drug related.

Five patients in the four-two arm developed grade 1-2 hemoptysis, and three developed grade 3 hemoptysis versus 15 patients with grade 1-2 hemoptysis and two with grade 3 hemoptysis in the continuous dosing arm, he said.

Eighteen percent of patients in the four-two arm had Sutent dose reduced to 37.5 mg and 30% of patients in the continuous dosing arm required dose reduction to 25 mg.

The average age of patients was 60 and roughly 80% were smokers. Sixty-five percent of patients in the four-two regimen were men as well 57% of the patients assigned to continuous dosing.

Ninety percent of patients in the four-two regimen and 87% of the continuous dosing patients had stage IV NSCLC.

Sixty-four percent of the cancers in the on-off regimen were adenocarcinoma, 22% were squamous cell carcinoma, 3% were bronchioalveolar and 11% were other cancers. In the continuous dosing arm the breakdown was 51% adenocarcinoma, 15% squamous cell, 4% bronchioalveolar, and 30% other cancers.