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GIDEON: Oncologists give lower doses, shorter duration of sorafenib for hepatocellular carcinoma
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SAN FRANCISCO — Medical oncologists treating patients with hepatocellular carcinoma, on average, administered a lower initial and daily dose of the kinase inhibitor sorafenib, and for a shorter time, compared with physicians in other specialties.
Interim results from GIDEON, an ongoing, global, prospective, non-interventional registry study of patients with unresectable hepatocellular carcinoma assigned to sorafenib (Nexavar, Bayer), showed that the use of sorafenib differed by region and specialty, Alan P. Venook, MD, said.
Venook, director of the UCSF Cancer Center Clinical Research Office in Mount Zion, Calif., and a member of the HemOnc Today Editorial Board, presented the results during the 2011 Gastrointestinal Cancers Symposium.
Currently, he said, the results generate more questions than answers. The apparent differences in use of sorafenib may be caused by patient factors, the extent of the cancer, liver dysfunction or general condition. These early results may also be attributable to medical specialty, physician expectations, patient preference, regional difference or simple selection bias based on the physicians who chose to participate.
“This is an early look,” Venook said. “Our hope is to mine the more mature data from GIDEON and look elsewhere to see if we can get to the bottom of why the drug is used differentially, if it is in fact used differentially.”
He said there were no clinically significant differences in overall adverse events or drug-related adverse events across specialties. Hepatologists/ gastroenterologists also treated patients for a longer duration than medical oncologists.
There were no requirements for follow-up intervals, dose adjustments or specific assessments. Venook said all of those were done at the discretion of the treating physician.
From January 2009 to September 2010, more than 2,220 patients from 32 countries were enrolled in the study. A total of 141 physicians participated: 49% were hepatologists/gastroenterologists; 39% were medical oncologists; and 12% were other specialties. Most of the oncologists were based in the United States, and the oncologists tended to treat patients with more advanced disease.
“Hepatologists use a higher dose of sorafenib, on average, in patients with [hepatocellular carcinoma] than do medical oncologists,” Venook said. “This is not explained by a difference in toxicity because, at least as reported, the toxicities appear to be comparable across the specialties.”
For more information:
- Venook AP. #157. Presented at: the 2011 Gastrointestinal Cancers Symposium; Jan. 20-22, 2011; San Francisco.
Disclosure: Dr. Venook reports receiving research funding from Bayer Pharmaceuticals, Genentech, the National Comprehensive Cancer Network, Novartis, Onyx, Pfizer and Roche, and serving as a consultant with NCCN.