NCI Clinical Trials Planning Meeting urges research on first-line therapies, prognostic indicators

-- Jeff Muise

Wednesday, August 4, 2010 (Last Updated: 08/05/2010)

WEDNESDAY, Aug. 4 (HealthDay News) -- Research in hepatocelluar carcinoma (HCC), the third most common cause of cancer-related death worldwide, should be prioritized to develop new prognostic indicators and effective therapies for the disease, according to the consensus recommendations of a National Cancer Institute Clinical Trials Planning Meeting published online Aug. 2 in the Journal of Clinical Oncology.

Melanie B. Thomas, M.D., of the Medical University of South Carolina in Charleston, and colleagues reviewed the literature on HCC; evaluated current staging, prognostic, and treatment approaches; identified key knowledge gaps; and produced recommendations for future clinical research priorities agreed on at the meeting.

The authors recommended that, because of the limited number of HCC patients, competing trials should be prioritized by scientific rationale for advancing new agents. Recommended trial parameters included the following: that trials of proposed first-line drugs use sorafenib as the control drug, that time to progression be the primary end point, that stratification factors be identified, that preclinical data for potential second-line therapies be developed, that organ dysfunction studies be performed in early clinical development of new drugs, and that tissue biorepositories be created. The researchers also recommended conducting studies to identify circulating biomarkers, studies of novel HCC imaging methods (e.g., positron emission tomography, diffusion magnetic resonance imaging, and perfusion methods), and studies of tumor markers for screening and to assess treatment response.

"Advanced HCC remains a significant unmet medical need for which available research resources should be prioritized. Current and future clinical trials could identify additional effective systemic agents, combination systemic therapies, and combined modality options," the authors write.

Several authors disclosed financial ties to pharmaceutical and/or medical device companies.

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Specialties Hematology & Oncology

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