When asked to comment on implications of this study, lead author Frank A. Greco, MD, remarked, “The use of this gene-expression profile assay (CancerTYPE ID, bioTheranostics, Inc) on the biopsy material of patients with carcinoma of unknown primary provides a single tissue of origin diagnosis in most patients. Previous studies have validated the accuracy of molecular assay diagnoses in carcinoma of unknown primary, and this study was designed to look at the outcome or survival in patients treated with site-specific therapies based on the assay diagnoses,” he said.

“The overall median survival in the 197 patients was prolonged compared to large studies (100 patients or more) of empiric chemotherapy (paclitaxel/carboplatin, gemcitabine/cisplatin, or similar regimens) reported in the past 9 months or so, as well as compared to survival in 396 patients with carcinoma of unknown primary (median survival = 9.1 months) with identical prognostic features treated with empiric therapy by our same cooperative group (Sarah Cannon Research Consortium) prior to the study reported at ASCO 2012. The survival met the expectations of the study design,” he noted.

“The fact that molecularly diagnosed patient groups with expected more responsive tumor types survived significantly longer than groups with assay diagnosed less responsive tumor types provides additional evidence of the usefulness of the molecular assay in carcinoma of unknown primary,” Dr. Greco continued. “These data support the use of molecular profiling in this setting when standard immunohistochemical staining patterns cannot provide a single diagnosis of the tissue or origin. The outcome overall in carcinoma of unknown primary appears improved, and for some diagnoses the survival is substantially better than the standard approach of empiric chemotherapy,” he concluded. ■

Disclosure: Dr. Greco has received honoraria from bioTheranostics.