Randomised phase 2 trial of site-specific treatment based on gene expression profiling versus carboplatin and paclitaxel in cancer of unknown primary
Using a gene expression test to guess where a cancer of unknown primary came from, and treating it as that cancer, did not help patients live longer than standard carboplatin and paclitaxel.
Overview
Japanese multicentre randomised phase 2 trial of 130 patients with cancer of unknown primary, assigned to site-specific chemotherapy chosen from a 2,000-gene expression tissue-of-origin assay or to empirical carboplatin plus paclitaxel.
One-year survival was 44.2 percent with site-specific treatment against 54.9 percent with empirical chemotherapy, and progression-free survival did not differ. The trial, like the earlier GEFCAPI 04 study, argued against routine tissue-of-origin testing to direct chemotherapy.
- One-year survival 44.2 percent with site-specific therapy versus 54.9 percent with carboplatin and paclitaxel; no improvement.
Predicting the primary site by gene expression and treating accordingly is not better than empirical chemotherapy, so guidelines do not recommend it; the field moved to genomic profiling for actionable targets instead.
- Randomised phase 2 with survival as the primary endpoint; underpowered for small differences.
- Some predicted primaries received chemotherapy of limited efficacy, which may have blunted any benefit.
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