Advancing Precision Oncology Through Biomarker-Driven Trials: Theory vs. Practice.

For example, breast cancer patients with estrogen and progesterone receptors are treated with endocrine therapy because they are expected to benefit from such treatment, while HER2 patients benefit from trastuzumab. Enrichment designs decrease patient heterogeneity, select high-risk patients, and select patients who are mostly likely to respond. Another example of predictive enrichment is the TOGA trial, where more than 3,800 gastric cancer patients were screened for HER2 expression and only patients who were HER2 positive were randomized to either trastuzumab plus chemotherapy or chemotherapy alone. Biomarker-driven trials may lead to the identification of patients who will benefit the most from treatment if such trials are well-designed, -conducted, and -analyzed. [Extracted from the article]