Marcia S. Brose, MD, PhD, assistant professor, Abramson Cancer Center at the University of Pennsylvania, discusses the rapidly changing treatment landscape for patients with differentiated thyroid cancer (DTC).
In November 2013, the FDA approved sorafenib as a treatment for patients with radioactive iodine (RAI)-refractory DTC, based on data from the DECISION trial. In this phase III study, the median progression-free survival (PFS) with sorafenib was 10.8 months versus 5.8 months for placebo (HR = 0.587; P
In October, the FDA granted a priority review designation to lenvatinib as a treatment for patients with RAI-refractory DTC, based on data from the SELECT trial. In this phase III study, the risk of progression was reduced by 79% in patients treated with lenvatinib compared with placebo. Furthermore, an updated analysis from the study indicated that patients in North America demonstrated similar benefits with lenvatinib as the full study population, Brose notes. A final decision date for this drug has been set for April 14, 2015.
In a subgroup analysis from the DECISION trial, patients with tumors that were smaller than 1.5 cm derived less of a benefit from sorafenib, suggesting a watch and wait approach might be ideal, Brose notes. Additionally, patients with pulmonary only disease seemed to benefit the most from sorafenib. Other subtypes, such as poorly differentiated tumors, were more likely to do poorly. As a result, patients with this subtype are ideal candidates for a clinical trial, Brose suggests.
Brose anticipates a similar subgroup analysis from the lenvatinib study, which could help find an optimal approach to treating patients with both drugs. Once more than 1 drug is available, studies should begin to focus on therapeutic sequencing, to find the most effective treatment strategy, Brose suggests. However, at this point, it remains unclear whether there is an ideal therapeutic sequence.
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