Martins on Lenvatinib's Significance in Differentiated Thyroid Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Feb 22, 2016

Renato G. Martins, MD

Renato G. Martins, MD

Since lenvatinib (Lenvima) landed in the treatment paradigm as an approved option for patients with differentiated thyroid cancer (DTC), it has had a noticeable effect, explains Renato G. Martins, MD.

Lenvatinib was approved by the FDA as a treatment for patients with progressive, radioactive iodine (RAI)–refractory DTC in February 2015, joining sorafenib (Nexavar), another tyrosine kinase inhibitor, as a first- or second-line treatment option.

The approval was based on findings from the phase III SELECT trial, in which treatment with the multikinase inhibitor reduced the risk of disease progression by 79% (HR, 0.21; 99% CI, 0.14-0.31; P <.0001).

In the SELECT trial, 392 patients with advanced RAI-refractory DTC were randomized in a 2:1 ratio to oral lenvatinib at 24 mg daily in 28-day cycles (n = 262) or placebo (n = 131). Pretreatment with one prior TKI regimen was permitted.

At a median treatment duration of 13.8 months with lenvatinib and 3.9 months with placebo, the median progression-free survival was 18.3 months versus 3.6 months, respectively.

The objective response rate with lenvatinib was 64.8% versus 1.5% with placebo. Four patients in the lenvatinib arm had complete responses versus none in the placebo group, with partial responses in 165 and 2 patients, respectively.

Treatment-related adverse events reported with lenvatinib include hypertension, proteinuria, decreased weight, fatigue, and diarrhea, along with palmar-plantar erythrodysesthesia syndrome.

In an interview with OncLive, Martins, medical director of Outpatient General Oncology/Hematology at Seattle Cancer Care Alliance, medical director of Thoracic/Head and Neck Oncology, and professor at University of Washington School of Medicine, discusses the impact of lenvatinib in patients with DTC, how and when it should be used in clinical practice, and the future potential for the agent.

OncLive: With lenvatinib being on the market for over 1 year, how has the treatment landscape of DTC changed?

Martins: The lenvatinib papers show something very important—that there is a lack of cross-resistance between these tyrosine kinase inhibitors for thyroid cancer. In one of the lenvatinib papers, the response rate in patients who had received a prior TKI was actually pretty high.

We now have 2 options that are FDA approved. The number of options for patients who have RAI-refractory disease has expanded quite a bit and, very frequently, these patients have the opportunity to go from one oral TKI to another oral TKI and remain with disease control.

I would say that lenvatinib is probably the one that has the highest response rates.

Is lenvatinib being used, more or less, as the standard of care in the first-line setting?

I think so. I don’t have the data to support that statement, but I would imagine that that is the case.

What factors are considered when choosing between sorafenib and lenvatinib as a first-line therapy for patients with DTC?

The first question in treating patients with thyroid cancer who are RAI-refractory is, “Do they need therapy, period?” Some patients have a very indolent course of their disease, and they may present with multiple small pulmonary nodules from which they have absolutely no symptoms. We should try to avoid making the treatment into a disease.

There are a number of patients who go years without receiving therapy with very slow-growing tumors. The question is, “When is the appropriate time to pull the trigger in therapy?”


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