Patient outcomes may vary with the use of lenvatinib (Lenvima®, Eisai) for differentiated thyroid cancer based on how closely patients are monitored and managed, according to recent study results.
At the 86th Annual Meeting of the American Thyroid Association (ATA), researchers said that adverse events reported in clinical trials occurred early after lenvatinib initiation.
“We looked into our institutional experience with lenvatinib use in progressive and imminently threatening radioactive iodine-resistant differentiated thyroid cancer patients since lenvatinib FDA approval for this indication. We studied 25 patients treated within the last year in our clinic,” Sina Jasim, MD, of the Mayo Clinic, Rochester, Minnesota, said.
During a presentation at the meeting, Dr Jasim told clinicians that this agent comes with significant toxicities. However, she said the toxicities occur early, and they require frequent dose adjustment.
The patients were followed for a mean duration of 6.5 months (range: 1-12 months) of lenvatinib therapy and the agent was discontinued in 7 patients (28%). Discontinuation was due to disease progression in 1 patient (4%) and serious adverse events in 6 patients (24%). Dr Jasim said RECIST partial response was achieved in 10 patients (40%).
“The take-home messages to endocrinologists in practice are several. Lenvatinib has important disease modifying activity in differentiated thyroid cancer, but is also correspondingly toxic, thereby necessitating frequent contact with patients to optimally address emerging side effects. It is important to note that not all practices and providers are equipped to do so without modifying their approaches and willingness to field patient calls in real time,” Dr Jasim told Endocrinology Advisor. “For example, hypertension was a prominent adverse event that arose in more than 60% of patients within the first month after lenvatinib initiation, thereby requiring frequent antihypertensive therapy dose adjustment (24%) or addition (48%).”
Patients in the study were consecutively treated between February 2015 and May 2016 and had progressive, metastatic radioactive iodine-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). The mean age was 55 years (range: 27 to 81 years) and 52% were women. Each patient previously had received radioactive iodine therapy, radiotherapy, and some received prior kinase inhibitor therapy. At the start of the study, 14 patients (56%) were on antihypertensive agents with controlled blood pressure. Mutation status was available in 13 patients (52%), of whom 2 had BRAF, 2 had TERT mutations, and 5 had both.
She said the starting lenvatinib dose was reduced in 4 patients due to old age, renal impairment, and history of colitis. Dose reductions due to adverse events occurred in 11 patients (44%) and therapy interruption of longer than 3 weeks occurred in 4 patients. The quality-of-life scores were maintained at initial follow-up.
“In our experience, despite issues with frequent side effects, responsive care and dosage modifications were associated with maintained patient quality of life, highlighting the significance of diligent and close monitoring by health care providers when treating patients on lenvatinib,” said Dr Jasim. “Using our very hands-on approach to interacting with patients especially early on in their treatment with lenvatinib, our experience is that lenvatinib dosage reductions were less frequently required than reported in clinical trials.”
Disclosures: Dr Jasim reports no financial relationships or commercial interests.
- Jasim S, Ariza NI, Hilger C, et al. Oral Abstract 11. Post-registration outcomes in differentiated thyroid cancer (DTC) patients treated with lenvatinib. Presented at: American Thyroid Association Annual Meeting; September 21-25, 2016; Denver, Colorado.