DENVER – Patients put on lenvatinib for the management of radioactive iodine–resistant differentiated thyroid cancer need to be taught how to monitor their blood pressure, be given a cuff with which to do so, and be called daily by someone on the medical staff for at least the first 2 weeks, according to Sina A. Jasim, MD, reporting on real world use of the drug since its approval in February 2015.
For now, oncologists prescribe and manage this drug. But as lenvatinib (Lenvima, Eisai) becomes more widely used, endocrinologists can expect to be the ones prescribing it sometimes and counseling patients in the practical aspects of using this drug, Dr. Jasim of the Mayo Clinic, Rochester, Minn., said in an interview.
Dr. Sina A. Jasim
It was with endocrinologists in mind that Dr. Jasim and her associates compiled postapproval data on adverse events and patient quality of life. To date, no such data – including those from Mayo – have been published, she said during her presentation at the American Thyroid Association’s annual meeting.
While lenvatinib seems to be a promising therapeutic agent, adverse events are common with its use and occur early. Patients treated with it at Mayo get called by someone on the medical staff daily for the first 2 weeks of therapy, are given a blood pressure cuff, and are taught how to use it. They also receive the cell phone number of a member of the medical staff to consult with about sudden symptoms.
This retrospective analysis involved 25 sequentially treated patients given lenvatinib for RAI-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). While all had received RAI, 11 also had received radiotherapy, 8 had been given at least one other kinase inhibitor previously, and 3 had received two. Fourteen were on an antihypertensive medication at baseline.
All patients initiated lenvatinib at the full dose, but it was reduced in four patients because of old age, renal impairment, or prior colitis. Twenty-one patients developed adverse events within the first month of being on the drug. Hypertension occurred in 16. Six of these required either a raising of the dose of antihypertensive drug they were on at baseline or initiation of antihypertensive therapy.
Adverse events were pronounced enough that the lenvatinib dose had to be lowered in 11 within a median 33 days of starting the drug. Drug treatment had to be interrupted for at least 3 weeks in four patients (two cases of cholecystitis, one case of diverticulitis, and one case of skin lesions).
Patients reported that their quality of life was stable at 2 months, but that their fatigue was worse.
The mean duration of lenvatinib therapy was 6.5 months. Twenty patients are alive at the time of this report.
The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.