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Vandetanib Clinical Research Experience
Jul 02, 2018

Patients treated with vandetanib 300 mg(n=231) or placebo (n= 99) had unresectable local progression or metastatic myeloid thyroid cancer. The researchers determined that the patient could continue to receive open vandetanib treatment after the patient's progress or data deadline.

Adverse events leading to death in vandetanib recipients (N=5) are respiratory failure, respiratory failure, aspiration pneumonia, arrhythmia, heart failure, and sepsis. Adverse reactions in patients receiving placebo resulted in death from gastrointestinal bleeding (1%) and gastroenteritis (1%). In addition, one case of sudden death and one death from cardiac arrest occurred in vandetanib patients after the data deadline. Vandetanib- termination causes in patients treated with >1 include weakness, fatigue, rashes, joint pain, diarrhoea, hypertension, prolonged QT interval, increased creatinine and fever. Severe adverse events in vandetanib-treated patients >2% included d diarrhea, pneumonia, and hypertension. Significant adverse drug reactions, including pancreatitis (0.4% vs. 0%) and heart failure (0.9% vs. 0%), are not common clinically in patients receiving vandetanib compared to patients receiving placebo. Pneumonia was the most common cause of death among vandetanib patients in the consolidated summary of the security database.

In the randomized part of the medullary thyroid cancer (MTC) study, the incidence of grade 1-2 bleeding events in vandetanib patients was 14% compared with 7% for placebo. There was a similar 13 percent incidence in the 300 mg single drug safety program.

Blurred vision was more common in patients with medullary thyroid cancer (9% versus 1%, respectively) in vandetanib compared to placebo. Planned slit lamp examination revealed that in the treated patients, the turbidity of the cornea (vortex keratopathies) may lead to halos and reduced vision. It is not known whether this will improve after termination. Eye examinations, including slit lamps, are recommended in patients reporting vision changes. If the patient has blurred vision, do not drive or operate machinery.

In the randomized medullary thyroid cancer (MTC) study, 51 percent of vandetanib patients had elevated alanine transaminase. Two percent of the patients saw a 3-4 ALT level increase but no patients had a concurrent bilirubin increase. Elevated ALT caused a brief termination of vandetanib. However, in 16/22 patients with continuing 300 mg vandetanib, ALT level 2 was increased. Seven patients who continued to use vandetanib had normal ALT for six weeks. In the scheme, ALT and instructions are monitored more frequently every 3 months.