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Cabergoline May Be Safely Withdrawn From Select Patients With Hyperprolactinomas

Patients with nontumoural hyperprolactinaemia, microprolactinomas, or macroprolactinomas can safely withdraw from cabergoline therapy if they have normalised prolactin levels and no evidence of tumour, researchers report.

"Our study showed that, in general, remission of hyperprolactinaemia persisted after the withdrawal of cabergoline, without any evidence of renewed tumour growth," writes Annamaria Colao, MD, PhD, and colleagues at Federico II University of Naples, Italy, adding "neither sex nor age was associated with the recurrence of hyperprolactinaemia."

The researchers analysed recurrence following cabergoline withdrawal over a minimum of 24 months in 200 newly diagnosed patients who underwent first line-treatment with oral cabergoline (0.5 mg in first week followed by 0.5 mg twice per week adjusted after 2 months according to serum prolactin levels) for at least 12 months. The population had obtained normal levels of prolactin and had magnetic resonance imaging (MRI) findings that showed no tumour or tumour reduction of 50% or more with more than a 5 mm distance from the optic chiasm and no invasion of the cavernous sinuses or other critical areas.

In the 25 patients (all female, median age 28 years) with nontumoural hyperprolactinaemia recurrence rates were 24% at 2 to 5 years after cabergoline withdrawal while among the 105 patients (94 female and 11 male, median age 30 years) with microprolactinomas and the 70 (37 female and 33 male, median age 40 years) with macroprolactinomas the 2 to 5 year recurrence rates were 31% and 36%, respectively. No patient showed renewed tumour growth, however gonadal dysfunction redeveloped among 10 female and 7 male patients with recurrent hyperprolactinaemia. At the time of recurrence prolactin levels were significantly lower than at diagnosis (P < .001) in all groups.

Kaplan-Meier estimates show that patients with either macroprolactinomas or microprolactinomas with MRI identified remnant tumours prior to withdrawal of cabergoline had 5-year recurrence rates of 78% or 42%, respectively, compared with patients with no MRI evidence of tumour (33% or 26%, respectively).

"Cabergoline can be safely withdrawn in patients with normalized prolactin levels and no evidence of tumour," the authors conclude. "However, until data from a study with a longer follow-up period are available," they suggest, "close monitoring for recurrent hyperprolactinaemia and renewed tumour growth is important, particularly in patients with macroprolactinomas, in whom renewed growth may compromise vision."

N Engl J Med 2003;349:2023-33.

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