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Long-Term and Low-Dose Treatment with Cabergoline Induces Macroprolactinoma Shrinkage

Department of Molecular and Clinical Endocrinology and Oncology (A.C., A.D.S., M.L.L., F.S., G.F., R.P., B.M., G.L.), Radiology (S.C.), and Unit of Pharmacology, Department of Neurosciences (M.C., L.A.), Federico II University of Naples, 80131 Napoli, Italy

Address all correspondence and requests for reprints to: Annamaria Colao, M.D., Ph.D., Department of Molecular and Clinical Endocrinology and Oncology, Federico II University, via S. Pansini 5, 80131 Napoli, Italy.

	Abstract

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Cabergoline (CAB), a long-lasting dopamine-agonist, specific for the D₂ receptor, is effective in normalizing serum PRL levels in most patients with microprolactinoma or idiopathic hyperprolactinemia. Because few data are presently available on the effects of CAB treatment in macroprolactinomas, the aim of this open-label study was to investigate whether this drug was effective in producing tumor shrinkage, as well as in normalizing PRL levels.

Twenty-three patients with macroprolactinoma entered this study: 15 patients had had no treatment, whereas the remaining 8 patients had been previously treated with bromocriptine, which was withdrawn because of intolerance. Three of 23 patients had undergone unsuccessful surgery. Pretreatment serum PRL levels ranged from 100-3860 µg/L.

CAB was administered at a dose of 0.5–3 mg once or twice a week for 12–24 months. Magnetic resonance imaging (MRI) scans were performed before and 3, 6, 12, and 24 months after the beginning of treatment, to evaluate tumor shrinkage, defined as a decrease of at least 80% of baseline tumor volume.

After 3–6 months of treatment with a low dose (0.5–1 mg/week), serum PRL levels normalized in 18 patients. In the remaining 5 patients, whose serum PRL levels were not normalized, the dose was increased to 2–3 mg/week. This schedule caused the normalization of PRL levels in 1 patient, whereas in the remaining 4 patients, PRL levels were reduced to 30–82 µg/L. A tumor volume reduction greater than 80% at MRI occurred in 14 of 23 patients (61%) after CAB treatment (from 2609.4 ± 534.7 to 530.1 ± 141.3 mm³ at the 12–24th month follow-up, P < 0.001). A volume reduction of 41.8 ± 3.4% was already evident after 3 months (1436 ± 285.9 mm³; P < 0.001). The complete disappearance of the tumor mass at MRI occurred after 6 months of treatment with CAB in 1 patient, and in 5 patients after 1 yr of treatment. An improvement of visual field defects was obtained in 9 of the 10 patients presenting visual impairment before CAB treatment. The drug was tolerated well by all patients. Only 1 patient experienced mild nausea, which disappeared spontaneously after the 2nd day of treatment.

Long-term, a low dose of the D₂ receptor agonist CAB significantly reduced tumor volume and normalized serum PRL levels in a great majority of patients bearing macroprolactinoma. This treatment met with excellent patient compliance. This study suggests that CAB can be used as a first choice drug treatment in macroprolactinomas, as already shown for microprolactinomas and idiopathic hyperprolactinemia.

	Introduction

Top Abstract Introduction Subjects and Methods Results Discussion References

 
PROLACTINOMAS are the most common type of pituitary adenomas in both sexes (1). Medical therapy is presently used as first-line treatment, except in those patients presenting a sudden occurrence of visual impairments caused by a large adenoma that needs to be surgically debulked. In particular, bromocriptine, an ergot-derivative that activates D₁ and D₂ receptors, has been the most widely used drug administered at doses ranging between 5 and 20 mg daily (2). Usually, serum PRL levels are normalized by bromocriptine, which also possesses a strong antitumoral effect, being able to cause shrinkage of tumor mass in about 60–75% of macroprolactinomas (2, 3, 4). These important clinical effects, however, often are limited by the occurrence of a broad spectrum of side-effects such as nausea, vomiting, postural hypotension, headache, and dizziness. These reactions are probably caused by the rapid absorption of the drug, which causes high drug blood levels (2, 4). To improve the tolerability, several drugs with different molecular structure or half-life (such as lisuride, pergolide, and mesulergine) or provided with a greater specificity for the D₂ receptor (such as quinagolide) were tested with different results (5, 6, 7, 8). Recently, cabergoline (CAB), another dopamine-agonist with specificity for D₂ receptor and characterized by a longer half-life (as compared with bromocriptine) was introduced into the medical management of hyperprolactinemia (9, 10, 11, 12). CAB is specially effective in normalizing serum PRL levels and restoring gonadal function in most patients with microprolactinoma or idiopathic hyperprolactinemia (9, 10, 11, 12). In addition, CAB also was effective with patients previously shown to be poorly responsive, or even resistant, to bromocriptine and/or quinagolide, because it normalized serum PRL levels in all 8 microprolactinomas, as well as in 15 of 19 patients with macroprolactinoma (13). Recently, while the present study was being carried out, it was reported that CAB is effective in shrinking tumor mass at the end of a 6- to 12-month period of treatment in 11 of 15 patients with macroprolactinoma (14). This open-label study (with a low dose of CAB) was designed to correlate the serum PRL-lowering effect with: 1) the entity of volume reduction detected at magnetic resonance imaging (MRI); 2) the time-course of tumor volume reduction; and 3) the persistence of tumor reduction effect of CAB after 1–2 yr of continuous treatment in macroprolactinomas.

	Subjects and Methods

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Patients

Twenty-three patients with macroprolactinoma (15 females and 8 males, 17–64 yr old) entered this study after their informed consent had been obtained. Patients’ profile at study entry is shown in Table 1. Three patients had previously undergone unsuccessful surgery (nos. 2, 11, and 17; Table 1). Before starting CAB treatment, mean ± SEM serum PRL levels were 841.4 ± 222.2 µg/L (range 100-3860 µg/L). Eight patients (nos. 7–9, 13, 19, 20, 22, and 23; Table 1) had been treated with bromocriptine for 3–6 months before CAB treatment. They spontaneously withdrew from the bromocriptine treatment because of intolerance. Before starting CAB treatment, all patients were free of drugs for at least 15–30 days. All men had libido and potency failure, whereas all females, except one in menopausal age (no. 22; Table 1), had amenorrhea. Eight women had spontaneous or provocative galactorrhea, and 10 patients had visual field defects.

Routine clinical and hormonal evaluations showed no evidence of any thyroid or adrenal functional abnormalities. Before treatment, the average serum PRL level was calculated on the basis of a 6-h time-course with hourly sampling (0800 h-1400 h). After 1, 2, 3, 6, 12, 18, and 24 months of treatment, serum PRL levels were assayed at 0800 h in a single sample. A general clinical examination was performed every month for the first 3 months, then quarterly. CAB therapy was started at a dose of 0.25 mg once a week for the first week, twice a week during the second week, and then 0.5 mg twice a week for 10 weeks. In 5 patients who did not achieve serum PRL normalization, the dose of CAB was progressively increased to 1 mg twice a week, starting from the fourth month of treatment. The dose of 2 mg/week was maintained for 6 months and then increased to 1.5 mg twice a week in 4 of these 5 patients (nos. 4, 10, 17, and 18; Table 1). All other prolactinoma-bearing patients continued the treatment schedule with 0.5 mg once or twice a week during the whole study period.

Radiological imaging

The MRI was carried out using a superconductive magnetic resonance (1.0 Tesla) and superficial coil in axial, coronal, and sagittal sections. The acquisitions were spin echo with 1000 msec repetition time and 40–120 msec echo time of 21 msec. MRI was performed before and after 3, 6, 12, and 24 months of CAB administration. Tumor shrinkage was evaluated, both as a reduction to less than 80% of the pretreatment tumor volume [in line with Di Chiro and Nelson formula: volume = height x length x width x /6 (15)] and as a decrease greater than 25% in the maximal tumor diameter.

Visual field

Visual field examination was performed with the Goldmann-Friedmann perimetry. Visual field assessment was performed in all patients before CAB treatment and every 3 months in those patients who showed visual field defects.

Assay

Serum PRL levels were assessed by RIA using commercial kits (Radim, Pomezia, Italy). The intra- and interassay coefficients of variation for PRL were 5% and 7%, respectively. The normal range was below 20 µg/L.

Statistical analysis

Data were expressed as mean ± SEM. The statistical analysis was performed by the Student’s t test for paired data. The significance was set at 5%.

	Results

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Effects of long-term CAB treatment on tumor mass and visual perimetry

A tumor volume decrease greater than 80% of pretreatment values was observed in 14 of 23 patients after 6–24 months of CAB treatment (Fig. 1). Pretreatment tumor volume was 2609.4 ± 534.7 mm³; after 3 months of therapy, it decreased to 1436 ± 285.9 mm³ (41.8 ± 3.4% of pretreatment volume, P < 0.001). After 12–24 months of CAB treatment, tumor volume was further decreased to 530.1 ± 141.3 mm³ (79.8 ± 4.1% of pretreatment values, Table 2). The most evident tumor shrinkage occurred in the vertical diameter, with complete disappearance of the suprasellar extension and/or appearance of a secondary empty sella in 6 patients (nos. 7, 9, 12, 19, 20, and 22; Table 1). In another patient (no. 16), the most relevant consequence of tumor size decrease was the disappearance of pituitary stalk deviation, as shown in Fig. 2. The complete MRI disappearance of the macro-prolactinoma occurred in 1 patient (no. 6) after 6 months and in 5 patients after 12 months of treatment (nos. 3, 5, 13, 14, and 17; Table 2). In one of these 5 patients (no. 17; Tables 1 and 2), although the macroprolactinoma disappeared at MRI, PRL levels remained slightly above the normal values. In 8 of the remaining 23 patients, tumor volume decreased from 52.3 to 79.5% of pretreatment values. In one older patient (no. 23; Tables 1 and 2) tumor volume was not modified by 24 months of CAB treatment, likely because of tumor calcification, although serum PRL levels were suppressed. If the criteria adopted to define tumor shrinkage were less restrictive than those previously described (e.g. if a 25% reduction of the maximal tumor diameter was accepted instead), 21 of the 23 treated patients would have displayed significant macroprolactinoma shrinkage (Table 2). Among the 10 patients affected by bitemporal hemianopia, 4 patients had normalization of visual perimetry after 3 months (nos. 13, 16, 20, and 21), and 5 after 6–12 months of treatment (nos. 4, 11, 19, 22, and 23; Table 2).

View larger version (19K): [in this window] [in a new window]   Figure 1. Profile of tumor volume (mm3) decrease assessed by MRI during chronic treatment with CAB in the 23 patients with macroprolactinoma.

View larger version (150K): [in this window] [in a new window]   Figure 2. MRI in two different coronal sections (A and B) of a macroprolactinoma with mild suprasellar extension and pituitary stalk deviation (patient no. 12; Table 1) before and after 3 months of treatment with CAB. The maximal diameter of the adenoma reduced from 11.5 to 6 mm, and the pituitary stalk returned on the midline.

During the whole 12- to 24-month study period, CAB treatment caused the normalization of serum PRL levels in 19 of 23 patients (from 841.4 ± 222.2 to 12.2 ± 4.1 µg/L, Fig. 3). In the remaining 4 patients, serum PRL levels were decreased from 427.7 ± 120.4 to 53.4 ± 13.3 µg/L (86.9 ± 1.2% reduction of pretreatment values) but were not normalized. The time-course analysis of the 1-mg/week CAB treatment showed that the serum PRL lowering effect was already present at the 3-month follow-up in 16 of 23 patients (69.9%) and, after 6 months, in 18 of 23 patients (78.3%). Increase of the CAB dose to 2 mg/week in the remaining 5 patients caused the normalization of serum PRL levels in only 1 (no. 22; Table 1), whereas, despite a further dosage increase (3 mg/week), a mild hyperprolactinemia persisted in the other 4 patients (nos. 4, 10, 17, and 18; Table 1).

View larger version (29K): [in this window] [in a new window]   Figure 3. Serum PRL profile in the 23 patients with macroprolactinoma during chronic treatment with CAB. The interrupted lines indicate the normal range.

Tolerability

The 12- to 24-month CAB treatment was tolerated well by all patients. After the first administration of CAB, only one patient (no. 19; Table 1) referred mild nausea, which spontaneously disappeared after the second day. This patient had previously interrupted a 2.5-mg/day bromocriptine schedule for recurrent vomiting, severe dizziness, and hypotension. As shown in Table 1, CAB treatment was tolerated well also by seven patients previously shown to be intolerant to bromocriptine.

	Discussion

Top Abstract Introduction Subjects and Methods Results Discussion References

 
The results of the present study demonstrated that in patients bearing macroprolactinoma (one of the most frequent pituitary adenomas) CAB, at a low, once- to twice-a-week dose, administered for 12–24 months, induced a notable tumor volume reduction, a disappearance of neurological and clinical signs, and serum PRL suppression. This remarkable improvement of the clinical course of the macroprolactinoma was associated with an excellent tolerability of the long-term treatment and, therefore, to a high degree of patients’ compliance.

Until now, it has been demonstrated that CAB can be used as a first choice treatment in microprolactinomas and idiopathic hyperprolactinemic (12). Only very recently, Biller and co-workers (14) reported that CAB reduces the maximal cranio-caudal tumor height, of 11 out of 15 of the macroprolactinomas they studied, by a mean of 31 ± 9.3%. The results of the present clinical study clearly show that CAB treatment caused a tumor volume shrinkage greater than 80% in 61% of patients, and of 50–79% in 34.7% of the remaining patients. Interestingly, it should be mentioned that the majority (15 patients) of those enrolled in the present study did not receive any PRL-lowering drug before CAB therapy, a condition which favors optimal responsiveness, in terms of tumor shrinkage (because fibrosis does not occur) (16).

The time-course analysis of CAB treatment effect on the cardinal clinical signs of macroprolactinomas (hyperprolactinemia, gonadal failure, and visual field defects) showed that a significant therapeutical effect can be observed already after 1 month. This efficacy is identical to that previously observed with other dopamine-agonist compounds (i.e. bromocriptine, quinagolide, and pergolide) (4). However, the treatment with the previously available dopamine-agonists needs a twice-to-trice daily administration (with the frequent occurrence of serious and unwanted effects, including: postural hypotension, dizziness, and nausea or vomiting, which, because of the severity, may compromise the continuation of therapy).

An important aspect that emerges from the results of the present study is the excellent tolerability of the long-term (12–24 months) treatment observed in all patients and the convenience of the once-to-twice a week drug assumption. These pharmacological properties are of particular relevance if one considers that this therapy must be performed for a long and undetermined time (17) and that good patient compliance is required to guarantee an effective control of tumor growth and hormonal suppression. The peculiar pharmacological profile of CAB [characterized by a longer half-life of approximately 65 h and higher affinity for D₂ dopamine binding sites, as compared with BRC (18, 19)] enhances patient compliance.

In recent years, special attention has been devoted to pharmacoeconomics, because of the increasing cost of drug treatment of several diseases. Although the cost of CAB for 1 month of treatment (at the dose of 1 mg/week) is 4 times higher than that of BRC (at the dose of 5 mg/day), i.e. drug cost in Italy, it should be considered that the lack of disturbing, unwanted side effects often avoids the prescription of additional drugs and, in rare but severe cases, hospitalization.

In conclusion, the results of the present study demonstrate that CAB, besides being an effective treatment of prolactinomas that are resistant or poorly responsive to other dopamine-agonists (13), can be considered a first-line pharmacological treatment of macroprolactinomas, together with bromocriptine; or rather, it can substitute the parent ergot derivative in those patients who are poorly tolerant or completely intolerant to it.

Received March 10, 1997.

Revised May 29, 1997.

Revised July 31, 1997.

Accepted August 5, 1997.

	References

Top Abstract Introduction Subjects and Methods Results Discussion References

 

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