ORIGINAL ARTICLE
Pleomorphic adenoma of the parotid gland 1985–2010: A Danish nationwide
study of incidence, recurrence rate, and malignant transformation
Simon Andreasen, MD,1,2,3* Marianne H. Therkildsen, MD, DMSc,4 Kristine Bjørndal, MD, PhD,5 Preben Homøe, MD, PhD, DMSc1,3
1
Department of Otorhinolaryngology and Maxillofacial Surgery, Køge University Hospital, Køge, Denmark, 2Department of Otolaryngology Head and Neck Surgery and Audiology,
Rigshospitalet, Copenhagen, Denmark, 3University of Copenhagen, Copenhagen, Denmark, 4Department of Pathology, Rigshospitalet, Copenhagen, Denmark, 5Department of
ORL–Head and Neck Surgery, Odense University Hospital, Odense, Denmark.
Accepted 20 July 2015
Published online 18 September 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/hed.24228
ABSTRACT: Background. Pleomorphic adenoma is the most frequent
salivary gland tumor and is known for its tendency to recur and for its
ability to transform to carcinoma ex pleomorphic adenoma (Ca-ex-PA).
Along with pleomorphic adenoma demographics, we present the first
nationwide study with long-term follow-up on these topics.
Methods. The Danish Pathology Data Bank was searched for parotid
pleomorphic adenoma and Ca-ex-PA in the period 1985 to 2010 and all
pathology descriptions were reviewed. Ca–ex–PA specimens were
reviewed by a pathologist.
Results. A total of 5.497 patients were identified and 2.86% had at least
one recurrence. An incidence of 4.29/100,000/year was found. The rate
INTRODUCTION
The pleomorphic adenoma is the most common tumor of
the salivary glands with a reported incidence of 2.4 to
3.05/100,000 persons/year, and constitute two thirds of
parotid tumors.1 Approximately two thirds of these
patients are women and the peak incidence is in the fifth
decade, but pleomorphic adenomas are found in both
sexes in all ages.1 Although a common disease, demo-
graphic data are scarce and most studies involve only
small or selected populations.
Surgical treatment of pleomorphic adenoma is war-
ranted because of tumor growth and the ability of pleo-
morphic adenoma to undergo malignant transformation to
carcinoma ex pleomorphic adenoma (Ca-ex-PA). Further
complicating the management of these patients is the risk
of recurrences and by the location of the facial nerve in
the parotid gland. Recurrence has been attributed to rup-
ture of the tumor capsule during surgery and to pseudopo-
dia extending through the capsule, making the surgical
technique the prime determinant for the rate of recur-
rences.2–4 Consequently, recurrence rates spanning from
0% of pleomorphic adenomas treated with superficial
parotidectomy up to 45% with the enucleation technique
*Corresponding author: S. Andreasen, Department of Otorhinolaryngology and
Maxillofacial Surgery, Køge University Hospital, Lykkebækvej 1, 4600 Køge,
Denmark. E-mail: Simon@Andreasen.pm
E1364 HEAD & NECK—DOI 10.1002/HED APRIL 2016
of malignant transformation in recurrent pleomorphic adenoma
was 3.3%.
Conclusion. We report an up-to-date assessment of the epidemiology
of pleomorphic adenoma. We found an increasing incidence and low
recurrence rate compared with previous studies. The risk of Ca-ex-PA
for patients with recurrent pleomorphic adenoma was low compared to
the literature. V
C 2015 Wiley Periodicals, Inc. Head Neck 38: E1364–
E1369, 2016
KEY WORDS: pleomorphic adenoma, carcinoma, parotid,
epidemiology
have been reported in smaller studies with limited follow-
up.5,6 In Denmark, depending on the location with respect
to the facial nerve, the consensus is that parotid pleomor-
phic adenomas are preferred to be treated with either
complete or partial superficial parotidectomy when
located to the superficial lobe and with total parotidec-
tomy when located in the deep lobe.3 As these approaches
are consistently used in Denmark, we conducted a survey
of recurrence rates in patients treated with the current sur-
gical approaches.
Besides repeated surgery and risk of damaging the facial
nerve, recurrences are feared because long-lasting tumors
are reported to implicate an up to 24% risk of malignant
transformation of pleomorphic adenoma to Ca-ex-PA.7
These previous studies are small single-center studies, but
for these rare entities large-scale surveys are warranted.
To ascertain the issues of incidence, recurrence rate, and
risk of malignant transformation in pleomorphic adenoma
and recurrent pleomorphic adenoma, we conducted a sur-
vey of the entire Danish population consisting of more
than 5 million people over a 26-year period. This is the
largest study of its kind and will be valuable for clinical
decision-making and in informing patients about the risks
of subsequent recurrence and malignant transformation.
PATIENTS AND METHODS
The Ethics Committee of the Capital Region of Den-
mark (H-1-2012-061 add. 36819) and the Danish Data
 DEMOGRAPHICS OF PLEOMORPHIC ADENOMA IN THE DANISH POPULATION 1985–2010

specimen with a histologic pathology description of

parotid pleomorphic adenoma with the same laterality.
Search results were reduced after removal of duplicates,
recurrences, and miscoded entries (Figure 1). All pathol-
ogy reports were read to ensure that all cases were coded
and classified correctly and it was noted whether the
patient was operated or only diagnosed with cytology.
Median follow-up time was 11.5 years for the entire
cohort and 15.4 years for patients with recurrences.
To assess the incidence of malignant transformations, we
identified all Ca-ex-PAs in the period. All Ca-ex-PAs from
January 1, 1990, to December 31, 2005, has previously
been revised by Bjørndal et al,9 including 7 in situ Ca-ex-
PAs (Figure 2). Therefore, we retrieved specimens of all
available Ca-ex-PAs from all Danish pathology depart-
ments from January 1, 1985, to December 31, 1989, and
from January 1, 2006, to December 31, 2010. Non-retriev-
able specimens were included only if the pathology report
clearly described residual pleomorphic adenoma or previ-
ous pleomorphic adenoma in the same location. All cases
were checked in the Danish Cause of Death Registry to
assess time under observation for recurrence and malignant
transformation, as patients were excluded at date of death.
Microsoft Office Excel 2010 for Mac (Microsoft, Red-
mond, WA) was used for data registration.

FIGURE 1. Identification of pleomorphic adenomas. Of the identi-

fied 9,528 pleomorphic adenomas, a total of 4,031 cases were
excluded leaving 5,497 primary pleomorphic adenomas. To esti-
mate the rate of recurrence, 222 patients were excluded as they
had not undergone surgery. Of the remaining patients, 151 expe-
rienced recurrence(s).

Protection Agency (Journal No. 12-000179) approved this

protocol. The investigation adheres to the tenets of the
Declaration of Helsinki (version 2008).
Patients diagnosed with pleomorphic adenoma or Ca-
ex-PA from January 1, 1985, to December 31, 2010, were
identified in The Danish Pathology Data Bank, which is a
national database, including all histological and cytologi-
cal reports made in Denmark.8 This registry was searched
with combinations of codes for pleomorphic adenoma,
Ca-ex-PA, parotid gland, and recurrence. Patients were
traceable by their unique social security numbers. The
inclusion criteria were pleomorphic adenoma or Ca-ex-
PA in the parotid gland diagnosed with histology or
cytology. Sex and age was determined with social secu-
rity numbers, and incidences were calculated based on
demographic data from Statistics Denmark (www.dst.dk).
Incidence rates were calculated as the number of pleo-
morphic adenoma or Ca-ex-PA in period / population in
period x 100,000. In accordance with the 2005 World
Health Organization classification, we included in situ
Ca-ex-Pas.1 Incidence rates were based on registered FIGURE 2. Identification of carcinoma ex pleomorphic adenomas
cases from January 1, 1990, as reporting to The Danish (Ca-ex-PAs). Of the 156 entries, 120 were unique. Of 116 avail-
Pathology Data Bank is only nationally complete from able specimens, 4 were excluded after revision and 4 unavailable
this date. A recurrence was defined as a histological or were included based on pathology report, identifying a total of
116 unique Ca-ex-PAs.
cytological diagnosis of pleomorphic adenoma after previ-
ous surgery of pleomorphic adenoma. Surgery for pleo-
morphic adenoma was registered for each separate

HEAD & NECK—DOI 10.1002/HED APRIL 2016 E1365

ANDREASEN ET AL.

TABLE 1. Demographics of patients with pleomorphic adenoma in five-year intervals.

Total no. of Total incidence Male incidence Female incidence

cases/no. of 100,000 persons/y Total median 100,000 persons/y Male median 100,000 persons/y Female median
5-y interval women (95% CI) age, y (range) (95% CI) age, y (range) (95% CI) age, y (range)

1985–1989* 761/466 2.98 (1/- 0.001) 47 (9–86.4) 2.34 (1/- 0.001) 46.1 (10–85) 3.59 (1/- 0.001) 48.6 (9–86.4)
1990–1994 1,061/670 4.13 (1/- 0.001) 49 (9.8–89.8) 3.09 (1/- 0.001) 49.0 (14.5–89.3) 5.15 (1/- 0.001) 49.2 (9.8–89.8)
1995–1999 1,147/694 4.40 (1/- 0.001) 49 (11.4–94.2) 3.52 (1/- 0.001) 49.0 (13.6–92.2) 5.25 (1/- 0.001) 50.3 (11.4–94.2)
2000–2005 1,262/720 4.74 (1/- 0.001) 51 (9.1–93.9) 4.12 (1/- 0.001) 50.3 (11.8–91.6) 5.34 (1/- 0.001) 52 (9.1–93.9)
2006–2010 1,266/920 3.90 (1/- 0.001) 53 (9.1–93.2) 2.14 (1/- 0.001) 50.9 (12.1–91.3) 5.61 (1/- 0.001) 54.6 (9.1–93.2)
1990–2010† 4,736/3,004 4.29 (1/- 0.001) 51.1 (9–94.2) 3.6 (1/- 0.001) 50.3 (10–92.2) 5.4 (1/- 0.001) 52.8 (9–94.2)

Abbreviation: 95% CI, confidence interval.

* Data in this period are not complete as a few departments did not report consistently to the Danish Pathology Data Bank.
†
Because of incomplete registration, 1985–1989 data are not included.

Statistics 1985-1989 to 53 years in 2006 to 2010 (p < .001). A

Statistical analyses were performed using the Mann– steady increase in median age from 46.1 to 50.9 years in
Whitney U and chi-square tests in SPSS version 22.0 for men (p 5 .008) and from 48.6 to 54.6 years in women
Mac (SPSS, Chicago, IL). Probability values (p values) < was found (p 5 .001) (Table 1). In the entire period,
.05 were considered statistically significant. women were older than men when diagnosed (p < .001).

RESULTS
Incidence
A total of 5,497 cases of primary pleomorphic adenoma
of the parotid gland were recorded during the 26-year
period (Figure 1). The distribution in 5-year intervals as
well as the distribution between sexes and median age is
presented in Table 1. The distribution of age by decade at
diagnosis is illustrated in Figure 3. Women accounted for
63.1% (95% confidence interval [CI] 5 61.8% to 64.4%)
and men for 36.9% (95% CI 5 35.62% to 38.18%) of all
pleomorphic adenomas. The distribution between the
sexes was relatively stable in the study period. We found
the incidence to be normally distributed with peak inci-
dence in the fifth and sixth decade for men and women,
respectively (Figure 3). Incidence from 1990 to 2010 in
the entire Danish population was 4.29/100,000 persons/
year (see Table 1). The median age at diagnosis was 50.3
years for men and 52.8 years for women (p < .001). The
median age at diagnosis increased from 47 years in
Recurrence
In the study period, we identified 148 patients with one
or more recurrences after the primary operation for pleo-
morphic adenoma. Three additional patients were identi-
fied with alternative search strategies (Figure 1). Sex and
median age of the recurrences are presented in Table 2.
The overall frequency of a minimum of one recurrence
was 2.86% (men 5 2.77% and women 5 2.92% [not sig-
nificant]). In addition, there was no significant difference
in age at diagnosis of the primary pleomorphic adenoma
between sexes. Patients with recurrences were signifi-
cantly younger at diagnosis of the primary pleomorphic
adenoma as compared with patients who remained recur-
rence free (Tables 1 and 3; p < .001).
The 151 patients with recurrent pleomorphic adenoma
were observed with respect to number and time between
recurrences (Figure 4). In the 26-year period, there was
an overall median follow-up time of 11.5 years and 15.4
years for patients with recurrent pleomorphic adenoma.
There were large variations in intervals between surgeries
and between sexes, but none were significant. The overall
rate of re-recurrence was 46.4% among those with recur-
rent pleomorphic adenoma.

Malignant transformation of primary and recurrent

FIGURE 3. Distribution of primary pleomorphic adenoma by sex
and age at diagnosis. A normal distribution for both sexes, peak-
ing in the fifth and sixth decade for men and women, respec-
tively, was seen.
pleomorphic adenoma
Demographics of patients with Ca-ex-PA are shown in
Table 4. Of the 116 Ca-ex-PAs identified, the majority
was diagnosed as “de novo” in patients with no history of
pleomorphic adenoma (83.6%). Only 12% were in
patients with a previous operation for one pleomorphic
adenoma and 4.3% were in patients operated for recurrent
pleomorphic adenoma. The frequency of malignant trans-
formation in patients operated for recurrent pleomorphic
adenoma was 3.3% as opposed to 0.25% in patients oper-
ated for only primary pleomorphic adenoma. Patients
with de novo Ca-ex-PA were older than the patients with
pleomorphic adenoma (p < .001), but there was an equal
sex distribution.

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 DEMOGRAPHICS OF PLEOMORPHIC ADENOMA IN THE DANISH POPULATION 1985–2010

TABLE 2. Demographics of patients with recurrent pleomorphic adenoma at diagnosis of last recurrence.

Median age Median age of Median age of women

No. of No. of when diagnosed Men/ men at diagnosis of at diagnosis of last
recurrences patients with last recurrence, y women, % last recurrence, y (range) recurrence, y (range)

1 81 49.0 32.1/67.9 42.8 (15.2–75.7) 42.8 (17.0–61.5)

2 42 50.9 39.0/61.0 53.6 (26.9–78.7) 50.9 (15.8–80.2)
3 14 47.1 38.5/61.5 39.5 (31.3–76.3) 54.7 (30.9–79.0)
4 6 48.4 16.7/83.3 41.9 (33.4–49.0) 55.8 (34.7–80.7)
5 4 49.0 25/75 49.0 63.1 (35.6–83.7)
6 2 43.0 50/50 43.3 43.0
7 2 43.0 50/50 43.0 42.7

Patients are divided with respect to number of recurrences and sex.

DISCUSSION tal pathology database, we did not depend on correct dis-

To be able to evaluate the epidemiology of pleomor-
phic adenoma and Ca-ex-PA, high quality data collected
over a long time period is needed. Our data comes from
The Danish Pathology Data Bank where all pathology
diagnoses in Denmark are registered making this nation-
wide population-based study on this topic the largest of
its kind to date.
We found the incidence in 5-year intervals to be stable
between 1990 and 2010 but significantly lower in 1985 to
1989. This is probably caused by incomplete registration to
the Danish Pathology Data Bank before 1990 from some
institutions.8 Therefore, we chose to include patients from
this period only in the recurrence analysis, as this popula-
tion had the longest follow-up. Based on the stable 21-year
period from 1990 to 2010, we found an incidence of 4.29/
100,000 persons/year. This is higher than reported in previ-
ous studies referred to by the World Health Organization in
which the incidence has been reported to be 2.4 to 3.05/
100,000 persons/year, including pleomorphic adenomas in
all locations in the head and neck and not only in the
parotid, as in our study.1 The incidence of 2.4/100,000 per-
sons/year was based on a material of only 71 benign
tumors.10 The other study by Pinkston and Cole11 found an
incidence of 3.05/100,000 persons/year in the population of
Alabama in 1968 to 1989. These differences might be
explained by differences in available methods and inclusion
criteria. For inclusion in the study, Pinkston and Cole11
manually reviewed the patients’ medical records and
required the discharge diagnosis to be a salivary gland
tumor as well as an available pathology report confirming
the diagnosis. In our study, by identifying patients in a digi-
charge diagnosis and eliminated the risk of missing patient
records. Also, two studies on salivary gland tumors from
Africa have found a 50/50 benign to malignant distribution,
only 40% to 45% of tumors located to the parotid and only
40% to 44% of salivary gland tumors to be pleomorphic
adenomas.12,13 Alabama had more than 25% African Amer-
icans at the time of the study, whereas non-western immi-
grants only constituted 2.2% of the Danish population in
1990 and 6.5% in 2010 (www.dst.dk). When looking only
at the white population in the Pinkston and Cole11 study,
the incidence was only slightly below the findings in our
study. Our material is complete from 1990 and we therefore
believe that our results indicate the incidence in a European
population dominated more by white people.
Previous studies have found median ages from 41 to 46
years at diagnosis.14,15 We found that age at diagnosis grad-
ually increased during the period, starting at 47 years in
1985 to 1989 increasing to 53 years in 2005 to 2010. Sig-
nificant increasing age at diagnosis was observed for both
men and women with women being older than men (Table
1). To our knowledge, this is the first study to document
this difference in age at presentation between the sexes.
When looking at the distribution of pleomorphic adeno-
mas, we found that 60% of pleomorphic adenomas arose
in women and 40% in men. This was comparable to that
of other large-scale surveys.16,17 We found the incidence
in both sexes to be normally distributed with a peak inci-
dence for women in their sixth decade and for men in
their fifth decade (Figure 3). A steep incline in incidence
in both sexes from the second to the third and from the
third to the fourth decades was noted, this is in agreement
with previous studies.16,17

TABLE 3. Age at diagnosis of primary pleomorphic adenoma of patients with subsequent recurrence(s).

Median age at Median age of men at diagnosis Median age of women

No. of diagnosis of primary of primary pleomorphic at diagnosis of primary
recurrences pleomorphic adenoma, y (range) adenoma, y (range) pleomorphic adenoma, y (range)

1 40.9 (13.4–85.7) 48.0 (13.4–76.4) 39.7 (23.3–85.7)

2 43.6 (13.7–77.5) 47.3 (29.6–70.8) 41.6 (13.7–77.5)
3 40 (22.8–61.9) 30.1 (22.8–61.9) 42.3 (27.7–54.3)
4 28.8 (21.8–60.9) 23.6 36.5 (21.8–60.9)
5 61.6 (61.9–67.3) 28.8 64.4 (61.6–67.3)
6 41.1 (37.7–44.6) 44.6 37.7
7 28.9 (27.6–30.3) 27.6 30.3

Demographics of patients with subsequent recurrence(s) at diagnosis of primary pleomorphic adenoma. Patients are divided with respect to number of recurrences and sex.

HEAD & NECK—DOI 10.1002/HED APRIL 2016 E1367

ANDREASEN ET AL.
FIGURE 4. Time between operations for recurrences of pleomor-
phic adenoma. Data are presented for both sexes as pooled, and
for men and women separately. Error bars indicate range. No sig-
nificant differences between sexes or in time between surgeries
were found.
The time from surgery of the primary pleomorphic ade-
noma to recurrence is known to be extremely variable,
and it can be argued that a low frequency of recurrences
is due to insufficient follow-up.18 Reporting to the Danish
Pathology Data Bank has been done by all institutions
doing salivary gland pathology examinations since 1990.8
Therefore, our data are of very high quality with a gen-
eral median follow-up time of 11.5 years and 15.4 years
in the patients with recurrences. We found the frequency
of a minimum of one recurrence to be 2.86%. Recent
studies on patients treated with partial superficial paroti-
dectomy for superficial lobe pleomorphic adenomas and
total parotidectomy for deep lobe pleomorphic adenomas
found recurrence rates between 2% and 3%, with 2% in
only superficial lobe tumors.6,19,20 No large-scale studies
of deep-lobe pleomorphic adenomas has been performed,
however, in a study by Leverstein et al,21 all recurrences
developed in patients with deep-lobe tumors treated with
total parotidectomy. As partial superficial parotidectomy
and total parotidectomy for superficial-lobe and deep-lobe
pleomorphic adenomas, respectively, is the surgical
approach of choice in Denmark, a recurrence rate of
2.86% in our material is therefore acceptable. We found
no difference between men and women with respect to
rate and time to recurrence. As illustrated in Figure 4,
TABLE 4. Demographics of patients with carcinoma ex pleomorphic adenoma divided with respect to previous operation for pleomorphic adenoma.
Ca-ex-PA relation to pleomorphic adenoma
De novo Ca-ex-PA
Ca-ex-PA after 1 pleomorphic adenoma operation
Ca-ex-PA after >1 pleomorphic adenoma operation
Abbreviation: Ca-ex-PA, carcinoma ex pleomorphic adenoma.
Distribution of Ca-ex-PA according to previous surgery for pleomorphic adenoma. De novo Ca-ex-PA is diagnosed in patients not previously operated for pleomorphic adenoma. Ca-ex-PA after 1
and >1 operation(s) is diagnosed in patients having undergone 1 or more surgeries for pleomorphic adenoma, respectively.
* After 2, 3, 4, 6, and 7 recurrences, respectively.
E1368 HEAD & NECK—DOI 10.1002/HED APRIL 2016
large variations were found. This is in accordance with
previous studies and document the unpredictable behavior
of pleomorphic adenoma.20
Young age at presentation of primary pleomorphic ade-
noma is reported to be associated with recurrences.22–24
When diagnosed with primary pleomorphic adenoma, we
found that patients with recurrences had a median age of
41.3 years compared to a median age of 50.9 years in the
entire cohort (p < .001; Tables 1 and 2). Although young
age at presentation was associated with recurrence, when
comparing patients developing one recurrence with
patients developing multiple recurrences we found no sig-
nificant difference in our population, although a tendency
toward young age at diagnosis of primary pleomorphic
adenoma was noted in patients with multiple recurrences
(Table 3).
The recurrent pleomorphic adenoma recurrence rate of
46.6% seems high, but is similar to results from other
materials of patients treated with surgery alone.23 Rates as
low as 8% to 15% has been reported from studies treating
recurrences with adjuvant radiotherapy.23,25,26 However,
randomized controlled trials as well as assessment of side
effects are warranted to confirm this as an effective and
safe treatment of recurrent pleomorphic adenoma.
The majority of Ca-ex-PAs (83.6%) were diagnosed as
de novo cases, whereas 12% was diagnosed after an initial
operation of pleomorphic adenoma. Although the latter con-
sisted of only 14 patients, it is a substantial portion of the
total incidence of Ca-ex-PAs, and is likely to arise from
subclinical residual tumor calling for alertness in rapidly
growing recurrent parotid tumors in these patients. The
remaining 4.3% of Ca-ex-PAs were found among the 151
patients operated for recurrent pleomorphic adenoma (Table
4). This 3.3% risk of malignant transformation in recurrent
pleomorphic adenoma occurred after a median of 70
months after the initial pleomorphic adenoma diagnosis
(Table 3). In a review on this topic, Phillips and Olsen27
reported frequencies of malignant transformation in recur-
rent pleomorphic adenoma 3.8% to 24%. All of these were
small studies, including 19 to 28 patients7,28–31 where refer-
ral bias in the studies with the highest frequencies cannot
be excluded. This is not the case in our study as we report
the national material.
As our pleomorphic adenoma data are from unrevised
material, we cannot exclude that some may be miscoded,
but we attempted to minimize this by reading the pathol-
ogy reports of all included specimens. As Ca-ex-PA is a
far more complex entity, we verified the diagnosis in all
available specimens, which was 96.7% of Ca-ex-PAs.
No. of patients Median age,
(% of all Ca-ex-PA) Men (%) y (range)
97 (83.6) 48 (49.5) 63 (29–86)
14 (12) 5 (35.7) 57 (30–86)
5 (4.3)* 2 (40) 46 (31–60)
 DEMOGRAPHICS
Combined with complete data from Statistics Denmark
we assume that our results are robustly founded.
CONCLUSIONS
This is the largest series of consecutively treated
parotid pleomorphic adenomas reported, covering the
Danish population in a 26-year period. We found a higher
incidence of pleomorphic adenoma than in previous
reports and the age at diagnosis to be increasing with
women being older than men. When operated for pleo-
morphic adenoma, 2.86% experienced recurrence and
these patients were younger when diagnosed with their
primary pleomorphic adenoma than patients who
remained recurrence free. In addition, recurrence primar-
ily affected women, calling for special attention to
younger women with pleomorphic adenoma. Time to
recurrence varied widely, and the rate of re-recurrence
was 46.6% making the latter the dominating problem for
these patients, as malignant transformation of recurrent
pleomorphic adenoma occurred in 3.3%.
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HEAD & NECK—DOI 10.1002/HED APRIL 2016 E1369