Full text of DOI:10.1007/BF03345066

J. Endocrinol. Invest. 23: 755-7761, 2000
A multimodality therapeutic approach in anaplastic thyroid
carcinoma: Study on 39 patients
B. Busnardo*, O. Daniele**, M.R. Pelizzo***, R. Mazzarotto****, D. Nacamulli*,
D. DeVido*, C. Mian*, and M.E. Girelli*
*Endocrinology and **Surgery Clinic III of the Department of Medical and Surgical Sciences, University
of Padova; **Medical Oncology and ****Radiotheraphy, Azienda Ospedaliera of Padova, Padova, Italy
ABSTRACT. The aim of this study was to investi-
gate the role of multimodality treatment in pa-
tients with anaplastic thyroid carcinoma. From
1992 to 1999, 39 consecutive patients with a his-
tologically or cytologically proven anaplastic thy-
roid carcinoma were referred to the Thyroid
Center of Padua General Hospital. There were 28
females and 11 males with a median age of 69
years (range 39-88 years). About one-third of pa-
tients had a history of preceeding nodular goiter.
Two patients had areas of differentiated thyroid
carcinoma at histological examination. Local dis-
ease was present in 26 patients while distant
metastases, mainly to the lung, were present in
22 at diagnosis or quickly developed during the
observation period in all the others except one.
Thirty-two patients were previously untreated: 9
of them were in good general condition, 1 had
limited lung metastases, and the tumor mass was
considered resectable by the surgeon. These 9
patients were treated with cisplatin once a week
and radiotherapy (RT) 36Gy in 18 fractions over
three weeks, followed by total thyroidectomy (TT)
and by further chemotherapy (CHT) with adri-
amycin and bleomycin in 4 patients. Seven pa-
tients, 3 with lung metastases at diagnosis, had
undergone TT, followed by RT in 5, in another
hospital and were subsequently referred to our
center due to the presence of distant metastases.
Therefore, a total of 16 patients (Group 1) was
treated with TT, RT and CHT in various order.
Nine patients with distant metastases at diagno-
sis (Group 2) received CHT; one of them had a
disappearance of lung metastases and was then
treated by TT and further CHT. Group 3 consist-
ed of 14 elderly patients in poor general condi-
tions; 4 of these received local RT, while the re-
maining did not receive any treatment. Four com-
plete responses were seen in patients from Group
1, and 1 from Group 2. One patient without dis-
tant metastases at diagnosis is alive and free of
disease 6 months after TT and adjuvant CHT, and
12 months after diagnosis. Three had long-term
survival (14, 24, 27 months) with a disease-free
interval of 6-8-10 months. The patient from
Group 2 who was treated in a second time by TT
is alive without disease after 60 months. Median
survival rate was 11 months for Group 1, 5.7
months for Group 2 and 4 months for Group 3. In
some patients multimodality treatment (TT, RT
and CHT) is associated with increased survival.
Nine out of 16 patients, who underwent surgery
and complementary treatment, had no local pro-
gression. In all but one distant metastases devel-
oped, mainly in the lung, during or after post-sur-
gical CHT. The best results were obtained in
younger patients with less advanced disease.
Early diagnosis is mandatory. Only a few patients
responded to CHT, confirming that anaplastic thy-
roid carcinoma is often resistant to anticancer
drugs. Our experience with combination modali-
ties suggests that aggressive and appropriate
combinations of RT, TT and CHT may provide
some benefit in patients with anaplastic thyroid
carcinoma. Preoperative CHT and RT may enhan-
ce surgical resectability of the primary tumor.
(J. Endocrinol. Invest. 23: 755-761, 2000)
©2000, Editrice Kurtis
INTRODUCTION
Key-words: Thyroid, anaplastic carcinoma, radiotherapy, chemotherapy,
Anaplastic thyroid carcinoma accounts for 5-10%
of primary malignant thyroid neoplasms being one
of the most aggressive malignant tumors in man,
with a median estimated survival of 3 to 6 months
(1-5). Long-term survival of more than 24 months is
surgery.
Correspondence: Dr. B. Busnardo, Dipartimento di Scienze Mediche e
Chirurgiche, Endocrinologia, ex Istituto di Semeiotica Medica, Via
Ospedale 105, 35100 Padova, Italy.
Accepted August 7, 2000.
755

B. Busnardo, O. Daniele, M.R. Pelizzo, et al.
rare and standard treatment usually unsatisfactory.
The best survival results have been obtained with a
combination of surgery, external radiotherapy, and
chemotherapy (6-11). We here report our experi-
ence on 39 consecutive patients, with anaplastic
thyroid carcinoma, referred to our Center from
1992 to 1999. As in other studies, age, stage, gen-
eral conditions and previous treatment carried out
in other sites, varied a great deal. Combined treat-
ment consisting of thyroidectomy, preceded or fol-
lowed by external radiotherapy and/or chemo-
therapy was carried out in only 50% of cases. In
these patients the overall survival was much longer
than in patients who did not undergo surgery de-
spite being treated with radiotherapy or chemo-
therapy.
gone total thyroidectomy, plus radiotherapy in five,
in another hospital (Group 1B, median age 54 yr, 4
females and 3 males) and had been referred to our
Center for chemotherapy due to the presence of
distant metastases, after treatment in 4, or already
present at diagnosis to the lung in 3. Of the pa-
tients referred to our Center prior to treatment on-
ly 9 were in good general conditions: 8 were with-
out distant metastases, (M0), and 1 had limited
metastases to the lung (M1). (Group 1A, median
age 72 yr, 5 females e 4 males). All 9 patients had
a local tumor that was considered resectable by our
surgeon and were treated by an original multi-
modality treatment scheme designed at our center
in 1992 (12) which combined low dose cisplatin as
chemoradiosensitizer, conventional external beam
radiotherapy, followed by surgery and then by adi-
uvant chemotherapy (bleomycin and adriamycin).
The aim of this protocol was to help radical surgery
of the primary tumor and to prevent or reduce dis-
tant metastases. Cisplatin had been used for many
years in the treatment of thyroid tumors (13).
Moreover the radiosensitizer effect of cisplatin was
clearly shown in experimental tumors: cisplatin, giv-
en before irradiation, causes an increase in the
slope of the radiation dose-response curve (14).
The combined treatment regimen consisted of a
once weekly administration of 50 mg cisplatin 1.5
hours before radiotherapy. Radiotherapy was car-
ried out as a daily dose of 2 Gy for 6 days per week
to a total tumor dose of 36 Gy in 3 weeks. After an
interval of 3 weeks, extracapsular total thyroidec-
tomy with resection of perithyroid muscles, if in-
volved, and additional central plus lateral nodal
neck dissection were performed. After a further in-
terval of 3 weeks, adriamycin (50 mg/mq, bolus)
and bleomycin (15 mg daily infusion for 3 days)
were administered every 14 days for three cycles.
Nine patients had multiple distant metastases and
locally advanced disease at diagnosis (Group 2, me-
dian age 71 yr, 7 females e 2 males), but were in
relatively good general conditions and were treat-
ed with chemotherapy. Patients from group 1B and
2 received chemotherapy adopting a multidrug
schedule previously used at our Center (15, 16): 30
mg/day bleomycin for 3 days by continuous infu-
sion, followed by adriamycin 60 mg/mq and cis-
platin 60 mg/mq on day 5 (BAP). This schedule was
repeated every 4 weeks for three times or more ac-
cording to the results.
PATIENTS AND METHODS
From 1992 to 1999, 39 patients with anaplastic thy-
roid carcinoma were referred to the Thyroid Center
of Padua General Hospital. There were 28 females
and 11 males (female to male ratio of 2.5). Age
ranged between 39 and 88 yr (median 69 yr).
Diagnosis of anaplastic thyroid carcinoma was es-
tablished on the basis of clinical features and cyto-
logical examination. Positive immunocytochemical
staining when using antikeratine antibodies and neg-
ative reaction when using antibodies directed against
common leukocyte antigen and calcitonin allowed
the diagnosis of anaplastic carcinoma, thus exclud-
ing lymphomas and medullary thyroid carcinomas.
Diagnosis was confirmed by histological examination
in patients who underwent surgery. Areas of differ-
entiated follicular carcinoma were found in 2 patients.
All patients had a neck mass at presentation with a
diameter greater than 5 cm in 60% of cases. All but
one had lymphnode involvement. Twenty-six pa-
tients had signs of local compression, including dys-
pnoea, dysphagia, dyshonia or radiological and/or
endoscopical documentation of trachea and/or oe-
sophagus compression. Twenty-two patients had
distant metastases, mainly to the lung, at presen-
tation. About one-third of patients had a history of
preceding nodular goiter.
According to the treatment modalities, age, gen-
eral conditions, tumor invasion and previous treat-
ment, patients were divided into 3 groups:
- Group 1: patients treated with surgery, plus radio-
therapy, all but two, and chemotherapy, all but one;
- Group 2: patients treated with chemotherapy alone;
- Group 3: patients treated with radiotherapy alone
or no treatment at all.
Fourteen patients were of advanced age and in
poor general conditions (Group 3, median age 75
yr, 12 females, 2 males). Ten of these patients had
distant metastases: 4 received palliative radiother-
apy alone and 4 (3 without distant metastases) a
The majority of patients (32/39) had not received
any previous treatment. Seven patients had under-
756

Therapy of anaplastic thyroid carcinoma
complete course of radiotherapy to the neck and
upper mediastinum. None of these 14 patients un-
derwent surgery or chemotherapy.
The World Health Organization (WHO) response
criteria were used.
tant metastases, mainly to the lung, during follow-
up. According to the surgeon, the operation see-
med easier in these 9 patients. Three patients from
this group obtained a complete response, lasting
6, 8 and 10 months respectively but died after 14,
24 and 27 months respectively: one patient had a
complete response, lasting 6 months, followed by
a local relapse and lung metastases, one had a
complete response lasting 8 months but subse-
quently developed lung metastases and died after
24 months, and one had a local relapse after 10
months followed by lung metastases after 20
months and subsequently died 27 months after
treatment. The median survival rate was 12 months,
excluding the 2 deaths for other causes. Out of the
7 patients from Group 1B, who had previously been
treated by surgery and radiotherapy in other hos-
pitals and treated by chemotherapy in our Center,
one is alive and disease-free 6 months after the
completion of chemotherapy and 12 months from
diagnosis (M0). Three developed a local relapse
within 1-2 months after surgery and progression
RESULTS
Group 1 consisted of 16 patients treated with
surgery preceded or followed by external radio-
therapy and/or chemotherapy (Table 1). Group 1A:
consisted of 9 patients who were treated with the
multimodality treatment scheme designed at our
Center. Two patients died after surgery: one in the
first few days due to myocardial infarction and the
other one (M1) after two months because of a
stroke. Two patients did not complete post-surgical
adiuvant chemotherapy: one because of a local fis-
tula, and one due to myocardic disease. Five out
of these patients had no local relapse until death,
while 2 had local progression during post-surgical
chemotherapy. All these patients developed dis-
Table 1 - Clinical data of 16 patients treated by surgery, radiotherapy and chemotherapy.
Group 1A
Patient
Age
Sex
Extent of
disease
Chemo-radio
Surgery
Chemo
Response duration Relapse
(months)
Survival
(months)
1
68
86
79
74
72
65
70
69
79
F
F
M0
M0
M0
M0
M1
M0
M0
M0
M0
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
No
Yes
No
No
No
0
-
N, M
-
7
3
2*
3
F
Yes
0
0
-
M
11
7
4
F
Yes
M
5*
6
M
F
Yes
-
5
Yes
8
10
6
0
M
24
27
14
6
7
M
M
M
Yes
N, M
N, M
N
8
Yes
9
Yes
Group 1B
Patient
Age
Sex
Extent of
disease
Surgery
Radio Response duration
(months)
Relapse
Chemo no. Survival
of course (months)
10
11
12
13
14
15
16
46
66
39
54
54
57
68
F
M
M
F
M0
M0
M1
M1
M0
M0
M0
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
No
Yes
2
1
N, M
N, M
M
3
3
3
4
4
6
3
6
13
0
7
0
M
13
M
F
0
N, M
No
10
12
0
12 alive
11
F
N, M
*Death for other causes. F: Female; M: male; N: lymph-nodal; M: distant metastases.
757

B. Busnardo, O. Daniele, M.R. Pelizzo, et al.
Table 2 - Clinical data of 9 patients treated by chemotherapy alone.
Group 2
Patients
Age
Sex
Extent of
disease
Surgery
Radio
Chemo no.
of course
Survival
(months)
17
59
59
78
64
78
71
71
55
73
F
F
M
M
M
M
M
M
M
M
M
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
2
2
3
2
3
1
2
1
5
3
6
18
19
M
F
7
20
6
21
F
6
22
M
F
3
23
5
24
F
2
25
F
60
F: female; M: male.
even after radiotherapy. In the other patients, dis-
tant metastases were observed 4-5 months after
surgery. In this group the median survival rate was
10.5 months. It is worthwhile to note that the two
young patients (one was only 46 yr old, M0 at di-
agnosis, and survived only 6 months!) had an out-
come similar to that of older patients, showing that
not always young age and precocious stage are
synonimous of favorable prognosis.
locally and distant, and with a median age of 71 yr,
were treated with chemotherapy alone (Table 2). One
patient, who showed a complete disappearance of
lung metastases after 3 cycles of BAP, underwent
surgery followed by further chemotherapy with two
cycles of BAP. This patient is still alive without evi-
dence of disease after 60 months. Another patient
showed a partial response and died after 7 months;
the other survived less than 6 months. The median
survival rate of this group was 5.7 months.
Group 2 patients, with a very advanced disease, both
Table 3 - Clinical data of 14 patients treated by radiotherapy alone or untreated.
Group 3
Patients
Age
Sex
Extent of
disease
Surgery
Radio
Chemo
Survival
(months)
26
27
28
29
30
31
32
33
34
35
36
37
38
39
78
82
87
64
86
83
63
71
72
80
88
72
66
60
M
F
F
M
F
F
F
F
F
F
F
F
F
F
M
M
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
1
1
M
5
M
3
M0
M
4
4
M
3
M
8
M
4
M
4
M0
M0
M0
M
5
11
9
3
F: female; M: male.
758

Therapy of anaplastic thyroid carcinoma
In all 4 cases in Group 3 treated with radiotherapy (3
M0 and 1 M1) a partial response was observed (Table
3). In 2 cases distant metastases appeared leading to
death 4 and 11 months from the diagnosis, respec-
tively. One died of a heart failure after 5 months and
one after 9 months due to leucopenia after 1 dose of
adriamycin. Median survival rate was 4 months.
tant metastases. At presentation, one-third of the
patients had advanced age and disease and/or
were in poor general conditions so that no treat-
ment was adopted except for local radiotherapy
that was administered in some. Others had diffuse
distant metastases, and chemotherapy was admin-
istered as initial treatment, adopting a multidrug
scheme (BAP) used for several years in our institu-
tion in advanced thyroid cancer, by which two com-
plete responses in patients with anaplastic thyroid
carcinoma were obtained (16). These two patients
were a 66-yr-old female patient, with lung and neck
node metastases, and a 44-yr-old male patient, with
neck node metastases: they were treated by sur-
gery and BAP with complete response and are now
alive without disease after 10 yr.
The median survival of the 16 patients who under-
went the multimodality treatment (surgery plus ex-
ternal radiotherapy and chemotherapy in various
order) was 11 months, which is without doubt high-
er than the average for this type of tumor. Mean re-
ported survival times of anaplastic thyroid carcino-
ma patients ranged from 2.5 to 7.5 months (2, 4, 5)
with median survival of 4-12 months. From 82 to
90% of patients expire by 6 months (2, 4). Survival
was slightly better in patients operated after radio-
therapy (12 months) than in patients treated with
surgery as first procedure (10.5 months); however
one of these last patients is still alive and without
disease after 12 months.
Few patients developed a local relapse, which is nor-
mally the main cause of death in patients not sus-
ceptible to surgery. In the patients of Group 1 the
cause of death was related to distant metastases, al-
ready present at diagnosis in a few, or occurred dur-
ing or after treatment in the others. It is possible that
the 2-week interval between the end of the external
radiotherapy and the initiation of chemotherapy may
explain the high incidence of distant metastases in
patients treated by our protocol.
Systemic chemotherapy should therefore be in-
cluded in the treatment programme of anaplastic
thyroid carcinoma, and in the absence of local dis-
ease could be carried out very early even before
surgery and/or radiotherapy. In our patients the re-
sults of chemotherapy were unsatisfactory. However
a complete response with disappearance of lung
metastases after surgery was seen in one patient,
who is still alive and in complete remission 60
months from the diagnosis.
DISCUSSION
Anaplastic thyroid carcinoma is one of the most ag-
gressive tumors with a median survival rate of 7% at
5 yr. It is resistant to all therapeutic approaches and
is rarely treated radically. The best results in terms
of survival are obtained with a multidisciplinary
treatment combining surgery, external beam ra-
diotherapy and chemotherapy.
Local control is an important goal in clinical man-
agement. If possible radical surgery with lym-
phadenectomy should be carried out (5). However,
due to involvement of bordering organs, many pa-
tients cannot undergo radical surgery at diagnosis.
Radiotherapy can help obtain local control even if
the anaplastic carcinomas are relatively radio-resis-
tant (17-20). Chemotherapy administered togeth-
er with radiotherapy is an effective radiosensitizer
and both increase the surgeon’s capability in radi-
cally removing the tumor mass which may not be
normally resectable. Metastases are present at di-
agnosis in approximately 50% of patients. The oth-
ers rapidly develop distant metastases even if local
control is obtained. The impact of distant metas-
tases on survival of patients with anaplastic thyroid
carcinoma is clearly shown in the literature: in one
report, patients presenting with clinical evidence of
only local disease had a 8.1 months median survival
compared to 3.3 months median survival of patients
with distant metastases (4). Therefore an effective
systemic therapy is essential for survival of these
patients (20, 21). Unfortunately, anaplastic thyroid
carcinoma is normally a drug-resistant disease and
no effective systemic chemotherapic regimen ex-
ists (22-24). Furthermore this cancer is characteris-
tic of elderly patients, frequently associated with
diseases limiting the range of therapeutic options.
In 1992 we introduced a multimodal therapeutic
protocol which consisted of chemoradiosensitisa-
tion with low dose cisplatin, conventional external
beam radiotherapy, followed by surgery and final-
ly by adjuvant chemotherapy with bleomycin and
adriamycin. Our patient population is quite similar
to others reported in the literature: average age
was 68 yr, female to male ratio was 2:1. The ma-
jority of patients had advanced disease at presen-
tation; almost all patients were T4 and 22 had dis-
In the 4 elderly patients with advanced disease,
treated with external radiotherapy alone, one par-
tial response with a reduction of the primary tumor
was obtained. The survival of these 4 patients was
less than that of patients who had undergone
759

B. Busnardo, O. Daniele, M.R. Pelizzo, et al.
8. Tenvall J., Tallroth E., El Hassan A., Lundell G.,
Akerman M., Biorklund A., Blomgren H., Lowhagen
T., Wallin G.
surgery, but significantly greater than that of pa-
tients who had not received any treatment due to
poor general conditions or advanced disease.
The results of this study are very similar to those
obtained with other protocols of combined treat-
ment (5-11) and clearly demonstrate that only a
multimodal approach combining surgery, chemo-
therapy and external radiotherapy may improve the
outcome of anaplastic thyroid carcinoma. Survival
was clearly better when surgery was possible. This
is confirmed by all other studies reported in the lit-
erature. Since more radical surgery purely reflects
more localised diseases, an early diagnosis and
rapid staging is a fundamental feature in order to
programme an adequate therapy in a short time.
Radiochemotherapy in first instance seems to help
subsequent surgery and in some inoperable pa-
tients, even alone, seems to be able to limit local
disease evolution. This study also confirms the poor
or even absent results in the cases with distant
metastases. New chemotherapeutic agents are
needed for the systemic treatment of anaplasic thy-
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