Elective Versus Therapeutic Radical Neck Dissection

in Epidermoid Carcinoma of the Oral Caviiy

Results of a Randomized Clinical Trial
C. VANDENBROUCK, MD,* H. SANCHO-GARNIER, MD,t D. CHASSAGNE, MD,* D. SARAVANE, MD,t
Y. CACHIN, MD,* AND C. MICHEAU, MDS

This study concerns 75 patients with squamous cell carcinoma of the oral cavity who were patients at the
Gustave-Roussy Institute between December 1966 and July 1973. These patients were divided into two
groups. The first group was comprised of 39 patients who underwent elective radical neck dissection;
nodal involvement was present in 49% with capsular rupture in 13%. In the second group of 36, neck
disease appeared during follow up in 19 cases. Therapeutic radical neck dissection was carried out in
17; the nodes were histologically positive in 15, 9 of which had a capsular rupture. In 2 cases, local or
general conditions did not permit operative intervention. In this group, the involvement rate was 47%
with a 25%capsular rupture rate. However, the comparison of the survival curves by the log-rank test
did not reveal any differences, even though histologic prognostic factors were taken into account. These
findings led to the conclusion that in squamous cell carcinoma of the oral cavity staged TINo,T,No, or
T,N,, (from AJCs and UICCs clinical staging system), it seems possible, without risk, to delay neck
dissection until a node is detectable, although it is reasonable to perform elective neck dissection in those
cases in which the patient is unavailable for regular followup.
Cancer 46:386-390, 1980.

squamous cell carcinoma of the oral

cavity without evidence of clinical lymph node
involvement, the management of the cervical area
depends mostly upon the treatment of the primary
tumor. If interstitial curietherapy is planned, a decision
must to be made as to the treatment of the cervical
lymph node area. There are two options: 1) to perform
an elective neck dissection at once; or 2 ) to wait until
there is evidence of disease and then carry out a delayed therapeutic dissection.
The proponents of the first method point out the
high rate of histologically positive nodes in clinically
disease-free necks (from 36 to 49% found at elective
s ~ r g e r y ) , ~ and
, * , ~the often rapid growth of the nodes
when they ultimately appear. However, others believe
that surgery is useless or even harmful when histologic
involvement is not evident, not to mention the patients
pain, shoulder disability, and the cosmetic effects after
major neck surgery. Furthermore, acute nodal growth

is not often observed, and the value of an elective

operative procedure designed to increase the survival
rate has never been proven.
We found that all the studies attempting to compare
the patients and the controls at several hospitals varied
or were biased, depending on the different protocols
used, and therefore the only valuable way to gather
reliable data was to conduct a randomized trial. Our
study started at the Gustave-Roussy Institute in late
1966 and ended in 1973.

N CASES OF

Materials a n d Methods

From the Departments of *Head and Neck, t Statistics (Clinical

Research), $Curietherapy , and %Pathology,Institut Gustave-Roussy
and Inserrn, Villejuif, France.
Address for reprints: C. Vandenbrouck, MD, Institut GustaveRoussy, Rue Camille Desmoulines Couturier, 94800 Villejuif,
France.
Accepted for publication July 10, 1979.

The study was to include patients of any age and sex

who had biopsy-proven squamous cell carcinoma of the
oral cavity. We used the latest official classification
by UICC (1978) which was similar to the AJCs final
form dated 1977.
In tumors of the oral cavity staged T,No, T2N0,and
T3N,,, T, indicates that the greatest diameter of the
primary tumor is less than 2 cm; T2, the greatest diameter of the primary tumor is 2-4 cm; T3, the greatest
diameter of the primary tumor is more than 4 cm
(without deep invasion); and No, there is no clinically
positive node. The tumor had to be located in the
tongue or in the floor of the mouth with an extent of

0008-543X/80/0715/0386 $0.75 0 American Cancer Society

386

No. 2

ORALCAVITYCARCINOMA. Vandenbrouck et al.

TI, TP,or T,. There must not have been any previous
transcutaneous radiotherapy or intraarterial chemotherapy infusion. The neck had to be free of disease
or with a movable submaxillary node or nodes no
larger than 1 cm (clinically considered to contain no
growth (No). Figure 1 shows the breakdown of the
cervical node area for histologic examination as determined by our pathologists. Patients with any other
primary lesions (except for basal cell tumors of the
skin) or distant metastases were excluded, as well as
patients previously treated or in such poor general
condition as to contraindicate surgery, or patients who
refused the operation. Finally, patients who could not
come for regular examinations at our clinics for at
least three years were excluded.
The treatment of the primary site, consisting of an
interstitial curietherapy with iridium- 192, was carried
out prior to randomization. Six weeks later, the patients were assigned to either the elective neck dissection group (Group A), or to the delayed therapeutic
dissection group (Group B).
In Group A, the dissection was performed within
two months after treatment of the primary lesion.
In cases of lateral tumor, an ipsilateral radical neck
dissection was performed with removal of the sternocleidomastoid muscle and the internal jugular vein,
without sparing the spinal accessory nerve. In cases of
tumor crossing or close to the midline, this procedure
was completed by a submental, submaxillary , and
jugulodigastric contralateral node dissection. When
node involvement was proven histologically, postoperative irradiation was given with dosages of up to
55 grays* to the entire neck over a period of five and
a half weeks, with additional reduced fields if capsular
nodal rupture had occurred.
In Group B, all the patients were asked to return
for regular clinical examinations for at least three years.
They were, moreover, requested to return if at any time
symptoms of disease became evident. If a cervical
lymph node became enlarged, a therapeutic neck dissection was carried out, and if nodal involvement was
found, postoperative irradiation was given.
The technical data were identical for Groups A and
B . The follow-up examinations were conducted
monthly for the first year, every two months for the
second year, and every three months during the third
year.
Provision for Quality and Statistical Control

All the patients were evaluated before and after

treatment concurrently by the same members of our
* 1 gray = 100 rad (K. Liden, The New Special Names of SI Units in
the Field of Ionizing Radiations,Phys Med B i d 20: 1029- 1036, 1975).

387

II

111

IV

FIG. 1. Break-down of cervical lymph node area according to

pathologic examination (Gustave-Roussy Institute). I . Submental
and submaxillar area. 11. Jugulodigastnc area. 111. Juguloomohyoid
area. IV. Supra clavicular and spinal accessory area.

team (head and neck surgeons and radiotherapists).

Randomization was under the control of a statistician
who observed the strictest protocol, and who was responsible for the statistical data (analysis of the results
and determination of their significance).
The calculation of the number of patients needed
for this study (80 cases) was based on selecting the
best of the two treatments within a 5% probability of
choosing a treatment with a three-year survival rate
which would be lower than the other by lO%.I4 The
TABLE1 .

General Characteristics of Patients

Number of patients
Sex (males)
Age (mean rC_ IT)
Localization
Oral tongue
Floor of mouth
Tumor extent
TI
T2
T3

Elective
dissection
group

Therapeutic
dissection
group

39
89%
57 rC_ 3

36
89%
57 rC_ 3

54%
46%

56%
44%

23%
56%
21%

17%
72%
6%

CANCER
July 15 1980

388
T A B L E2.

Macroscopic Aspect and Histologic Type

Elective
dissection
group

Therapeutic
dissection
group

Macroscopic aspect
Vegetan
Ulcerated
Infiltrating

26%
30%
44%

22%
36%
42%

Histologic type*
Well differentiated
Poorly differentiated
Undifferentiated

87%
8%
5%

86%
11%
3%

All tumors are squamous cell carcinoma.

T A B L E3. Histologic Nodular Involvement

Therapeutic dissection
group

Elective
dissection
group
Negative nodes

With
dissection

51%

Without
dissection

6%*

47%
53%

Positive nodes

49%

41%

6%t
47%

Positive nodes with

capsular rupture

25%

13%

False = positive nodes.

t Proven by cytologic examination and presumably with capsular
rupture.

survival curves were plotted according to the method

of Kaplan and Meierg and based on the elapsed time
from the treatment of the primary tumor. The statistical
analysis was carried out using the Log-rank test in
order to compare the survival curves.'2 Data were
T A B L E4. Site of Nodular Involvement (Except Partial
Cervical Node Dissections)
Areas of positive
involvement
One area
Submaxillar (SM)
Jugulodigastric (JD)
Juguloomohyoid (JOH)
Posteroinferior (PI)
More than one area
SM -1 JD
SM t JOH
SM + PI
JD + JOH
JD + PI
JOH + PI
SM + JD + JOH

Elective
dissection
group

2
7
1

2
2
1
1

Therapeutic
dissection
group

Vol. 46

computerized on UNIVAC 1106; the program of the

analysis was the PASTIS ONE from I.N.S.E.R.M."
Results
The purpose of this trial was to discover the survival
rates of both groups, but it was also of some value to
note other carcinogenic developments which might
take place during the follow-up period,such as local and
lymph node recurrence and metastasis. Also of interest
were second primary tumors which have been reported
to develop in the upper digestive tract; their presence
was likely to disturb the end results of the trial.
Between December 1966 and July 1973, 80 patients
with intraoral squamous cell carcinoma were selected
for the trial, 40 in the elective neck dissection, Group A,
and 40 in the delayed therapeutic dissection, Group B.
Five patients were excluded after randomization: 1 in
Group A who refused surgery, and 4 in Group B who
underwent unavoidable elective neck dissections (2
during the removal of a residual primary tumor and
2 because of an inability to be followed up regularly).
At the time of final analysis, all 75 cases had been
followed for five years.
The sex and age of each patient, the site and extent
of the tumor, the macroscopic features, the histologic
type, and the staging were compared, and no statistical
differences were found between the two groups (Tables
1 and 2 ) .
In Group A, 32 patients underwent an ipsilateral
radical neck dissection. In 1 case, this procedure was
repeated on the opposite side because of a contralateral
positive node. In 6 other cases, the operative field
was reduced to just the suprahyoid area as the frozen
section was negative and the general condition of the
patients was poor. The histologic results showed that
49% of the patients had involved nodes (19 of 39),
and that 13% had a nodal capsular rupture (5 of 39)
(Table 3). Each patient with positive nodes was given
postoperative irradiation. The level of histologic involvement is described in Table 4, except for the cases
with partial neck dissection. In 9 of 19 cases (47%) the
jugulodigastric and submaxillary nodes were free of
involvement. This fact confirms the results of our previous study that, in intraoral tumors (and likewise in
laryngeal tumors) staged No, it is impossible to predict,
as usual, the absence of growth in lower neck nodes
by just sampling the jugulodigastric group.
In Group B, the cervical nodes became involved in
19 of 36 cases. The interval between treatment of the
primary site and the occurrence of neck disease was
less than nine months in 12 cases, and within 18 months
in all but I (Fig. 2). Seventeen of the 19 patients underwent neck resections, but in the other 2 cases, the

No. 2

ORALCAVITY CARCINOMA. Vundenbrouck et ul.

operation could not be performed because of an increasingly poor general condition in 1, and acute nodal
growth in the 2. In both cases, the node involvement
was proven by cytologic examination. The nodes were
involved in 15 of the 17 patients who underwent operations and a capsular nodal rupture in at least one node
was observed in 9. In brief, the nodal involvement rate
in Group B was 47% (17 of 36) and the capsular rupture rate was at least 25% (9 of 36) and perhaps 30%
(1 1 of 36) if the two nonoperated cases are taken into
account (Table 3).
The sites of involvement are shown in Table 4. The
juguloomohyoid nodes were involved in 3 of 15 cases
(20%) without involvement of the submaxillary or
jugulodigastric area.
Comparison between the two groups leads to the
conclusion that the histologic involvement rate was the
same for Groups A and B, but that the capsular rupture rate was quite different, and nearly statistically
significant when considering the number of involved
cases (5% > P < 10%). It would become significant if
the two nonoperated cases in Group B were included
(P< 5%) (Table 3). Capsular rupture has been demonstrated to be an ominous prognostic sign; therefore
a better prognosis should be ensured for patients of
Group A. This foresight is not confirmed, however,
since comparison of the survival curves shows that they
are almost identical (Fig. 3). Even though the two
main prognostic factors, i.e., node involvement and
capsular rupture, are taken into account, it is difficult
to detect a difference between the survival curves of
the groups (Table 5). If such a difference could be
detected through a greater number of patients, it would
be so small that it would be considered negligible
when compared to the drawbacks of the elective
treatment.
In each group, the disease-free curves summarizing
the behavior of the disease were similar to the survival
curves (Fig. 3). The causes of failure in both groups
are shown in Table 6. Three strictly local recurrences
were noted in each group; 3 node recurrences in the
elective group, and 5 in the therapeutic group, 2 of
which were combined with a local recurrence. The
high rate of second primary tumors (16%) had already
been emphasized before the trial; the rate was similar
in both groups. These cases and the two intercurrent
deaths increase the variability of the results and lead to
the conclusion that 45% of the deaths were not caused
by the original tumor.

389

FIG. 2. Delay between interstitial therapy and appearance of

palpable nodes in the therapeutic group (17 cases).

based on comparisons of patients from different hospitals undergoing different protocols, or on historical
comparisons in the same hospital. Because it is impossible to compare such groups, the results are of
little value. Our trial, conducted at the GustaveRoussy Institute, is the first one which was based on
a methodologic and correct approach to the problem,
and the results have provided information about the
value of elective neck dissection.
It is tempting to extend our findings to elective irradiation of the neck (as advised by Fletcher in No
cases),' but in order to do so, it would be necessary
to assert that elective surgery and elective radiotherapy would give the same results, and this should
not be considered without the help of another randomized trial.
The lack of a statistically significant difference between the two therapeutic approaches seems to weigh
in favor of surgical abstention in cases of carcinoma

Conclusions

Mnn!h\
h

All the reports of this topic advocating either an

elective"' or a therapeutic neck dissection10 have been

12

i%

21

10

16

42

48

54

60

*I,

.2

Fic;. 3. Life table for the two treatment groups. ( -) Therapeutic group: ( - - - ) Elective group.

CANCER
July 15 1980

390

cessory nerve in order to avoid undesirable postoperative side-effects.*

T A B L E5. Comparison of Survival Adjusted by

Histologic Nodular Involvement

Group

Number of
observed
deaths

Expected

O/E

Elective dissection
Therapeutic dissection

16
15

16,56
14,44

0.966
1.038

Xz value

0.0004

Log-rank test: not significant

TABLE
6 . Three-Year Follow-up Data

Free of disease

Elective
dissection
group

Therapeutic
dissection
group

18

21
2 Local recurrences

Alive with
recurrences
Dead after:
Local recurrence
Local and nodular
recurrence
Nodular
recurrence
Metastasis
Second primary
tumor
Unknown or
intercurrent

1 Nodular recurrence

16

Vol. 46

0
15

2
2

3*

* Two patients without delayed nodular surgery.

of the oral cavity, provided they are staged TINo,

T2No,or T3No. However, it is wise to plan an elective
neck dissection after the treatment of the primary lesion
whenever the patients cannot be regularly followed
up. In these No cases, there is no apparent risk in
carrying out a functional neck dissection and removing
all the nodal groups except the sternocleidomastoid
muscle, the internal jugular vein, and the spinal ac-

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