Br. J. Surg. 1987, Vol.

74, June,
449454 The future of external beam
irradiation as initial treatment of
rectal cancer
Several trials have demonstrated that pre-operative irradiation for rectal
cancer decreases signijcantly the incidence of pelvic recurrence.
However, this method is far @om being generally accepted. I t is now
possible to enhance the effectiveness of external beam irradiation and to
use it to extend the j e l d of sphincter-saving and conservative procedures.
Our protocol consists of a split-course regimen with a short course of
cobalt40 arc rotation (3000cGy in 12 days). After 2 months rest, the
second stage of treatment depends upon the pressure of residual disease
and the site of the tumour. I t consists of either radical surgery (82 cases)
or conservative treatment by intracavitary irradiation in the event of a
favourable initial response or in the case of poor risk patients (73 cases).
I n the radiotherapy-surgical group, the subsequent operative specimens
were tumour p e e in 17 per cent of cases and assigned to Dukes’ A
category in 32 per cent of cases. Of 91 patients with T, or T3 tumour
involving the lower third of the rectum (followed up for more than 3
J. Papillon years) 72 (84 per cent) had no recurrence. Thirty-three of these patients
(46 per cent) underwent a colostomy while 39 (54 per cent) had normal
University of Lyon and Centre
Leon Bbrard, 69008 Lyon, France
anal function. These results demonstrate the major place that a properly
Correspondence to: Dr J Papillon,
planned external beam irradiation can have in the curative management
12, Quai Gbnbral Sarrail, 69006 of cancers of the low rectum.
Lyon, France Keywords: Rectal cancer, radiotherapy, surgery, conservative treatment

Optimal treatment of rectal cancer aims to give patients the best
chance of cure while retaining normal anal function. Substantial
progress has been made in the development of restorative
procedures. However, tumours of the lower third of the rectum,
which represent approximately 40 per cent of cancers of the
rectum are usually treated by abdominoperineal resection, and
have a poorer prognosis than those situated in the upper or
middle third because of a higher rate of locoregional
recurrences.
The results of radical surgery, whether abdominoperineal
resection or low anterior resection, have not improved
significantly during the past 30 years. The average 5 year
survival rate remains fairly constant at about 50 per cent. Local
recurrence is one of the principal causes of failure following
surgery. The main purpose of pre-operative irradiation is not to
alter the surgical procedure, but to improve the cure rate by
increasing resectability rates and reducing the incidence of
pelvic recurrences due to seeding at the time of surgery or the
presence of cancer cells in the perirectal tissues. The decision to
use pre-operative irradiation may be made on the basis of the
clinical evaluation at the time of diagnosis.
Nicholls et a[.’ have shown that the clinician is able to assess
the extent of palpable rectal cancers with satisfactory accuracy.
Rectal carcinomas suitable for curative treatment may be
divided into three general groups. The early or limited cancers
are well differentiated adenocarcinomas not larger than 4 cm in
diameter, freely mobile and confined to the bowel wall. For
these cancers conservative treatment such as local excision,
electrocoagulation or intracavitary irradiation may be an
alternative to radical surgery. At the other extreme are advanced
cases with large tumours deeply infiltrating the perirectal fat,
some degree of stenosis of the rectal lumen and impaired
mobility. Between these groups is an ‘intermediate group’ made
up of tumours larger than 4 cm, moderately infiltrating, freely
mobile and with little or no extrarectal spread. Currently,
intermediate and advanced cases are treated by radical surgery,
which is considered to be the only means of controlling the
disease. However, in elderly poor risk surgical patients with
intermediate tumours, it would be rational to try to avoid
abdominoperineal resection by using external beam irradiation
to convert the tumours into lesions amenable to conservative
treatment.
The first important work devoted to pre-operative
irradiation dates back to 1959 with the publication of a
retrospective study from the Memorial Sloan-Kettering Cancer
Center by Stearns et al.’. This report aroused much interest, and
a large number of studies have since been published. Many of
them are non-randomized, the figures are not convincing, and a
bewildering variety of conclusions has been drawn3-”. Most
studies have been conducted according to two principles: (1)
homogeneous doses of radiation are distributed to large target
volumes which include most, if not all, of the pelvic cavity. The
tumour does not receive a higher dose than the surrounding
normal structures. ( 2 ) Surgery is performed shortly after
completion of irradiation.
When conservative treatment can be used in patients with
rectal cancer it must be stressed that, regardless of the method
employed (local excision, electrocoagulation or intracavitary
irradiation),the approach is only applicable to selected patients
with tumours less than 4 cm in size. At present these indications
embrace less than 10 per cent of all patients with rectal cancer
suitable for curative management, whereas more than
90 per cent of patients will undergo radical s ~ r g e r y ’ ~ . ’ ~ .
The purpose of the present article is to evaluate a new
protocol of external beam irradiation in the treatment of rectal
cancer. Patient tolerance and treatment efficacy are assessed
with particular reference to the possibility of avoiding
abdominoperineal resection in favour of sphincter saving
resection or conservative treatment.
Patients and methods
Radiotherapy technique
A particular treatment technique has been applied at the Centre Leon

0007-1323/87/060449-06$3.00 0 1987 Butterworth & Co (Publishers) Ltd 449

External beam irradiation in the treatment of rectal cancer: J. Papillon
Figure 1 Isodose distribution of pre-operative irradiation by cobalt40
for cancer of the rectum. Irradiation is performed by 120" arc rotation
through a 9 x 12cm sacral $eld. The patient is in the prone position with
$11 bladder. A dow of3000 cGy calculated at isocentre which is at 10 cm
depth is delivered in I0 fractions within I2 days. Note that a hot spot at
3500-3900 cGy is centred on the tumour area and that the target volume
includes most of the posterior pelvic area with satisfactory protection of
small bowel, urinary bladder and bony structures
Bkrard, Lyon, France since 1977, the main features of which are as
follows' 3 . 1 4 .
(1) The target volumeis limited yet includes the most important sites
of regional spread of rectal cancer and the main lymphatic drainage
areas of the rectum, especially the presacral area, the sidewalls of the
posterior pelvic cavity, and the soft tissues anterior to the rectum. (2)
Satisfactory protection of the urinary bladder and the small bowel is
essential. (3) A short course of intensive irradiation delivers a minimum
turnour dose of 3000cGy in 10fractions of 300cGy within 12 days. The
treatment starts on a Monday and ends on the Friday of the following
week. This treatment is at least equivalent to a dose of 4500cGy in 4.5
weeks. (4) A non-homogeneous dose distribution delivers a 2&
30 per cent higher dose in the tumour area. ( 5 )Surgery is not performed
immediately following irradiation but after 2 months rest which
allows optimal shrinkage of the tumour.
The irradiation is given by cobalt40 using 120" arc rotation through
a 9 x 12 cm sacral field and with the patient in the prone position. The
doseof3000cGyiscalculatedat theisocentrewhichis lOcmdeep to the
posterior surface. The isodose distribution shows that the tumour
receives a dose of about 35W3900cGy (Figure 1).
One of the advantages of this method is its flexibility and the
possibility of adapting the isodose distribution and its 'hot spot' to the
site and spread of the tumour. This adaptation can be achieved by
changing parameters such as the field size or the depth of axis of
rotation. In very frail patients the overall treatment time may be
protracted to 16 days by treating only four times a week.
The small bowel is protected by bladder distension, which displaces
the small bowel anteriorly and superiorly. Patients are asked to drink as
much water as possible 2 h before treatment and to keep a full
bladder. Small bowel X-ray films are taken after opacification with
barium sulphate, the patient being in the treatment position to simulate
accurately the relative position of the small bowel with respect to the
planned isodoses. Small bowel is excluded from the target volume.
Delaying operation for 8 weeks after completion of the short-term
irradiation is a key factor in the method, because at this time the
inflammatory phase following radiation has subsided, the fibrotic
reaction has not begun and the optimal effect of the irradiation has been
achieved. The clinician is able to take advantage of any tumour
regression in assessing tumour spread and can make a more enlightened
choice between radical, restorative and conservative treatment options.
Patients
This protocol of irradiation has been applied to 155 patients (median
age, 69 years) who have now been followed up for periods of 6 months to
450
9 years (mean follow-up, 3 years). All patients were considered clinically
to have resectable, biopsy proven T, or T3tumours ofthe rectum, that is
tumours with involvement of muscle wall or serosa only (T,), or
tumours involving all layers with extension to immediately adjacent
structures (T3).
Patients given palliative treatment for unresectable or disseminated
tumours were excluded from this study. The following results were
observed in 82 patients who were subsequently operated on, and in 73
patients who were treated conservatively.The 82operations consisted of
abdominoperineal resection in 65 cases and low anterior resection in 17
cases. All operative specimens were examined to define the Dukes' grade
of the tumour.
Patients were only selected for conservative treatment after
radiotherapy if any of the following criteria were fulfilled:
(1) well or moderately well differentiated adenocarcinoma
(2) tumours of the lower third of the rectum which were too large
(4-6cm) or too close to the anus to be treated by intracavitary
irradiation
(3) tumours which were mobile and moderately infiltrating in that there
was little or no detectable extrarectal spread
(4) absence of palpable metastatic lymph nodes
(5) normal carcinoembryonic antigen (CEA) levels and CT scan
(6) patients considered to be high surgical risks because of their age or
general condition
(7) limited residual disease detectable 2 months after completing
external beam irradiation.
Results
Tolerance of radiotherapy
This radiotherapy course was well tolerated despite the
advanced age of many of the patients. After irradiation, proctitis
rarely lasts more than 3 weeks and responds rapidly to
symptomatic management. There is no cystitis and no skin
reaction in the sacral area. When the tumour is located close to
the sphincter area, the perineal skin is included in the target
volume, but its reaction is easily relieved by ointment. After this
3 week period, the symptoms related to the rectal tumour
decrease and gradually disappear. After the 2 months rest most
patients have gained weight and are in good condition.
Eficacy of radiotherapy
Of the 82 patients who underwent radical surgery, no technical
difficulties were encountered in defining fascia1 planes or due to
fibrosis or excessive bleeding related to the irradiation. In many
cases the surgeon stated that the excision was especially easy.
No particular delay in perineal wound healing was noted. Two
patients (2.4per cent) died within 30 days of operation. The
efficacy of pre-operative irradiation was evaluated by the study
of operative specimens and the status of patients followed up for
more than 3 years. In 14 cases (17 percent) the operative
specimen was tumour free; this is the highest rate ever published.
In 27 cases (33 per cent) the tumour was confined to the bowel
wall. This high figure suggests that some Dukes' B tumours with
extension through the serosa may have shrunk to become
Dukes' A tumours. The relatively low incidence of Duke's C
tumours (27 per cent)may be interpreted as due to the control of
some metastatic lymph nodes.
Fifty patients treated by radiotherapy and surgery have been
followed-up for more than 3 years; 42 underwent an
abdominoperineal resection, eight a low anterior resection.
Four patients died of intercurrent diseaie but were apparently
cancer free, six developed distant metastasis but were locally
controlled, four (8.3 per cent) died of local failure after total
rectal excision. These figures demonstrate that the protocol can
achieve the usual objective of pre-operative irradiation, namely a
reduced incidence of pelvic recurrence after surgery (Table 1).
Extension of the applicability of restorative procedures
Of the 17 patients who underwent a low anterior resection, 10
had tumours within 6 cm of the anal verge. Operative specimens
were tumour free in six cases (Figure 2), and allocated to Dukes'
A, B and C categories respectively in five, four and two cases.
Br. J. Surg., Vol. 74, No. 6, June1987
 External beam irradiation in the treatment of rectal cancer: J. Papillon

The apparent tumour regression following radiotherapy
improved the prospects for a low anterior resection in lOof these
17 cases, mostly with colo-anal anastomosis. Three patients had
a diverting loop colostomy, which was closed after 3 months.
Three patients developed anastomotic leakages; one following
resection for a high located tumour, two after resection of low-
lying lesions. These three patients underwent temporary
colostomy which was closed 3 4 months later. No failure, either
local or distant, occurred in these 17 patients. Of eight patients
followed up for more than 3 years, one died within 30 days of
operation while seven are still alive and apparently disease-free,
three of them after colo-anal anastomosis for low-lying cancer.
E x t e n s i o n of the role of conservative treatment
In retrospect it can be argued that the 14 patients with tumour-
free surgical specimens could have been spared radical surgery,
Table 1 Outcome in 50 patients treated by pre-operative irradiation and
radical surgery (minimum follow-up: 3 years)
Dead
Dead of of cancer
No. of Alive and intercurrent or alive Postoperative
cases well disease with cancer death
50 34 (68%) 4 (8%) 10 (20%) 2 (4%)
and that some of the 27 patients with Dukes’ A tumour could
have been treated conservatively given that tumour regression
was significant.
For patients unfit for surgery and for frail, poor surgical risk
patients with low-lying tumours the usual choice lies between
radical surgery and palliative treatment. The theoretical
advantage of radical surgery may be offset by its mortality” and
it is rational to consider a third option, namely concentrated
irradiation followed by a wait of 2 months before a final decision
is made about the most appropriate form of further treatment.
Seventy-three patients with T, tumours of the lower half of
the rectum belonging to the ‘intermediate group’ were
irradiated according to the above protocol. Their median age
was 75 years. After 2 months rest the tumour shrinkage was
substantial, the residual disease was limited and the great
reparative capacity of the normal rectal mucosa was evident. In
such cases abdominoperineal resection was abandoned in
favour of a conservative procedure such as intracavitary
irradiation (72 cases) or local excision and electrocoagulation
(one case). Intracavitary irradiation was used to deliver a
booster dose to the tumour bed to optimize local control. It
consisted of one application of contact X-ray therapy with the
50 kV Philips machine to a dose of 2500 cGy and an iridium
implant to a dose of 2000 cGy. Local excision was performed in
one patient with residual tumour on the posterior wall in the
sacral concavity and not easily accessible to intracavitary
irradiation (Figure 3 ) .
In this group of 73 patients treated conservatively but with
curative intent, 45 have been followed up for more than 3 years.

Figure 2 (a) Female aged 44 years. Barium enema showing a bulky well differentiuted adenocarcinoma 7 c m in length locuted 5-11 cm from the dentate
line before pre-operative irradiation. (b) Same patient. Tumour-jkee operative specimen of low anterior resection 2 months after short course of irradiation.
The tumour has disappeared and is replaced by a shallow ulceration. Patient alive and well 4 years after treatment

8 r . J. Surg., Vol. 74, No. 6, June 1987 451

External beam irradiation in the treatment of rectal cancer: J. Papillon
Figure 3 a Male aged 60 years, poor surgical risk because of medical illness. Barium enema shows a bulky and ulcerative adenocarcinoma of the lower
half of the rectum, 7 c m in length, located 3-10 cm from the dentate line before irradiation. b Same patieni after split-course irradiation. The substantiul
shrinkage of tumour 2 months after a short course of irradiation allowed conservative treatment by intracauitary irradiation (Contact X-ray and iridium-1YZ
implant). Patient clinically controlled 3 years after treatment.
Table 2 Results afier conversion j o m radical into conservative
treatment. Policy applied to 45 poor risk patients with moderately
infiltrating cancer of the lower rectum (minimum follow-up: 3 years)
Dead from
No. of Alive and intercurrent Dead from Postoperative
cases well disease cancer death
45 25 (55%) 13 (28.9%) 6 (13.3%) 1 (2.2%)
The results are reported in Table 2. Of eight patients
(17-8per cent) who developed local failure, three are alive and
well after subsequent abdominoperineal resection (2) or
electrocoagulation (l), one aged 84 died within 30 days of
operation, and four died from cancer (three of them were
deemed inoperable because of their general condition). Two
patients died from distant metastasis but were locally
controlled. Thirteen (28.9 per cent) died from intercurrent
disease. This high figure reflects the advanced age of patients.
Twenty-five patients are alive and well after 3-8 years of follow-
up, 23 with normal anal function, and as previously mentioned,
two after salvage surgery, Of these 45 patients, the disease has
been controlled in 36 (80 per cent) with preservation of a normal
anal sphincter (Figure 3).
During the first years of this study only elderly patients were
accepted into this extension of conservative treatment. Analysis
of the results prompted us to enlarge the indications during the
past 2 years to middle-aged, good risk patients. To answer
possible criticism concerning the question of lymphatic spread,
three patients underwent an inferior mesenteric and
extramesenteric lymphadenectomy. This operation, initiated at
the Centre Leon Berard13,16,aims to check the main lymphatic
drainage areas of the rectum and to explore the pelvis without
bowel excision. The operation was performed 3 months after
control of the primary tumour had been achieved. No involved
nodes were found and all these patients are clinically well.
Overall outcome
Of the 95 patients followed up for more than 3 years, 4 had
turnour located in the upper two-thirds of the rectum suitable
452
Table 3 Overall results following external beam irradiation as initial
treatment for T2 and T3 cancers involving the lower third of the rectum
(minimum follow-up: 3 years)
Dead from
No. of Alive and intercurrent Dead from Postoperative
cases well disease cancer death
91 55 (60.4%) 17 (18.7%) 16 (17.6%) 3 (3.3%)
for restorative surgery and 91 had T, or T, tumours ofthe lower
third of the rectum treated either by radiotherapy and surgery
(46)or by conservative method (45).Fifty-five (60-4per cent) are
alive and well, 17 died of intercurrent disease but were cancer-
free; 16 (17.6 per cent) died of cancer (Table 3 ) .No patients were
lost to follow-up. Among the 72 patients who had no failure,
neither local nor distant, 39 (54.1 per cent) had no colostomy.
Discussion
The revival of interest in radiotherapy in the management of
rectal cancer is due to the increased effectiveness of irradiation of
a tumour which, 25 years ago, was considered to be
radioresistant. Among the numerous studies devoted to pre-
operative irradiation, the most informative is the second trial of
the European Organization for Research on Treatment of
Cancer in which 318 patients were randomized to receive
3450cGy in 19 days pre-operatively, or surgery alone. In the
radiotherapy group, operation was performed 2 weeks after the
completion of irradiation. The results published by Gerard et
ul1’ showed that 85percent of patients were free of local
recurrence at 5 years after radiotherapy as opposed to only
65 per cent in the surgery alone group ( P = 0401). There is also
a significant differencein the survival between the two treatment
groups, and the percentage of patients disease free at 5 years is
70 per cent for the radiotherapy group verws 60 per cent for the
control group (P=O,O32). It must be noted that in this trial
13 per cent of patients underwent a restorative procedure,
81 per cent an abdominoperineal resection and 6 per cent other
surgical procedures. These figures contrast with those of the
Br. J. Surg., Vol. 74, No. 6, June 1987
 External beam irradiation in the treatment of rectal cancer: J. Papillon
Rectal Cancer Group reported by Porter and Nicholls'8 who
cited a 52.9 per cent incidence of anterior resection, showing the
recent progress made in the development of sphincter-saving
procedures. However, in almost all studies of combined
treatment the irradiation does not interfere with the surgery and
the type of operation is only chosen according to the site and
spread of the tumour and to the local and general conditions at
the time of surgery.
In spite of technical progress, pelvic recurrence remains the
main cause of treatment failure after restorative surgery. The
incidence of locoregional recurrences is mainly related to the
distance of the primary tumour from the dentate line. In the
Mayo Clinic experience", this rate is 9 per cent for tumours
located between 8 and lOcm from the dentate line and
22.2 per cent for low-lying lesions. In the same institution the
rates are between 10 and 26 per cent according to the suture
technique". The results obtained by combining irradiation and
abdominoperineal resection may strengthen the case for pre-
operative radiotherapy before restorative surgery in order to
decrease the rate of pelvic failure. However, the fear of increased
postoperative morbidity, particularly anastomotic leakage, has
deterred many surgeons from using external beam irradiation
before anterior resection for tumours of the upper and middle
thirds of the rectum. They consider that the safety of an
intestinal anastomosis in irradiated bowel has not yet been
established.
Nicholls" has highlighted the high incidence of anastomotic
leakage after surgery alone when the anastomosis is made below
the peritoneal reflection. The frequency ranges from 5 to
30 per cent of cases. The literature contains only relatively
limited statistics on patients who have actually received
adequate doses of pre-operative irradiation. After pre-operative
irradiation the rates of anastomotic leaks vary from 0'' to
20 per centz3 and 22 per cent in the experience of Stevens et
aLZ4,who advised protective colostomies. Roberson et ~ 1 . ' ~
conducted a study of 40 patients treated for rectal cancer with
4500cGy over 5 weeks followed within 1-3 weeks by low
anterior resection. Fourteen of the forty patients with low-
lying tumours had diverting colostomies performed because of
dificult anastomoses. There were no clinical anastomotic leaks
and no postoperative deaths. In a median follow-up of 44
months one patient had local recurrence. Factors thought to
favour reduction of anastomotic leakage were close
collaboration between surgeons and radiotherapists, limited
target volume of irradiation and meticulous surgical technique.
These data demonstrate that colorectal anastomosis is possible
after irradiation to 4500 cGy without serious complications but,
in selected cases, a diverting colostomy is still advisable. At the
Centre Leon Berard, the present tendency is to advise a
protective colostomy for most patients with very low tumours in
whom the surgeon took advantage of tumour shrinkage to
extend the indications for sphincter preservation. For tumours
of the upper or middle third of the rectum, it is advisable to
extend the fractionation so that the overall treatment time of
irradiation is no shorter than 16 days.
The irradiation used at the Thomas Jefferson University
Hospital, Philadelphia, USAZ5sz6and at the Centre Leon
Berard, L y ~ n ' ~aims
* ' ~ not only to improve the long-term
results after surgery but also to convert some low tumours into
lesions amenable to restorative surgery. Marks et reported
24 patients with tumour located more than 3cm from the
dentate line who were treated with 4500cGy followed by an
abdominotrans-sacral resection and proximal transverse
colostomy. One patient sustained an anastomotic leakage and
no pelvic recurrences were observed.
The last area for discussion concerns the possible control of
rectal tumours by irradiation alone. In many series of combined
radiotherapy and surgical management, some tumour-free
operative specimens have been reported"~'2~17~23~z4~z6~z7 . The
high rate of tumour-free operative specimens in the series of
Stevens et aLZ4is explained both by the high dose of radiation
Br. J. Surg., Vol. 74, No. 6, June 1987
(5000cGy) and the interval of 4 7 weeks between the
completion of irradiation and the surgery.
Wang and Schulz'' in 1962 were among the first to report
cure at 5 years after irradiation therapy alone and considered
that 6 of their 58 inoperable patients may have been cured in this
way. Rider et al.29 and C ~ m m i n g showed
s ~ ~ that protracted
irradiation is able to control mobile rectal tumours in
38 per cent of cases. They emphasized that the tumour response
is particularly slow and that an early decision may be
inadequate. The present series corroborates these data, but the
technique of irradiation used in our centre is quite different from
those previously employed. When assessed 6 8 weeks after the
completion of treatment the effectivenessof a short but intensive
course of irradiation is greater than expected. The tumour
response allows the most appropriate approach to be selected
for each patient.
The low rate of local failures after surgery among patients
followed up more than 3 years, and the results obtained in
patients with low-lying tumours treated either by sphincter
preserving surgery or by irradiation alone support a plea for
external beam irradiation as the initial treatment in most cases
of non-obstructive rectal cancers suitable for curative
management. The results in terms of the extension of the role of
restorative surgery and of conservative treatment are
encouraging. It is now possible to spare a larger number of
elderly patients a permanent colostomy without jeopardizing
their chance of cure.
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Paper accepted 11 February 1987

Announcement

Overseas Doctors Training Scheme (Surgery)

At the request of the Department of Health and Social Security (DHSS), the Royal
College of Surgeons of England is setting up a training scheme in general surgery
and orthopaedics for doctors from abroad. This will be under the arrangements for
double sponsorship introduced by the General Medical Council. The posts
included in the scheme will be established National Health Service posts subject to the
DHSS Terms and Conditions of Service and with Royal College recognition. In the
main overseas doctors will be appointed to rotational programmes of surgical training,
where possible including University Teaching Hospitals, in regions throughout
England and Wales, and Northern Ireland. The principle aim of this scheme is to
provide a high standard of surgical training for doctors outside the United Kingdom
and the European Community to help them in their work when they return home.
Further particulars can be obtained from the ODTS office, Royal College of Surgeons
of England, 3 5 4 3 Lincoln's Inn Fields, London WC2A 3PN, UK.

454 Br. J. Surg., Vol. 74, No. 6, June1987