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1387
Is Chemoradiation Feasible in Elderly Patients?
A Study of 17 Patients with Anorectal Carcinoma
Vincenzo Valentini, M.D.
Alessio G. Morganti, M.D.
Stefano Luzi, M.D.
Giovanna Mantello, M.D.
Giovanna Mantini, M.D.
Giovanna Salvi, M.D.
Numa Cellini, M.D.
BACKGROUND. Cancer in the elderly is becoming an increasing public health problem. Nevertheless, several authors have noted the relative lack of information
regarding the treatment of cancer in the elderly. The aim of this study was to
determine the tolerance of concomitant chemoradiation in patients age ¢ 75 years
with anorectal carcinoma.
METHODS. The patients were selected for treatment on the basis of the absence of
Radiation Therapy Department, Policlinico ‘‘A.
Gemelli,’’ Università Cattolica del S. Cuore,
Rome, Italy.
major concurrent diseases, normal blood count values, good cardiac and renal
function, and good general condition (defined as not requiring personal assistance). Seventeen patients (8 men and 9 women with a median age of 79 years
[range, 75–90 years]) were treated with concomitant chemoradiation (bolus mitomycin C, 10 mg/m2 on Day 1 and continuous infusion 5-fluorouracil [5-FU], 1000
mg/m2 for 24 hours on Days 1–4 [FUMIR]). The doses and volumes of pelvic
radiation therapy ranged between 38–45 grays according to the primary tumor
site and the intent of treatment (curative vs. palliative).
RESULTS. The total incidence of Radiation Therapy Oncology Group Grade 3 acute
toxicity was 18% (3 of 17 patients). Only 1 patient (6%) was unable to complete
the treatment course. With a median follow-up of 26 months, no severe late toxicity
was recorded. Sixteen of 17 had ú50% reduction in the greatest dimension of the
lesion, 6 patients had a complete response (2 rectal and 4 anal tumors), and 12
patients preserved their sphincter function. Of the four patients who had presented
with pelvic pain, all had pain relief. Of the six patients who had presented with
rectal bleeding, the bleeding was controlled in five patients.
CONCLUSIONS. Concomitant chemoradiation according to the FUMIR schedule
used in selected patients age ¢ 75 years with anorectal carcinoma can be performed safely. Cancer 1997;80:1387–92. q 1997 American Cancer Society.
KEYWORDS: rectal neoplasms, anal neoplasms, combined modality therapy, aged,
continuous infusion, 5-fluorouracil, mitomycin C, external radiation therapy.
I
Presented in part at the Fifth National Congress
of the Italian Association of Radiation Therapy,
Genoa, Italy, September 27–30, 1995.
Address for reprints: Vincenzo Valentini, M.D.,
Cattedra di Radioterapia - Ist. Radiologia,
U.C.S.C., Policlinico Universitario ‘‘Agostino
Gemelli,’’ Largo A. Gemelli, 8, 00168 Rome, Italy.
Received February 3, 1997; revision received
May 8, 1997; accepted May 8, 1997.
n 1990, the incidence of cancer mortality in Italy was ú148,000
deaths, with an increase of 1.7% compared with the previous year.
This trend has been explained by Decarli and La Vecchia, who noted
an overall increase in the elderly population as well as a higher incidence of cancer mortality in persons age ú than 65 years.1 These data
are confirmed in some epidemiologic studies in Western countries,
in which it has been observed that approximately 50% of all cancers
are diagnosed in patients age ú 70 years.2,3
Cancer in the elderly thus is becoming an increasing public health
problem. Nevertheless, several authors have noted the relative lack
of information regarding cancer in the elderly.4 – 6 Many randomized
clinical trials exclude elderly patients from participation; thus the
outcome of elderly patients undergoing radical treatment and the
ability of older patients to tolerate radical treatment is not well known.
q 1997 American Cancer Society
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W: Cancer
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CANCER October 15, 1997 / Volume 80 / Number 8
There are a number of issues that need to be addressed
in the treatment of malignancies in the elderly. It must
be established whether treatment can be curative with
preservation of function of the affected organ or is
only for palliation.7 The quality of life that is desired
also must be evaluated with the patient and/or with
the patient’s relatives.8 Last, the role of concurrent
medical problems must be examined.
Gastrointestinal malignancies in the elderly are reported to be diagnosed at an earlier stage compared
with younger adults,9,10 and the incidence of metastasis is lower11 whereas the grading is higher.12
The extensive use of concomitant combined
chemoradiation in the treatment of gastrointestinal
malignancies started in 1989 at the radiotherapy division of the Università Cattolica del S. Cuore in Rome,
which has supplied a great deal of information on the
toxicity and effectiveness of this treatment.13 Based
on this experience, concomitant chemoradiation was
extended to patients age ¢ 75 years. In this study, the
authors present the toxicity, response, organ-preserving ability, and local control of a concomitant chemoradiation schedule used in 17 patients with anorectal
carcinoma age ¢ 75 years.
MATERIALS AND METHODS
From June 1991 to April 1995, 17 patients with anorectal carcinoma underwent concomitant chemoradiation with continuous infusion 5-fluorouracil (5-FU)
plus bolus mitomycin C (MMC). There were eight men
and nine women with a median age of 79 years (range,
75 – 90 years). Overall, 42% of patients were age 80 – 90
years.
The selection of patients was based on the following criteria: Eastern Cooperative Oncology Group performance status õ 214; adequate bone marrow function (leukocyte count ú 4000, and Platelet count ú
100,000/mm3); adequate renal function (blood urea
nitrogen õ 25 mg/dL, and creatinine õ 1.5 mg/dL);
normal liver function (bilirubin õ 2 mg/dL); and adequate cardiovascular and pulmonary function.
The site of primary tumor, International Union
Against Cancer TNM stage15 at diagnosis and the objective of treatment are reported in Table 1. Patients
with rectal carcinoma had lesions within 12 cm of the
anal verge by proctoscopic examination. Six patients
presented with rectal bleeding, three presented with
tenesmus, and one presented with pain related to a
pelvic recurrence and was taking NSAID (nonsteroidalantiinflammatory drugs). Of the seven patients with
anal carcinoma, five had a lesion at the level of the
anal canal and two at the anal margin. One patient
was receiving treatment for recurrent breast carcinoma after mastectomy. One patient with rectal carci-
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noma was receiving treatment for hypertension and
another was diabetic and receiving insulin therapy.
Five patients with rectal carcinoma were referred
to treatment for cure because radical surgery was believed to be feasible and there was no medical contraindication for surgery. According to the TNM staging
system, three patients were T3N1 and two patients
were T3N2. Five patients with rectal carcinoma were
unresectable (three patients had a T4 tumor and two
patients a local recurrence). For patients with anal carcinoma, the indication for radical treatment was based
on the tumor extent: two patients were T2N0, one was
T3N0, and two were T3N3. In the remaining two patients the intent of treatment was palliative due to
concomitant advanced breast carcinoma and unresectable local recurrence of anal carcinoma respectively.
Concomitant irradiation and chemotherapy, according to the 5-FU, MMC, and radiation (FUMIR)
protocol proposed by Nigro et al.16 for anal carcinoma,
was used. The schedule was: bolus intravenous (i.v.)
MMC, 10 mg/m2 on Day 1; 24-hour continuous infusion i.v. 5-FU, 1000 mg/m2/day, on Days 1 – 4; and
concurrent external beam radiotherapy with doses
and volumes according to the site of the primary tumor. Informed consent to undergo chemoradiation
was obtained in all patients.
In patients with rectal carcinoma the clinical target volume included the tumor, mesorectum, and posterior pelvic lymph nodes. Box or three-field (one posterior and two lateral) technique was performed. The
dose was 38 grays (Gy) (180 centigrays [cGy]/day) in
patients treated preoperatively for cure. Concomitant
chemotherapy was delivered on the first week of radiotherapy. For patients treated for palliation, the total
radiation dose was 48 Gy (180 cGy/day); 2 courses of
24 Gy were administered with a 4 – 5 week interval.
Concomitant chemotherapy was delivered in the first
week of radiotherapy of each course. For patients with
rectal carcinoma treated curatively, surgery was
planned 5 – 6 weeks after concomitant chemoradiotherapy. For patients with anal carcinoma, the clinical
target volume included the tumor together with pelvic
and inguinal lymph nodes in both curative and palliative treatments. Two opposed coaxial anteroposterior/
posteroanterior fields were used. Treatment was divided into 2 24-Gy courses (180 cGy/daily) with a 4 –
5 week split. In 3 patients treated curatively a boost
dose (15 Gy) was delivered to the tumor bed by interstitial brachytherapy (2 patients) or external beam radiation (1 patient), 5 – 6 weeks after the second FUMIR
course. The dose of external beam radiation was determined according to ICRU Report 50.17 Treatment
schedules are summarized in Table 2.
W: Cancer
Chemoradiation in Elderly Patients/Valentini et al.
1389
TABLE 1
Distribution of Patients by Tumor Site, Stagea at Diagnosis, and Indication for Treatment
Stage
Indication
Tumor
site
No. of
patients
II
III
IV/Rec
Cure
Palliation
Rectum
Anus
10
7
1
3
7
3
2
1
5
5
5
2
a
Rectal Carcinoma, Stage II (T3–4N0M0), and Stage III (T1–4N1–3M0); Anal Carcinoma, Stage II (T2–3N0M0) and Stage III (T4N0M0, T1–4N1–3M0).
TABLE 2
Treatment Schedules According to Tumor Site
and Treatment Objective
Tumor site and
treatment
objective
Rectum, curative
Rectum, palliative
Anus, curative and
palliative
Schedule
FUMIR-38 Gy
5–6 week split
Surgery
FUMIR-24 Gy
4–5 week split
FUMIR-24 Gy
FUMIR-24 Gy
4–5 week split
FUMIR-24 Gy
TABLE 3
Distribution of Acute Toxicity According to RTOG, Assessed
during FUMIR
Clinical target
volume
No. of
patients
Tumor, mesorectum,
and posterior
pelvic lymph
nodes
Tumor mesorectum,
and posterior
pelvic lymph
nodes
Tumor, pelvic and
inguinal lymph
nodes
5
Grade
1
Grade
2
Grade
3
5
Intestinal
(%)
Skin
(%)
18
23
18
18
18
18
12
—
6
Bladder
(%)
6
RTOG: Radiation Therapy Oncology Group; FUMIR: 5-fluorouracil, mitomycin C, and radiation.
Toxicity assessments were performed according to
the Radiation Therapy Oncology Group acute and late
toxicity criteria.18 This scale grades the toxic events
in five steps. For skin toxicity, Grade 1 indicated dry
desquamation, Grade 2 patchy moist desquamation,
and Grade 3 confluent moist desquamation. For intestinal toxicity, Grade 1 indicated change in bowel habits, Grade 2 diarrhea requiring drugs, and Grade 3 diarrhea requiring parenteral support. For bladder toxicity,
Grade 1 indicated increased frequency of urination,
Grade 2 dysuria, urgency, and bladder spasm requiring
local anesthetic, and Grade 3 urinary frequency (¢
once hourly), bladder spasm requiring narcotics, and
hematuria. Grade 0 indicated no toxicity. Patients were
assessed weekly for acute toxicity during treatment
and a complete blood count was obtained weekly.
RESULTS
Acute toxicity is reported in Table 3. Two patients
showed Grade 3 hematologic toxicity. One was an 80year-old patient with a tumor of the anal verge and the
other was a 75-year-old patient with rectal carcinoma.
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Hematologic
(%)
7
FUMIR: 5-fluorouracil, mitomycin C, and radiation; Gy: grays.
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RTOG
acute
toxicity
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This patient also developed Grade 2 skin, lower gastrointestinal, and bladder toxicity; at surgery, he had a
pathologic complete response. One 76-year-old patient with carcinoma of the anal canal had Grade 3
skin toxicity. The total incidence of Grade 3 acute toxicity was 18% (3 of 17 patients). A 77-year-old patient
with rectal carcinoma who was treated curatively, developed cerebral ischemia 16 days after completing
concurrent chemotherapy. He was hypertensive and
during treatment had Grade 1 hematologic toxicity.
The patient was not considered a candidate for surgery
and died of liver metastasis without requiring intestinal diversion.
The median follow-up duration was 26 months.
No severe late toxicity was recorded during this period.
Treatment compliance was good. One patient
(6%) was unable to complete the treatment course
because of Grade 3 hematologic toxicity from which
he did not recover promptly after 1 week. In 1 patient
who was treated with two cycles of 24 Gy, MMC was
not administered. He was the first patient age ú 80
years and thus a cautious approach was preferred;
however, MMC was used in subsequent patients.
Response to treatment is reported in Table 4. In
all patients with rectal carcinoma treated curatively, a
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CANCER October 15, 1997 / Volume 80 / Number 8
TABLE 4
Distribution of Response and Sphincter Preservation According to the
Treatment Objective and the Site of Disease
Lesion site and
treatment
objective
No. of
patients
Response
Sphincter
preservation,
(no. of patients)
Rectum, cure
Rectum, palliation
Anus, cure
Anus, palliation
5
5
5
2
2 CR, 3 PR
4 PR, 1 NC
4 CR, 1 PR
2 PR
3
3
5
1
cure: curative; CR: complete response; PR: partial response; NC: no change.
ú50% reduction in the greatest dimension of the lesion was observed. Two patients had a complete
pathologic response. In 3 of the 4 patients (age 75, 76,
and 77 years, respectively) who underwent surgery, a
sphincter-preserving anterior resection was performed. A temporary colostomy was performed in one
patient. There was no severe perioperative morbidity
and patients were discharged between Postoperative
Days 10 and 18. In the five patients with rectal carcinoma treated for palliation there were four partial responses observed.
Of the five patients with anal carcinoma treated
curatively, four patients completed treatment and had
achieved a complete response at last follow-up. One
80-year-old patient with carcinoma of the anal verge
whose treatment was interrupted due to Grade 3 hematologic toxicity underwent local excision of the residual tumor, with a partial response. Sphincter function was preserved in all five patients, although one
patient was incontinent at last follow-up. The two patients treated for palliation had a partial response. Intestinal diversion was necessary in 1 patient due to
local regrowth of the tumor at 14 months, with consequent loss of sphincter function.
All four patients who had presented with pelvic
pain sustained pain relief. Of the six patients who had
presented with rectal bleeding the bleeding was controlled in five patients.
Finally, 16 patients of 17 patients had a ú 50%
reduction in the greatest dimension of the lesion, 6
patients had a complete response (2 with rectal tumors
and 4 with anal tumors), and 12 patients preserved
their sphincter function.
With a median follow-up of 33 months, none of
the 4 patients with rectal carcinoma who underwent
surgery developed local or distant failure; all were alive
at last follow-up. The fifth patient of this group had a
cerebral ischemia 16 days after completing concurrent
chemotherapy; he was not considered a candidate for
surgery and died of liver metastasis. In the patients
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treated for palliation, 3 patients developed local progression at 6, 19, and 27 months respectively. One 81year-old patient subsequently underwent an anterior
resection and was free of cancer at 15 months’ followup, whereas the remaining patient showed stable local
disease with no signs of obstruction at 19 months’
follow-up. Three patients developed distant metastasis
at 6, 14, and 23 months, respectively, and 2 had died
at 22 and 47 months.
With a median follow-up of 21 months, no patients with anal carcinoma who was treated for cure
had developed local or distant failure. One patient was
incontinent. In the 2 patients treated for palliation,
both developed local progression after 1 year and died
at 20 and 26 months, respectively.
DISCUSSION
Elderly patients are selected mainly for palliative approaches for a variety of reasons: the presence of concurrent medical problems, presumed lower tolerance
for toxicity, less effective social care, lower income,
and the lack of information regarding cancer treatment in the elderly.7,19 The exclusion of elderly patients
from multicenter trials has resulted in a lack of oncologic knowledge that in turn favors the selection of
palliative therapies.5
Data to evaluate whether age is related to tolerance or to the results of treatment are reported in few
series of radical radiotherapy. In the study by Chin at
al.20 of 88 patients with oropharyngeal malignancies,
the older patients appeared to be equally able to tolerate the courses of radiotherapy and outcomes similar
to those in younger patients were observed. Mitsuhashi et al.21 analyzed 293 patients with cervical carcinoma in which survival curves, patterns of failure, recurrence rates, and incidence of radiation complications were not affected by age. Hanks et al.22 observed
that a total dose increase of 8% in the radical radiotherapy of prostate carcinoma by conformal radiotherapy did not affect the treatment tolerance for elderly
or younger patients. Nevertheless, particular attention
should be paid to limiting the amount of small bowel
in the irradiated fields in conventional radiation techniques to prevent radiation-related damage in the
aged patient.23
In the authors’ experience of concomitant chemoradiation for gastrointestinal malignancies, the analysis of overall acute toxicity by age does not show
any differences; the incidence of hematologic toxicity
observed in 97 patients of all ages treated with three
similar FUMIR regimens was 28-54% for Grades 1 – 2
and 3 – 12% for Grade 3. Similarly, the incidence of
gastrointestinal toxicity was 31 – 36% for Grades 1 – 2,
and 3 – 7% for Grade 3. Grade 1 – 2 skin toxicity oc-
W: Cancer
Chemoradiation in Elderly Patients/Valentini et al.
curred in 28 – 42% of patients.13 These data are consistent with this series of only elderly patients; moreover,
no severe late toxicity was recorded.
The authors’ choice to include elderly patients in
treatment using the FUMIR schedule was supported
by evidence that the administration of 5-FU in continuous infusion in several experimental and clinical
studies was shown to enhance the action of radiotherapy with low hematologic or gastrointestinal toxicity.24,25 The use of MMC is based on its activity on
the hypoxic neoplastic cells, a percentage of which
appears increase in the tumors of elderly, in animal
models.26,27 Pharmacokinetic studies in the elderly do
not appear to indicate contraindications for the use of
these two drugs by the route and doses administered.28
Data to evaluate the effect of age on results of
treatment show, in some reports, that the use of chemotherapy and radiotherapy does not appear as effective in elderly patients as in younger patients. Veronesi
et al.29 referred to a study of 22 patients age ú than
70 years with locally advanced (T3 – 4, M0) transitional
cell bladder carcinoma who were treated by transurethral resection, three chemotherapy cycles (5-FU, epirubicin, and cisplatin), and, in 12 patients, by radiotherapy. He observed that the chemotherapy regiment
employed was not as active as current regiments used
in younger patients. In an analysis of 41 patients with
Stage I – II non-Hodgkin’s lymphoma by Saito et al.,30
the combination of irradiation and chemotherapy produces less effective results in elderly patients than in
the younger patients.
These negative findings are not confirmed in the
authors’ experience. The response rate in patients
treated for cure was favorable. It should be noted that
of the five patients with rectal carcinoma treated for
cure, two had a complete pathologic response. This
compares favorably with the response rate recorded
in the general population.13 Of the five patients with
anal carcinoma treated for cure, four had a complete
response. All four patients who had presented with
pelvic pain were able to obtain sustained pain relief.
Five of six patients who had presented with rectal
bleeding had their bleeding controlled.
Major surgery also was undertaken in the selected
elderly patients with rectal carcinoma after preoperative chemoradiation; 4 anterior resections and 1 abdominoperineal resection were performed, with no severe perioperative morbidity, and all patients were discharged within 3 weeks. As reported by McGuirt et al.31
in a series of patients with head and neck carcinomas,
appropriate surgical therapy can be as effective in elderly as in younger patients without a significant increase in complications.
Sphincter preservation was possible in three of
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1391
the five patients with rectal carcinoma and in all
the anal carcinoma patients treated for cure. The 3
rectal carcinoma patients treated for palliation who
had a functioning sphincter at the time of treatment
had retained sphincter function at 13 and 19
months after the start of therapy; 1 of the 2 patients
with anal carcinoma treated for palliation retained
sphincter function. Sphincter preservation was obtained in 12 of 17 patients, with an evident impact
on their quality of life
CONCLUSIONS
Owing to an increased life expectancy, the number of
elderly individuals is rapidly increasing in developed
countries. The incidence of cancer in this age group
also is on the increase.
Elderly patients very often are treated less aggressively.32,33 Some studies have shown that elderly patients with the same risk factors as younger adults
have similar toxicity, compliance, and percentage of
response.20,21,22,34
The current data appear to suggest that concomitant chemoradiation according to the FUMIR schedule
can be administered safely in selected patients age ¢
75 years.
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