BRIEF
REPORT:
EXPERIMENTAL
CLINICAL
STUDY
OF
ENTEROSGEL
(METHYLSILICIC ACID HYDROGEL) APPLICATION IN ONCOLOGY PATIENTS
DURING
THE
COURSES
OF
GAMMA
TELETHERAPY
AND
CHEMORADIOTHERAPY
Shevchenko Yu.N., Serezhko Yu.A.
Federal State Prof. A.I. Kolomiychenko Institute of Otolaryngology of the AMS of Ukraine, Kiev, Ukraine,
2001
Radiation therapy holds one of the main positions in the treatment of cancer patients. It is used in more
than 80% of patients. In oncology, radiotherapy can be used alone or as part of combination therapy in
the surgical / medical treatment. As a result of the combined treatment, toxicity from chemotherapy
joins endogenous intoxication caused by radiotherapy. Accordingly, there is an increasing load on the
body detoxification system of the patients.
Study objectives
To identify effective methods of intestinal sorption (enterosorption) with the new-generation adsorbent
Enterosgel during gamma teletherapy (EBRT) and chemoradiotherapy (CRTx).
Materials and methods
47 men aged 47 to 68 years with malignant tumors of the upper respiratory tract were examined. On
histological examination, the majority of patients (78%) was diagnosed with non-keratinizing squamous
cell carcinoma.
The patients were divided into groups:
• 1st, control group: 14 patients receiving EBRT;
• 2nd, study group: 13 patients receiving CRTx;
• 1st experimental group: 10 patients treated with EBRT and adsorbent Enterosgel;
• 2nd experimental group: 10 patients receiving CRTx and Enterosgel.
Enterosgel was administered at adose 15 g 3 times daily for the entire EBRT or CRTx course.
The drug choice for CRTx depended on the tumor localization:
• 5-fluorouracil (250 mg) daily for 10 days in cases of the tumor site in the laryngopharynx and
nasopharynx. The average total dose (ATD) was 2.5 g;
• cisplatin 100 mg/m2 (hydration mode) or carboplatin of 400 mg/m2 once a month during EBRT at the
tumor site in case of nasopharynx and laryngopharynx tumor.
In all the patients, the level of endogenous intoxication and immunological status was determined
before treatment and after 9-10 and 20 EBRT sessions. Concentration of circulating immune complexes
(CIC) was expressed in absorbance units (AU).
Results and discussion
Results of treatment of patients with tumors of the upper respiratory tract with EBRT and EBRT +
Enterosgel.
In all patients of the 1st control group (n = 14) radioepithelitis was observed: complaints about
swallowing problems and sore throat appeared in 11 (79%) patients at a dose of 15-20 Gy, the rest after 25-30 Gy. The need of antibiotic therapy had arisen in all patients of the first control group. In this
case, one patient experienced such EBRT complication as fistula, with ATD being 20 Gy.
A significant CIC increase in patients of the 1st control group both in the middle, and at the end of EBRT
shows the antigenic load. At EBRT sessions 9-11 and after session 20, CIC content in serum was 67 ± 5.2
AU and 68 ± 5.6 AU, respectively, versus 31 ± 2.3 AU before treatment (p <0.001).
The level of medium-weight molecules in the serum of patients of the 1st control group had reached
0.523 relative units of extinction. After antibiotic therapy, medium-weight molecules did not exceed
0.320 extinction units in most patients in the control group.
Among the patients of the 1st experimental group (n = 10), only 3 (30%) had radioepithelitis symptoms
for EBRT session 9-11 (ATD 18-22 Gy). In the future, these patients were put on parenteral
administration of broad-spectrum antibiotics, while they did not interrupt EBRT course. The remaining
six patients experienced sore throat in 50% of cases and insignificant pain in 40% of cases (ATD 30-36
Gy). One patient (after rhinotomy) had no complaints.
In patients of 1st experimental group, CIC concentration did not statistically change and remained the
same as before the treatment, but, in spite of enterosorption, the gradual CIC accumulation was still
going on.
The use of Enterosgel during EBRT allowed to reduce local inflammatory response of irradiated tissues
and serum level of medium-weight molecules: by session 9-11, the level of medium-weight molecules
did not exceed 0.300 relative units of extinction, and by the end of treatment it was in the range from
0.240 to 0.264 relative units.
Changes in the number of leukocytes, erythrocytes and platelets in both groups occurred within the
normal range generally recognized. The absolute number of red blood cells throughout EBRT course
remained reliably unchanged in both groups.
Results of the treatment of patients with tumors of the upper respiratory tract CRT and CRT +
Enterosgel
Changes in the level of medium-weight molecules in both groups were less pronounced than in the
previous observations.
By EBRT session 9-11, when regional chemotherapy had been completed, low medium-weight
molecules remained in 6 (46%) patients of the 2nd control group and 5 (50%) patients of the 2nd
experimental group, however, in the experimental group the level of medium-weight molecules did not
exceed 0.257 relative units of extinction in the middle and at the end of the treatment. It can be
assumed that binding and excretion of toxins by the adsorbent allows to improve detoxification body
functions, in case of CRTx almost back to normal.
In 7 (54%) patients of the 2nd control group, medium-weight molecules level was 0.307 ± 0.0107 relative
units of extinction, with clinically observed significant radoiepithelitis signs. By the 20th EBRT session, of
the remaining 10 patients in the control group seven patients had a higher level of medium-weight
molecules (0.277 ± 0.011 relative units extinction). In three patients the level of medium-weight
molecules was equal to 0.185 ± 0.016 relative units of extinction.
With the increase in radioepithelitis symptoms, patients of the 2nd control group experienced an
increase of CIC concentration up to 50 ± 6.4 relative units of extinction versus 29 ± 2.9 units before
treatment (p <0.05). At the same time, no statistically significant increase in CIC concentration was
determined in the 2nd experimental group of patients who took Enterosgel. Obviously, this was due to
enteric sorption of substances with antigenic properties.
It should be noted that due to enterosorption clinical manifestations of radioepithelitis decreased, while
subjective feelings of patients in the exposed pharynx improved.
The absolute number of leukocytes and platelets by EBRT session 9-11 were at baseline values in both
groups. Decrease in the absolute number of red blood cells in both groups was not statistically
significant.
Conclusions
1. During EBRT, all patients have experienced an increase of endogenous intoxication, which can be an
indicator of the level of medium-weight molecules. However, in patients treated with Enterosgel,
medium-weight molecules level was lower than in the control group and did not rise above 0.300
relative units of extinction.
2. It has been proved that the method of intestinal drug absorption Enterosgel reduced antigen load.
3. Analysis of the results shows feasibility of increasing the daily dose of Enterosgel by 2 times at CRTx.
Especially the dose should be increased in the first 15 days of treatment, when the negative influence of
EBRT is aggravated by chemotherapy.
4. Application of intestinal adsorbent Enterosgel during EBRT significantly reduces clinical manifestations
of radioepithelitis. Improvement of the general condition of all 10 patients allowed to conduct a full
treatment course without interruption.