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PubMed1993

One hundred and forty-five consecutive pancreaticoduodenectomies without mortality.

OBJECTIVE: A review of mortality and morbidity for pancreaticoduodenectomy was performed for 145 consecutive patients who underwent the operative procedure between 1988 and 1991. SUMMARY BACKGROUND DATA: In the past, pancreaticoduodenectomy has carried a high hospital morbidity and mortality. During the 1970s, many considered that the operation should be abandoned. Recent data, however, suggest that a marked drop in both morbidity and mortality have occurred for this operative procedure. METHODS: Among the 145 consecutive patients who underwent pancreaticoduodenectomy, 108 patients were 69 years of age or younger, and 37 were 70 years of age or older. Four patients were 80 years of age or older. One hundred and seven patients had a malignant neoplasm, whereas 38 patients had benign disease. There were no significant differences in preoperative risk factors when the younger and older, and benign disease and malignant disease groups were compared. RESULTS: Mean operative time was 7.3 hours. Median blood loss was 0, indicating that more than one-half of the patients underwent pancreaticoduodenectomies without blood transfusions. There were no significant differences in postoperative complications when the younger and older, and benign disease and malignant disease groups were compared. There was no hospital or 30-day mortality. CONCLUSIONS: With appropriate preoperative selection, virtually any patient in any age group, with benign or malignant disease, can undergo pancreaticoduodenectomy with minimal risk of hospital mortality.

Adult↗
PubMed1997

[Antigens CA-50 and CA-242 in digestive tract and thyroid neoplasms].

The aim of the study was to assess the CEA antigen and glycoproteins associated antigen CA-50 and CA-242 in tumours of digestive tract and thyroid gland. 84 patients were the material of the study-33 with digestive tracts' neoplasms (among them 22 cases of large bowel cancer and 11 with cancer of pancreas) and 51 with thyroid neoplasms (30 patients with well differentiated thyroid cancer, 21 follicular adenomas of thyroid). There were assessed level of CA-50 and CA-242 glycoprotein associated antigens. Results were compared with CEA-for digestive tract cancer and Tg levels in thyroid neoplasm respectively. In large bowel cancer (22 cases) there were in 10 patients (45%) with elevated level of CEA, 14 patients with elevated CA-50 (63%) and the same number for CA-242 (14 patients-63%). In cancer of pancreas (total 11 patients) there were CEA elevated level in 3 (27%) patients, CA-50 in 7 (64%) patients and CA-242 in 6 (55%) patients. Patients with well differentiated thyroid cancer (30 cases) revealed elevated level of Tg in 24 (80%) patients, CA-50 in 4 (13%), and CA-242 in 4 (13%) ones. The patients with follicular adenomas (21) had elevated Tg level in 17 (80%) cases, CA-50 in 3 (14%) cases and CA-242 in one patient (4.7%).

Adenocarcinoma↗
PubMed1994

Keratinocyte growth factor induces proliferation of hepatocytes and epithelial cells throughout the rat gastrointestinal tract.

Keratinocyte growth factor (KGF), a member of the fibroblast growth factor (FGF) family, was identified as a specific keratinocyte mitogen after isolation from a lung fibroblast line. Recently, recombinant (r)KGF was found to influence proliferation and differentiation patterns of multiple epithelial cell lineages within skin, lung, and the reproductive tract. In the present study, we designed experiments to identify additional target tissues, and focused on the rat gastrointestinal (GI) system, since a putative receptor, K-sam, was originally identified in a gastric carcinoma. Expression of KGF receptor and KGF mRNA was detected within the entire GI tract, suggesting the gut both synthesized and responded to KGF. Therefore, rKGF was administered to adult rats and was found to induce markedly increased proliferation of epithelial cells from the foregut to the colon, and of hepatocytes, one day after systemic treatment. Daily treatment resulted in the marked selective induction of mucin-producing cell lineages throughout the GI tract in a dose-dependent fashion. Other cell lineages were either unaffected (e.g., Paneth cells), or relatively decreased (e.g., parietal cells, enterocytes) in rKGF-treated rats. The direct effect of rKGF was confirmed by demonstrating markedly increased carcinoembryonic antigen production in a human colon carcinoma cell line, LIM1899. Serum levels of albumin were specifically and significantly elevated after daily treatment. These results demonstrate rKGF can induce epithelial cell activation throughout the GI tract and liver. Further, endogenous KGF may be a normal paracrine mediator of growth within the gut.

Animals↗
PubMed1989

Cancer mortality among a cohort of chromium pigment workers.

A study of mortality among 1,879 male workers employed in a New Jersey chromium pigment factory was carried out, with follow-up from 1940 to 1982. Vital status of 1,737 (92%) of the eligible cohort members was determined. For all malignant neoplasms, 101 deaths were observed while 108.8 were expected, SMR = 93 (standardized mortality ratio; n.s.). For the entire study group, no significant excess was observed for respiratory cancer or cancer at other sites. However, the total number of years of employment in the factory and the total number of years of exposure to chromate dusts were both statistically significantly (p less than .05, for trend) associated with an increased risk for lung cancer. The excess risk for lung cancer associated with duration of exposure to chromate dusts was, however, only clearly apparent for subjects followed for 30 years or more after initial employment. For this group, the SMRs were 81, 139, 201, and 321 for the subjects with 0 years, less than 1 year, 1-9 years, and 10+ years of exposure to chromate dusts (p less than .01, for trend), respectively. The risk for digestive cancer was only weakly associated with exposure to chromate dusts.

Chromium↗
PubMed1990

Trend surface models in the representation and analysis of time factors in cancer mortality.

A method of graphic representation of time factors in cancer mortality is presented, based on different tonalities of grey applied to the surface of the matrix defined by various age-specific rates. It is illustrated using mortality data from cancers of the mouth or pharynx, oesophagus, larynx and lung in Italian and Swiss males. Progressively more complex regression surface equations are defined, on the basis of two independent variables (age and cohort) and a dependent one (each age-specific rate). General patterns of trends were thus identified, showing important similarities in cohort and period effects, but also noticeable differences in time-related factors in mortality from various neoplasms of the upper digestive and respiratory tract. For instance, there were declines in mortality from cancers of the mouth or pharynx in the oldest age groups, whereas rates were appreciably upwards at younger and middle age, particularly in Italy. Likewise, cancers of the oesophagus and, chiefly, of the larynx were substantially increasing, on a cohort basis, in oldest Italian males. Temporal pattern for laryngeal cancer in Italy was similar to that of lung cancer, thus suggesting that (cigarette) smoking has a greater impact on this cancer site as compared with alcohol. However, it is difficult to explain, on this basis alone, the totally diverging pattern for cancer of the larynx (downwards) and of the lung (upwards) observed among older Swiss males. These examples indicate that trend surface models are a useful summary guide to illustrate and understand the general patterns of age, period and cohort effects in cancer mortality.

Adult↗
PubMed1994

[The initial symptom attributable to cancer in digestive tube tumors. A study of agreement between the patient and the physician].

BACKGROUND: Clinical practice shows that certain patients may underestimate and others overestimate some initial symptoms of their disease. In studies on the interval between first symptoms and treatment onset, estimating the date in which symptoms first appeared is crucial. The study analyzed patient-physician agreement in assessing first symptom attributable to cancer. METHODS: During two years, two physicians personally interviewed, through a structured questionnaire, all symptomatic patients with a neoplasm of the digestive tract admitted to Hospital del Mar (Barcelona, Spain). Patients had a mid-low sociocultural profile and most had been admitted through the Emergency Department. RESULTS: Absolute agreement (symptom and date) occurred in 85% of the 183 subjects. In most discordant cases, patients had overlooked some component of the "toxic syndrome", and the date of symptom onset was, based on physician's assessment, chronologically prior to the date elicited from the patient. Disagreement was directly related to the patient's health status (p < 0.05) and to the number of reported symptoms until hospital admittance (p = 0.002), but not to tumour stage. Agreement increased with the importance attributed by the patient to the first symptom (p < 0.05). CONCLUSIONS: In spite of difficulties inherent to measuring symptomatic onset of diseases, structured patient interviews appear to be a reasonably valid method and deserve further development in this and other areas of research.

Aged↗
PubMedDate not supplied

[Detection of liver metastases from digestive cancer. Value of alkaline phosphatases, their macromolecular isoenzyme and of ceruloplasmin].

In order to improve the non aggressive diagnosis of hepatic metastasis from digestive neoplasm, the authors analyzed the following biological parameters: aminotransferases, alkaline phosphatase and lacticodehydrogenase isoenzymes, gammaglutamyl-transpeptidase, conjugated and total bilirubin, C-reactive protein, type A, G, M immunoglobulins, C3 complement factor, alpha-1 acidic glycoprotein (orosomucoid), haptoglobin, ceruloplasmin, transferrin, albumin, prealbumin, ferritin. This work included 54 patients with digestive tract cancer (esophageal, gastric, colic, rectal, anal localizations), divided in two groups: M- (n = 27), without hepatic metastasis), and M+ (n = 27, with histological confirmed hepatic metastasis). The Mann-Whitney test showed significant differences for 12 parameters between the 2 groups. With more than 60% sensitivity (Se) and specificity (Sp), according to the ROC curves, the following parameters can be selected: Total alkaline phosphatase (Se 89%, Sp 70%) and their macromolecular H2 fraction, lacticodehydrogenase fraction 4 (Se 63%, Sp 63%), gammaglutamyl-transpeptidase (Se 85%, Sp 82%), ceruloplasmin (Se 64%, Sp 65%), aspartate-aminotransferase determination (Se 63%, Sp 65%).

Adult↗
PubMed2006

Carcinoid tumors.

Carcinoid tumors are rare, slow-growing neuroendocrine neoplasms that often are indolent and may not become clinically apparent until there has been metastatic spread or evidence of carcinoid syndrome. Recent evidence has revealed that the overall incidence of carcinoid tumors has been steadily increasing, and although the disease was thought to be relatively benign, it is now considered one of increasing malignancy. Carcinoid tumors derive from different embryonic divisions of the gut: foregut carcinoid tumors commonly originate in the lungs, bronchi, or stomach; midgut carcinoid tumors in the small intestine, appendix, or proximal large bowel; and hindgut carcinoid tumors in the distal colon or rectum. Carcinoid syndrome, although rare, is most associated with midgut carcinoid tumors. The diagnosis of a carcinoid tumor often is coincidental with surgery performed for another reason. Treatment and prognosis are dependent on the location of the primary tumor and the degree and extent of metastasis at the time of diagnosis.

Carcinoid Tumor↗
PubMed1980

Carcinogenicity of N-nitrosomethyl(2-oxopropyl)amine in Syrian hamsters.

7-Methylguanine was found in hydrolysates of liver and pancreas DNA from Syrian golden hamsters given a single dose of N-[1-14C]nitrosobis(2-oxopropyl)amine (BOP). This led us to examine the carcinogenicity of a potential methylating metabolite of BOP, N-nitrosomethyl(2-oxopropyl)amine (MOP). MOP was found to be a potent pancreatic carcinogen by either single or weekly s.c. injections. A single MOP treatment (25 mg/kg body weight) induced ductular adenomas and/or adenocarcinomas in 80% of the hamsters. A higher incidence of these neoplasms was found in 93% and 87% of animals receiving, respectively, 3.5 and 1.75 mg MOP per kg body weight weekly for life. However, the lower dose (0.87 mg/kg body weight) was less effective, resulting in a 33% tumor incidence. Compared with the known potent pancreatic carcinogen BOP, MOP seemed to have a greater affinity for the pancreas since considerably lower doses were required to induce similar incidences of equivalent pancreatic tumors. Like BOP, MOP caused tumors of the liver (7 to 100% incidence), kidneys (7 to 80% incidence), and vascular system (7 to 27% incidence). However, in contrast to BOP, which was noncarcinogenic to the upper respiratory tract, MOP-treated animals developed a high incidence of nasal cavity tumors (40% after a single treatment and 27 to 100% after weekly injections). The mutagenesis studies using hamster liver cell-mediated V79 cells confirmed the stronger effect of MOP compared to BOP. The assumption that MOP might be a proximate carcinogenic metabolite of BOP could not be substantiated by our methods for determining the in vivo and in vitro metabolites of BOP.

Adenocarcinoma↗
PubMed1997

[Activity of cathepsin D in some neoplasms of the gastrointestinal tract].

In the present paper we analyzed cathepsin D activity in digestive tract cancers. Cathepsin D activity was estimated in 10% homogenates of oesophageal cancer, gastric cancer and colon cancer tissues and in the blood serum and expressed as the amount of liberated tyrosine which was assayed acc. to Folin-Ciocalteau. Mean cathepsin D activities in neoplastic tissues and normal counterparts were as follows: oesophaged cancer (218.5 mM Tyr/1/2 h vs 145.0 mM Tyr/1/2 h), gastric cancer (285.4 mM Tyr/1/2 h vs 142.3 mM Tyr/1/2 h) and colon cancer (233.7 mM Tyr/1/2 h vs 159.5 mM Tyr/1/2 h). In all examined neoplastic tissues cathepsin D activity was almost too-fold higher than in the normal counterparts. Cathepsin D activity in the sera of cancer patients was too a lesser degree higher than in the sera of normal subjects. The data indicate that estimating of cathepsin D activity in the neoplastic tissues homogenates and in the blood serum may be of diagnostic value and may constitute an information which is complementary to the analysis of other tumor markers and histopathologic examination.

Adult↗
PubMed2003

Factors determining the post-operative hypo-albuminaemia in cancer patients--stepwise regression analysis.

AIM: To investigate factors influencing post-operative hypo-albuminaemia in cancer patients, with special reference to low dose albumin and/or immunoglobulins administration. PATIENTS AND METHODS: In 270 patients with malignant neoplasms, who underwent extensive chest and/or abdominal surgery, albumin concentrations on the first four postoperative days were examined. One hundred and three high-risk patients received human immunoglobulins intravenously; 44 were given albumin. Univariate and multivariate regression analyses were used to determine the factors influencing albuminaemia on the first four postoperative days. RESULTS: Mean nadir of hypo-albuminaemia occurred on the third postoperative day. In the multivariate analysis, a positive correlation was found between postoperative albuminaemia and pre-operative albuminaemia (b = 0.4919; p = 0.0000) as well as male gender (b = 2.0939; p = 0.0025). A negative correlation was found with the duration of surgery (b = -0.0416; p = 0.0212), pre-operative plasma protein (b = -0.2118, p = 0.0130) and postoperative immunoglobulin administration (b = -1.8858, p = 0.0074). CONCLUSIONS: Postoperative albuminaemia is positively correlated with pre-operative albuminaemia and male gender and negatively correlated with the duration of surgery, pre-operative proteinaemia and postoperative Ig administration.

Aged↗
PubMedDate not supplied

CT and MR imaging findings of bowel ischemia from various primary causes.

Ischemic bowel disease represents a broad spectrum of diseases with various clinical and radiologic manifestations, which range from localized transient ischemia to catastrophic necrosis of the gastrointestinal tract. The primary causes of insufficient blood flow to the intestine are diverse and include thromboembolism, nonocclusive causes, bowel obstruction, neoplasms, vasculitis, abdominal inflammatory conditions, trauma, chemotherapy, radiation, and corrosive injury. Computed tomography (CT) or magnetic resonance (MR) imaging can demonstrate the ischemic bowel segment and may be helpful in determining the primary cause. The CT and MR imaging findings include bowel wall thickening with or without the target sign, intramural pneumatosis, mesenteric or portal venous gas, and mesenteric arterial or venous thromboembolism. Other CT findings include engorgement of mesenteric veins and mesenteric edema, lack of bowel wall enhancement, increased enhancement of the thickened bowel wall, bowel obstruction, and infarction of other abdominal organs. However, regardless of the primary cause, the imaging findings of bowel ischemia are similar. Furthermore, the bowel changes simulate inflammatory or neoplastic conditions. Understanding the pathogenesis of various conditions leading to mesenteric ischemia helps the radiologist recognize ischemic bowel disease and avoid delayed diagnosis, unnecessary surgery, or less than optimal management.

Abdominal Injuries↗
PubMed1986

[Neoplasm risk in men occupationally exposed to asbestos dust].

To evaluate the magnitude of cancer risk in those occupationally exposed to asbestos dust, a historically prospective cohort has been investigated. The observation covered 2403 men employed for at least 3 months, within 1945-1973, in a factory producing various asbestos products--including chrysotile. The cohort availability on 31 Dec. 1981 was 91.3%. The risk analysis was based on the standardized mortality ratio (SMR) calculated by the man-years method. The reference group was composed of general men population in Poland. Totally, in the test cohort 401 deaths were certified, in this 73 due to malignant tumours and 31 due to the respiratory system cancer. The total standardized mortality ratio (SMR) came to 85, for malignant tumours, SMR = 104.8 for the respiratory system cancer SMR = 144.7, lung cancer-139.5%. Those values were not statistically significant. In the cohort of those employed during 1945-1955, selected due to a very high concentration of asbestos dust at this time and long observation time from the first contact with asbestos dust, the total SMR was 90.7, the one for malignant tumours-136.2 (p less than 0.05). In this cohort 21 deaths for the respiratory system cancer were observed, the total SMR = 191.1 (p less than 0.01), in this 18 for the lung cancer, SMR = 187.1 (p less than 0.05). The other cancer groups did not exhibit any statistically significant standardized mortality rate. The analysis points to a considerable lung cancer risk in those occupationally exposed to asbestos dust at the time of high non-controlled asbestos dust concentrations.

Asbestos↗
PubMed2003

Zero mortality after 152 consecutive pancreaticoduodenectomies with pancreaticogastrostomy.

BACKGROUND: Since 1968, there have been three published reports in the United States literature of 41, 118, and 145 consecutive patients undergoing pancreaticoduodenectomy without mortality. In all of these series, the pancreatic remnant was anastomosed to the jejunum. STUDY DESIGN: This study was designed to review 152 consecutive patients who underwent pancreaticoduodenectomy in whom the pancreatic remnant was anastomosed to the stomach (pancreaticogastrostomy). RESULTS: A total of 152 patients underwent pancreaticoduodenectomy with pancreaticogastrostomy between July 1992 and May 2002. There were 85 men and 67 women with a mean age of 65.7 years (range 31 to 90 years). Of the patients, 87 were less than 69 years of age and 65 were more than 69 years. A total of 114 patients had a malignant neoplasm and the remaining 38 had either cystic neoplasms or benign disease. When the two groups were compared, the patients who were more than 69 years of age had a significantly high incidence of hypertension, previous cancer, atrial fibrillation, and coronary artery disease. In addition, patients more than 69 years of age had a significantly high incidence of jaundice and placement of preoperative stents. Patients more than 69 years of age had significantly less operative time but there was no between-group difference in estimated blood loss, transfusion, number of units transfused, and postoperative length of stay. There was no postoperative mortality [corrected] in this series. Pancreatic leak and fistulae were the most common complications, followed by intraabdominal abscess, wound infection, and delayed gastric emptying. CONCLUSIONS: In this study, 152 consecutive patients underwent pancreaticoduodenectomy with pancreaticogastrostomy without postoperative mortality. Morbidity was mostly because of pancreatic leaks and fistulae, which were successfully treated nonoperatively. With proper selection, careful preoperative preparation, and proper intraoperative conduct of operation, the Whipple procedure can be performed without postoperative mortality.

Adenocarcinoma↗
PubMed2000

Laparoscopic ultrasound enhances diagnostic laparoscopy in the staging of intra-abdominal neoplasms.

Routine laparoscopy and laparoscopic ultrasound (LUS) for staging intra-abdominal malignancies remains controversial. Thus, we undertook a prospective study to assess the value of preoperative laparoscopy with LUS for patients with intra-abdominal tumors judged resectable by preoperative studies. Laparoscopy was successfully performed in 76 of 77 patients, and 60 underwent LUS. Of 33 patients with presumed pancreatic cancer, laparoscopic findings changed the operative management of 11 patients, and LUS altered the management of an additional 6 patients. Laparotomy was avoided in 9 patients (27%). Among 14 patients with hepatobiliary tumors, laparotomy was avoided in 9 patients in whom laparoscopy and/or LUS revealed either benign or advanced disease. Operative management was altered in 4 of 18 patients with gastric or esophageal cancer by laparoscopic findings. LUS did not add to the management of these patients. Of 12 patients with presumed intra-abdominal lymphoma, 9 were diagnosed with lymphoma and 3 with benign disease, without laparotomy in all but 1 case. Laparoscopy and LUS are valuable tools for evaluating the resectability of pancreatic and hepatobiliary tumors. Laparoscopy, and to a lesser degree LUS, greatly facilitates diagnosing patients with intra-abdominal lymphomas and spares an occasional patient with esophagogastric carcinoma from undergoing laparotomy.

Carcinoma↗
PubMed1991

Morphologic analysis of digestive cancers from the registry of Vaud, Switzerland.

Detailed data and statistics per each morphological site of various digestive neoplasms were obtained for the period 1976-87 from the Vaud Cancer Registry datafile, a population-based cancer registration scheme covering about 530,000 inhabitants from the French-speaking part of Switzerland. Tabulations presented include absolute number of cases (1,041 oral and pharyngeal, 545 oesophageal, 1,131 gastric, 83 small intestine, 1,980 colon, 1,267 rectal, 357 liver, 328 gallbladder and 725 pancreatic cancers), percent distributions, age-standardised rates, sex ratios and 5-year survival. The report has essentially a descriptive value, and should be viewed as a contribution towards quantification, in a well surveilled population of the West-central part of Europe, of the proportional distribution of digestive neoplasms by morphological type, and corresponding incidence and survival rates. Among the points deserving specific attention, there are the elevated frequency of upper digestive tract cancers, the very high male-to-female ratios for squamous cell carcinomas, adenocarcinomas of the oesophagus and hepatocellular carcinomas of the liver, the female excesses in infiltrating carcinoids of the colon, transitional and squamous cell carcinomas of the rectum and adenocarcinomas of the gallbladder, and the crossover in male-to-female ratio in squamous cell carcinoma along the digestive tract (i.e. from 6.0 at the level of the mouth/pharynx to 0.5 in the rectum). As concerns survival, rates were higher for lymphomas and sarcomas than for carcinomas in oral cavity and stomach, similar for carcinoids and carcinomas in the small bowel (about 35% at 5 years), as well as for colon (34%) and rectal (37%) cancers. Some of the findings, such as the higher survival of carcinomas arising from polyps in the colon and rectum, or the higher proportion of cholangiocellular and combined cholangio- and hepatocellular carcinomas in females than in males find plausible prognostic or aetiologic correlates, but others, such as the large proportions of squamous and transitional cell cancers of the rectum in females are more difficult to explain. These and several other indications emerging from careful examination of the data herein presented underline the interest of morphological analyses of digestive tract cancers.

Adult↗
PubMed2001

Cancer mortality in rubber tire workers in Poland.

The study aimed at assessing cancer risk in a cohort of workers employed in the rubber tire production. The cohort consisted of 17,747 workers (11,660 men and 6087 women) employed in a rubber tire plant for at least three months during the years 1950-1995. The cohort follow-up was completed on December 31, 1995. Deaths by causes were analyzed using standardized mortality ratio (SMR) calculated by the person-years method. The mortality pattern of the general population of Poland was used as the reference. The study indicated significantly lower total mortality in the cohort (men: SMR = 72; women: SMR = 62) as compared to the general population, which is an example of a well known "healthy worker effect". The number of deaths from malignant neoplasms was also lower than expected (men: SMR = 67; women: SMR = 64). Only in a very small sub-cohort of men involved in dosing and mixing of raw material for the production of rubber, an excess of total mortality (SMR = 104) and from all cancers (SMR = 115) was found. Mortality from all neoplasms was enhanced (SMR = 108) in the sub-cohort of women employed in the technical service work area. When analyzing individual cancer sites in men of the whole cohort or sub-cohorts, the observed number of deaths from cancers of the lip, tongue, pharynx, stomach, gallbladder, pancreas, peritoneum, articular cartilage, connective tissue, skin, testis, prostate, bladder, kidney, brain, as well as from Hodgkin's disease, multiple myeloma and leukemia was larger than the expected number. Among women the excess mortality was due to cancers of the large myeloma and leukemia. The SMR calculated for these sites were statistically insignificant. The cohort under study was "young" and thus relatively small numbers of deaths were recorded. The excess mortality, based quite frequently on single cases of selected cancer sites, cannot be regarded as a basis for final conclusions. Nevertheless, the fact that these observations are in agreement with the findings of other authors who carried out studies in the rubber industry of other countries justifies the need to follow-up this cohort in the future.

Adult↗
PubMed1993

Immunotherapy with subcutaneous low-dose interleukin-2 and the pineal indole melatonin as a new effective therapy in advanced cancers of the digestive tract.

The advanced tumours of the digestive tract are generally less responsive to conventional chemotherapies. Moreover, preliminary results with IL-2 immunotherapy also seem to show a low efficacy. On the basis of our previous studies suggesting s synergistic action between IL-2 and some neurohormones, such as the pineal indole MLT, a clinical trial was performed to investigate the clinical efficacy and tolerability of an immunotherapy with IL-2 plus MLT in patients with advanced neoplasms of the digestive tract. The study included 35 patients (colorectal cancer: 14; gastric cancer: 8; hepatocarcinoma: 6; pancreas adenocarcinoma: 7). Distant organ metastases were present in 31/35 patients. MLT was given orally at a daily dose of 50 mg at 8.00 p.m., starting 7 days before IL-2, which was given subcutaneously at a dose of 3 million IU/day at 8.00 p.m. for 6 days/week for 4 weeks, corresponding to one cycle of immunotherapy. In nonprogressed patients, a second cycle was given after a 21-day rest period. A complete response was achieved in two patients (gastric cancer: 1; hepatocarcinoma: 1). Six other patients obtained a partial response: (gastric cancer: 2; hepatocarcinoma: 2; colon cancer: 1; pancreas cancer: 1). Therefore, the overall response rate was 8/35 (23%). Stable disease was obtained in 11/35 (31%) patients, whereas the remaining 16 patients (46%) progressed. The response rate was significantly higher in untreated patients than in those previously treated with chemotherapy. Toxicity was low in all patients, who received the treatment as a home therapy. This study shows that the immunotherapy with low-dose IL-2 plus the pineal hormone MLT is a new well tolerated and effective therapy of advanced tumours of the digestive tract, mainly in gastric cancer and hepatocarcinoma.

Adult↗