Prognostic value of lymph node ratio in resectable rectal cancer after preoperative short-course radiotherapy-results from randomized clinical trial.

PURPOSE: The value of the lymph node ratio (LNR) in patients with rectal cancer has not yet been unequivocally established. This study aims to assess the effect of the lymph node ratio on the prognosis of rectal cancer in patients operated after short-course preoperative 25 Gy radiotherapy, at 10-year follow-up. METHODS: This is a substudy based on data from a prospective randomized clinical trial. A total of 141 patients with resectable rectal cancer were included. Lymph node yield was compared in patients with short and long time intervals between radiotherapy and surgery. Survival curves were compared between patients with different ypN and LNR categories. Univariate and multivariate analyses were performed to identify independent prognostic factors for overall survival and disease-free survival. RESULTS: Survival and recurrence data were available for a median follow-up of 11.6 years. The lymph node yield did not differ significantly between the patients in the short- and long-interval groups. A greater difference in 10-year survival was observed in patients with LNR ≤ 0.41 and > 0.41 when compared to the ypN categories. Separate prognostic factor analyses were performed for the entire population and for subgroups that had < 12 and 12 lymph nodes resected. LNR was identified as an independent prognostic factor for overall survival, in multivariate analyses, for all patients and those with less than 12 retrieved lymph nodes. CONCLUSION: The lymph node yield is comparable in patients with different time intervals between radiation therapy and surgery. LNR better discriminates patients in terms of overall survival than ypN categories. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01444495, date of registration: September 30, 2011.

T Regulatory CD4+CD25+FoxP3+ Lymphocytes in the Peripheral Blood of Left-Sided Colorectal Cancer Patients.

Background and objectives: T regulatory lymphocytes (Treg) are one of the subsets of T-lymphocytes involved in the interaction of neoplastic tumors and the host immune system, and they may impair the immune reaction against cancer. It has been shown that Treg are increased in the peripheral blood of patients with various cancers. In colorectal cancer, the prognostic role of Treg remains controversial. Colorectal cancer is a heterogenous disease, with many variations stemming from its primary tumor location. The aim of this study is to analyse the relationship between the amount of Treg in the peripheral blood of patients with left-sided colorectal cancer in various stages of disease and long-term survival. Materials and Methods: A prospective analysis of 94 patients with left-sided colorectal cancer and a group of 21 healthy volunteers was carried out. Treg levels in peripheral blood were analysed using flow cytometry. Results: There was a statistically significant difference between the amount of Treg in the Ist and IInd TNM stages (p = 0.047). The number of Treg in the entire study group was significantly lower than in the control group (p = 0.008) and between patients in stages II and III and the control group (p = 0.003 and p = 0.018). The group of pT3+pT4 patients also had significantly lower Treg counts in their peripheral blood than the control group (p = 0.005). In the entire study group, the level of Treg cells in the peripheral blood had no influence on survival. The analysis of the TNM stage subgroups also showed no difference in survival between patients with "low" and "high" Treg counts. Conclusion: The absolute number of Treg in the peripheral blood of patients with left-sided colorectal cancer was significantly decreased in comparison to healthy controls, especially for patients with stage II+III disease. Treg presence in the peripheral blood had no impact on survival.

The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients - Randomized Clinical Trial.

BACKGROUND: Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival. The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients. METHODS: A group of 98 gastric cancer patients was randomly assigned for postoperative immunomodulating enteral nutrition n = 44 (Reconvan, Fresenius Kabi, Bad Homburg, Germany), or standard enteral nutrition n = 54 (Peptisorb, Nutricia, Schipol, The Netherlands). Postoperative complications, mortality, 6-mo and 1-yr survival were analyzed. RESULTS: The overall postoperative morbidity did not differ between the groups. The rate of pulmonary complications (excluding pneumonia) was significantly lower in immunomodulation group (0% vs 9.3%, p = 0.044), as well as 60-day mortality (0% vs. 11.1%, p = 0.037). There was no difference in 6-mo and 1-yr survival between the groups. CONCLUSIONS: Postoperative immunomodulating enteral nutrition may reduce respiratory complications and postoperative mortality in comparison to standard enteral nutrition. Despite this effect, it did not improve 6-mo and 1-yr survival in immunomodulation group. Probably the beneficial effect of immunomodulating enteral nutrition is too weak to be significant in such a number of patients.

[The model of perioperative risk assessment in elderly patients - interim analysis]. / Model oceny ryzyka okolooperacyjnego u chorych w wieku podeszlym ­ analiza okresowa.

Demographic changes in contemporary society require implementation of proper perioperative care of elderly patients due to an increased risk of perioperative complications in this group. Preoperative assessment of health status identifies risks and enables preventive interventions, improving outcomes of surgical treatment. The Comprehensive Geriatric Assessment contains numerous diagnostic tests and consultations, which is expensive and difficult to use in everyday practice. The development of a simplified model of perioperative assessment of elderly patients will help identifying the group of patients who require further diagnostic workup. AIM: The aim of the study is to evaluate the usefulness of the tests used in a proposed model of perioperative risk assessment in elderly patients. MATERIALS AND METHODS: In a group of 178 patients older than 64 years admitted for surgical procedures, a battery of tests was performed. The proposed model of perioperative risk assessment included: Charlson Comorbidity Index, ADL (activities of daily living), TUG test (timed "up and go" test), MNA (mini nutritional assessment), AMTS (abbreviated mental test score), spirometry measurement of respiratory muscle strength (Pimax, Pemax). Distribution of abnormal results of each test has been analysed. RESULTS: The Charlson Index over 6 points was recorded in 10.1% of patients (15.1% in cancer patients). Abnormal result of the TUG test was observed in 32.1%. The risk of malnutrition in MNA test has been identified in 29.7% (39.2% in cancer patients). CONCLUSIONS: Abnormal test results at the level of 10-30% indicate potential diagnostic value of Charlson Comorbidity Index, TUG test and MNA in the evaluation of perioperative risk in elderly patients.

Selected Body Composition Parameters Analysis Based on Bioelectrical Impedance in Patients Operated for Gastrointestinal Cancer.

BACKGROUND/AIM: Bioelectrical Impedance Analysis is a method that evaluates body composition, useful in assessing the nutritional status of cancer patients. The analysis of its indicators may be helpful in predicting clinical course. The aim of the study was to evaluate the following body composition parameters: fat mass (FM), fat-free mass (FFM), skeletal muscle mass (SMM), muscle mass index (MMI), visceral fat (VF) and body mass index (BMI) measured before and after surgery in patients with gastrointestinal cancer and to determine the relationship between body composition and the course of treatment. PATIENTS AND METHODS: The study included 125 patients, aged 65-68, operated on due to gastric, pancreatic or colorectal cancer. Body composition was assessed with electrical bioimpedance before and on the fifth postoperative day. The severity of complications was assessed with the Clavien-Dindo classification. RESULTS: In the whole group of patients, the percentage of FM, VF, and BMI levels measured before surgery were significantly higher in curative surgery patients in comparison to palliative surgery patients, p<0.001. The MMI value was also significantly higher, p=0.045. In patients after curative surgery, the values of BMI and FM significantly decreased (BMI - p<0.001; FM - p=0.003) after the surgery. There was no relation between body composition parameters and severity of postoperative complications. CONCLUSION: In the investigated group, body composition differed between radical and palliative surgery groups. Surgery with curative intent produced more changes in body composition parameters in the early postoperative period than palliative surgery. These observations may be helpful in prehabilitation planning for such patients.

IL-6 serum levels predict postoperative morbidity in gastric cancer patients.

BACKGROUND: Despite progress in surgical techniques and perioperative care, gastrectomy remains a procedure of significant morbidity. Several scoring systems and clinical measures have been adopted to predict postoperative complications in gastric cancer patients. The aim of this study was to investigate whether high serum levels of interleukin 6 (IL-6) in the early postoperative period may be a prognostic factor of postoperative morbidity. METHODS: A group of 99 consecutive patients with resectable gastric cancer were enrolled. The mean age was 62.9 years and the male/female ratio was 72:27. Subtotal gastric resection was performed in 22 patients and total gastric resection in 77. The IL-6 serum level was measured on the 1st postoperative day (POD). RESULTS: Complications were recorded in 28 patients (28.3%). The observed case-fatality rate was 3.03%. An IL-6 serum level of >288.7 pg/ml on the 1st POD in univariate and multivariate Cox proportional hazard models was an independent prognostic factor for overall complications and infective complications. CONCLUSION: Our study showed an association between perioperative IL-6 serum levels and postoperative morbidity in gastric cancer patients. The IL-6 serum level on the 1st POD was shown to be an independent prognostic factor for both overall complications and infective complications.

[Elevated blood glucose level as a risk factor of hospital-acquired pneumonia among patients treated in the intensiv care unit (ICU)]. / Podwyiszone stezenie glukozy jako czynnik ryzyka szpitalnego zapalenia pluc u chorych w oddziale intensywnej terapii.

Hospital acquired-pneumonia is the most frequently occurring hospital-acquired infection in intensive care units (ICU). The study group consisted of 233 patients treated over 12 months in the ICU of the 1st Department of General Surgery and Gastroenterological Surgery Clinics, University Hospital in Krakow. Patients were divided in two groups: experimental--consisting of 92 patients with hospital-acquired pneumonia, and control--consisting of 141 patients without the disease. The following risk factors of hospital-acquired pneumonia risk were analysed for both groups: length of stay in the ICU, duration of mechanical ventilation, kind of treatment applied, presence of a gastrointestinal tube, blood glucose levels. Significantly more patients with hospital-acquired pneumonia than controls had blood glucose level above 6 mmol/l (OR = 2.23). Monitoring and maintainment of glucose level within the normal ranges is an important element of successful treatment. In fact, glucose level is the only risk factor that can be easily modified compared with other analyzed factors.

[The effect of immunomodulating enteral nutrition on postoperative cytokine profile in gastric cancer patients]. / Wplyw immunomodulujacego leczenia zywieniowego na pooperacyjny profil cytokin u chorych na raka zoladka.

UNLABELLED: The operative injury affects the immune system what results in cytokine production--mediators of immune response. Intensity of this reaction depends on the extent of surgery, the time of procedure and actual status of the immune system. In gastric cancer patients malnutrition is diagnosed in as much as 60-80% and increases postoperative morbidity, and the time to functional recovery. The implementation of immunonutrition correlates with the improvement of postoperative course. The aim of this study was to evaluate the influence of immunonutrition on postoperative cytokine (IL-6, IL-10, TNF-alpha) plasma levels in gastric cancer patients. MATERIAL AND METHODS: The group of 99 gastric cancer patients was enrolled. In 54 patients standard postoperative enteral nutrition and in 45 patients immunonutrition was administered. Preoperatively and in 1., 3. and 7. postoperative day plasma levels of IL6, IL10 and TNFalpha were measured. RESULTS: The mean absolute levels of IL-6 and TNF-alpha did not differ statistically between the groups. However, the increment of changes of these cytokines was higher in immunonutrition group reaching statistical significance at day 7 for TNF-alpha (26 pg/ml for immunonutrition vs -10 pg/ml for standard nutrition p = 0.024). IL-10 levels were significantly higher in immunonutrition group at 1. and 3. postoperative days. CONCLUSIONS: The postoperative profile of proinflammatory cytokines did not differ significantly between immunonutrition and standard nutrition groups. The increase of IL-10 plasma levels in early postoperative period in immunonutrition patients may suggest that one of the effects of this therapy is the inhibition of early inflammatory reaction.

Impact of disseminated tumor cells in the bone marrow on survival and disease progression in patients with left-sided colorectal cancer.

INTRODUCTION: Disseminated tumor cells (DTCs) are a subset of circulating tumor cells that migrate to the bone marrow. Colorectal cancer is a heterogeneous disease depending on the site of the primary tumor. OBJECTIVES: We aimed to assess the association between the presence of DTCs in the bone marrow and tumor characteristics as well as long­term treatment outcomes in patients with left­sided colorectal cancer. PATIENTS AND METHODS: This prospective study included 91 patients with left­sided colorectal cancer (37 with colon cancer and 54 with rectal cancer) treated between 2007 and 2012 in a single tertiary center. Fifteen patients had stage I cancer; 26, stage II; 26, stage III; and 24, stage IV. Overall survival and cancer relapse rates were compared between patients with different cancer stages and DTC status. RESULTS: Bone marrow DTCs were identified in 42 patients (46.1%). The prevalence of DTCs was not related to tumor infiltration depth, nodal involvement, distant metastasis, tumor stage, or primary tumor site. The 5­year overall survival rates were 59.5% and 53% in the DTC­positive and DTC­negative groups, respectively (P = 0.19). There was a notable trend favoring survival in patients with DTCs with stage II and III disease (both separately and when combined). The number of metachronous distant metastases was significantly lower in DTC­positive patients. CONCLUSIONS: The presence of DTCs in the bone marrow is not associated with primary tumor characteristics and seems to reduce metastasis formation in left­sided colorectal cancer. There is also a trend for improved overall survival in DTC­positive patients. These results are intriguing and warrant further confirmation.

The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial.

BACKGROUND AND AIM: Immunomodulating nutrition is supposed to reduce the number of complications and lengthen of hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients. MATERIAL AND METHODS: Between June 1, 2001, and December 31, 2005, a group of 214 well-nourished patients was initially assessed (150 men, 64 women, mean age 61.2 years) to participate in the study. Nine patients were subsequently excluded and the remaining 205 subjects were randomly assigned in a 2 x 2 factorial design into 4 study groups, ie, standard enteral nutrition (n = 53), immunomodulating enteral nutrition (n = 52), standard parenteral nutrition (n = 49), and immunomodulating enteral nutrition (n = 51). The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. The study was registered in the Clinical Trials Database-number NCT 00558155. RESULTS: The overall morbidity rate was 33% and the incidence of individual complications was comparable between all groups. Infectious complications occurred in 26 of 102 patients given standard diets and in 22 of 103 patients receiving immunomodulatory formulas (odds ratio 0.81; 95% CI, 0.43-1.50). There were no significant differences between infectious complications in patients using parenteral nutrition (22 of 100 patients) and parenteral formulas (26 of 105, odds ratio 1.14; 95% CI, 0.61-2.14). Neither immunostimulating formulas nor enteral feeding significantly affected secondary outcome measures, including overall morbidity and mortality rates, and hospital stay. CONCLUSIONS: Our study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery. Both enteral and parenteral treatment options showed similar efficacy, tolerance, and effects on protein synthesis. Parenteral nutrition composed according to contemporary rules showed similar efficiency to enteral nutrition. However, because of its cost-efficiency, enteral therapy should be considered as the treatment of choice in all patients requiring nutritional therapy.

Clinicopathological profile and long-term outcome in young adults with gastric cancer: multicenter evaluation of 214 patients.

BACKGROUND AND AIMS: Gastric cancer (GC) is usually diagnosed in the sixth and seventh decade of life, although it may also be found in younger patients. The aim of this study was to analyse the potential differences in demographic and clinicopathological factors between the younger (40 years of age and less) and older (above 40 years) population of GC. MATERIALS AND METHODS: An electronic database covering all gastric cancer patients treated between 1977 and 1998 at eight university surgical centres was reviewed. RESULTS: Of 3,431 patients treated, 214 (6.2%) were 40 years of age or younger. No differences in tumour staging or location could be identified, but the diffuse type lesions were more common in the younger patients (52.6 vs 29.8%). No differences were found in morbidity and mortality rates, except a higher incidence of cardiopulmonary complications in older patients undergoing stomach resection (6.6 vs 12.3%). Median survival of patients after gastrectomy was 24.7 months (95% confidence interval [CI] 22.7-26.6) and was insignificantly longer in younger (30.8 months, 95%CI 21.0-40.5) than older (24.1 months, 95%CI 22.1-26.1) patients (P = 0.056). Median survival for unresectable cases was 5.4 months (95%CI 5.1-5.7) and was comparable in the younger (median 5.5 months, 95%CI 5.2-5.8) and older (median 4.4 months, 95%CI 3.7-5.1) groups. CONCLUSION: GC in young adults demonstrates only minor deviations from the general population with a similar long-term outcome.

Is coagulopathy a common consequence of a Vipera berus bite? A retrospective single centre study.

INTRODUCTION: The Vipera berus (common viper) is the only species of venomous snake found in Poland. The aim of this study was to determine to what extent coagulopathy has occurred as a post-bite complication. MATERIAL AND METHODS: The medical records of 138 adult patients in the Sucha Beskidzka hospital with the diagnosis of snake bite between 2001-2014 were retrospectively analyzed. Demographic, clinical and laboratory data were collected. Antivenom was given to all patients, except one, with snake bites, but laboratory test were taken prior to administration of antivenom. Obtained results were compared to those of the control group, composed of 176 adults hospitalized in the same period for an elective laparoscopic cholecystectomy. RESULTS: The mean platelet count in the study group was 239.94×109/L (SD=56.56) and 248.77×109/L (SD=57.82) in the control group. In 98% of the study group and 100% of the control group the platelet value (PLT) fell within laboratory norms (130 to 420×109/L), 2 patients after snake bites had a PLT lower than normal, and thrombocytosis was not observed in either group. A reference range of 0.85-1.3 INR below normal was found in 2 patients in the study group and 15 from the control group, while values above the normal range were found in 8 patients (6.7%) from the snake bite group and no patients from the control group. In the study group, the INR ranged from 0.78-1.43 with a mean of 1.046 (SD=0.14), while in the control group the range was from 0.79-1.28, with a mean of 0.95 (SD=0.08). There was a significant difference in INR between the study and control groups (p<0.0001). CONCLUSIONS: The bite from V. berus does not result in severe thrombocytopenia, with only a moderate increase in INR values observed in about 7% of patients.

Clinical predictors of malignancy in patients diagnosed with atypical ductal hyperplasia on vacuum-assisted core needle biopsy.

INTRODUCTION: Atypical ductal hyperplasia (ADH) is a benign lesion, which due to the risk of coexisting cancer is classified as a lesion of uncertain malignant potential. AIM: To identify clinical predictors of cancer underestimation in patients with ADH diagnosed after vacuum-assisted breast biopsy (VABB). MATERIAL AND METHODS: Between 2001 and 2016, a total of 3804 vacuum-assisted core needle biopsies were performed at the First Chair of General Surgery of the Jagiellonian University Medical College in Krakow, including 2907 ultrasound (US)-guided biopsies and 897 digital stereotactic procedures. Seventy-six women were diagnosed with ADH and 72 of them underwent subsequent surgical excision. Demographic factors, medical history, family history, clinical symptoms, type and size of lesion determined in imaging scans, size of biopsy needle, and presence of coexisting lesions in VABB specimens were analysed as potential predictors of malignancy underestimation. RESULTS: Underestimation of breast carcinoma occurred in 21 (29.2%) patients. The upgrade rate was significantly higher only in patients with a lesion visible both in mammography (MMG) and US examinations and combined BIRADS-5. CONCLUSIONS: Vacuum-assisted core needle biopsy is a minimally invasive technique used in diagnosing ADH. As the risk of breast malignancy underestimation is relatively high, open surgical biopsy remains the recommended procedure, especially in patients with lesions detected both in mammography and US examination. As we could not identify the factors that preclude cancer underestimation, all the women diagnosed with ADH should be informed about the risk of cancer underestimation.

Alternative staging of regional lymph nodes in gastric cancer.

The TNM pN stage based on the number of metastatic lymph nodes is an independent prognostic factor in gastric cancer. Many studies have highlighted the phenomenon of stage migration and problems in comparing groups of patients with different numbers of total lymph nodes harvested within TNM staging. The current version of UICC/AJCC and JGCA TNM classifications postulates a minimal number of 16 lymph nodes as the base for N stage determination. Alternative systems such as lymph node ratio (LNR), positive to negative lymph node ratio (PNLNR), and LOGODDS (or LODDS), were implemented to increase the quality of LN assessment. These methods have reached the background in the literature, but to date no standard approach according to the cut-offs for the stages has been implemented. LOGODDS is the method that most reflects the number of harvested lymph nodes. The rationale for alternative staging methods, their correlations, and limitations are presented.

Preoperative serum chemokine (C-C motif) ligand 2 levels and prognosis in colorectal cancer.

INTRODUCTION: Chemokines are cytokines with chemotactic functions in the initiation and maintenance of immune reactions. They have also been shown to regulate other processes such as cancer progression and cancer cell migration. OBJECTIVES: The aim of this study was to determine the prognostic role of serum levels of chemokine (C-C motif) ligand 2 (CCL2) and chemokine (C-C motif) ligand 5 (CCL5) in patients with colorectal cancer. PATIENTS AND METHODS: The study included a group of 45 patients with colorectal cancer. The serum concentrations of CCL2 and CCL5 were measured preoperatively. Peripheral blood mononuclear cells (PBMC) from patients' blood were isolated and cultured alone or with cancer cells. The concentrations of chemokines in serum and culture supernatants were measured using the cytometric bead array method. The cut-off points for serum chemokine levels were set based on the receiver-operating characteristic curve analysis at a level of 103.6 pg/ml for CCL2 and of 11933.2 pg/ml for CCL5. The survival analysis and multivariate analysis of prognostic factors were performed. RESULTS: The 5-year survival was 57.5% for the group with low CCL2 levels and 23.87% for the group with high CCL2 levels. For the groups with low and high CCL5 levels, the survival was 18.3% and 49.3%, respectively. For CCL2, the survival of the low-level group was significantly better than that of the highlevel group (P = 0.0028). In the Cox proportional hazard model, radicality of resection (P = 0.001) and CCL2 levels (P = 0.029) were independent prognostic factors. CONCLUSIONS: The serum level of CCL2 in patients with colorectal cancer may have prognostic value. One of the possible mechanisms of CCL2 production is the interaction of PBMC with cancer cells.

[Perioperative infections in implantative surgery. Patogenesis and prevention]. / Zakazenia w chirurgii implantacyjnej. Patogeneza i zapobieganie.

The last decades have been witnessing rapid development of the implantation surgery. The use of artificial materials to replace damaged tissues has become more and more popular. One of the complications of these procedures is graft infection. The presence of foreign body can impair local host defence on the tissue level and reduce the number of contaminating microorganisms necessary for infection to 104-105. The most common pathogens responsible for graft infections are S. epidermidis, S. aureus and other Gram + and Gram - bacteria. The sources of infection are numerous and include patients, operative, and personnel factors. Graft-related infections are hazardous to the patients and can have even fatal consequences. Due to the limited effectiveness of applied methods to treat graft infections, more attention should be paid to prophylactic measures. These should cover all range of problems related to hospital work organisation, adequate sanitary and epidemiological conditions in the hospital wards and operating theatres as well as the use of local and systemic perioperative antibiotic prophylaxis.

T-regulatory lymphocytes in peripheral blood of gastric and colorectal cancer patients.

AIM: To assess the absolute number of T-regulatory cells (Tregs; CD4+CD25+Foxp3+) in the peripheral blood of gastric and colorectal cancer patients. METHODS: We enrolled 70 cancer patients (33 gastric cancer, 37 colorectal cancer) and 17 healthy volunteers. The CD3+CD4+ lymphocytes and CD4+CD25+Foxp3+ Tregs in the peripheral blood were analyzed with flow cytometry. The absolute numbers of Tregs were calculated based on the CD4+CD25+Foxp3+ cells percentage of CD3+CD4+ cells and the absolute numbers of CD3+CD4+ cells per microliter. RESULTS: The mean number of CD4+CD25+Foxp3+ cells per microliter in colorectal cancer patients was 15.7 (SD: 21.8), for gastric cancer patients 12.2 (SD: 14.3), and for controls 17.5 (SD: 11.4). The absolute number of Tregs was significantly lower in gastric cancer patients than in controls (P = 0.026). There was no statistically significant difference for gastric vs colorectal cancer or colorectal cancer vs controls. The absolute number of Tregs was also significantly depressed in N+ vs N⁻ cancer patients [22.0 (27.7) vs 10.1 (9.0), P = 0.013], and in the subgroup of gastric cancer patients [30.3 (27.6) vs 9.6 (8.0), P = 0.003]. No statistical difference was observed in the proportion of Tregs in the CD4+ population between the groups. CONCLUSION: The absolute number of Tregs in peripheral blood of gastric cancer but not colorectal cancer patients was significantly decreased in comparison with that in healthy controls.

Standard and immunomodulating enteral nutrition in patients after extended gastrointestinal surgery--a prospective, randomized, controlled clinical trial.

BACKGROUND & AIM: The immunomodulating enteral diets are intended to reduce the incidence of postoperative complications in surgical patients. The aim of the study was to assess the clinical effect of such nutrition. MATERIALS AND METHODS: Between June 2004 and September 2007 196 well-nourished patients undergoing resection for pancreatic and gastric cancer were randomized in double-blind manner to receive postoperative enteral nutrition with immunostimulating diet (IMEN group) or standard oligopeptic diet (SEN group). Outcome measures were: number and type of complications, length of hospital stay, mortality, treatment tolerance, liver and kidney function. RESULTS: One hundred and ninety six patients were initially enrolled, finally 183 patients (91 SEN, 92 IMEN group; 69 F, 114 M, median age 61.2) were analyzed. Median postoperative hospital stay was 12.4 days (SD 5.9) in SEN and 12.9 days (SD 8.0) in IMEN group (p=0.42). Complications were observed in 21 patients (23.1%) in SEN and 23 (25.2%) in IMEN group (p>0.05). Four (4.4%) patients in SEN group and 4 (4.4%) in IMEN had surgical complications (p>0.05). There were no differences in liver and kidney function, visceral protein turnover and treatment tolerance. CONCLUSION: Results of our study showed no benefit of immunomodulating enteral nutrition over standard enteral nutrition in patients after major gastrointestinal surgery. The Trial was registered in Clinical Trials Database--number: NCT00576940.

Efficiency of adjuvant immunochemotherapy following curative resection in patients with locally advanced gastric cancer.

BACKGROUND: Despite curative resection, 50%-90% of gastric cancer patients die of disease relapse. Although some clinical trials have indicated that chemotherapy and immunochemotherapy may be effective modalities, more recent studies have not been able to define the standard treatment for advanced gastric cancer. The present study evaluated the effect of adjuvant immunochemotherapy with the use of BCG (bacille Calmette-Guerin) and FAM (5-fluorouracil, adriamycin, mitomycin C) chemotherapy on the survival of patients with locally advanced resectable gastric cancer. METHODS: A total of 156 patients with stage III or IV gastric cancer who had undergone curative resection were randomly assigned to three treatment groups: BCG + FAM (immunochemotherapy), FAM (chemotherapy), and control (surgery only). Treatment was continued for 2 years or until death. Further postsurgical follow up was carried on for up to 10 years. RESULTS: Overall 10-year survival was 47.1% for the immunochemotherapy group (P < 0.037 vs FAM and P < 0.0006 vs control), 30% for the chemotherapy group (vs control, NS), and 15.2% for the control group. In patients with pT2/T3 primary tumors, 10-year survival was 55.3% for BCG + FAM vs 28.2% for FAM (P < 0.01) and 14.6% for the control group (P < 0.00018). BCG + FAM significantly improved the survival of patients with intestinal-type but not diffuse-type cancer. Immunochemotherapy was well tolerated. CONCLUSION: This study, based on a limited number of patients, indicates that adjuvant immunochemotherapy (BCG + FAM) may prolong the survival of gastric cancer patients after curative gastrectomy; in particular, in patients with pT2/T3 tumors and intestinal-type primary tumors. There was no survival benefit from FAM adjuvant chemotherapy.