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1.
Int J Colorectal Dis ; 33(8): 1087-1096, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29656304

ABSTRACT

PURPOSE: A previous randomized study conducted by our group showed that application of gentamicin-collagen implant (GCI) into the pelvic cavity after total mesorectal excision (TME) reduced the incidence of distant metastases. Therefore, we decided to conduct a confirmatory study. METHODS: Patients with rectal cancer were included in the study if they met the following criteria: adenocarcinoma of the rectum, preoperative short-term radiotherapy (5 × 5 Gy), and WHO performance score 0-1. RESULTS: One hundred seventy-six patients were randomly assigned either to an experimental group in which GCI was applied (n = 81) or to a control group without GCI (n = 81). Median follow-up was 80 months. Cumulative incidence of distant metastases at 5 years was higher in the control group compared to the experimental group: 23.5 vs 8.6% (HR 2.4 [95% CI 1.1-5.5], P = 0.005). Overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) did not differ between the experimental group and the control group: HR 0.95 [95% CI 0.55-1.70], P = 0.864; HR 0.85 [95% CI 0.50-1.45], P = 0.548, and HR 0.5 [95%CI 0.22-1.22], P = 0.093, respectively. The predefined by the protocol subgroup analysis for yp stage III disease showed better DFS in the experimental group compared to the control group; HR 0.47 [95%CI 0.23-0.97], P = 0.042). CONCLUSIONS: The results confirmed our previous finding that GCI applied in the pelvis significantly reduced the rate of distant metastases in patients after radical rectal cancer resection.


Subject(s)
Adenocarcinoma/drug therapy , Anti-Bacterial Agents/administration & dosage , Gentamicins/administration & dosage , Neoplasm Metastasis/prevention & control , Rectal Neoplasms/drug therapy , Adenocarcinoma/pathology , Aged , Collagen , Disease-Free Survival , Female , Humans , Male , Middle Aged , Neoplasm Recurrence, Local , Neoplasm Staging , Rectal Neoplasms/pathology , Rectum
2.
Minerva Chir ; 73(3): 261-268, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29397632

ABSTRACT

BACKGROUND: The aim of this study was to verify if positive results yielded with conventional cytology and immunocytochemical analysis of peritoneal washes correlate with established prognostic factors and overall survival (OS) in gastric cancer patients. METHODS: The study included the data of 271 gastrectomized patients. Peritoneal washes of 131 (48.3%) patients were examined by means of conventional cytology, and material from 140 (51.7%) subjects treated surgically after this date was subjected to immunocytochemical analysis. RESULTS: Free cancer cells (FCCs) were detected significantly less often in patients from conventional cytology group than in those from immunocytochemistry group (4.6% vs. 12.1%). Positive result of immunocytochemical analysis was significantly more often associated with presence of pT3/4 tumor (94.1% vs. 60.2%), lymph node ratio ≥0.2 (82.4% vs. 43.1%) and involvement of blood vessels (64.7% vs. 28.5%). Median OS in patients with immunocytochemical evidence of FCCs in peritoneal washes was significantly shorter than in those without (11 vs. 45 months). Moreover, the two groups differed significantly in terms of 5- (0% vs. 43.1%) and 10-year OS rates (0.0% vs. 29.3%). CONCLUSIONS: In contrast to conventional cytology, immunocytochemically documented presence of FCCs in peritoneal washes correlates with established prognostic factors and OS in gastric cancer patients.


Subject(s)
Adenocarcinoma/secondary , Cytological Techniques , Gastrectomy , Immunohistochemistry , Peritoneal Lavage , Peritoneal Neoplasms/secondary , Stomach Neoplasms/surgery , Adenocarcinoma/chemistry , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Adult , Aged , Aged, 80 and over , Biomarkers, Tumor , Female , Humans , Kaplan-Meier Estimate , Keratins/analysis , Lymph Node Excision , Male , Middle Aged , Neoplasm Proteins/analysis , Neoplasm Staging , Peritoneal Neoplasms/diagnosis , Peritoneal Neoplasms/pathology , Proportional Hazards Models , Stomach Neoplasms/chemistry , Stomach Neoplasms/pathology
3.
Minerva Chir ; 72(5): 368-374, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28425683

ABSTRACT

BACKGROUND: The aim of this prospective study was to compare subjective and objective quality of life (QoL) of gastric cancer patients after total gastrectomy with and without preservation of the duodenal passage during short- and long-term follow-up. METHODS: The study included 68 patients, among them 37 (54%) persons subjected to total gastrectomy with Roux-Y reconstruction (R-Y group) and 31 (46%) individuals in whom gastrectomy was followed by formation of Henley-Longmire loop (H-L group). Subjective and objective QoL was determined 1 and 10 years postsurgery. During each visit, subjective QoL was determined with EORTC QLQ-C30 questionnaire, along with markers of nutritional status and self-reported incidence of symptoms specific to postgastrectomy syndrome. RESULTS: The two groups did not differ significantly in terms of their subjective QoL and markers of nutritional status at 1 and 10 years postsurgery, and none of these parameters underwent significant changes between the first and second evaluation. Patients from R-Y group reported subjective weight loss significantly more often during both visits, and individuals from H-L group significantly more often complained on postprandial diarrhea during long-term follow-up. Moreover, both groups showed an increase in the incidence of postprandial vomiting between the first and second evaluation. CONCLUSIONS: QoL of gastric cancer patients subjected to total gastrectomy stabilizes at relatively high level within a year from the surgery. Preservation of the duodenal passage does not exert a beneficial effect on both objective and subjective QoL after total gastrectomy.


Subject(s)
Duodenum , Gastrectomy , Quality of Life , Stomach Neoplasms/surgery , Adult , Aged , Anastomosis, Roux-en-Y , Duodenum/surgery , Female , Follow-Up Studies , Gastrectomy/methods , Humans , Male , Middle Aged , Poland , Prospective Studies , Risk Factors , Surveys and Questionnaires , Time Factors , Treatment Outcome , Weight Loss
4.
Target Oncol ; 12(1): 97-109, 2017 02.
Article in English | MEDLINE | ID: mdl-27975152

ABSTRACT

BACKGROUND: Activating KRAS mutations are reported in up to 90% of pancreatic cancers. Refametinib potently inhibits MEK1/2, part of the MAPK signaling pathway. This phase I/II study evaluated the safety and efficacy of refametinib plus gemcitabine in patients with advanced pancreatic cancer. METHODS: Phase I comprised dose escalation, followed by phase II expansion. Refametinib and gemcitabine plasma levels were analyzed for pharmacokinetics. KRAS mutational status was determined from circulating tumor DNA. RESULTS: Ninety patients overall received treatment. The maximum tolerated dose was refametinib 50 mg twice daily plus standard gemcitabine (1000 mg/m2 weekly). The combination was well tolerated, with no pharmacokinetic interaction. Treatment-emergent toxicities included thrombocytopenia, fatigue, anemia, and edema. The objective response rate was 23% and the disease control rate was 73%. Overall response rate, disease control rate, progression-free survival, and overall survival were higher in patients without detectable KRAS mutations (48% vs. 28%, 81% vs. 69%, 8.8 vs. 5.3 months, and 18.2 vs. 6.6 months, respectively). CONCLUSION: Refametinib plus gemcitabine was well tolerated, with a promising objective response rate, and had an acceptable safety profile and no pharmacokinetic interaction. There was a trend towards improved outcomes in patients without detectable KRAS mutations that deserves future investigation.


Subject(s)
Antimetabolites, Antineoplastic/therapeutic use , Deoxycytidine/analogs & derivatives , Diphenylamine/analogs & derivatives , Pancreatic Neoplasms/drug therapy , Sulfonamides/therapeutic use , Antimetabolites, Antineoplastic/pharmacokinetics , Antimetabolites, Antineoplastic/pharmacology , Deoxycytidine/pharmacokinetics , Deoxycytidine/pharmacology , Deoxycytidine/therapeutic use , Diphenylamine/pharmacokinetics , Diphenylamine/pharmacology , Diphenylamine/therapeutic use , Disease-Free Survival , Female , Humans , Male , Middle Aged , Sulfonamides/pharmacokinetics , Sulfonamides/pharmacology , Treatment Outcome , Gemcitabine
5.
Pol Przegl Chir ; 85(8): 460-3, 2013 Aug.
Article in English | MEDLINE | ID: mdl-24009057

ABSTRACT

The paper contains a description of the case--63 year old patient with surgery due locally advanced cancer of the gastric cardia. In 28 postoperative day symptoms of GI bleeding occurred. Despite the endoscopic attempts undertaken to stop bleeding, the patient died in the course of hemorrhagic shock. Posed by the post-mortem consider: aorto-esophageal fistula, is a rare complication in surgery of the esophagus. The rapidly increasing symptoms and deterioration of the patient, in most cases, despite the measures taken, ending in death of the patient. In the literature, there are few reports of this complication. There is also no clear guidelines on how to proceed. Reminder of the possibility of bad promising complications and the analysis carried out on the basis of this case and the available literature can be helpful for specializing in surgery of the digestive tract.


Subject(s)
Adenocarcinoma/surgery , Aortic Diseases/etiology , Esophageal Fistula/etiology , Esophageal Neoplasms/surgery , Esophagectomy/adverse effects , Gastrectomy/adverse effects , Gastrointestinal Hemorrhage/etiology , Abscess/etiology , Abscess/therapy , Adenocarcinoma/diagnostic imaging , Anastomosis, Roux-en-Y , Aortic Diseases/surgery , Drainage , Esophageal Fistula/surgery , Esophageal Neoplasms/diagnostic imaging , Fatal Outcome , Gastrointestinal Hemorrhage/surgery , Hematemesis/etiology , Humans , Male , Middle Aged , Radiography , Reoperation , Splenectomy/adverse effects
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