Background: Ether lipids could provide new prospects in cancer therapy after successful preclinical investigations. Edelfosine has been the most thoroughly investigated substance in the ether lipid group. So far, no standard therapy has been set up for advanced non-small-cell bronchogenic carcinoma. Therefore, in a phase II study 116 patients with advanced inoperable non-small-cell bronchogenic carcinoma were treated with the alkyl-lysophospholipid edelfosine (EF). Material and Methods: The phenotype modifier EF was initially applied in a daily oral dosage of 300 mg (dissolved in milk) over a period of 4 weeks, then increased to a daily dosage of 900 mg if tolerated well, and continued with the highest tolerable dosage. Therapy was continued until either tumor progression or negative side effects were documented. 35 patients could not be treated for the intended therapy period of at least 8 weeks due to early tumor progression (18 patients), unacceptable gastrointestinal side effects (14 patients), lack of compliance (1 patient), refusal of therapy (1 patient) and change of therapy (1 patient). Results: 81 patients could be evaluated for remission status; of these, 2 showed partial remission, 68 showed ‘no change’, and 11 had unaltered progression of the tumor. Median survival time for these 81 patients was 244 days, for all 116 patients it was 199 days. Retrospectively, in these 81 patients the spontaneous tumor development during the 2 months before EF therapy could be analyzed. Tumor progression during this period could be documented in 1 patient with partial remission, in 46 patients with diagnosis ‘no change’, and in 11 patients with unaltered tumor progression. The survival times of these three groups of patients did not differ significantly. All 116 patients were evaluable for toxicity. Manifestations of gastrointestinal problems were anorexia, nausea, vomiting, diarrhea, obstipation (mostly WHO grades I+Π), but treatment was not required. Toxic effects on organs or late toxicity could not be documented.Conclusions: The high proportion of patients with stationary tumor status was remarkable. Objective tumor remission was extremely rare. On the other hand, the rate of progression was low. This might be explained by the fact that EF is rather a phenotype modifier than a typical cytostatic drug.
the Helicobacter pylori in this association being discovered at the end of the last century by Marshall and Warren. Since then, studies have related H. pylori to several gastric illnesses, including gastric cancer [1,2]. The eradication of this bacteria is one of the subjects most studied in this regard [3,4]. Most of the published studies are about the eradication of H. pylori in nonoperated stomachs; however, there are few references to this eradication in gastrectomized patients; in particular, in those with a Roux-en-Y diversion [5]. As far as we know the efficacy of antibiotics for the eradication of H. pylori depends on several factors: the gastric pH, the level of drug in the gastric mucosa, and acquired resistance [6]. These factors could explain some of the alterations that occur in the efficacy of H. pylori eradication when medications are used in patients with a partially removed stomach.The cause of gastric stump cancer is multifactorial, and H. pylori seems to be one of these factors [7]. The eradication of H. pylori decreases the risk of the development of gastric stump cancer [8]. Therefore, it is considered of fundamental importance to carry out a clinical study that could verify the efficacy of a triple therapy regimen in gastrectomized patients. This study was carried out to compare the efficacy of H. pylori eradication with a triple therapy regimen (clarithromycin, amoxicillin, and lansoprazole) in gastrectomized and nongastrectomized patients, having as an hypothesis that there could be alterations in the efficacy of the treatment (due to the physiological and anatomical differences of the gastrectomized stomach), which could mean that a new therapeutic regimen would be needed. AbstractBackground. The cause of cancer in the gastric stump is multifactorial, and Helicobacter pylori is one of these factors. Its eradication has been recommended; however, there are few studies about of H. pylori eradication in gastrectomized patients. Methods. Twenty gastrectomized patients with gastric adenocarcinoma and Roux-en-Y reconstruction (study group) infected by H. pylori were compared with nongastrectomized patients (control group) also infected by H. pylori. The presence of H. pylori was determined by the ultra-quick urease test and from a histological sample obtained by endoscopy. Both groups received the same triple therapy regimen. Results. The rate of eradication of H. pylori in the study group was 90% and in the control group, it was 85%. Sex, age, and postoperative time did not influence the rate of eradication. Conclusion. There were no differences in the efficacy of H. pylori eradication between the two groups; therefore, the triple therapy regimen is effective for the eradication of H. pylori in gastrectomized patients with a Roux-en-Y reconstruction.
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