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Background: The American Joint Committee on Cancer (AJCC) staging system has limited accuracy in predicting survival of gastric cancer patients with inadequate counts of evaluated lymph nodes (LNs). We therefore aimed to develop a prognostic nomogram suitable for clinical applications in such cases. Methods: A total of 1511 noncardia gastric cancer patients treated between 1990 and 2010 in the academic surgical center were reviewed to compare the 7th and 8th editions of the AJCC staging system. A nomogram was developed for the prediction of 5-year survival in patients with less than 16 LNs evaluated (n = 546). External validation was performed using datasets derived from the Polish Gastric Cancer Study Group (n = 668) and the SEER database (n = 11,225). Results: The 8th edition of AJCC staging showed better overall discriminatory power compared to the previous version, but no improvement was found for patients with < 16 evaluated LNs. The developed nomogram had better concordance index (0.695) than the former (0.682) or latest (0.680) staging editions, including patients subject to neoadjuvant treatment, and calibration curves showed excellent agreement between the nomogram-predicted and actual survival. High discriminatory power was also demonstrated for both validation cohorts. Subsequently, the nomogram showed the best accuracy for the prediction of 5-year survival through the time-dependent ROC curve analysis in the training and validation cohorts. Conclusions: A clinically relevant nomogram was built for the prediction of 5-year survival in patients with inadequate numbers of LNs evaluated in surgical specimens. The predictive accuracy of the nomogram was validated in two Western populations. [ABSTRACT FROM AUTHOR]

Background and Aims OncoGel (Protherics Salt Lake City, Inc, Salt Lake City, UT) is paclitaxel (PTX) formulated in a thermosensitive, biodegradable copolymer for focused cytotoxicity and radiosensitization. A phase 2a study suggested that EUS-guided PTX injection into esophageal tumors subsequently receiving radiotherapy was safe. Methods In an international multicenter, prospective, randomized phase 2b study, patients with local or locoregional adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus/gastroesophageal junction and eligible for neoadjuvant chemoradiotherapy (CRT) before surgery were randomized to standard of care (SOC) plus EUS-guided PTX injection or SOC alone. PTX was injected in 0.5 to 1.0 mL aliquots throughout the tumor. Planned CRT as SOC was intravenous 5-fluorouracil for the first 4 days (weeks 1 and 5), intravenous cisplatin on the first day of each 5-fluorouracil course, and radiotherapy over 5.5 weeks. Patients were evaluated weekly during CRT and re-evaluated at 12 weeks for surgical eligibility and CT for change in overall tumor volume. Results The analysis included 137 patients (97 males; mean age, 58 ± 9.1 years) randomized to PTX + SOC (n = 72) and SOC (n = 65) by using a modified intention-to-treat approach. Overall response by tumor volume between the PTX (12.5%) and the SOC group (20.0%; P = .24; odds ratio, 0.57; 95% confidence interval, 0.23-1.44) was similar. Pathologic complete response was higher in the SOC group (26.2% vs 12.5%; P = .046); however, 12-month survival ( P = .412) and the overall frequency of 1 or more adverse events ( P = .17) were similar between the 2 groups. Conclusions SOC + PTX is safe but does not improve overall survival or overall tumor response at the primary tumor site for patients with local or locoregional cancer of the esophagus/gastroesophageal junction. (Clinical trial registration number: NCT00573131 .) [ABSTRACT FROM AUTHOR]

Background & Aims: Tegaserod, a serotonin 5-hydroxytryptamine (5-HT)4 receptor agonist, is thought to stimulate intestinal secretions. The aim of the current study was to assess the effect of tegaserod vs placebo on salivary and esophageal protective factors in patients with gastroesophageal reflux disease (GERD). Methods: This study was a randomized, double-blind, placebo-controlled, cross-over trial in 38 GERD patients treated with tegaserod 6 mg twice a day vs placebo. Salivary samples were collected basally and during mastication. In addition, in 32 GERD patients, salivary and esophageal secretions also were collected during infusion of NaCl, HCl/pepsin, and NaCl in a consecutive fashion using a specially designed esophageal catheter. Saliva and esophageal perfusates were assessed for the pH, volume, content of buffers, protein, mucin, epidermal growth factor (EGF), transforming growth factor α (TGFα), and prostaglandin E (PGE)2 and analyzed statistically. Results: Salivary flow rates during administration of tegaserod increased over corresponding values during both basal conditions (P < .01) and mastication (P < .001). The rate of secretion of salivary bicarbonate and nonbicarbonate buffers also increased in basal conditions (P < .001 and P < .01, respectively) and during mastication (P < .05 and P = .05). Salivary EGF increased during mastication (P < .05), whereas PGE2 and TGF α increased in basal conditions (P < .05 and P < .01). Esophageal perfusate volumes increased during administration of tegaserod in basal conditions (P < .05), whereas esophageal EGF secretion increased after mucosal exposure to HCl/pepsin and subsequent final perfusion with NaCl (P < .05). Conclusions: Significant stimulatory impact of 5-HT4 agonist on several salivary protective factors as well as esophageal EGF secretion may have esophagoprotective implications in patients with GERD and may help to address new therapies in the future. [Copyright &y& Elsevier]

Objectives: The aim of this research was to examine whether Perfusion Computed Tomography (P-CT) can qualitatively and quantitatively help detect gastric cancer neoangiogenesis in vivo as well as treatment response evaluation. We attempted to explore which P-CT parameters are best used in neoangiogenesis and neoadjuvant therapy for most effective evaluation. We also tried to recognize a positive prediction value of P-CT in early responders and non-responders patients identification.Materials and Methods: Twenty-four patients with positive biopsy results and/or clinically proven gastric cancer were enrolled in the P-CT exam. Patients were qualified for systemic treatment (16 patients received chemotherapy and 8 patients received radiochemotherapy). The baseline Perfusion-CT exam and after neoadjuvant treatment Perfusion-CT exam were conducted using a 64-row GE tomograph based on a deconvolution model in first-pass protocol perfusion. The P-CT examined the following parameters: Blood Flow (BF), Blood Volume (BV), Mean Transit Time (MTT) and Permeability Surface (PS). Positive clinical response to neoadjuvant treatment (CHT and RCT) was defined as tumor size reduction 25% or more.Results: Tumor dimension reduction after neoadjuvant therapy was significantly correlated with the BF and the PS. Neoadjuvant therapy was more effective for patients with higher output BF and PS values. We did not register a significant relationship between BV and MTT parameters and tumor dimension reduction. Patients with a positive treatment response showed a decrease in BF, BV and PS perfusion parameters with an increase in MTT.Conclusions: P-CT examination allows a noninvasive neoangiogenesis assessment in vivo, leading to early identification of responding and non-responding patients. As a standard procedure, a full evaluation of treatment response should include a P-CT exam assessing neoangiogenesis. [ABSTRACT FROM AUTHOR]