bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase I study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for gastric cancer with peritoneal metastasis.
Authors: Kobayashi Daisuke , Ishigami Hironori , Kanda Mitsuro , Tanaka Chie , Yamaguchi Hironori , Kitayama Joji , Kodera Yasuhiro 
Published: February 2017

115 Background: Intraperitoneal (IP) chemotherapy is a promising treatment option for gastric cancer (GC) with peritoneal metastasis (PM). Efficacy of IP paclitaxel (PTX) combined with S-1 and intravenous PTX was reported in a phase II study. Attempts to combine IP PTX with other systemic therapies with higher efficacy are warranted. We designed a new regimen combining IP PTX with S-1/cisplatin (SP) which is regarded as the standard first-line treatment of metastatic GC in Japan. We subsequently carried out a dose-escalation study to determine the maximum-tolerated dose (MTD) and recommended dose (RD). Methods: The combination was a five-week regimen. IP PTX was to be administered on days 1, 8 and 22 with an initial dose of 15 mg/m2 at level 1 and 20 mg/m2 at level 2. S-1 was to be administered orally at a fixed dose of 80 mg/m2 bid for 21 days followed by a 14-day rest. Cisplatin was to be administered intravenously at a dose of 60 mg/m2 on day 8, and was to be decreased to 50 mg/m2 (level 0) if necessary. Since the dosage of S-1 at the fixed dose and cisplatin at level 1 were identical to SP regimen, no further dose-escalation was planned. Dose-limiting toxicities (DLTs) were defined as Grade 4 (G4) leukopenia, G3 febrile neutropenia, G3 thrombocytopenia, and G3 non-hematological toxicity. The MTD was defined as the dose level at which ≥2 of 3 or 6 patients developed DLTs during the first course of treatment. The RD was defined as one level below the MTD. Results: A total of 9 patients with macroscopic PM were enrolled. No DLTs were observed among the 3 patients at level 1 and 6 patients at level 2. Furthermore, no G3 toxicities were observed in any of the patients enrolled. Anemia in 1 patient at level 2 was the only G2 toxicity observed. No adverse events or technical problems associated with the IP administration were observed. Consequently, the MTD was not reached, and the RD of IP PTX was determined as 20 mg/m2 (level 2). As for the efficacy, peritoneal lavage cytology turned negative after the first course in 4 of 7 patients who had positive cytology before treatment. Conclusions: Addition of IP PTX at 20 mg/m2 to the SP regimen at an established dose/schedule was safe and promising, and further evaluation in a phase II trial is underway. Clinical trial information: UMIN000013528.
T-shaped linear-stapled intrathoracic esophagogastric anastomosis for minimally invasive Ivor Lewis esophagectomy.
Authors: Dong YiNan 
Published: February 2017

137 Background: Linear stapler is increasingly used for the gastroesophageal anastomosis in minimally invasive esophageal cancer surgeries; however, it is more commonly used in cervical delta anastomosis, less in totally thoracoscopic Ivor Lewis esophagectomy for esophageal cancer. A standardized rapid linear stapler based gastroesophageal anastomotic technique remains to be developed. Methods: Here we report a new technique for the endoscopic gastroesophageal anastomosis that is completed just with a linear stapler (Ethicon Flex 60). In this technique, a linear stapler is first fired upward to establish the side to side anastomosis of the esophagus and stomach. This creates the anterior and posterior wall of the anastomotic site. The linear stapler is then fired along the extension line of the gastric conduit, to complete the anastomosis and at the same time resect the lesser curvature of the stomach and the esophageal cancer. Upon completion, the anastomotic plane is axial, and contains a superior edge, inferior edge, and anterior edge. Results: By the middle of September 2015, we have performed the minimally invasive Ivor Lewis esophagectomy with this anastomosis for 26 esophageal cancer patients. We are following these patients, and the longest follow up time is about 18 month and the shortest is 12 month. None of these patients has had any anastomotic bleeding, leak, or stenosis. Conclusions: This new technique is less restricted by the limited space during minimally invasive Ivor Lewis procedure. The anastomotic technique is easy to perform and appears to be reliable, safe and effective judging from our limited clinical experience up to this date.
Radiofrequency ablation for pulmonary metastases from esophageal squamous cell carcinoma.
Authors: Shigaki Hironobu , Kosumi Keisuke , Tokunaga Ryuma , Harada Kazuto , Kurashige Junji , Iwatsuki Masaaki , Baba Yoshifumi , Sakamoto Yasuo , Miyamoto Yuji , Yoshida Naoya , Baba Hideo 
Published: February 2017

138 Background: Radiofrequency ablation (RFA) is increasingly being used for the treatment of intrathoracic malignancies. Although RFA has been found to be promising in the treatment of lung metastases from some types of neoplasms, little is known concerning its clinical significance in the treatment of pulmonary metastasis from esophageal squamous cell carcinoma (ESCC). This retrospective study evaluated the feasibility, safety, and effectiveness of computed tomography-guided RFA for pulmonary metastasis from ESCC. Methods: Of 322 patients with ESCC underwent esophagectomy at Kumamoto University Hospital between January 2007 and May 2015, 23 cases had pulmonary recurrence. Selection criteria for CT-guided RFA for pulmonary metastasis were as follows: (i) there were no distant metastases except for pulmonary lesions, when there were extrapulmonary recurrences that had to be controlled by additional therapies; (ii) there were up to three pulmonary tumors; (iii) the number of pulmonary tumors did not increase over a certain period while receiving pre-RFA chemotherapy; (iv) the metastatic lesions were not adjacent to major pulmonary vessels, major bronchi, or the heart. 17 patients who underwent CT-guided RFA for metachronous pulmonary metastasis from ESCC were included in this study. Results: Correct placement of the ablation device into the target tumor proved to be feasible in all tumors (100%). The mean visual analog scale score, with values that ranged from 0 (no pain) to 10 (worst pain possible), was 1. This suggested that this procedure was well tolerated. No procedure-related deaths occurred. A pneumothorax needing drainage was a major complication in two patients. 6 patients died of recurrent disease. The predicted 1- and 2-year overall survival rates after lung RFA were 78.8% and 46.7%, respectively. Conclusions: Percutaneous computed tomography-guided RFA yielded relatively high levels of local control in patients with pulmonary metastases from ESCC and was associated with an acceptable level of complications. It was concluded that a prospective study will be necessary to evaluate the effectiveness of a combination of systemic therapy and RFA for ESCC lung metastases.
Prognostic factors for survival in patients with advanced gastric cancer treated with chemotherapy.
Authors: Mangas Montserrat , Carmona Bayonas Alberto , Sanchez Lorenzo Maria Luisa , Ramchandani Avinash , Garcia Teresa , Custodio Ana B. , Lorenzo Barreto Jose Enrique , Echavarria Diaz Guardamino Isabel , Diaz Serrano Asuncion , Cano Juana Maria , Azkarate Aitor , Longo Federico , Mugica Maitane , Sanchez Rodrigo , Serrano Raquel , Alvarez Manceñido Felipe Jose , Alsina Maria , Jiménez-Fonseca Paula , Garrido Marcelo , Gallego Plazas Javier 
Published: February 2017

142 Background: A prognostic model in advanced gastric cancer that integrates the Her2 status,histopathological classifications and other patient’s or treatment-dependent parameters is lacking. The aim is to identify clinicopathological factors for overall survival in a cohort of patients with advanced gastric cancer. Methods: 526 consecutive patients with advanced adenocarcinoma of the distal esophagus, gastroesophageal junction or stomach were analyzed. All patients were treated with poly-chemotherapy ( ≥ 2 drugs) at 19 Spanish and one Chilean centers between 2012 and 2015. Characteristics of patients, tumors, therapies and pathological factors, were analyzed by a Cox proportional hazards model. Results: The median overall survival was 10.3 months [95% confidence interval (CI), 9.5-11.1], and the time to progression was 6.7 months (95% CI, 6.1-7.2). Independent prognostic factors associated with overall survival were: distal non-diffuse histopathological subtype (hazard ratio, (HR) 0.73), Her2 positive 3+ (HR 0.54), Her2 positive 2+ with FISH + (HR 0.68), surgery of metastases (HR 0.34), Eastern Cooperative Group performance status (ECOG PS) 2 (HR 2.5), ECOG PS 3 (HR 7.37), and only distant lymph node metastases (HR 0.63) (Table 1). Conclusions: We have identified clinicopathological prognostic factors that could be important to stratify advanced gastric cancer, with potential implications in research and treatment. [Table: see text]
Phase II study of bevacizumab combined with capecitabine and oxaliplatin in patients with advanced adenocarcinoma of the small bowel or ampulla of vater.
Authors: Gulhati Pat , Raghav Kanwal Pratap Singh , Shroff Rachna T. , Varadhachary Gauri R. , Kopetz Scott , Javle Milind M. , Qiao Wei , Wang Huamin , Morris Jeffrey , Wolff Robert A. , Overman Michael J. 
Published: February 2017

144 Background: Capecitabine with oxaliplatin (CAPOX) is used in front-line management of metastatic small bowel adenocarcinoma (SBA) and ampullary adenocarcinoma (AAC). In a prior single arm phase 2 study (n = 30), CAPOX showed an overall response rate (ORR) of 52%. The purpose of this study was to evaluate safety and activity of bevacizumab and CAPOX in this population. Methods: We conducted a single-center open-label single arm phase 2 study in patients with treatment naïve metastatic SBA and AAC between 8/2011 to 11/2014. Prior fluoropyrimidine-based adjuvant therapy was allowed if completed ≥ 52 weeks. Bevacizumab-CAPOX was administered as a 21-day cycle with capecitabine 750 mg/m2 orally twice daily on days 1-14, oxaliplatin 130mg/m2intravenously on day 1 and bevacizumab 7.5mg/kg intravenously on day 1. The primary endpoint was progression-free survival (PFS) at 6 months. Secondary objectives included ORR, overall PFS, overall survival (OS) and toxicity. Results: A total of 30 patients with median age of 63 years (range 33-78) were enrolled. Six (20%) patients had AAC and 24 (80%) had SBA (duodenal: 18). Treatment was well tolerated and most common grade 3/4 toxicities included fatigue (23%), hypertension (23%), neutropenia (30%), and diarrhea (10%). Common grade 2 toxicities included anorexia (50%), fatigue (47%), and nausea (37%). 4 patients remain on study treatment to date. In 29 evaluable patients the ORR was 48.3% (1 complete and 13 partial responses). Eleven (37.9%) patients had stable disease. The PFS at 6 months was 68% (95% CI: 52%-88%). The median PFS and median OS were 8.7 (95% CI: 6.6-13.4) and 14.98 (95% CI: 10.2-21.3) months, respectively. Comparing the current study to a subset of 25 patients with metastatic disease from our prior phase 2 CAPOX study demonstrated similar ORR, 48.3% vs. 52% (p = 0.79) and PFS 8.7m vs. 6.6m (p = 0.73). Conclusions: In patients with untreated metastatic SBA and AAC, therapy with bevacizumab and CAPOX was well-tolerated and showed efficacy comparable to published regimens. Further studies are warranted to evaluate the benefit of targeting angiogenesis in this rare tumor.
A proposal for the management guideline of superficial esophageal squamous cell carcinoma: After endoscopic resection.
Authors: Lee Yong Chan , Park Jun Chul , Shin Sung Kwan , Lee Sang Kil , Lee Hyun Jik 
Published: February 2017

145 Background: We tried to analyze and deduce a treatment guideline after endoscopic resection of superficial esophageal squamous cell carcinoma in a retrospective analysis. Methods: Medical records of 37 patients who had been treated by endoscopic resection during a 6-year period in single institution were retrospectively analyzed. Results: Mean tumor size was 11.5±5.5 mm (range 3-31). Thirty-one lesions (83.8%) were treated by endoscopic submucosal dissection and 6 lesions by endoscopic mucosal resection (16.2%). En bloc resection rate and complete resection rate was 91.9% and 81.8%, respectively. The tumor invasion depth was diagnosed as epithelium: 5(13.5%), lamina propria mucosa: 12 (32.4%), muscularis mucosa: 10 (27.0%), submucosa: 10 (27.0%) respectively. The lymphovascular invasion was 3 lesions (8.1%). The rates of adverse events were 13.5% including 3 cases (8.1%) of perforation. Ten patients of the invasion depth as muscularis mucosa and submucosa received additional treatments including 6 patients of esophagectomy, 3 patients with radiotherapy and 1 patient with chemoradiotherapy. One patient of lamina propria received radiotherapy due to resection margin positive. The median follow-up duration was 22 month (range, 4-79) and there was no recurrence or metastasis during follow-up. Conclusions: We propose that adequate tailored management strategy after endoscopic resection of superficial esophageal squamous cell carcinoma may provide the favorable clinical results in outcome in treating early stage esophageal carcinoma.
The prognostic significance of perineural invasion in patients with esophageal adenocarcinoma treated with neoadjuvant chemoradiotherapy.
Authors: Patel Ankur Kaushik , Pan Xueliang Jeff , Williams Terence M , Wuthrick Evan John 
Published: February 2017

146 Background: Perineural invasion (PNI) is the process of neoplastic invasion of nerves. PNI has been reported as a prognostic indicator in malignancies of the pancreas, stomach, colon, rectum, prostate, head and neck, and biliary tract. However, studies examining the prognostic significance of PNI in esophageal cancer have shown inconsistent results. Analyses in patients with esophageal adenocarcinoma (EAC) have alternatively shown PNI to be a significant and a nonsignificant predictor of OS and DFS in both univariate and multivariate analysis. The majority of these studies analyzed patients who had not received any preoperative therapy. We sought to identify the prognostic significance of PNI in patients with EAC treated with neoadjuvant chemoradiotherapy (nCRT). Methods: We performed a retrospective analysis of 108 patients treated with nCRT and surgery for EAC at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute from 1996-2015. The final analysis identified 73 patients with data on PNI. We evaluated the association of PNI with disease-free survival (DFS), loco-regional progression-free survival (LRFS), distant metastasis-free survival (DMFS), and overall survival (OS) using log-rank and Cox proportional hazard modeling. Results: Of 73 patients, 17 patients (23%) had PNI and 56 patients (77%) did not have PNI at the time of surgery. The median follow-up was 15.3 months (range 5.8 to 179.3 months). The median DFS was 12.4 months for PNI+ and 36.4 months for PNI- (p = 0.042). The median LRFS was 48.2 months for PNI+ and median not reached for PNI- (p = 0.003). We did not detect a significant association between the presence of PNI and worse OS or DMFS. In a multivariate model including age, sex, gastric involvement, biopsy grade, presence of pathologic complete response, and pathologic N stage, PNI remained a significant independent predictor of LRFS (HR 0.37, 95% CI 0.14 to 1, p = 0.05). Conclusions: In patients with esophageal adenocarcinoma treated with neoadjuvant chemoradiotherapy, PNI discovered at the time of surgery is significantly associated with worse DFS and LRFS.
Prospective results of perioperative chemotherapy (PCT) with cisplatin and irinotecan for locally advanced gastric cancer.
Authors: Pereira Guilherme Luiz Stelko , Fonseca Leonardo Gomes da , Ramos Marcus Fernando Kodama Pertille , Ribeiro Ulysses , Pereira Gabriel , Pereira Marina Alessandra , de Mello Evandro Sobroza , Sabbaga Jorge , Hoff Paulo Marcelo 
Published: February 2017

147 Background: An overall survival (OS) benefit with PCT over surgery alone for locally advanced gastric cancer was seen in phase III trials. The best PCT regimen is uncertain and options based in infusional 5-FU or capecitabine have cost limitation in the context of Brazilian public health system. The combination of cisplatin and irinotecan is active in the metastatic setting, with no need of ambulatory infusion devices. The aim of this study is to evaluate safety and preliminary efficacy of this scheme as PCT. Methods: This prospective single arm study included patients (pt) with locally advanced gastric cancer, T3/T4 and/or evident lymph node involvement, to receive PCT cisplatin (30 mg/m2) and irinotecan (60 mg/m2) D1 and D8, each 21 days, in total of 6 cycles (Cy). Results: Between June/2011 and January/2014, 25 pt were included, with the following characteristics: 64 years (34-78) as median age; 10 (40%) pt with intestinal subtype and 10 with diffuse; 24% of cases were proximal gastric tumors; 20% had dysphagia and 24% bleeding signs before treatment. The median number of Cy before surgery was 3; 19 (76%) pt had surgery and 8 (32%) re-started Cy after surgery. Toxicity grade 3 or 4 was seen in 13 (52%) pt and 3 had unexpected arterial ischemic events. Radiologic progression occurred in 8 (32%) pt. Of the 21 tissue samples available, the expression of MLH-1, HER-2 (+++), p53, p16, Ki67 and EGFR was detected in 100% (21/21), 9.5% (2/21), 90.5% (19/21), 81% (17/21), 100% (11/21 < 50% and 10/21 > 50%) and 100% (10/21 +1/2 and 11/21 +3/4) of the cases, respectively. No correlation was seen between them and pathologic response. With a median follow up of 382 days, 13 (52%) pt were alive and the median OS was 15.2 (IC95% 4.9-24.5) months. In a univariate analysis, dysphagia, less than 3 Cy, progressive disease and neutrophil-to-Lymphocyte ratio (NLR) > 2, were significantly related to shorter OS. In multivariate analysis, only NLR > 2 (p = 0.019) and dysphagia were negatively impacting on OS (p = 0.02). Conclusions: Although PCT with cisplatin and irinotecan for evident locally advanced gastric cancer showed acceptable resection rate and local control, the overall prognosis was limited in this setting.
Clinical outcome of endoscopic submucosal dissection versus surgery for patients with early gastric cancer.
Authors: Shim Ki-Nam , Chang Ji Young , Tae Chung Hyun , Son Hyo Moon , Lee KoEun , Ryu Min Sun , Moon Chang Mo , Kim Seong-Eun , Jung Hye-Kyung , Jung Sung-Ae , Lee Joo-Ho 
Published: February 2017

15 Background: This study aimed to compare the clinical outcomes of endoscopic submucosal dissection (ESD) and surgery for the patients with early gastric cancer (EGC). Methods: Data of 79 EGCs in 76 patients treated with ESD and 59 EGCs in 57 patients treated with surgery between 2005 and 2015 were analyzed retrospectively. We only included EGCs confined to the mucosal layer. Demographic data, pathologic data, complication, 5-year overall survival (OS) data were collected. Results: The clinicopathological characteristics of the patients were shown in Table 1. The mean follow-up periods were 31.5 months (5-96 months) for ESD group and 68.4 months (1-139 months) for surgery group (P < 0.001). One patient (1.9%) in ESD group has experienced metachronous tumor, but there was no patient who had recurrence tumor or metastasis in surgery group. The 5-year OS rates did not differ between two groups (91.2% in ESD group versus 87.4% in surgery group, respectively; P = 0.490 by log-rank test). The early complication rates happened within 3 months of procedure were similar in both groups (P = 0.501). However, the late complication rates were significantly higher in surgery group than those in ESD group (P = 0.002). Conclusions: The clinical outcomes after ESD including 5-year OS were comparable to those of surgery. Regarding the late complication, ESD was superior to surgery.
Small caliber covered self expanding metal stents in the management of malignant dysphagia.
Authors: Kucera Steven , Shridhar Ravi , Klapman Jason , Harris Cynthia L. , Hoffe Sarah E. , Barthel James S. , Almhanna Khaldoun , Meredith Kenneth 
Published: February 2017

151 Background: Use of large caliber ( ≥ 18 mm body diameter) self expanding metal stents (SEMS) for management of malignant dysphasia is associated with substantial adverse event (AE) and mortality rates (MRs). We sought to determine dysphagia response, stent migration rates, and AE and MRs, for small caliber covered SEMS (sccSEMS) with body diameters (BDs) between 10 - 16 mm in malignant dysphagia. Methods: We identified 31 patients underwent direct endoscopic placement of 50 sccSEMS. Patients were monitored for change in dysphagia score (DS), stent migration, AEs, and death. Results: The cohort consisted of 23 (74%) men and 8 (26%) women with a median age of 64 years (35 - 87 years). Esophageal adenocarcinoma (AC) was present in 19 (61%) patients and squamous cell carcinoma (SCCA) in 12 (39%) patients. Of the patients with SCCA, 2 tumors were located in the proximal esophagus, 7 in the mid-esophagus and 3 in the distal esophagus. All 19 ACs were located in the distal esophagus. The AJCC clinical stages at time of sccSEMS placement were: 1 (3%) Stage II, 8 (26%) Stage III, and 22 (71%) Stage IV. The initial pre-stent lumen diameter was less than 8 mm in 77% (24/31) of patients. The initial pre-stent lumen diameter was equal to 9 mm in 1 patient (3%), equal to 10 mm in 4 patients (13%), and equal to 11 mm in 2 patients (6%). The median pre-stent tumor length was 5.0 cm (interquartile range 4.0 – 7.0 cm). Dysphagia score improved in 30 of 31 patients (97%). The median DS decreased from 3 to 2 (p < 0.0001). The median effective duration of first sccSEMS placement was 116 (95% CI: 75-196) days. Major and minor AE rates were 6.5% and 19.4% respectively. No stent related deaths were encountered. The overall migration rate was 36% (18/50). The anticipated migration rate was 45.7% (16/35) and the unanticipated migration rate was 13.3% (2/15) (p = 0.052). Positive effective clinical outcome occurred in 93.5% (29/31) of cases. Conclusions: In malignant dysphagia, direct endoscopic sccSEMS placement provided acceptable dysphagia control and migration rates with substantial reductions in stent related AEs and MRs compared to those reported for large caliber SEMS.