bluuebunny/crossref_metadata_2025_split huggingface dataset:
Analysis of esophagogastric cancer patients enrolled in National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored phase I trials.
Authors: Bando Hideaki , Rubinstein Larry , Harris Pamela Jo , Yoshino Takayuki , Doi Toshihiko , Ohtsu Atsushi , Welch Jack , Takebe Naoko 
Published: February 2017

12 Background: In phase I trials, an important entry criterion is life expectancy predicted to be more than 90 days, and this is notoriously difficult to predict. The Royal Marsden Hospital (RMH) prognosis score was developed to help project patient outcomes. At present, there have been no systemic analyses of clinical benefits and prognoses for esophagogastric cancer patients who were registered in phase 1 trials. Methods: All non-pediatric phase I oncology trials sponsored by NCI-CTEP, that began between 2001 and 2013 were considered in this review. The RMH score was determined by 3 variables: LDH level, albumin level, and number of metastatic sites of disease. A log-rank test was used to assess the differences of treatment duration and overall survival (OS) between the groups with different RMH scores. Multivariate Cox proportional hazards model was also used to select the covariates related to the prognosis. Results: Of 4,722 patients with solid tumors, 115 (2.4%) patients were eligible for our analysis. Median age was 59 (range: 30-85), and 73% of patients were men. 54 (47%) patients with esophagus cancer and 61 (53%) with stomach cancer were analyzed. 86 (75%) patients had good (0-1) RMH score and 29 (25%) had poor (2-3) RMH score. Although response rates for good and poor RMH patients were not significantly different (8% vs. 3%; 1-side Fisher's exact test p=0.35), clinical benefit rate (complete response +partial response +stable disease) were significantly different (49% vs. 17%; 1-side Fisher's exact test p=0.002). The median treatment duration and OS for good and poor RMH patients were significantly different, respectively (treatment duration: 86 days and 29 days, Log-rank test P=0.016; OS: 332 days and 63 days, Log-rank test P<0.001). In the multivariate analysis that included the RMH score, age (≥60), ECOG PS (≥2) and the RMH score (2-3) were significant predictors of poor survival. Conclusions: The RMH score is a strong tool to predict the prognosis of esophago-gastric cancer patients who will participate in a phase I trial. The median OS of 63 days for patients with poor RMH score suggests that these patients should not be included in phase 1 clinical trials.
Post-hoc analyses of overall survival (OS) and progression-free survival (PFS) in the TRIO-013/LOGiC trial of lapatinib (L) in combination with capecitabine plus oxaliplatin (CapeOx).
Authors: Bang Yung-Jue , Qin Shukui , Chung Hyun-Choel , Xu Jian-Ming , Park Joon Oh , Jeziorski Krzysztof , Shparyk Yaroslav , Hoff Paulo M. , Sobrero Alberto F. , Salman Pamela , Li Jin , Protsenko Svetlana , Buyse Marc E. , Afenjar Karen , Houe Vincent , Garcia Agathe , Huang Yingjie , Armour Alison , Slamon Dennis J. , Hecht J. Randolph 
Published: February 2017

133 Background: Results of the primary and secondary endpoints (OS and PFS, respectively) in the primary efficacy population for the randomized, phase III trial (TRIO-013/LOGiC; NCT00680901), conducted in patients with advanced, HER2-positive upper gastrointestinal adenocarcinoma were previously presented (Hecht JR et al, ASCO 2013). Differences in OS were non-significant between the lapatinib (CapeOx + L) and placebo (CapeOx + P) arms. In prespecified analyses, a treatment effect of L was observed in Asian (majority Chinese or South Korean) patients and patients <60 years (y) when comparing OS in the two arms. Methods: Here, we present the results of post-hoc analyses in TRiO-013/LOGiC which assessed OS, PFS and safety by age and by region. Results: In the Asian subgroups, median OS was longer with L compared with P (see Table). In the rest of the world (ROW) subgroups, median OS was longer in patients <60 y but shorter in patients ≥60 y with L compared with P (see Table). Similar findings were observed for PFS in the 4 subgroups (see Table).More adverse events (AEs) were observed in the Asian subgroups; overall, the incidence of AEs (by region) was similar between age subgroups. Conclusions: OS and PFS were improved in Asian patients (both age subgroups) and younger patients in ROW given CapeOx + L, compared with CapeOx + P. The lower OS and PFS observed in older patients in the ROW subgroups may have affected the overall data. Further trials with CapeOx + L in Asian populations are being considered. Clinical trial information: NCT00680901. [Table: see text]
Outcomes after chemoradiation alone for adenocarcinoma of the esophagus and gastroesophageal junction.
Authors: Pham Anthony , Goodman Karyn A. , Ilson David H. , Janjigian Yelena Yuriy , Ku Geoffrey Yuyat , Rizk Nabil P. , Wu Abraham Jing-Ching 
Published: February 2017

138 Background: Definitive chemoradiation (CRT) is a standard treatment for esophageal cancer (EC), particularly squamous cell carcinoma (SCC). However, data for nonsurgical treatment of adenocarcinoma (AC) is limited, and response rates to CRT are lower in AC vs. SCC. Therefore, trimodality therapy is often preferred for AC. However, some patients with AC achieve clinical complete response (cCR) after CRT and decline surgery, or are medically inoperable. We therefore reviewed outcomes after CRT alone for esophageal AC. Methods: All patients receiving full-dose (≥ 50 Gy) CRT without surgery for Stage I-III AC of the esophagus or gastroesophageal junction (GEJ) from 2007-2012 at our institution were included. Complete clinical response (cCR) was defined as negative post-CRT biopsy, or SUVmax ≤ 3 on post-CRT PET if no biopsy was obtained. Local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: 105 patients were included. 11 patients (10%) had T1-2N0 disease; the rest had T3+ or N+ disease. Median follow-up was 49 months. 85 patients (81%) received induction chemotherapy prior to CRT. Median OS was 25 months, with 3/5 year OS of 35% and 20% respectively. 67 patients (64%) had cCR, with median OS of 33 months and 3/5 year OS of 48% and 30%, compared to 15 months in incomplete responders (p<0.001). There were no long-term survivors among incomplete responders. 31 (46%) of cCR patients developed local failure, with 3 and 5 year LRFS of 53% and 46%. Median DMFS was 33 months in cCR patients. Of 10 patients who developed isolated local failure, 6 had salvage surgery, 3 had brachytherapy and 1 had laser ablation. Of these, 3 are alive and 2 are free of disease. Conclusions: This is the largest reported series of CRT alone for esophageal AC. In cCR patients, CRT alone is associated with long-term survival comparable to that expected with trimodality therapy. However, local recurrence still occurs in nearly half of patients with cCR. More study is needed to define which patients with cCR will benefit from immediate surgery after CRT, and improvements in therapy are needed to reduce local failure in patients not eligible for surgery.
Prospective multicenter feasibility study of laparoscopic sentinel basin dissection for organ preserving surgery in gastric cancer: Quality control study for phase III trial.
Authors: Ryu Keun Won , Lee Young Joon , Jeong Sang-Ho , Hur Hoon , Han Sang Uk , Min Jae-Seok , Ahn Ji Yeong , Hyung Woo Jin , Cho Gyu Seok , Jeong Gui Ae , Jeong Oh , Park Young-Kyu , Jung Mi Ran , Kim Young Woo , Yoon Hong Man , Eom Bang Wool 
Published: February 2017

143 Background: Clinical application of sentinel node biopsy (SNB) in early gastric cancer (EGC) is still controversial even though promising multicenter trial result with minimal false negatives was already reported from Japan. Moreover laparoscopic approach is considered as minimally invasive in addition to organ preserving surgery. Therefore we conducted this study as a prerequisite quality control for phase III trial. Methods: Laparoscopic SBD was performed in patients with preoperative stage T1-2N0 and tumor size less than 4cm in maximal diameter. Intraoperative endoscopic submucosal injection of Technetium 99m-Human Serum Albumin and indocyanine green was done. All removed sentinel basin nodes (SBN) were investigated with intraoperative frozen Hematoxylin Eosin (HE) stain. Postoperative permanent HE stain was done for SBNs and non-SBNs. Strict checklist consisting of essential 7 steps during laparoscopic SBD was made as the quality control study for phase III trial. Ten cases completion of all essential steps in checklist were defined as qualified institution. Results: Seven institutions participated and 112 patients were enrolled in this study. However 4 patients were excluded due to screening failure. SB detection and SBD was performed in 100 of the 108. Lymph node metastases were found in 11 patients at postoperative permanent HE staining and SBD contained metastatic lymph nodes in 11 patients. The detection rate of SB was 92.6% with mean number of SB and SBN was 1.68 and 9.56. Sensitivity and accuracy were 100% in this study. Frozen results of SBN were compatible with permanent reports except one patient who had one SBN with micrometastasis. As the quality control of each institution for phase III trial, 13 to 20 cases were needed based on our strict checklist. Conclusions: Laparoscopic SBD is feasible and improve the sensitivity comparing to the previous study. This study suggests the promising phase III trial of laparoscopic SBD for minimally invasive and organ preserving surgery in EGC after qualifying participating institutions. Clinical trial information: NCT01544413.
The relationship between health utility, quality of life, and symptom scores in Canadian patients with esophageal cancer.
Authors: Doherty Mark , Naik Hiten , Eng Lawson , Patel Devalben , Kong Qin Quinn , Xu Wei , Brown Catherine , Espin-Garcia Osvaldo , Vennettilli Ashlee , Renouf Daniel John , Faluyi Olusola Olusesan , Knox Jennifer J. , Mackay Helen , Wong Rebecca , Howell Doris , Mittmann Nicole , Darling Gail Elizabeth , Cella David , Liu Geoffrey 
Published: February 2017

149 Background: Health Utility scores (HUS) are an increasingly important tool in helping to determine the cost-effectiveness of therapies worldwide. The EQ-5D is a validated HUS questionnaire, with reference data in numerous populations. Previously, HUS in esophageal cancer (EC) were based on limited datasets, and the relationship between HUS and either quality of life (QOL, through the validated FACT-E) or esophageal-specific symptoms such as dysphagia, has not been studied. Methods: This cross-sectional survey of EC patients at Princess Margaret Cancer Centre (2012-2014) assessed EQ-5D, FACT-E, a Visual Analog Scale (VAS), patient reported performance status (PRO-ECOG), and dysphagia scoring. EQ-5D scores were converted to HUS using Canadian references. Correlation analyses were performed between HUS and global FACT-E scores, global dysphagia scores, and specific esophageal symptom scores included in FACT-E. Results: Of 198 patients, median age was 67 (range 32-93) years, 76% were male, with localized (LD stage 1, 6%), regional (RD, stage II-IVA, 62%), and metastatic (MD, stage IVB, 27%) disease. Mean + SEM EQ-5D HUS was 0.80+0.01 (all patients), 0.90+0.05 (LD), 0.82+0.01 (RD), and 0.73+0.03 (MD) [p=0.03]. Mean FACT-E total score was 130, mean total FACT-G score was 80, and mean ECS score was 49. There was a strong correlation between FACT-E total scores and EQ-5D HUS (r=0.73, p<0.001), and mild-to-moderate correlation between FACT-E dysphagia questions and HUS (r= 0.28-0.37; p<0.001, each comparison) and between the odynophagia question and HUS (r=0.28, p<0.001). A moderate correlation was observed between a non-FACT-E based global swallow score and HUS (r=0.48, p<0.001). Conclusions: In this large cross-sectional study of EC patients, stage, QOL, and esophageal-specific symptoms were all associated with HUS. Additional results will be presented on the relationship of VAS, PRO-ECOG and specific FACT-E domains, with HUS and changes in questionnaire scores over time, as well as stage-specific EC reference HUS using UK and USA references. This research enhances our understanding of the factors driving EQ5D HUS in EC, thereby validating its potential usefulness in economic analyses.
Effect of clinical stage on survival outcome in patients with pathological stage I gastric cancer.
Authors: Tokunaga Masanori , Makuuchi Rie , Miki Yuichiro , Tanizawa Yutaka , Bando Etsuro , Kawamura Taiichi , Terashima Masanori 
Published: February 2017

178 Background: Patients with clinical stage (cStage) II or III gastric cancer are possible candidates for neoadjuvant chemotherapy. In this situation, contamination of pathological stage (pStage) I patients, for whom gastrectomy without adjuvant chemotherapy is a standard treatment of care, is a problem. However, it is unclear whether survival outcome in patients with cStage II-III / pStage I gastric cancer is as good as that of patients with cStage I / pStage I disease. The aim of the present study is to clarify the effect of clinical stage on survival outcome in patients with pStage I gastric cancer. Methods: The present study included 558 patients with pStage I gastric cancer who underwent gastrectomy between 2002 and 2006 at Shizuoka Cancer Center, Japan. Clinicopathological characteristics were investigated, and survival outcome was compared between cStage I and cStage II-III. In addition, we investigated the effect of other clinical factors, including clinically diagnosed tumor depth (cT) and nodal status (cN), on survival outcome. Results: The present retrospective cohort includs 368 male and 190 female patients, with median age of 64 years Five-year survival rate (5ysr) was significantly worse in cStage II-III (84.2%) than in cStage I (95.5%, p=0.003). 5ysr was also worse in cT2-4 (86.6%) than in cT1 (96.3%, p<0.001). On the contrary, clinical nodal status did not affect survival outcome of pStage I patients. Conclusions: cT and cStage affected survival outcomes of patients with pStage I gastric cancer. Patients who are preoperatively diagnosed with advanced disease have worse survival outcomes and can be candidates for neoadjuvant chemotherapy.
Prognostic factors for PFS in patients with advanced gastric cancer: Using the data from JCOG9912 study.
Authors: Takahari Daisuke , Boku Narikazu , Mizusawa Junki , Nakamura Kenichi , Yamada Yasuhide , Yoshino Takayuki , Yamazaki Kentaro , Koizumi Wasaburo , Fukase Kazutoshi , Yamaguchi Kensei , Goto Masahiro , Nishina Tomohiro , Tamura Takao , Tsuji Akihito , Ohtsu Atsushi 
Published: February 2017

180 Background: In advanced gastric cancer (AGC), there are many reports about prognostic factors for overall survival (OS), and we have proposed a prognostic index using four prognostic factors (PS, number of metastatic sites, prior gastrectomy and ALP; Oncologist 2014) based on a phase III trial JCOG 9912 for the first-line treatment (Lancet Oncol. 2009). However, there is no report about prognostic factors for progression free survival (PFS). In this ancillary study, we explored whether prognostic factors are similar or not between OS and PFS. Methods: The subjects of this study were selected from the JCOG9912 which intended to confirm the superiority of irinotecan plus cisplatin (IP) and the non-inferiority of S-1 to5-FU for patients with AGC. Of all enrolled patients in JCOG9912, those who had target lesions and whose complete data were available were analyzed with multivariate analysis using Cox proportional hazard model. Results: 492 out of the 703 pts of JCOG9912 were analyzed, who received either 5-FU (n=163), IP (n=164) or S-1(n=165). The median PFS was 3.7 months for all the subjects, and 2.2 months for 5-FU, 4.9 months for IP and 3.8 months for S-1. Multivariate analysis in all 492 analyzed patients demonstrated seven independent prognostic factors for PFS (Table). Prognostic factors in each treatment were; sex (HR 1.66, 95%CI 1.11-2.49), PS (1.51, 1.04-2.18), Ca (0.39, 0.17-0.86), GPT (2.46, 1.30-4.66) and LDH (1.67, 1.16-2.48) in 5-FU, sex (1.77, 1.10-2.86) in IP, and Na (2.00, 1.01-3.99) and creatinine clearance (0.37, 0.15-0.93) in S-1. Conclusions: There were no common prognostic factors among the three treatment regimens. Prognostic factors for PFS may be different by treatment regimen, although further investigations with larger sample size are needed. [Table: see text]
Do all patients with HER2-positive gastric/GEJ cancer benefit from trastuzumab?
Authors: Yi Jun Ho , Kang Jung Hun , Hwang In Gyu , Ahn Hee Kyung , Lee Soonil , Lim Do Hyoung , Won Young-Woong , Ji Jun Ho , Kim Hyo Song , Rha Sun Young , Oh Sung Yong , Lee Kyung Eun , Lim Taekyu , Kim Seung Tae , Lee Jeeyun , Park Joon Oh , Park Young Suk , Lim Ho Yeong , Kang Won Ki , Park Se Hoon 
Published: February 2017

185 Background: Trastuzumab-based chemotherapy became the standard option for patients with HER2 (+) metastatic gastric cancer after ToGA study. However, the OS benefit was not found in Asian and diffuse-type cancer patients. The aim of the current study is to analyze whether Asian ethnicity or poorly differentiated histology (PDH) affects the clinical outcomes of patients who were treated with trastuzumab-based chemotherapy. Methods: We collected the medical records of the patients with HER2 (+) (IHC3+ or IHC2+&FISH+) gastric/GEJ cancer who were treated with trastuzumab-based chemotherapy. The ORR, PFS, and OS were compared according to the patients’ clinicopathologic features and data from ToGA trial. Results: From March 2012 to June 2014, data of 163 Asian patients from 11 institutes in South Korea were collected. The median age was 60 (range 27-85) and the male:female ratio was 116 (71.2%):47 (28.8%). 157 (96.3%) had stomach cancer and 6 (3.7%) had GEJ cancer. Fourteen (8.6%), 62 (38.0%), 71 (43.6%) and 11 (6.7%) patients had well, moderately, poorly differentiated tubular adenocarcinoma (TAC) and signet ring cell carcinoma (SRC), respectively. The ORR was 52.7% (86/163) which is similar to that of the ToGA trial. (47%) The median PFS was 9.8 months (95% CI 8.6 – 11.0 and the median OS was 18.5 months. (95% CI 16.5 – 20.5) These numerical data are slightly better than those of the ToGA trial. (PFS, 6.7 months; OS, 16.0 months) Next, we investigated if PDH (poorly differentiated TAC + SRC) affected on clinical outcomes. The ORR (50.0% vs. 56.6%, p = 0.408) and the PFS (8.8 months vs. 11.2 months, p = 0.109) were slightly inferior in PDH patients but still, they were better than that of the ToGA trial. The median OS was significantly shorter for PDH patients (14.1 months vs. 19.0 months, p = 0.046). Conclusions: While subset analysis of ToGA trial has demonstrated that trastuzumab-based chemotherapy may not be beneficial for Asian ethnicity and poorly differentiated histology, our real world data suggested that even in Asian and patients with PDH, trastuzumab-based chemotherapy is associated with improved clinical outcomes in patients with HER2 (+) gastric cancer.
Comparison of radical surgery followed by adjuvant chemotherapy with radical surgery following neoadjuvant chemotherapy as initial treatment for patients with locally advanced thoracic esophageal squamous cell carcinoma.
Authors: Tsubosa Yasuhiro , Niihara Masahiro , Matsuda Satoru , Ogi Katsuhisa , Takebayashi Katsushi , Kawamorita Keisuke , Onozawa Yusuke , Yokota Tomoya , Tsushima Takahiro , Yasui Hirofumi , Mori Keita , Sato Hiroshi 
Published: February 2017

187 Background: Although radical surgery with neoadjuvant chemotherapy (NAC) is a standard therapy for locally advanced thoracic esophageal squamous cell carcinoma (ESCC) in response to the result of JCOG 9907 study in Japan, there was no significant difference in survival rate at adjuvant chemotherapy and neoadjuvant chemotherapy in cStage III at subanalysis. Methods: Consecutive patients histologically diagnosed with ESCC and planned to undergo radical surgery followed by adjuvant chemotherapy (ADJ) from September 2002 to April 2007 and radical surgery following NAC from May 2007 to December 2011 as initial treatment were eligible for this retrospective study. To select patients who could tolerate transthoracic esophagectomy, respiratory function, Eastern Cooperative Oncology Group performance status, and preoperative complications were considered. As adjuvant and neoadjuvant chemotherapy, cisplatin and 5-fluorouracil were administered every 3 weeks for 2 cycles (FP). Patient characteristics, 3-year overall survival (3yOS) and non complete resection rate were investigated. We analyzed in intent-to-treat analysis. Results: Ninety patients were included in ADJ group, 98 included in NAC group. No significant differences were observed in clinicopathological factors between ADJ group (cStage IB/II/III/IV=6/22/57/5) and NAC group (cStage IB/II/III/IV=10/28/52/8). In intention-to-treat analysis, there was no significant difference in 3yOS rate by ADJ group and NAC group (ADJ group, 67.2%; NAC group, 66.0%; p = 0.301). However, non complete resection rate was significantly higher for NAC group than for ADJ group {ADJ group, 16.7% (3/90); NAC group, 3.4% (14/98); p = 0.009}. In cStage III, non complete resection rate of ADJ group was 3.5% (2/57) and NAC group was 25% (13/52). In the patients with cStage III, NAC group had a tendency for 3yOS rate to be low rather than ADJ group (ADJ group, 66.3%; NAC group, 51.1%; p = 0.09). Conclusions: In cStage III advanced ESCC, FP as NAC may be insufficient and development of the more powerful NAC is desired.
Gastric epithelial dysplasia: Characteristics and long-term follow-up results after endoscopic resection according to morphological categorization.
Authors: Lee Bong Eun , Kim Gwang Ha , Baek Dong Hoon 
Published: February 2017

190 Background: Gastric epithelial dysplasia (GED) can be morphologically categorized into adenomatous and foveolar types. To date, there have been few studies on the clinical characteristics of GEDs according to the morphologic types. Therefore, we here aimed to elucidate the clinicopathologic characteristics of patients with GED and the long-term follow-up results after endoscopic resection according to the morphologic characteristics of GEDs. Methods: A total of 357 patients who underwent endoscopic resection for GEDs at Pusan National University Hospital between January 2008 and December 2009 were included in the study. Results: Patients with GED were divided into 3 groups: adenomatous (n = 167, 46.8%), foveolar (n = 103, 28.9%), and hybrid (n = 87, 24.3%) types. Compared to the adenomatous type, foveolar type lesions were more frequently located in the antrum/pylorus, flat/depressed lesions, and normal/reddish in color; and showed more frequent high-grade dysplasia. During the follow–up period (median, 37.3 months), the overall incidence of synchronous and metachronous lesions was 20.8% and 20.1%, respectively; of these, the incidence of synchronous and metachronous gastric cancer was 8.7% and 5.4%, respectively. There were no significant differences in the incidence of synchronous and metachronous lesions according to morphologic types. Conclusions: GEDs appear to have different clinicopathologic characteristics according to morphologic types. Irrespective of the morphology, synchronous and metachronous gastric cancers are commonly found after endoscopic resection of GEDs. Therefore, close follow-up surveillance after endoscopic resection of GEDs should be performed for all patients.