bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term survival results of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: A multicenter phase II trial (JCOG 0703).
Authors: Nakamori Mikihito , Katai Hitoshi , Mizusawa Junki , Nakamura Kenichi , Hiki Naoki , Yoshikawa Takaki , Kojima Kazuyuki , Imamoto Haruhiko , Ninomiya Motoki , Kitano Seigo , Sasako Mitsuru ,   JCOG Stomach Cancer Study Group
Published: February 2017

113 Background: Laparoscopic gastrectomy has been a common tool for gastric cancer patients in eastern Asian countries. A large-scale prospective study with a sample size sufficient to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) has never been reported. We conducted a multi-center phase II trial (JCOG0703) to evaluate the safety of LADG with nodal dissection for clinical stage I gastric cancer patients. A short-term outcome including postoperative complications of LADG as a result of this study was already reported and a following multi-center phase III trials (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of overall survival (OS) was already started. Long-term outcomes as the secondary endpoints of this study are reported here after 5-year follow up period. Methods: The subjects of this study comprised patients with clinical stage I gastric cancer that were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who experienced >=30 LADG and >=30 open gasterctomy. The primary endpoint was the proportion of patients who developed either anastomotic leakage or a pancreatic fistula. The secondary endpoints included surgical morbidity, short-term clinical outcome, OS, and relapse free survival (RFS). Results: Between November 2007 and September 2008, 176 eligible patients were enrolled. 140/23/9/4 patients had pStage IA/IB/II/IIIA disease respectively. No patients had recurrence. 3 patients died without recurrence. 5-year OS was 98.2% (95%CI, 94.7% to 99.4%). 5-year RFS was 98.2% (95%CI, 94.4% to 99.4%). Conclusions: The long-term outcome of LADG for Stage I gastric cancer patients seem comparable to those of open procedures. However, this result should be confirmed by a randomized control trial. We have just finished an accrual of 921 patients for a multi-center phase III trial (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of OS. Clinical trial information: UMIN000000874.
A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer who relapsed after S-1 adjuvant therapy, XP after TS-1 adjuvant failure (XParTS).
Authors: Takahashi Masazumi , Tsuburaya Akira , Nishikawa Kazuhiro , Tanabe Kazuaki , Yamaguchi Kensei , Yoshino Shigefumi , Namikawa Tsutomu , Yoshikawa Takaki , Rino Yasushi , Kawada Junji , Tsuji Akihito , Taira Koichi , Kawabata Ryohei , Kodera Yasuhiro , Hirashima Yoshinori , Yabusaki Hiroshi , Hirabayashi Naoki , Fujitani Kazumasa , Morita Satoshi , Sakamoto Junichi 
Published: February 2017

124 Background: For gastric cancer, standard regimens including S-1 for adjuvant and first-line chemotherapy have been established in Japan, while for early relapse after adjuvant therapy there is no standard treatment. In our retrospective analysis, relapse-free interval of less than 6 months was associated with poor progression-free survival (PFS) and overall survival (OS). To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment, for patients with advanced gastric cancer who relapsed within 6 months after S-1 adjuvant therapy, we conducted a multicenter phase II trial in Japan (NCT Identifier: NCT01412294). Methods: Patients who had received adjuvant chemotherapy for gastric cancer including S-1 for more than 12 weeks, thereafter relapsed within 6 months, 20–74 years of age and HER2- negative, were assigned to receive capecitabine 1000 mg/m2 bid for 14 days plus cisplatin 80 mg/m2 (day 1) every 3-week. The primary endpoint was PFS and the secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety. Planned sample size was 40 according to median PFS threshold of 2 months. Results: From June 2011 to April 2014, 40 patients were assigned. Median age was 64, 32 males (80%); adjuvant chemotherapy: regimen, S-1 monotherapy (n=34, 85%), and median number of course was 7.0 (3-18). In 40 patients median PFS was 20 weeks (95%CI, 17-24), which was longer than protocol-specified threshold of 2 months. Median OS was 77 weeks (95%CI, 34-NE), ORR was 8/40 (22% including 12 NE cases; 95%CI, 44-74). Most common grade ≥3 adverse events (AEs) were neutropenia (23%), anemia (18%), hypercreatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%). Conclusions: XP was safe and effective for those patients with relatively poor prognosis after S-1 adjuvant failure. Since profile of S-1 and capecitabine was different, XP can be recommended rather than S-1 plus cisplatin, Japanese standard first- line regimen. Clinical trial information: NCT01412294.
A prospective study of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104).
Authors: Takahashi Ikuo , Shimokawa Mototugu , Emi Yasunori , Tanioka Hiroaki , Shiraishi Takeshi , Oki Eiji , Saeki Hiroshi , Tsuji Akihito , Ishigami Sumiya , Kakeji Yoshihiro , Baba Hideo , Natsugoe Shoji , Maehara Yoshihiko ,   Kyushu Study Group of Clinical Cancer (KSCC)
Published: February 2017

129 Background: Capecitabine plus cisplatin (XP) is one of the standard therapies for metastatic gastric cancer (mGC). However there is no clinical practice date in Japan, and results from the ToGA and AVAGAST study suggested dose of cisplatin should be lower in Japanese. This study was designed to evaluate the efficacy and safety of mXP in the clinical practice in Japanese mGC patients (pts) including the elderly. Methods: The study design was multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated mGC; presence of measurable lesions; age 20 years; ECOG performance status (PS) 0–2; and adequate organ function. Pts received mXP (cisplatin 60 mg/m2 d1 plus capecitabine 1,000 mg/m2 bid d1-14) q3w. This schedule was repeated until unacceptable toxicity or disease progression occurred. The primary endpoint was RECIST-confirmed objective response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and expected value of 50%, with one-sided alpha of 0.05 and beta of approximately 0.2. Results: Of the 42 pts (male/female, 34/8; median age, 63.5 years (range 50-81); PS 0/1/2, 34/8/0) enrolled from Nov 2011 to Oct 2013. One patient did not fulfill the eligibility criteria. Forty one pts were assessed for response; CR 2 pts, PR 16 pts, SD 14 pts, PD 8 pts, and NE 1 pts. The confirmed ORR was 43.9% (90% CI; 31.2-56.7%, 95% CI; 28.7-59.1%). Median PFS and mOS were 4.5 months (95% CI; 3.9 – 6.5M) and 11.4 months (95% CI; 7.7 – not reached). The most common grade 3/4 adverse events were anorexia 24.4%, neutropenia 36.6%, fatigue 9.8%, hand-foot syndrome 7.3%. Grade 3/4 peripheral neuropathy did not occur. Conclusions: First-line chemotherapy for HER2-negative patient of mXP showed a promising response rate and an acceptable tolerability profile in the clinical practice in Japanese mGC pts including the elderly. Clinical trial information: UMIN:000006668.
Characteristics and prognosis of gastric cancer according to Helicobacter pylori.
Authors: Seo Ji Yeon , Jin Eun Hyo , Yoon Hyuk , Jo Hyun Jin , Shin Cheol Min , Park Young Soo , Kim Nayoung , Jung Hyun Chae , Lee Dong Ho 
Published: February 2017

14 Background: Different features of gastric cancer according to Helicobacter pylori(Hp) infection is still under debate. The aim of this study was to compare clinical, pathologic characteristics and prognosis of gastric cancer between Hp-positive (HpP) and Hp-negative (HpN) gastric cancer. Methods: Patients diagnosed as gastric cancer in Seoul National University Bundang hospital from June 2003 to December 2010 were reviewed. Status of Hp was evaluated by histology and rapid urease test (RUT). Patients who had positive histology and/or positive RUT were classified as HpP. Patients who had atrophic gastritis and/or intestinal metaplasia from histology were also classified as HpP. Patients who had both negative histology and RUT were defined as HpN. Results: The number of patients with HpP and HpN were 852 (62.6%) and 509 (37.4%), respectively. Antral location was more common in gastric cancer with HpP than in those with HpN (51.8% vs 44.9%, P = 0.003). Stage of gastric cancer was higher in patients with HpN than in patients with HpP (stage IV 17.9% vs 9.6%, P < 0.001). Age, sex of patients and Lauren classification of gastric cancer was not different according to Hp status. Recurrence and mortality was significantly higher in patients with HpN gastric cancer than those in HpP gastric cancer (P = 0.002 and P= 0.001). Conclusions: Gastric cancers have different clinical and pathologic features according to the Hp status. Patients with HpN gastric cancers have poorer prognosis than those with HpC or HpP gastric cancers.
Formulating a surveillance strategy following surgery for oesophagogastric cancer.
Authors: Moorcraft Sing Yu , Fontana Elisa , Cunningham David , Peckitt Clare , Waddell Tom Samuel , Smyth Elizabeth Catherine , Allum William H. , Thompson Jeremy , Rao Sheela , Watkins David , Starling Naureen , Chau Ian 
Published: February 2017

153 Background: Oesophagogastric adenocarcinoma (OGA) has a poor prognosis, even for patients (pts) with operable disease. We conducted a retrospective study to assess relapse characteristics to see if these could influence follow-up strategies. Methods: We performed a retrospective review of all pts with OGA who had surgery with radical intent at the Royal Marsden between January 2001 – December 2010. Details of first relapse, including date, site, symptoms, method of relapse detection, tumour markers and treatment were recorded. Association of survival outcomes with relapse characteristics was determined by Cox regression univariate analysis. Results: 360 pts with OGA had surgery and 72.8% received neoadjuvant or peri-operative chemotherapy. After a median follow-up of 61.7 months, the median disease-free survival (DFS) was 35.6 months (95% CI 27.0 – 65.4) and median overall survival (OS) was 59.6 months (95% CI 40.7 – 81.2). 147 pts (40.8%) had disease recurrence. 51.0%, 78.9% and 91.8% of relapses occurred within 1, 2 and 3 years respectively. 78.9% of pts had distant relapse only, 7.5% had anastomotic recurrence and 13.6% had both. R1/2 resection was associated with a shorter time to distant relapse (p <0.001) and OS (13.8 months vs 77.7 months, HR 2.76, 95% CI 1.97 – 3.88, p < 0.001). At relapse, 101 pts (68.7%) were symptomatic. The 46 asymptomatic relapses were detected by tumour markers (n = 30, 65.2%), routine CT (n = 10, 21.7%) and endoscopy (n = 3, 6.5%). Symptomatic pts were less likely to receive further treatment than asymptomatic pts (55.5% vs 82.6%, p = 0.001), had worse OS from the time of surgery (18.9 months vs 26.3 months, HR 1.57, 95% CI 1.07 – 2.30, p = 0.02) and worse survival beyond relapse (5.1 months vs 14.6 months, HR 2.05, 95% CI 1.40 – 3.00, p < 0.001). There was no difference in DFS between these two groups (HR 0.90, 95% CI 0.63 – 1.27, p = 0.539), thus excluding a lead time bias. Conclusions: In pts undergoing surgery for localised OGA, over 90% of relapses occurred within the first 3 years. Pts with asymptomatic relapses were more likely to receive further treatment with resultant prolonged OS. A more intensive surveillance program with regular tumour marker measurement should be considered for the first 3 years post surgery.
Clinical study on harvesting lymph nodes with carbon nanoparticles for advanced gastric cancer: A prospective randomized trail.
Authors: Li Ziyu , Ao Sheng , Ji Jiafu 
Published: February 2017

159 Background: There were no ideal materials nor quantizing regime for surgeons’ training on harvesting lymph nodes in advanced gastric cancer(AGC). A prospective randomized trial on Carbon Nanoparticles (CNP),a kind of lymphatic tracers, was designed to find a solution. Methods: Patients with previously untreated resectable AGC were eligible for inclusion in this study. All patients were randomly allocated to two subgroups. In experimental group, total of 1.0 mL CNP was injected into the subserosa of stomach around the tumor before gastrectomy with D2 dissection performed. On the contrary, the same procedure was performed directly without any coloring materials in control arm. Following surgery,the investigator harvested lymph nodes (LNs), counted colored LNs and measured the diameters with pathologist. Results: 30 patients were enrolled in the study. We observed no serious adverse effects related to CNP injection. The rate of stained LNs was 46.6%. The mean number of harvested LNs was larger in experimental than control group (38.33 vs. 28.27, p=0.041). Smaller diameter was recorded in experimental arm (3.32vs4.30mm,p=0.023), which might clarify the reason why the number of LNs was larger with CNP. In addition, we set up a model for predicting total number of LNs based on the data of CNP-staining LNs and metastatic LNs(MLNs), which might help the surgeons review their work of removing LNs so as to improve their surgical skills. Conclusions: CNP was a kind of safe materials and surgeons could harvest more LNs with it in AGC, which might benefit from the harvest of more smaller ones. Further study was needed to prove the model’s practicability. Clinical trial information: NCT02123407.
The impact of persistent dysphagia (PD) after induction chemotherapy in patients with locoregionally advanced (LRA) adenocarcinoma (ACA) of the esophagus and gastroesophageal junction (E/GEJ) receiving a trimodality treatment regimen.
Authors: McNamara Michael J. , Rybicki Lisa A. , Rodriguez Cristina P. , Videtic Gregory M.M. , Stephans Kevin L. , Greskovich John , Sohal Davendra , Murthy Sudish C. , Raja Siva , Ives Denise I. , Bodmann Joanna , Adelstein David J. 
Published: February 2017

160 Background: For patients with LRA ACA of the E/GEJ who receive pre-operative therapy, advanced pathologic stage at surgery is strongly associated with recurrence and death. Identification of such patients prior to resection, however, is problematic. Given the morbidity of esophageal resection, alternative treatment strategies may be desirable in this patient population. Methods: Between 2/08 and 1/12, 60 evaluable patients with LRA ACA of the E/GEJ enrolled in single arm phase II trial of induction chemotherapy, surgery, and post-operative chemoradiotherapy. A clinical stage of T3, N1 or M1a (AJCC 6th) was required for eligibility. Induction chemotherapy with epirubicin 50mg/m2 d1, oxaliplatin 130mg/m2 d1, and fluorouracil 200mg/m2/day continuous infusion for 3 weeks, was given every 21 days for 3 courses and was followed by surgical resection. Adjuvant CRT consisted of 50-55Gy @ 1.8-2.0 Gy/d and 2 courses of cisplatin (20mg/m2/d) and fluorouracil (1000mg/m2/d) given as 96 hour infusions during weeks 1 and 4 of radiotherapy. Dysphagia was assessed at baseline and after induction chemotherapy. Updated results as of March 2014 are presented. Results: Of the 60 evaluable patients enrolled, 54 completed induction therapy and underwent surgery. Of these 54 patients, 44 patients experienced complete resolution of dysphagia, while 10 patients had persistent symptoms. PD was associated with worse distant metastatic control [HR 3.48 (1.43 – 8.43), p=0.006], recurrence free survival [HR 3.04 (1.34 – 6.92), p=0.008], and overall survival [HR 3.31 (1.43 – 7.66), p=0.005]. PD was associated with more advanced pathologic T-descriptor (pT) (p=0.048) and N-descriptor (pN) (p=0.002), a greater median number of involved lymph nodes (3 v 1, p=0.003), and greater residual tumor viability (p=0.05). No patients with PD had pT0-T2 or pN0 disease. Of the 9 patients with pN3 disease, 5 (56%) had PD. Conclusions: PD after induction chemotherapy is associated with more advanced pathologic stage and inferior outcomes. These patients may require alternative treatment strategies. Clinical trial information: NCT00601705.
Trends in resected oesophageal and gastric adenocarcinoma (OGA) outcomes: Royal Marsden (RM) experience 2001-2010.
Authors: Fontana Elisa , Smyth Elizabeth Catherine , Cunningham David , Rao Sheela , Watkins David J. , Allum William H. , Thompson Jeremy , Waddell Tom Samuel , Peckitt Clare , Chau Ian , Starling Naureen 
Published: February 2017

169 Background: OGA is a lethal cancer globally. Overall survival (OS) has improved in the last decade, potentially due to stage migration and changes in management of early stage cancer. To examine this hypothesis we assessed outcomes of resected OGA patients (pts) at RM over 10 years (y), comparing 2 time periods, 2001-2005 (A) and 2006-2010 (B). Methods: Electronic records of all pts who had undergone surgery with radical intent for OGA between 01/2001 and 12/2010 were reviewed. Pt age, sex, ECOG PS, pre-operative staging investigations (CT, EUS, PET-CT), perioperative therapy, pathological stage, dates of death, last follow up and treatment for recurrent disease were recorded. Disease-free (DFS), OS and survival beyond relapse (SBR) were estimated using the Kaplan Meier method; co-variates were compared using the log rank test and Hazard ratios calculated using cox regression within the 2 time periods. Results: 367 pts were identified; 151 (A) and 216 (B). Median age was 67y (A) and 66y (B). Gender distribution, PS, site of primary and pre-intervention lymph node status were comparable. PET-CT use increased from 9% (A) to 37% (B), p<0.001, (84% in 2010). >75% pts in both groups were treated with chemotherapy; use of perioperative therapy increased over time (19% of treated pts in A vs 52% in B). Conversely use of pre-operative therapy alone decreased over time (75% of treated pts A vs. 45% in B). Rates of R0 resection increased from 75% (A) to 89 % (B) (p=0.001). Median number of resected lymph nodes was 20 (A) and 31 (B). ≥T3 tumours (46% vs 33%) and ≥N1 lymph nodes (53% vs 48%) were more common in A. After a median follow-up of 95 (A) and 59 (B) months, relapse occurred in 47% (A) and 38% (B). 5y DFS for A and B was 34% vs. 51% [HR 0.59, (0.45-0.78), p<0.001]. 5y OS for A and B was 40% vs. 55% [HR 0.58, (0.43-0.77), p<0.001]. Median SBR was 7.6 months in both groups (p=0.713). Conclusions: During 2001-2010 survival of pts with resected OGA improved. Relevant factors may include improved preoperative staging by PET, increased numbers of R0 resections and higher lymph node yield. Pattern of chemotherapy usage as a surgical adjunct may also be contributory. However survival for relapsed pts was unchanged.
Outcomes associated with minimally invasive esophagectomy techniques.
Authors: Abbott Andrea M. , Doepker Matthew , Shridhar Ravi , Hoffe Sarah E. , Almhanna Khaldoun , Meredith Kenneth L. 
Published: February 2017

171 Background: Surgery is pivotal in the management of patients with esophageal cancer. Recent prospective data demonstrates advantages of minimally invasive techniques. However, varying surgical techniques precludes the recommendation of a standard approach. We sought to examine our outcomes with differing approaches to minimally invasive esophagectomy. Methods: We queried a prospective esophageal database to identify patients who underwent minimally invasive esophagectomy (MIE) from 1994 and 2014. Surgical approaches included trans-hiatal (TH), Ivor Lewis (IVL), and robotic assisted Ivor Lewis (RAIL). Demographics, operative variables and post-operative complications were all compared. Results: We identified 280 patients who underwent MIE with a mean age of 65.65 ± 10.5 and a median follow-up of 48 months. Fifty-seven patients underwent IVL, 78 underwent TH, and 145 underwent RAIL. The length of operation was significantly longer in IVL and RAIL approaches compared to TH (TH=242, IVL=320, RAIL=415, p=0.001). Estimated blood loss did not differ between cohorts (TH=150, IVL=125, RAIL=158, p=0.8). Anastomotic leakage, stricture, pneumonia, and wound infections were all higher in the TH compared to the trans-thoracic approaches p=0.04, p=0.02, p=0.01, and p<0.001 respectively. Operative mortality was low for each cohort and did not differ between approaches (TH=2.6%, IVL=0%, RAIL=2%, p=0.2). The median length of hospitalization also did not differ between groups (TH=10 days, IVL=8.5 days, and RAIL=9 days, p=0.15). Adequacy of oncologic resection was measured by margins and nodal harvest. There was decreased R1 resections in both the IVL and RAIL compared to TH (TH=8%, IVL=0%, and RAIL=0% p=0.04). Additionally, the mean number of lymph nodes harvested was lower in patients undergoing TH compared to IVL and RAIL groups (TH=9.2, IVL=12.8, and RAIL=20.6, p=0.05). Conclusions: In our large series comparing minimally invasive approaches to esophageal resection we have demonstrated improved operative outcomes and oncologic outcomes in trans-thoracic approaches compared to trans-hiatal approaches. We recommend that patients undergoing minimally invasive esophagectomy be strongly considered for a trans-thoracic approach.
Does capecitabine plus cisplatin (XP) give advanced or recurrent gastric cancer (AGC) patients higher early tumor shrinkage (ETS) rate than S1 plus cisplatin (SP) with safety?
Authors: Sugimoto Naotoshi , Yoshinami Tetsuhiro , Yamamoto Sachiko , Yagi Toshinari , Imamura Fumio 
Published: February 2017

172 Background: Capecitabine plus cisplatin (XP) is defined as the platform regimen in many global trials (ex: ToGA, AVAGAST) for AGC in first-line setting. But in the Japanese Gastric Cancer Treatment Guideline (4th edition), S-1 plus cisplatin (SP) is mentioned the standard (recommendation 1), XP is considered as recommendation 2. Few reports were existed about the comparison between XP and SP. So we retrospectively compared the efficacy and toxicity of XP and SP for patients with AGC in our hospital. Methods: The selection criteria were pathologically proven AGC (HER2 negative or unknown); no previous chemotherapy; performance status 0-2; able to oral intake; and adequate organ functions. The patients in XP group, capecitabine 1,000mg/m2 was given orally twice daily for 14days followed by a 7-day rest; cisplatin 80mg/m2 on day1 was given by intravenous infusion. In SP group, S1 40mg/m2 was given orally twice daily for 21 days followed by a 14-day rest and cisplatin 60mg/m2 intravenous infusion on day8. Results: The analysis covered 115 patients over the period from May 2008 to June 2014. The median age was 64 years (range 22-81); 76 males and 39 females; PS 0/1/2 score 85/29/1; 31 patients were treated XP and 84 patients were treated SP. Progression-free survival and overall survival were 6.6 and 16.4 months with XP and 6.1 and 13.3 months with SP (no significant difference). The response rates were XP/SP 61%/50%. The ETS (over 20% tumor shrinkage in 6-8weeks) rate were 83% in XP and 61% in SP (p=0.09). The rate of grade 3-4 toxicity in XP/SP were; neutropenia 23%/15%, anemia 16%/20%, nausea 0%/3%, anorexia 3%/ 8%, fatigue 0%/ 4%, hyponatremia 3%/ 0%. There was no treatment death in both groups. Conclusions: It is suggested that XP give AGC patients high ETS rate with safety.