bluuebunny/crossref_metadata_2025_split huggingface dataset:
A NSQIP comparison of modern multicenter results for transhiatial versus transthoracic esophagectomy.
Authors: Papenfuss Wesley A. , Kukar Moshim , Hochwald Steven N. , Kakarla Venkata R. , Nurkin Steven J. 
Published: February 2017

68 Background: The surgical approach to esophageal cancer continues to be controversial. A transthoracic approach is often advocated for better oncologic staging and improved survival. A transhiatal approach is often preferred due to a perceived decreased operative morbidity and mortality. Methods: Using the American College of Surgeons-National Surgical Quality Improvement Project (ACS-NSQIP) participant-use file, patients were identified who underwent esophagectomy for cancer at the 240 participating hospitals from 2005-2011. Demographic, clinical, intra-operative variables and 30-day morbidity and mortality were collected. Results: Of the 1108 patients that had esophagectomy, 649 (58.5%) had a transhiatal (TH) resection and 459 (41.4%) had a transthoracic (TT) resection. There were no significant differences in age, gender, comorbid conditions, preoperative chemotherapy or radiation, or ASA class. Operative time was greater in the TT group (360.4 vs. 298.4min, p=0.0001). Thirty day overall mortality (TH=3.4%, TT=4.5%, p=0.3) and mean hospital length of stay(TH=15.25, TT=16.76, p=0.08) were not significantly different. The TH group had a significantly higher superficial wound infection rate (13% vs. 7.4%, p=0.002). The TT group had significantly higher rate of perioperative transfusion (9% vs. 5.1%, p=0.023) and septic shock (12.2% vs. 7.1%, p=0.004). On multivariate analysis, history of congestive heart failure and pneumonia were significant predictors of 30 day mortality. Diabetes, metabolic syndrome and COPD were predictors of morbidity. There were no differences in the rates of pneumonia, need for reintubation, ventilator requirements, or need for reoperation in both groups. Conclusions: In this modern series of patients, utilizing standardized national data collection tools, there was no significant difference in mortality of esophagectomy between transthoracic and transhiatal approaches. However, morbidity rates do vary with an increased rate of substantial morbidity in the transthoracic group including septic shock.
Association of increased time from chemoradiation (CRT) to esophagectomy (E) with increased surgical complications (Cx) in esophageal cancer (EC).
Authors: Meyer Joshua E. , Thomay Alan , Ruth Karen J. , Shaikh Talha , Konski Andre A. , Cohen Steven J. , Scott Walter Joseph 
Published: February 2017

77 Background: EC is often treated with CRT followed by E. E is typically performed 6 weeks after completion of CRT, but the optimal timing is unknown. Previous work has shown that a longer time interval (TI) between CRT and E resulted in a higher percentage of patients (pts) with pathologic complete response. This study was undertaken to determine whether this improved response comes at the expense of increased surgical Cx. Methods: Complete records were available for 85 pts who underwent CRT and subsequent E at a single academic center from 2001-2011. Surgical Cx were collected. Univariable and multivariable analyses were performed to investigate the association between length of TI from CRT to E and Cx, adjusting for age, gender, and surgery type. Multiple linear regression was performed to examine the association of length of stay (LOS) and estimated blood loss (EBL) with TI, adjusting for covariates. Results: Of 85 patients, 72 were male and the histology was adenocarcinoma in 72. The median age was 61 (range: 36-80), the most common clinical stage was T3N1 and 60% of pts had ECOG performance status of 1 (range 0-2). The median length of CRT (most commonly Cisplatin, 5FU and 50.4 Gy) was 37 days and median TI from initiation of CRT to E was 89 days (range: 64-242). 59 pts (69%) experienced at least 1 complication. The mean TIs for pts with and without Cx were 97 and 87 days (P=0.019). When specific Cx were examined, the mean TI for pulmonary Cx was greater (107 v. 89 days; P=0.018). Patients experiencing anastamotic leaks had shorter mean TIs (83 v. 96 days; P=0.022). Multiple linear regression showed a positive association between LOS and TI (p=0.0027) but none with EBL. On multivariable analysis, increased TI predicted for pulmonary complications (OR 1.05, P=0.0061) and LOS (OR 1.03, P=0.033). Increased TI predicted for decreased risk of anastamotic leak (OR 0.94, P=0.063). Conclusions: In this retrospective data set, we demonstrated an association between longer TI from CRT to E and pulmonary toxicity in EC pts. Longer TI was also associated with increased LOS. In contrast, anastamotic leaks were associated with shorter TIs. These data suggest TI from CRT to E may impact the risk of Cx.
Long-term oncologic outcomes of robotic gastrectomy for gastric cancer compared with laparoscopic gastrectomy.
Authors: Hyung Woo Jin , Obama Kazutaka , Kim Yu Min , Woo Yanghee , Pak Kyung Ho , Kim Hyoung-Il , Noh Sung Hoon 
Published: February 2017

8 Background: Although robotic gastrectomy (RG) showed satisfactory early postoperative outcomes, the oncologic safety of RG for gastric cancer remains a concern. We aimed to evaluate the oncologic safety of RG by comparing its long term outcomes with that of laparoscopic gastrectomy (LG). Methods: From July 2005 to December 2009, we performed 313 RGs and 524 LGs to the patients with gastric cancer. We retrospectively analyzed the patients’ characteristics, operative outcomes, overall survival (OS) and relapse-free survival (RFS), then compared between RG and LG groups using a prospectively maintained database. Results: With a median follow-up of 46 (1-80) months, there was no difference in the OS (log-rank p=0.625) nor in the RFS (p=0.761) between the two groups. When we compared the two groups stage by stage, the OS and RFS also did not differ significantly. Postoperative recurrence was observed in 17 patients (5.4%) in RG and 18 (3.4%) in LG, which showed no significant difference (p=0.745). The pattern of recurrence in RG showed 5 peritoneal, 5 loco-regional, 3 hematogenous,3 distant lymph node, and 1 mixed one. The recurence pattern of the two groups did not differ significantly. Conclusions: These data suggest that robotic assistance in gastrectomy for gastric cancer is acceptable because the oncologic outcome of RG was comparable to conventional LG in our experience.
Phase I study of neoadjuvant chemoradiotherapy as an outpatient setting for patients with resectable advanced gastric cancer.
Authors: Takahashi Tsunehiro , Saikawa Yoshiro , Wada Norihito , Kawakubo Hirofumi , Takeuchi Hiroya , Takaishi Hiromasa , Kitagawa Yuko 
Published: February 2017

84 Background: The prognosis for advanced gastric cancer remains poor because of a high rate of metastasis or recurrence. Therefore, treatment options that might improve the prognosis are needed. Radiation is expected to improve the rate of curable resection and local recurrence. To that end, neoadjuvant chemoradiotherapy with S-1 and cisplatin (CDDP) was investigated. Methods: Advanced gastric cancer patients with regional lymph nodes metastases enrolled in this study. The chemoradiotherapy consisted of S-1 on days 1–14 and CDDP on days 1 and 15. The dose range of CDDP in the study was 15 mg/m2 to 30 mg/m2. Radiation therapy was started concurrently with chemotherapy and repeated daily on days 1–5, 8–12, 15–19, and 22–26. After the initial chemoradiation therapy, the chemotherapy was repeated within 2 weeks after the termination of radiotherapy. Surgery was scheduled to take place within 6 weeks after completion of the second cycle of chemotherapy. Results: A total of 9 patients were recruited. There was no dose-limiting toxicity (DLT) in patients both 15 mg/m2 and 20 mg/m2. In the next three patients at 25 mg/m2, there were two cases with DLTs. Therefore, the recommended dose (RD) of CDDP was 20 mg/m2. Eight patients underwent surgery and all had an R0 resection. Postoperative complications occurred in two cases (pancreatic fistula and chylous ascites). However, there was no treatment-related death. The grades of histological therapeutic effect were Grade 1a in two patients, Grade 1b in one patient and Grade 2 in four patients. One patient had no viable cancer cells, which is classified as a Grade 3 histological therapeutic effect and represented a pathological CR. Conclusions: The recommended dose of CDDP is 20mg/m2 bi-weekly and its safety and feasibility as a preoperative therapy are supported in this study. Neoadjuvant chemoradiotherapy can provide remarkable shrinkage of tumors and increases in curability rate would be expected. Further clinical trials in a larger number of patients are recommended to evaluate the validation of neoadjuvant chemoradiotherapy with S-1 and CDDP as a standard treatment strategy for resectable advanced gastric cancer. Clinical trial information: UMIN000008941.
Long-term survival of EMR-PDT for gastric cancer.
Authors: Narahara Hiroyuki , Morita Kaori , Yasuda Kayo , Aoi Kenji , Saita Miki , Ikezoe Seriko , Yanagawa Kazunori , Masuda Eriko , Fukushima Juichi , Matsumoto Hitoshi , Yasunaga Yuichi , Inui Yoshiaki , Kawata Sumio , Higashino Koji 
Published: February 2017

85 Background: Some patients and their family refuse to undergo the surgical operation because of age or complicated diseases. Endoscopic mucosal resection (EMR) technique is popular in Japan. This method has the advantage of a histologic examination, but its uses are limited to mucosal lesions and a part of submucosal lesions (sm1). For early gastric cancer, we treated patients by photodynamic therapy (PDT) in combination with EMR (that is EMR-PDT). Methods: We treated twenty-five patients with gastric cancer by EMR-PDT from April, 1997 till March, 2004. The median age was 79 (56-88) years old. All the patients were diagnosed that it is impossible to undergo a surgical operation due to their age or complicated diseases. The endoscopic ultrasonography (EUS) showed massive invasion of the submucosal layer in sixteen cancer lesions and the muscularis propria in nine cancer lesions.In order to reduce the tumor size, piecemeal snarectomy (EMR) is performed. One week later, PDT is performed. After the intravenous injection of 2 mg/kg of Photofrin, the excimer dye laser (EDL) at 630 nm is irradiated transmitted endoscopically. The energy intensity is over 60 J/cm2. Results: 1. Early gastric cancer (sm massive): as for complications, two patients showed pyloric stenosis after treatment but both of them were cured successfully by endoscopic treatment. As for local response, 15 out of 16 patients showed cure completely. From a viewpoint of long-term outcome, during the observation period of five years (from one year to 11 years), nine patients died and six patients are alive. Only one patint died of gastric cancer four years later, and other eight patients died from other causes. The longest cancer survivor is still alive after 11 years after EMR-PDT with no recurrence of cancer. Disease-specific survival is 93%. Three- year survival rate is 85%. 2. Advanced cancer: Any of the patient were not alive more than three years. 3. Regardless of their advanced age and complications, such as liver dysfunction and renal dysfunctions, both PDT and EMR-PDT showed extremely high safety. No treatment related death was observed. Conclusions: EMR-PDT is a promising method for early gastric cancer because of its safety and long-term good outcome.
Preoperative chemoradiotherapy (CRT) in gastric cancer.
Authors: Trip Anouk Kirsten , Poppema Boelo Jan , van Berge Henegouwen Mark I. , Jansen Edwin PM , Siemerink Ester , Richel Dirk , Beukema Jannet C. , Plukker John Theodorus , van Sandick Johanna W. , Hulshof Maarten C. , Cats Annemieke , Verheij Marcel , Hospers Geke 
Published: February 2017

89 Background: The prognosis of gastric cancer patients remains poor even after radical surgery. Although local control and survival are significantly improved by postoperative CRT, treatment compliance is frequently compromised due to severe toxicity. On the other hand, treatment compliance is good with preoperative chemotherapy (CT) in gastric cancer and preoperative CRT in esophageal cancer. The current study was initiated to investigate the feasibility and efficacy of preoperative CRT for marginally resectable and initially irresectable gastric cancer. Methods: Patients with marginally resectable and initially irresectable gastric cancer, without signs of peritonitis carcinomatosa, stage IB-IV(M0) were treated with CRT. Treatment consisted of irradiation to a total dose of 45 Gy given in 25 fractions of 1.8 Gy combined with concurrent weekly carboplatin (AUC 2) and paclitaxel (50mg/m2) on days 1, 8, 15, 22 and 29 of irradiation, followed by standardized surgery 4-6 weeks after the last irradiation. Results: Between December 2007 and January 2012, 25 patients with stage II-IV(M0) marginally resectable (n=13) or initially irresectable gastric cancer received preoperative CRT. One patient discontinued concurrent CT in the 4th week due to toxicity, but completed radiotherapy, and another patient stopped CRT after the 3rd week due to progressive disease. During CRT, grade III gastrointestinal adverse events (AE) occurred in 3 patients (12%), grade III hematological AE in 3 (12%) and grade III other AE in 2 (8%). Twenty-four patients (96%) were operated following CRT. Surgery-related complications consisted of anastomotic leakage in 3 patients (12%) and bowel perforation in 2 (8%). Postoperative mortality was 4%. A microscopically radical resection was achieved in 18 patients (72%), 8 of whom had initially irresectable gastric cancer. The pathologic complete response rate was 16% (4/25 patients). Conclusions: In this study, preoperative CRT for marginally resectable and initially irresectable gastric cancer was associated with manageable toxicity and resulted in an encouraging pathologic response rate. A multicenter phase II study has recently been initiated.
Randomized phase II study of 6 versus 12 months of adjuvant imatinib for patients with intermediate- or high-risk GIST.
Authors: Muguruma Kazuya , Kurokawa Yukinori , Tsujinaka Toshimasa , Fujita Junya , Nakai Takuya , Takabayashi Arimichi , Hiramatsu Masako , Terashima Masanori , Iwasaki Yoshiki , Hasegawa Junichi , Kira Toshihiko , Shimokawa Toshio , Hirota Seiichi , Nishida Toshirou 
Published: February 2017

9 Background: The Z9001 study revealed adjuvant imatinib for 1 year significantly improved RFS in GIST patients (pts). The SSGXVIII study compared 3 years with 1 year of adjuvant imatinib for high risk GIST pts, but there was no study to evaluate shorter period of imatinib administration than 1 year. We conducted a randomized phase II study to compare 6 months (6-mo) with 12 months (12-mo) adjuvant imatinib for intermediate or high risk GIST pts. Methods: Inclusion criteria included ECOG-PS of 0 or 1, age between 20 and 79 years, and primary KIT-positive GIST with intermediate or high risk according to the Fletcher criteria. Pts were randomized assigned to the 6-mo or 12-mo treatment of imatinib 400 mg/day after complete resection. The primary endpoint was recurrence-free survival (RFS). The study was designed as a randomized screening trial to evaluate non-inferiority with margin of hazard ratio 1.67, 1-sided alpha 0.2 and power 0.8. Results: Ninety-two pts were randomly allocated the 6-mo group (n=45) or the 12-mo group (n=47) between Dec 2007 and Aug 2011, which was well balanced for baseline characteristics. One patient was ineligible due to non-GIST (desmoid) tumor at a central review. The proportions of pts completed their assigned adjuvant treatment were 80% in the 6-mo and 70% in the 12-mo group. The first interim analysis was conducted at Sep 2012 with the median follow-up time of 33 months. The 1- and 2-year RFS were 82% and 65% in the 6-mo group and 96% and 86% in the 12-mo group, respectively. Hazard ratio of recurrence was 1.81 (95%CI: 0.84-3.91), and the 2-sided log-rank p value was 0.12. Adjuvant imatinib was well tolerated, with one patient of Gr. 4 rash and no treatment-related death. Because of the lower efficacy of the 6-mo group than expected, the Data and Safety Monitoring Committee recommended the early release of first interim analysis results. Conclusions: Adjuvant Imatinib for 6-mo was inferior in efficacy to that for 12-mo in terms of RFS. Shortening of the adjuvant imatinib duration is not recommended for intermediate or high risk GIST pts. Clinical trial information: UMIN000000950.
Post-progression survival (PPS) and improvements in progression-free survival (PFS) in randomized controlled trials (RCTs) in advanced gastric cancer (AGC).
Authors: Shitara Kohei , Buyse Marc E. , Saad Everardo D. 
Published: February 2017

93 Background: Since PPS may influence overall survival (OS), studying PPS may help in understanding why gains in PFS do not always translate into gains in OS. Methods: We searched PubMed for RCTs on first-line therapy for AGC published between 01/82 and 01/12. We estimated mean PFS and OS (in months) using the area under the published Kaplan-Meier curves, computing mean PPS as mean OS minus mean PFS for each trial arm. We compared PPS between trial arms grouped according to PFS duration (longer versus shorter PFS, regardless of statistical significance) and world region (using t tests). Results: We retrieved 53 trials (25 were phase III, 24 were randomized phase II, and 4 had no explicit phase) enrolling 12,050 patients in 121 arms. We could estimate mean endpoints for 33 trials (26/6/1 with 2/3/4 arms), which were more likely to be phase III than the 20 trials with no Kaplan-Meier curves for both endpoints. The average mean PPS was almost identical between trial arms with longer or shorter PFS. Use of PPS assessed as median OS minus median PFS yielded qualitatively similar results. Conclusions: Treatments that improve PFS do not seem to influence PPS. Asian trials appear to have longer OS due to longer PPS, not PFS. Work with individual patient data collected worldwide by the GASTRIC group is under way to confirm our findings. [Table: see text]
SCALOP: Results of a randomized phase II study of induction chemotherapy followed by gemcitabine (G) or capecitabine (Cap) based chemoradiation (CRT) in locally advanced pancreatic cancer (LANPC).
Authors: Mukherjee Somnath , Hurt Chris , Griffiths Gareth , Bridgewater John A. , Crosby Thomas , Falk Stephen , Cummins Sebastian J. , Roy Rajarshi , Mangar Stephen , Mcdonald Alec , Staffurth John , Abrams Ross A. , Maughan Tim 
Published: February 2017

LBA146 Background: CRT with G or 5FU (F) is used to treat LAPC. No multicenter, randomized studies have compared G-CRT vs. F-CRT or the oral fluropyrimidine, Cap-CRT. In the UK, where chemotherapy is traditionally standard of care for LAPC, a trial was conducted to assess the safety, efficacy, and deliverability of G-CRT and Cap-CRT. Methods: Eligibility: histologically proven inoperable LAPC < 7 cm in diameter. Induction chemotherapy: 3 cycles of GEMCAP (G 1,000 mg/m2 days 1, 8, 15; Cap 830 mg/m2 days 1-21 q28 days). Patients with stable/responding disease, tumor diameter ≤ 6cm, and PS 0-1 were eligible for CRT randomisation where patients received a further cycle of GEMCAP followed by either Cap (830 mg/m2 bd weekdays only) or G (300 mg/m2 weekly) with radiation (50.4 Gy/28 fractions). Treatment volume = tumour plus enlarged nodes and margins of 2 cm sup-inf and 1.5 cm radially. Prospective RT quality assurance was mandated. Primary end-point was 9-month PFS (Fleming’s design). Funder: Cancer Research UK (CR UK 07/040). Results: Between July 2009 and October 2011, 114 patients from 28 UK centres were registered of whom 74 patients were randomised. Randomised patient characteristics: median age 64.6; 55.4% male; WHO PS (0:1) 41.9%:58.1%; median tumor diameter 4cm; site (head:body) 85.1%:14.9%. During CRT, more patients in the G arm experienced grade 3/4 haematological (18.4% vs 0%, p=0.007) and non-haematological (26.3% vs 11.1%, p=0.095) toxicity. Both C and G arms passed the primary endpoint with 9-month PFS of 62.9% (80% CIs: 50.6%-73.9%) and 51.4% (80% CIs: 39.4%-63.4%) respectively. OS was significantly superior in the Cap-CRT arm (median OS 15.2 vs 13.4 months, HR=0.50, log rank p=0.025). Conclusions: SCALOP is the largest RCT comparing radio-sensitizers in pancreatic cancer and demonstrates that both G-CRT and Cap-CRT can be delivered safely and effectively. Both regimens met the pre-specified PFS criteria. Compared to G-CRT, Cap-CRT demonstrated significantly better survival and toxicity and should form the template regimen for future trials investigating RT dose escalation and combination with novel radio-sensitizers. Clinical trial information: NCT01032057.
Results of a phase III, randomized, double-blind, placebo-controlled trial of pegfilgrastim (PEG) in patients (pts) receiving first-line FOLFOX or FOLFIRI and bevacizumab (B) for colorectal cancer (CRC).
Authors: Pinter Tamas , Abella Steve , Cesas Alvydas , Croitoru Adina , Decaestecker Jochen , Gibbs Peter , Hotko Yevhen , Jassem Jacek , Kurteva Galina Petrova , Novotny Jan , O'Reilly Seamus , Salek Tomas , Mo May F. , Choi L. Mi Rim , Blanke Charles Davic 
Published: February 2017

LBA445 Background: The literature reports that adding biologics to chemotherapy (ctx) may increase the incidence of clinically significant neutropenia. This trial was conducted to evaluate the efficacy of PEG in reducing the incidence of febrile neutropenia (FN) in pts with locally advanced (LA) or metastatic (m)CRC receiving first-line treatment with either FOLFOX/B or FOLFIRI/B. Methods: Key eligibility: ≥ 18 years old; measurable, nonresectable CRC per RECIST 1.1. Pts were randomly assigned 1:1 to either placebo or 6 mg PEG ~24 h after ctx/B. The study treatment period included four Q2W cycles, but pts could continue their assigned regimen until progression. Pts were stratified by region (North America vs rest of world), stage (LA vs mCRC), and ctx (FOLFOX vs FOLFIRI). Estimated sample size (N = 800) was based on the expected incidence of grade 3/4 FN (primary endpoint) across the first 4 cycles of ctx/B, powered for PEG superiority over placebo. Other endpoints included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: 845 pts were randomized (Nov 2009 to Jan 2012) and received study treatment; 783 pts completed 4 cycles of ctx/B. Median age was 61 years; 512 (61%) pts were male; 819 (97%) had mCRC; 414 (49%) received FOLFOX, and 431 (51%) received FOLFIRI. Grade 3/4 FN (first 4 cycles) for placebo vs PEG was 5.7% vs 2.4%; OR 0.41; p = 0.014. A similar incidence of other ≥ grade 3 adverse events was seen in both arms (28% placebo; 27% PEG). See Table for additional results. Conclusions: PEG significantly reduced the incidence of grade 3/4 FN in this pt population receiving standard ctx/B for CRC. Follow-up is ongoing. Clinical trial information: NCT00911170. [Table: see text]