bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessing cancer clinic visit time as a marker of quality care.
Authors: Hamel Lauren M. , Eggly Susan , Penner Louis , Chapman Robert , Vichich Jennifer , Tkatch Rifky , Albrecht Terrance Lynn 
Published: February 2017

95 Background: The uses of patient time and clinic space in outpatient cancer clinics can be indicators of efficiency and quality of cancer care. Inefficient use of these can have deleterious effects on clinic flow, patient satisfaction, physician/staff morale, and treatment adherence. We tested a unique method of assessing patient time and clinic space in cancer clinics as a measure of cancer care quality. Methods: We video recorded patient occupancy in exam rooms in two outpatient cancer clinics (n = 53) using an IRB-approved, custom-designed unobtrusive recording system (Albrecht et al. 2005) and analyzed use of time. Coders assessed: Patient Occupancy Time (total time in the exam room; POT); Patient Wait Time (time spent in the exam room prior to seeing the oncologist; PWT); and Physician-Patient Interaction Time (PPIT). POT was compared with Scheduled Occupancy Time (from clinic records; SOT) to obtain measures of Discrepancy in Occupancy Time (difference in scheduled exam room time and actual time the patient spent in the exam room; DiOT). Results: Mean POT across both clinics was 82.0 minutes (SD = 36.2), mean PWT was 24.8 minutes (SD = 26.0), and mean PPIT was 31.4 (SD = 14.9) minutes. SOT was only available for Clinic A in which case mean DiOT was 42.6 minutes with a range of 3.5 to 146.5 minutes. Only three cases used the room for less time than originally scheduled. SOT was unrelated to POT, PWT, and PPIT. DiOT was unrelated to PPIT. Conclusions: This method of objectively measuring cancer clinic time can help inform interventions to improve clinic efficiency. We found wait times were lengthy, suggesting an inefficient use of time and space. Importantly, there was no consistent relationship between scheduled and actual time spent in the exam room, reflecting an inefficient use of resources and potential inaccuracy in using scheduled time as a valid measure of quality. [Table: see text]
Predicting survival in stomach cancer: The role of quality-of-life assessment.
Authors: Braun Donald Peter , Gupta Digant , Staren Edgar Donald 
Published: February 2017

100 Background: Although assessment of quality of life (QoL) with validated instruments has been increasing in the clinical oncology community, there is little data examining its prognostic significance in stomach cancer. We investigated the association between baseline QoL and survival in stomach cancer. Methods: A consecutive case series of 129 stomach cancer patients treated between Jan 2001 and Dec 2009. QoL was evaluated at baseline using EORTC-QLQ-C30 which incorporates 1 global, 5 functional and 8 symptom scales. Scores range from 0-100 with higher scores in global/functional scales and lower scores in symptom scales indicating better QoL. Patient survival was defined as the time between the date of first patient visit and the date of death from any cause/date of last contact. Cox regression was performed to evaluate the prognostic significance of QoL. Results: Mean age at diagnosis was 60.9 years. 61 patients were newly diagnosed and received their first cancer treatment at our hospital, while 68 were previously treated elsewhere. Stage at diagnosis was I, 12; II, 11; III, 17; and IV, 89. Median overall survival was 8.4 months (95% CI: 5.9-10.7 months). QoL scales predictive of survival upon univariate analysis were global (p=0.001), physical (p=0.002) and fatigue (p=0.02). Upon multivariate analyses, after adjusting for age, gender, stage, and treatment history, global (HR=0.84; 95%CI=0.74, 0.93; p=0.001), physical (HR=0.83; 95%CI=0.73, 0.93; p=0.001) and fatigue (HR=1.10; 95%CI=1.02, 1.18; p=0.02) scales were significantly associated with survival, such that patients with higher (better) global and physical scores and lower (better) fatigue scores had better survival. For both newly diagnosed and previously treated patients, global and physical scales were significantly predictive of survival. Conclusions: Baseline QoL elements that reflect specific functional and symptomatic attributes provide useful prognostic information in stomach cancer. Significantly, this held true for global and physical function for both newly diagnosed and previously treated patients. Such determinations should be considered when designing clinical trials with survival endpoints and may aid decision-making in clinical practice.
The impact of modified Glasgow prognostic score on survival in patients with gastric cancer.
Authors: Goto Hironobu , Tokunaga Masanori , Makuuchi Rie , Tanizawa Yutaka , Bando Etsuro , Kawamura Taiichi , Kinugasa Yusuke , Tsubosa Yasuhiro , Kanemoto Hideyuki , Uesaka Katsuhiko , Terashima Masanori 
Published: February 2017

104 Background: Modified Glasgow Prognostic Score (mGPS), based on serum C-reactive protein (CRP) and albumin-levels, was reported to be a good prognosticator for survival in patients with lung cancer. However, the role of mGPS in gastric cancer is still controversial. The aim of this study is to clarify the significance of mGPS as a prognosticator in patients with gastric cancer. Methods: This study included 1,062 patients who underwent gastrectomy for gastric cancer at Shizuoka Cancer Center between September 2002 and December 2006. Patients who received neoadjuvant chemotherapy, and those who had other cancers were excluded from the analysis. mGPS is defined by serum CRP level and serum albumin level. Patients with serum CRP level of 1.0mg/dl or lower were classified to mGPS 0 irrespective to the serum albumin level. Patients with elevated serum CRP level (>1.0mg/dl) were classified to mGPS1 or mGPS2 according to the serum albumin level (mGPS1, albumin≥3.5g/dl; mGPS2, albumin<3.5g/dl). We compared relationships between mGPS and clinicopathological characteristics of patients, the incidence of intra-abdominal infectious complications (Clavien-Dindo grade II or more severe), and overall survival. Results: There were 712 male and 350 female patients. The median age was 65 years old. The number of patients classified to the mGPS0, mGPS1, and mGPS2 group were 970 (91.3%), 59 (5.6%), and 33 (3.1%), respectively. The incidences of intra-abdominal infectious complications were 27.1% in mGPS1, and 24.3% in mGPS2, and were significantly higher than that in mGPS0 (9.5%, P< 0.001). Overall five-year survival rates were 74.6% in mGPS0, 61.4% in mGPS1, and 34.6% in mGPS2. The overall survival was significantly worse in patients with mGPS2 than those with mGPS0 or mGPS1 (P<0.001). Conclusions: mGPS was correlated with the incidence of intra-abdominal infectious complications. In addition, mGPS was found to be a prognosticator for survival in patients with gastric cancer. Preoperative nutritional support may lead to reduced incidence of surgical complications and improved survival outcome after gastrectomy in patients with gastric cancer.
Impact of pathologic complete response to preoperative docetaxel-based chemotherapy on disease-free survival in esophagogastric adenocarcinoma.
Authors: Lorenzen Sylvie , Homann Nils , Al-Batran Salah-Eddin , Lordick Florian , Schuster Tibor , Peschel Christian , Pauligk Claudia , Thuss-Patience Peter C. 
Published: February 2017

123 Background: The aim of this study was to evaluate the impact of pathologic complete response (pCR) on outcome in patients with gastric or esophagogastric junction (EGJ) adenocarcinoma after treatment with preoperative docetaxel/platin /fluoropyrimidine based chemotherapy. Methods: This analysis of a prospective database identified patients who received at least one cycle of preoperative docetaxel/platin/fluoropyrimidine-based chemotherapy for at least T3/4 and N+ disease. An association of pretreatment clinicopathologic factors and pCR was investigated. Overall survival, disease-free survival and disease-specific survival were analyzed according to the achievement of a pCR. Results: A total of 120 patients received preoperative docetaxel-based chemotherapy and underwent subsequent resection of the primary tumor. 15 pts (13%) had distant metastases (M1) at initial diagnosis. 18 patients achieved a pCR in the primary (15%). Median follow-up was 41.1months. The median DFS and OS for the whole population was 24.1 and 48.6 months, respectively. DFS was significantly prolonged in pCR compared to non-pCR patients (HR 2.65, 95% CI 1.1- to 6.2; 3-year DFS probability: 71.8%±10.7 and 37.7%±5.1, respectively, P-value log-rank test=0.018). For patients with a pCR the median DFS was not reached and for those without pCR the median DFS was 22.1 months. Patients with a pCR showed an almost 50% decreased risk of death compared to non-pCR patients (HR 0.53; 95%CI 0.23 to 1.23; P=0.131). Disease-specific survival (DSS) was significantly longer in pCR vs. non-pCR patients (HR 0.188, 95%CI 0.046-to 0.77; P= 0.021). Two clinicopathological parameters were identified as predictors of pCR: tumor localization in the EGJ (p=0.019) and intestinal tumor type according to Laurén’s classification (p=0.042). Conclusions: The analysis confirms that pCR to neoadjuvant chemotherapy is a predictor of favourable patient outcome in patients with gastric or EGJ adenocarcinoma. Tumor location in the EGJ and intestinal histology represent factors significantly associated with the achievement of pCR.
Neoadjuvant DCF in resectable esophageal cancer: Single-center experience.
Authors: Noronha Vanita , Gulia Seema , Joshi Amit , Prabhash Kumar 
Published: February 2017

124 Background: Despite improvement in surgical techniques and peri-operative care, the 5 yr OS in esophageal cancer is 10%. RCTs comparing NACT to surgery alone have demonstrated a significant increase in median survival from 13 months to 17 months. We aimed at studying impact of DCF NACT. Methods: Retrospective analysis of prospective database of patients with locally advanced esophageal cancer. All patients had ECOG performance status of 0 to 1, with no uncontrolled comorbidities. Chemotherapy consisted of 3 cycles of standard DCF (Docetaxel 75 mg/m2 on day1, Cisplatin 75 mg/m2 on day 1 and 5 fluorouracil 750mg/m2 as a continuous intravenous infusion for 5 days) with growth factors and prophylactic antibiotics were administered. Following chemotherapy, a restaging scan was performed. If disease was deemed resectable, surgery was performed. Patients were followed up after surgery and then 3-monthly. Toxicity was graded according to CTCAE v.4.03, response was calculated as per RECIST 1.1 and statistics were by simple percentages. OS and PFS calculated by Kaplan–Meier method. Results: Between February 2010 and April 2012, there were 22 patients who received neoadjuvant DCF chemotherapy. Male to female ratio 1.2. Median age 44.5 years (range: 32- 63 yrs). 20 patients had squamous histology and 2 had adenocarcinoma. Middle one third of esophagus was the primary site in 54.5%. Response rate: CR-32%, PR-55%, SD-9% and PD-4.5%. 16 (73%) patients underwent R0 resections, 1-R1 resection, 3-R2 resection, 1 was deemed unresectable preoperatively and treated with chemo-radiotherapy and 1 had CR but surgery was postponed due to hyperthyroidism. 7 patients (31.8%) had pathologic complete remission. Toxicities grade (3/ 4) included neutropenia (77.3%), febrile neutropenia (86.4%), diarrhea (45.5%), hyponatremia (45.5%), fatigue (18.2%), and mucositis (13.5%). Dose reduction due to toxicities was done in 50% patients. At a median follow up period of 13 months (range 4-31 months), the PFS is 81.8% and OS is 90.9%. Conclusions: Response rate to DCF is 87%, with a pathologic CR rate of 32%. The complete responders appear to have a durable benefit; all remain disease free at the last date of follow up. Our initial data looks promising but follow up period is short.
Efficacy and safety of endoscopic submucosal dissection for superficial squamous esophageal neoplasia: A systematic review and meta-analysis of the literature.
Authors: Kim Joon Sung , Kim Byung-Wook , Ji Jeong-Seon , Lee Bo-In , Choi Hwang 
Published: February 2017

127 Background: The number of ESD candidates with esophageal neoplasia has increased with the recent development of endoscopy. Increasing number of studies has recently reported the application of endoscopic submucosal dissection (ESD) for treatment of esophageal lesions. However, most of these series were retrospective and single center studies that included only a relatively small number of cases. The aim of this systematic review and meta-analysis was to assess the efficacy and safety of ESD for esophageal lesions. Methods: Comprehensive literature searches were performed on studies that reported ESD for the removal of esophageal dysplasia or esophageal squamous cell carcinoma. MEDLINE, EMBASE and the Cochrane Library were searched using the primary keywords “endoscopic submucosal dissection”, “esophagus” and “esophageal”. Statistical analyses were executed by the aid of Comprehensive Meta-analysis software version 2. Results: A total of 17 studies were identified. Meta-analysis revealed pooled estimates of complete cure en bloc resection as 89.7% (95%CI 85%-93%; I2 =54.6%) and pooled estimates of en bloc resection as 96% (95%CI;93%-98%; I2=21.2). The pooled estimates of complications of ESD such as bleeding, perforation and stenosis were 2%, 5%, 12%, respectively. Subgroup analysis was performed by grouping studies into two groups. Complete cure en bloc resection was 92.4% for studies from Japan and 81.6% for studies from other countries than Japan. Conclusions: ESD appeared to be an extremely effective technique to achieve complete cure en bloc resection of superficial squamous esophageal neoplasia. The very low rate of complications also shows the potential safety of this approach. However, the resection rates were statistically different for studies from Japan and for studies from other countries. Standardization of techniques and equipment may be needed before ESD can be widely accepted for treatment of superficial squamous esophageal neoplasms.
Retrospective study regarding the efficacy of second- or higher-line chemotherapy (CT) of patients in advanced or recurrent gastric cancer (ARGC) after the failure of S-1 or S-1 combination chemotherapy (S+α).
Authors: Kobayashi Kazuma , Negoro Yuji , Hata Yasuhiro , Morita Sojiro , Aiba Keisuke , Tsuji Akihito 
Published: February 2017

129 Background: At the 2007 ASCO meeting, two RCTs from Japan showed that S-1 (S) and S-1/CDDP (S+P) therapy now are an accepted standard 1st-line chemotherapeutic regimens for ARGC. Today in Japan, S+α are the mainstay CTs for ARGC. However, it is important to acquire a longer survival for ARGC and therefore development of a 2nd or higher line CT after S+α failure is thus required. At the 2012 ASCO meeting, WJOG4007G trial showed that weekly PTX was regarded as a temporary standard 2nd-line CT for ARGC after the failure of S+P. However, some clinical questions to appropriate 2nd-line CT have been unsolved. The present study set out to identify the factors, which make it appropriate to perform the CT after S+α failure, and to examine the validity of this treatment. Methods: Sixty-one pts with ARGC who failed to sufficiently respond to S+α therapy between Dec. 2004 and May 2010 were retrospectively reviewed. Results: The patient characteristics were: mean age, 63.8 y.o.; sex, M/F=42/19; patient status: unresectable: 35, non-curative operation: 17 and postoperative recurrence: 9. The initial CT regimens consisted of S: 32, S+α: 29. The 2nd-line CT regimens included Taxanes (TA): 40, CPT-11 (IRI): 20, S+α: 1. The median number of 2nd or higher treatment courses was 2 (1-6). The RR of 2nd-line CT was 24.6%. The mTTF and MST since the 2nd-line CT was administered were 112 days and 311 days, respectively. The transition rate to 3rd-line was 65.6%. The OS since the S+α administration significantly correlated with the TTF of S+α (p<0.001), while the OS since the 2nd-line CT administration (2nd OS) was independent of the TTF of S+α. The 2nd OS did not correlate with either the specific type of 2nd-line CT. However, the 2nd OS of pts receiving both TA and IRI was significantly longer than ones only either TA or IRI (p=0.0012). Conclusions: The findings of this study suggest that the addition of a 2nd or higher line CT is expected to result in a longer survival for pts with ARGC, even when the anti-tumor effect was deemed to be insufficient following the S+α therapy, and that the strategy of using all available agents in the treatment course of ARGC might be needed.
A retrospective study of neoadjuvant DCF (docetaxel, cisplatin, 5-fluorouracil) for locally advanced gastric or gastro-esophageal junction adenocarcinoma (GC).
Authors: Castellanos Raquel , Ernani Vinicius , Bayraktar Ulas Darda , Portelance Lorraine , Montero Alberto J. , Rocha Lima Caio Max S. , Hosein Peter Joel 
Published: February 2017

138 Background: Perioperative chemotherapy (chemo) with ECF (epirubicin/cisplatin/5-fluorouracil) plus surgery improved survival over surgery alone in GC in the MAGIC trial. Herein we report our experience using DCF in the perioperative setting in patients (pts) with locally advanced GC. Methods: We conducted a retrospective IRB-approved study of pts with potentially resectable locally advanced GC who were treated with DCF with neoadjuvant intent. Pts received 3 cycles of preoperative (pre-op) DCF every 3 weeks, followed by surgery, then 3 cycles of postoperative (post-op) DCF. Patients with a poor pathologic response could be changed to radiation (RT) or an alternate chemo regimen postop. Results: A total of 41 pts were identified, 24 with gastric and 17 with GEJ adenocarcinoma. All pts received at least 1 cycle of DCF and 78% received at least 3 cycles pre-op. Five pts progressed during neoadjuvant DCF, 4 were unresectable by CT after neoadjuvant DCF and 2 were lost to follow-up. The remaining 30 pts had surgery with curative intent. Post-op, 2 pts were lost to follow-up, 12 received DCF (with 6 of these also receiving RT), 11 received a different chemo regimen due to a poor response to neoadjuvant DCF (including 6 pts who also received RT). Two pts received post-op RT only. The median PFS was 16.8 months (95% CI 7.7 - 25.9) and the median OS was 26.9 months (95% CI 18.7–35.1). The PFS was longer for pts who had a radiological or pathological response to neoadjuvant DCF (log rank p = 0.005 and 0.02 respectively) and for pts who received DCF post-op (log rank p = 0.005). Among pts who did not receive DCF post-op, there was no survival difference between the pts who were switched to an alternative chemo or chemoRT regimen post-op compared to those who received no further therapy. The most common chemo-related adverse events were anemia (27% grade 3 or 4), nausea/vomiting (17% G3 or 4), and febrile neutropenia (12%). Conclusions: The DCF regimen is well tolerated in locally advanced GC. Patients who do not have a good response (either radiologic or pathologic) to pre-op DCF appear to have a poor prognosis regardless of the post-op treatment given.
Phase II trial of sorafenib (S) and erlotinib (E) in unresectable pancreas cancer (UPC): Final results and correlative findings.
Authors: Cardin Dana Backlund , Goff Laura Williams , Chan Emily , Holloway Melanie , McClanahan Pamela , Shyr Yu , Li Chung-I , Meyer Krista , Grigorieva Julia , Berlin Jordan 
Published: February 2017

191 Background: The MAP kinase pathway plays a central role in PC pathogenesis. Blockade of this pathway at multiple levels using S and E is attractive mechanistically. S also targets VEGF receptors. Evidence suggests that dual blockade of both EGFR and VEGF pathways has potential for additive, if not synergistic, effects. This phase II trial was designed to evaluate the efficacy of the combination of S and E in patients (pts) with UPC. An exploratory correlative study analyzing pre-treatment serum samples using a proteomic mass-spectrometry test (VeriStrat), previously shown to correlate with outcomes in lung cancer pts treated with E or the combination of E and S, was performed to evaluate the possible clinical utility of the test in pts with UPC. Methods: Pts with UPC received S 400mg daily along with E 150mg daily as primarily second-line therapy (first-line was allowed). Primary endpoint was 8-week progression free survival (PFS) rate. Pre-treatment serum sample analysis by proteomic test was done blinded to clinical and outcome data; the endpoints were PFS and overall survival (OS). Difference between groups was assessed using log-rank p values; hazard ratios (HR) were obtained from Cox proportional hazards models. Results: Thirty-seven pts received study drugs and were included in the survival analysis. Eight-week PFS rate 0.47 (95% CI 0.32-0.67) did not meet the primary endpoint of a rate of ≥ 0.70. Thirty two pts were included in the correlative analysis. VeriStrat “Good” pts had superior PFS and OS compared to VeriStrat “Poor” pts (Table). Conclusions: This study did not meet the primary endpoint and this drug combination will not be further pursued. In this small retrospective analysis the proteomic classification was significantly associated with clinical outcomes (PFS and OS), meriting further evaluation. This will include a companion study to an ongoing phase I study evaluating gemcitabine, erlotinib and dasatinib in UPC (NCT01660971). Clinical trial information: NCT00837876. [Table: see text]
Phase II/III clinical trial with VEGFR2-epitope peptide and gemcitabine for patients with locally advanced, metastatic, or unresectable pancreatic cancer: Pegasus-PC study.
Authors: Yamaue Hiroki , Tani Masaji , Miyazawa Motoki , Yamao Kenji , Mizuno Nobumasa , Okusaka Takuji , Ueno Hideki , Boku Narikazu , Fukutomi Akira , Ishii Hiroshi , Ohkawa Shinichi , Furukawa Masayuki , Maguchi Hiroyuki , Ikeda Masafumi , Nishio Kazuto , Ohashi Yasuo , Tsunoda Takuya 
Published: February 2017

223 Background: Gemcitabine is a key drug for treating pancreatic cancer; however, with the limitation in clinical benefits, the development of another potent therapeutic was strongly called for. VEGF-receptor 2 (VEGFR2: Flk-1 and KDR) is an essential target for tumor angiogenesis, and we have executed a phase I clinical trial using gemcitabine and VEGFR2-peptide (Cancer Sci 2010). Based on promising phase I trial results, a multicenter, randomized, placebo-controlled, double-blind phase II/III clinical trial has been conducted (UMIN000001664). Methods: The eligibility criteria are: locally advanced, metastatic, or unresectable pancreatic cancer. Patients were allocated to either VEGFR2 peptide (OTS102) + gemcitabine group or placebo + gemcitabine in 2:1 ratio by dynamic allocation method. The primary endpoint was overall survival. The Harrington-Fleming test, with the weight proportional to cumulative death probability, was used for the statistical analysis under the time-lagged effect of immunotherapy. Sample size was estimated presuming the effects will be observed from the time point of 50% cumulative survival rate. Assuming a type I error alpha (two-sided) level of 5% and a power of 80% or more for 50%-60% reduction of hazard, sample size necessary was estimated as 100 patients for the active group and 50 patients for the placebo group. Results: No statistically significant survival time prolongation was observed in OTS102 add-on group (p = 0.92). However, the three-month landmark analysis revealed significant interaction between the treatment and reports of indurations or ulcerations (p = 0.005) in add-on group, and if patients survived for over three months, grade 1-2 patients had better survival than grade 0 (1-year survival: 47%(23/49) and 22%(9/44), respectively) in add-on group. Conclusions: Despite the lack of survival time prolongation by OTS102 add-on to gemcitabine therapy, patients experienced injection site indurations or ulcerations may have better survival, suggesting new prognostic factors for VEGFR2-epitope peptide. Our results indicate the possibility of epitope peptide used in cocktail therapies. Clinical trial information: UMIN000001664.