bluuebunny/crossref_metadata_2025_split huggingface dataset:
Using mobile app technology for patient data capture and implementation.
Authors: Nurkin Steven J. , Edge Stephen B. , Kakarla Venkata R. , Khushalani Nikhil I. 
Published: February 2017

317 Background: Mobile application technology has quickly become an integral part of clinical cancer care. While this technology is most commonly used as a point of care reference or educational tool, it may also be an effective method to capture patient data. The purpose of this project was to create a mobile solution for fast, point-of-care data capture and implementation, patient reported outcomes, to generate a patient treatment summary and provide data for cancer registry and clinical trials. Methods: Using the “MedDB app” (Bitwise Analytics) on an iPad2 (Apple) device, an application was developed to collect patient data following breast surgery for cancer. Collected data included elements required for pathologic staging using the American Joint Committee on Cancer TNM system (7th Edition) with the application deriving pathologic TNM and Stage Group. In addition, the type of breast surgery, lymph node surgery, and the expected next steps in treatment are coded for collection. Data are entered into the App in the clinic and transferred using a blinded code number to a web-based database. This database is then used to generate a patient surgical treatment summary and care plan, and is available for uploading into a research database. We then developed an individual patient App for their own personal mobile device. The purpose was to collect patient reported outcomes through their adjuvant care and surviorship. Results: The initial pilot included data entry on 20 breast cancer patients who had surgery prior to adjuvant therapy. The time to complete data entry was less than 60 seconds per case. Conclusions: Mobile communication devices are increasingly becoming key tools for clinicians. They are primarily used to search for medical resource information and the review of medical records. This pilot demonstrates the potential for use of mobile computer devices for collecting key data for clinical trials, the cancer registry, generating a patient treatment summary and care plan at the point of service as well as patient reported outcomes through personalized patient apps. Future development will include studies of integration with the electronic health record, the cancer registry systems, and expansion to a complete survivorship care plan system.
Prevalence of overweight and obesity in a population of childhood leukemia patients and survivors.
Authors: Jordan Jennifer Lyn , Cooper Robert Michael 
Published: February 2017

324 Background: Overweight and obesity (BMI>95 percentile) in the pediatric population has become a prominent problem. The prevalence of pediatric obesity has increased from 5% in 1976-1980 to 17% among children and adolescents in 2007-2008. The presence of obesity in survivors of certain childhood cancers has been identified as a late effect of therapy, especially in survivors of ALL and brain tumors. Obesity prevalence following treatment for ALL ranges from 11-57%. The long-term health consequences of obesity include diabetes mellitus, hypertension, cardiovascular disease, metabolic syndrome and certain cancers. Kaiser Permanente (KP) tracks pediatric BMI as part of routine health maintenance. There is an initiative to promote Healthy Eating and Active Living (HEAL) and reduce childhood obesity. As part of this initiative the HEAL clinic provides a multi-disciplinary weight management program for the general adolescent population at KP Los Angeles Medical Center (LAMC). Methods: A chart review was conducted using the electronic medical record system at LAMC. 99 records, 22 current patients and 77 survivors of ALL, were identified and reviewed for Body Mass Index (BMI) and compared to the general pediatric population of KP in Southern California. Results: See Table. 57 leukemia patients and survivors were identified as overweight or obese, which is a 57.5% prevalence rate. This is significantly higher than the rate of pediatric overweight and obesity of 37.1% in the KP Southern California general population. Conclusions: The use of an electronic medical record system confirms a higher prevalence of overweight and obesity in the ALL patients and survivors at KP LAMC than the general pediatric population in Southern California. The intervention piloted by the HEAL clinic has been adapted to treat this group of overweight and obese cancer patients and survivors. [Table: see text]
Measuring the improving quality of outpatient care in medical oncology practices in the United States.
Authors: Neuss Michael N. , Malin Jennifer , Chan Stephanie , Kadlubek Pamela , Adams John L. , Joseph Jacobson , Blayney Douglas , Simone Joseph V. 
Published: February 2017

66 Background: The American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) has provided a method for measurement of process based practice quality since 2006. We sought to determine whether QOPI participants show improvement in measured quality over time, and if change is demonstrated, those factors in either the measures or participants which are associated with change. Methods: 156 participant medical practice groups, which did not submit trainee data, participated in at least two collection rounds from 2006 through 2010, and reported on ≥30 patients per round from were included in analysis from a larger group of 306 participants from this time period. A database of these reports was used to evaluate trends in scoring among participants. A linear regression model, which controlled for varied initial performance, was used to estimate the effect of participation over time and evaluate participant and measure characteristics. Measures were aggregated into categories to evaluate which factors correlated with change. Results: Participants completed a mean of 5.71 (S.D. 1.84) rounds of data collection. Adjusted mean quality scores improved from 0.71 (95% C.I. 0.42 – 0.91) to 0.85 (95% C.I. 0.60 – 0.95). Overall odds ratio of improvement over time was 1.09 (p < 0.0001). The greatest improvement was seen in measures assessing newly introduced clinical information, where the mean scores improved from 0.05 (95% C.I. 0.01 – 0.17) to 0.69 (95% C.I. 0.33 – 0.91), (p ≤ 0.0001). Many measures showed no change over time. Conclusions: QOPI has gained widespread adoption and approximately 15% of U.S. medical oncologists participate. Participation over time is highly correlated with improvement in measured performance. Much of this improvement is the result of the adoption of newly introduced clinical information. Some measures show no change despite significant opportunity for improvement.
RTOG 0825: Phase III double-blind placebo-controlled trial evaluating bevacizumab (Bev) in patients (Pts) with newly diagnosed glioblastoma (GBM).
Authors: Gilbert Mark R. , Dignam James , Won Minhee , Blumenthal Deborah T. , Vogelbaum Michael A. , Aldape Kenneth D. , Colman Howard , Chakravarti Arnab , Jeraj Robert , Armstrong Terri S. , Wefel Jeffrey Scott , Brown Paul D. , Jaeckle Kurt A. , Schiff David , Atkins James Norman , Brachman David , Werner-Wasik Maria , Komaki Ritsuko , Sulman Erik P. , Mehta Minesh P. 
Published: February 2017

1 Background: Chemoradiation (CRT) with temozolomide (TMZ/RT→TMZ) is the standard of care for newly diagnosed GBM. This trial determined if the addition of Bev to standard CRT improves survival (OS) or progression-free survival (PFS) in newly diagnosed GBM. Methods: This phase III trial was conducted by the RTOG, NCCTG, and ECOG. Neurologically stable pts > 18 yrs with KPS ≥ 60, and > 1cm3 tumor tissue block, were randomized to Arm 1: standard CRT + placebo or Arm 2: standard CRT plus Bev (10 mg/kg iv q 2wks). Experimental treatment began at wk 4 of radiation then thru 6-12 cycles of maintenance chemotherapy. Protocol specified co-primary endpoints were OS and PFS, with significance levels of .023 and .002, respectively. At progression, treatment was unblinded and pts allowed to crossover or continue Bev. Symptom, QOL and neurocognitive (NCF) testing was performed in the majority of pts. Secondary analyses evaluated impact of MGMT methylation (meth) and prognostic 9 gene signature status. Results: From 978 registered pts, 637 were randomized. Inadequate tissue (n=105) and blood on imaging (n=40) were key reasons for non-randomization. No difference was found between arms for OS (median 16.1 vs. 15.7 mo, p = 0.11). PFS was extended for Arm 2 (7.3 vs. 10.7 mo, p = 0.004). Pts with MGMT meth had superior OS (23.2 vs. 14.3 mo, p < 0.001) and PFS (14.1 vs. 8.2 mo, p < 0.001). Neither the 9 gene signature nor MGMT predicted selective benefit for Bev treatment, but best prognosis pts (MGMT meth, favorable 9-gene), had a worse survival trend with Bev (15.7 vs 25 mo p = 0.08). To date, 128 pts were unblinded on Arm 1 (salvage Bev in 86) and 87 pts on Arm 2 (continued Bev in 39). Increased grade ≥ 3 toxicity was seen with Bev, mostly neutropenia, hypertension, and DVT/PE. Conclusions: The addition of Bev for newly diagnosed GBM did not improve OS, did improve PFS but did not reach the significance criterion. MGMT and 9 gene profile did not identify selective benefit, but risk subset results suggested strongly against the upfront use of Bev in the best prognosis pts. Full interpretation of the PFS results incorporating symptom burden, QOL, and NCF is ongoing. Support: NCI U10 CA 21661, U10 CA37422, and Genentech. Clinical trial information: NCT00884741.
Effect of visual inspection with acetic acid (VIA) screening by primary health workers on cervical cancer mortality: A cluster randomized controlled trial in Mumbai, India.
Authors: Shastri Surendra Srinivas , Mittra Indraneel , Mishra Gauravi , Gupta Subhadra , Dikshit Rajesh , Badwe Rajendra A. 
Published: February 2017

2 Background: Cervical cancer is the most common cancer among women in developing countries and is the leading cause of cancer death in Indian women. Since cytology-based screening is not easily implementable in India, there is a need to evolve simpler alternatives. Methods: We initiated a cluster-randomized controlled trial in 1998 to investigate the efficacy of VIA screening by primary health workers (PHWs) in reducing cervical cancer mortality. Women aged 35-64 years with no prior history of cancer were included. The study was designed to include 20 clusters with an average of 7,500 eligible women per cluster. Four rounds of cancer education and VIA screening were conducted by PHWs at 24-month intervals in the screening group, while cancer education was offered once at recruitment to the control group. Recruitment was completed in March 31, 2002. Although the study was planned for 16 years, we analysed the results on the advice of the DSMC at 12 years. Results: We recruited 75,360 women from 10 clusters in the screening group and 76,178 women from 10 comparable clusters in the control group. The analysis is on an intention-to-treat basis. In the screening group, we achieved 89% participation for screening and 79% compliance for post-screening diagnostic confirmation. The quality of screening by PHWs was comparable to that of an expert gynecologist (κ=0.84). The incidence of invasive cervical cancer was 26.74 per 100,000 (95%CI: 23.41-30.74) in the screening group and 27.49 per 100,000 (95%CI: 23.66-32.09) in the control group. Compliance to treatment for invasive cancer was 86.34% in screening group and 72.29% in the control group. The screening group showed a 31% reduction in cervical cancer mortality (mortality rate ratio RR=0.69; 95%CI: 0.54-0.88; p=0.003) compared to the control group. A 7% reduction was also observed in all-cause mortality (mortality rate ratio RR=0.93; 95%CI: 0.79–1.10; p=0.41). Conclusions: VIA screening conducted by PHWs significantly reduced cervical cancer mortality. VIA screening is easily implementable and could prevent 22,000 cervical cancer deaths in India and 72,600 deaths in resource poor countries annually. Clinical trial information: NCT00632047.
Comparison of chemoradiotherapy (CRT) and chemotherapy (CT) in patients with a locally advanced pancreatic cancer (LAPC) controlled after 4 months of gemcitabine with or without erlotinib: Final results of the international phase III LAP 07 study.
Authors: Hammel Pascal , Huguet Florence , Van Laethem Jean-Luc , Goldstein David , Glimelius Bengt , Artru Pascal , Borbath Ivan , Bouche Olivier , Shannon Jenny , André Thierry , Mineur Laurent , Chibaudel Benoist , Bonnetain Franck , Louvet Christophe 
Published: February 2017

LBA4003 Background: CRT in patients with LAPC controlled after induction CT could be superior to continuing CT (Huguet, JCO 2007). The role of erlotinib is unknown. We aimed to define the role of 1) CRT after disease control with gemcitabine, 2) erlotinib in LAPC. Methods: LAPC PS 0-2 patients were first randomized to gemcitabine alone or plus erlotinib 100 mg/d for 4 months (R1, stratification: center, PS). Patients with controlled disease were then randomized to 2 additional months of CT (Arm 1) or CRT (Arm 2) 54 Gy and capecitabine 1600 mg/m2/d (R2, stratification: center, initial arm). Patients receiving erlotinib at R1 had maintenance with this drug after protocol completion. Quality control for radiotherapy included dummy runs and assessment of treated patients. Primary objective: overall survival (OS) in R2 patients. Secondary objectives: role of erlotinib on OS (R1), tolerance, predictive markers, and circulating tumor cells. Taking into account a 30% progression rate between R1 and R2, and 5% lost to follow-up, 722 patients were required to observe 392 deaths to show a median OS increase from 9 to 12 m (HR=0.75) in the CRT arm (2 sided α=5% and β=20%) with planned interim analyses using alpha spending function and O’Brien Fleming boundaries (to reject H0 or H1). Kaplan-Meier, log rank and univariate Cox tests were used. Results: From 442 pts included for R1, 269 pts reached R2 (arm1:136; arm 2:133). Main baseline characteristics in arms 1/2: female 44%/56%, mean age 63/62, head tumor 65%/62%, PS 0 56%/48%. After a median follow-up of 36 m, 221 deaths had occurred allowing the planned interim analysis (information fraction 56.4%). OS in R2 pts was 16.5 m [15.5-18.5] and 15.3 m [13.9–17.3] in arms 1 and 2, respectively (HR=1.03 [0.79-1.34], p=0.83). IDMC has confirmed that the futility boundary for the hypothesis of CRT superiority was crossed and considered this as the final analysis of the study. Conclusions: Administering CRT is not superior to continuing CT in patients with controlled LAPC after 4 months of CT. Clinical trial information: NCT00634725.
A phase III randomized trial of chemoimmunotherapy comprising gemcitabine and capecitabine with or without telomerase vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer.
Authors: Middleton Gary William , Valle Juan W. , Wadsley Jonathan , Propper David , Coxon Fareeda Y. , Ross Paul J. , Madhusudan Srinivasan , Roques Tom , Cunningham David , Corrie Philippa , Greenhalf William , Shaw Victoria , Cox Trevor F. , Silcocks Paul , Nanson Gemma , Neoptolemos John P. 
Published: February 2017

LBA4004 Background: GV1001, a promiscuous class II epitope encompassing aa 611-626 of hTERT led to the development of CD4+ clones recognizing hTERT in patients with advanced pancreatic cancer (APC). Preclinically gemcitabine increases antigen cross-presentation, enhances T cell trafficking/activation, and reduces MDSCs and Tregs. Methods: Patients with APC were randomized 1:1:1 to: Arm 1 GemCap; 2 GemCap for 8/52 followed by GV1001 followed by further GemCap if no PD at week 8; 3 concurrent administration of GemCap and GV1001. 735 (69.2%) had metastatic disease and 948 (89.3%) had ECOG PS=0 or 1. Randomization was stratified by stage and PS. Primary endpoint was overall survival (OS); secondary endpoints included ORR, TTP, and AEs. Recruitment target was 1,110 patients (780 deaths) to permit detection of a hazard ratio of 0.748 between either GV1001 arm and Arm 1 using a 2-sided α=0.025 level of significance with at least 80% power. Results: 1,062 pts from 51 centers were randomized. Trial maturity was high (72.7% patients died): median follow-up was 6.11 months. The overall response rates were Arm 1=17.6%; Arm 2=8.9% (p=0.001); Arm 3: 15.5% (p=0.460 compared with Arm 1). Conclusions: OS with concurrent GemCap/GV1001 was not different to that with GemCap alone. OS with sequential GV1001 was not statistically different to GemCap alone as it did not meet the criterion for statistical significance (p<0.0175). The addition of a T helper epitope vaccine to GemCap did not improve outcome compared to GemCap alone. Clinical trial information: 43482138. [Table: see text]
A randomized multicenter phase III study comparing weekly versus every 3 weeks carboplatin (C) plus paclitaxel (P) in patients with advanced ovarian cancer (AOC): Multicenter Italian Trials in Ovarian Cancer (MITO-7)—European Network of Gynaecological Oncological Trial Groups (ENGOT-ov-10) and Gynecologic Cancer Intergroup (GCIG) trial.
Authors: Pignata Sandro , Scambia Giovanni , Lauria Rossella , Raspagliesi Francesco , Benedetti Panici Pierluigi , Cormio Gennaro , Katsaros Dionyssios , Sorio Roberto , Cavazzini Giovanna , Ferrandina Gabriella , Breda Enrico , Murgia Viviana , Sacco Cosimo , Asensio Sierra Nuria Maria , Pisano Carmela , Salutari Vanda , Weber Beatrice E. , Pujade-Lauraine Eric , Gallo Ciro , Perrone Francesco 
Published: February 2017

LBA5501 Background: Three-weekly (3w) CP is standard first-line chemotherapy for AOC pts. Weekly (w) P combined with 3w C prolonged PFS and OS in a JGOG phase III trial. MITO-7 is an academic randomized phase III study, comparing 3w vs. w CP. Methods: AOC chemonaive pts, stage IC-IV, age≤75, ECOG PS≤2, were randomized to 3wCP (C AUC6 + P 175mg/m², d1q21) for 6 cycles or to wCP (C AUC2 + P 60mg/m²) for 18 administrations. Coprimary endpoints were PFS and quality of life (QoL), measured by FACT-O and FACT/GOG-Ntx. With 80% power in detecting HR of 0.75, 2-sided α=0.05, 383 events were needed for PFS analysis. The arms were compared with a log-rank test and in a Cox model adjusted by stage, PS, residual disease, age and size of institution, following intention-to-treat. QoL was measured at baseline and weekly for 9 wks. Interaction between arm and QoL time was tested in a linear mixed model. Toxicity was coded by NCI-CTCAE v3.0. Results: 822 pts were enrolled by MITO, MANGO, and GINECO. Median age was 60; stage III (66%) and IV (18%) were prevalent. As of March 18, 2013, with median follow-up 20 months, 410 PFS events were recorded. Median PFS was 18.8 months with wCP and 16.5 months with 3wCP (HR 0.88, 95%CI 0.72-1.06, p=0.18). Lack of significant difference was confirmed (HR 0.87, 95%CI 0.71-1.05) in Cox model. For all scores, QoL course was significantly different between arms (p<0.0001). With 3wCP, QoL scores clearly worsened after each chemotherapy course (weeks 1, 4, 7), whilst with wCP, after a small and transient worsening at week 1, scores remained stable. Considering severe grades (≥3), wCP produced significantly less neutropenia, febrile neutropenia, thrombocytopenia, renal toxicity, and neuropathy. Conclusions: Compared to standard CP every 3 weeks, weekly CP did not demonstrate a significant benefit in PFS, but was associated with better QoL and toxicity. Clinical trial information: NCT00660842.
Interim analysis of the Spanish Lung Cancer Group (SLCG) BRCA1-RAP80 Expression Customization (BREC) randomized phase III trial of customized therapy in advanced non-small cell lung cancer (NSCLC) patients (p) (NCT00617656/GECP-BREC).
Authors: Moran Teresa , Cobo Manuel , Domine Manuel , Sanchez-Ronco Maria , Bover Isabel , Provencio Mariano , Massuti Bartomeu , Vergnenegre Alain , Lopez-Vivanco Guillermo , Robinet Gilles , Insa Amelia , Majem Margarita , De Las Penas Ramon , Sala María Ángeles , Isla Dolores , Baize Nathalie , Garde Javier , Chaib Imane , Camps Carlos , Rosell Rafael ,   Spanish Lung Cancer Group
Published: February 2017

LBA8002 Background: Findings from the SLCG phase II customized chemotherapy trial (NCT00883480) showed that RAP80, a component of the BRCA1 complex, influenced outcome both in p with low BRCA1 expression treated with cisplatin (cis)/gemcitabine (gem) and in p with intermediate/high BRCA1 levels treated with cis/docetaxel (doc) or with doc alone. Together with the French Lung Cancer Group, the SLCG has performed a prospective, randomized phase III trial comparing noncustomized cis/doc with customized therapy in metastatic NSCLC p. A parallel phase II study (ChiCTR-TRC-12001860) is being carried out in China under the auspices of the SLCG. Methods: Since 6 March 2008, 391 p with wild-type EGFR have been randomized 1:1 to the control or experimental arm. p in the control arm receive cis/doc; p in the experimental arm receive treatment according to their BRCA1 and RAP80 levels: p with low RAP80, regardless of BRCA1 levels, cis/gem; p with intermediate/high RAP80 and low/intermediate BRCA1, cis/doc; p with intermediate/high RAP80 and high BRCA1, doc alone. The primary endpoint is progression-free survival (PFS). Results: At the planned interim analysis (cut-off, 15 October 2012; N=279), PFS was 5.49 months (m) in the control and 4.38 m in the experimental arm (P=0.07). Overall survival (OS) was 12.66 m in the control and 8.52 m in the experimental arm (P=0.006). Response rate (RR) was 37.3% in the control and 27% in the experimental arm (P=0.07). In the multivariate analysis including PS, treatment arm, BRCA1, RAP80, histology, smoking status, and metastatic site, only extrathoracic metastases were associated with an increased risk of progression (HR, 1.78; P=0.02). Conclusions: Based on the negative results for PFS at the interim analysis, accrual has been closed on this study. Negative results may be due to the poor predictive capacity of RAP80 and the inclusion of doc alone as a treatment in the experimental arm. In addition, doc/cis may not be the ideal combination for the control arm. Clinical trial information: NCT00617656.