tbuckley/cabot-search huggingface dataset:
Development and evaluation of the TrueNTH-Prostate Cancer Canada electronic Library for Improved (urinary and bowel) Function post Treatment (TrueNTH-PCC-eLIFT).
Authors: Kristin Tangen-Steffins, Nelson Leong, Sally Hodgson, Elizabeth Wambolt, Catherine Hildebrand, Chantalle Willie, Khurram Siddiqui, Garson Chan, Hon Leong, Joseph Chin, Jennifer Goulart
Journal: Journal of Clinical Oncology (2016)

161 Background: The TrueNTH program is a Movember-funded, pan Canadian effort to develop a comprehensive patient-centered online portal in English and French that will cover a full spectrum of prostate cancer survivor needs. Through the support of Prostate Cancer Canada, the TrueNTH-PCC-eLIFT resource, as part of the TrueNTH program, is being developed by a multi-disciplinary team of urologists, radiation oncologists, gastroenterologists, researchers, nurses and survivors at pilot sites in Victoria, BC and London, ON. eLIFT will address urinary and bowel side effects that may be experienced after curative intent treatment by External Beam Radiation Therapy (EBRT), Brachytherapy (BT), combined EBRT + BT or Radical Prostatectomy (RP). Methods: eLIFT includes a didactic electronic library, symptom assessment tool and content tailored to treatment or symptoms experienced. A sequential prospective cohort study is underway to evaluate the impact of the resource. A baseline cohort of eighty patients per site receiving standard of care is currently open. A second cohort of eighty patients per site will be accrued to receive the eLIFT intervention. The study measurespatient self-efficacy, knowledge, Health Related Quality of Life (HRQoL), urinary and bowel function, health resource usage and satisfaction. Results: eLIFT content, with a total of 22 video modules is complete and in production. Preliminary results from the first cohort of patients, receiving standard care, confirm a need for a reliable, online resource in Canada. Patients note that the oral information provided by their oncologist at their preliminary consultation, while informative, is not easily retained. Information that was provided as print varied and was often outdated. Further, patients deem websites outside of Canada as the most reliable and helpful, which may not reflect Canadian recommendations. Conclusions: eLIFT will provide a unique and scalable centralized resource that will allow for expansion to a National level and increase access to a scientifically-sound library of information with the goal of improving the quality of care for prostate cancer patients across Canada.
The 12-gene colon cancer assay validation and utility: Summary of clinical evidence.
Authors: Emily Burke, Haluk Tezcan, Margarita Lopatin, Kim Michelle Clark-Langone, Mark Lee, Steven Shak, Amy P. Sing
Journal: Journal of Clinical Oncology (2014)

3547 Background: The 12-gene colon cancer assay is the first commercially available molecular assay to predict the risk of recurrence in stage II/III colon and rectal cancer. Rigorous evidence for clinical validity and utility of an assay is imperative since the result is used for treatment decision-making. This summary outlines the studies that meet an established definition of clinical validation and additional studies that support the utility of the assay. Methods: Prospectively designed studies using archival tissue with pre-specified methods, clinical outcomes, and analysis plan were considered clinical validation studies (Simon et al. JNCI 2009). Additional studies that demonstrated the utility of the assay in a clinical setting were considered supportive. Results: The assay has been clinically validated in four independent studies with 3,315 patients (2,390 stage II/628 stage III colon and 130 stage II/167 stage III rectal). All four studies demonstrated a significant association (p<0.05) between the result and outcome (e.g. recurrence risk and cancer specific survival). The score was examined in the context of other variables, including T and N stage, mismatch repair status, number of nodes examined, lymphovascular invasion, and tumor grade; across all studies, the result consistently contributed to risk stratification beyond these variables. Three clinical utility studies with 502 patients showed that 29-45% of initial treatment recommendations in stage IIA colon cancer were changed, with a net reduction in use of adjuvant chemotherapy. Conclusions: Clinical validation of the 12-gene assay followed a now-standard approach of using archived tissue from multiple large, prospectively-designed studies with documented long-term outcomes; the 12-gene colon assay meets level IB evidence criteria. Subsequent studies showed the assay has impact on clinical practice. The underlying tumor biology assessed by the score is relevant in both colon (stage II and III) and rectal cancer, providing information beyond conventional features, and can help guide treatment decisions regarding adjuvant chemotherapy.
Enhancing a culture of patient safety in an oncologic hospital setting.
Authors: Nicole Worthington, Shannon Bristow
Journal: Journal of Clinical Oncology (2016)

135 Background: Patient safety is a priority for all hospitals and staff members. With approx. 1:10 hospitalized patients experiencing an adverse event 1 , healthcare lags behind other industries with regards to safety. Oncology patients have an increased risk of adverse events due to an immunocompromised status, coupled with complex treatments. Cancer Treatment Centers of America at Eastern Regional Medical Center (ERMC) recognized the need to heighten patient safety while maintaining a positive patient experience. Methods: ERMC participates in the Agency for Healthcare Research and Quality (AHRQ) Hospital Survey on Patient Safety Culture to assess employee’s perception of the organization’s patient safety, conducted every 18-24 months. The most recent survey was conducted between May 11 - June 1, 2015. Interventions to enhance safety culture from 2013 to 2015 survey results included: daily safety check-ins for all hospital departments for both day and night shifts; sharing safety stories before routine meetings; leadership rounding; and enhanced transparency of safety events that occurred throughout the hospital. Routine in-servicing was also completed to educate staff members on reportable safety events for Pennsylvania and foster ongoing discussions about patient safety. Results: Survey response rate experienced a 236% increase from 2013 to 2015 (218 to 628 responses respectively). Of the 12 patient safety composites, 11 showed an increase in scores from 2013 to 2015, the outlier being “overall perceptions of patient safety” composite score which dropped by two percentage points. Furthermore, ERMC was above the national benchmark in all 12 patient safety composite categories for the 2015 survey. Conclusions: The ERMC staff considers safety a priority, as evidenced by the increase in AHRQ survey scores from 2013 to 2015. Perceptions of safety throughout the system have increased with the initiation of several safety projects. Based on raw comments from the AHRQ culture of safety survey, more work is needed to involve non-clinical staff in hospital safety. Moving forward, ERMC will investigate innovative solutions to involve all staff, clinical and non-clinical alike, to be engaged in patient safety.
Cytoreductive nephrectomy (CN) in patients with synchronous metastases from renal cell carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC).
Authors: Daniel Yick Chin Heng, Brian I. Rini, Benoit Beuselinck, Jae-Lyun Lee, Jennifer J. Knox, Georg A. Bjarnason, Sumanta Kumar Pal, Christian K. Kollmannsberger, Takeshi Yuasa, Sandy Srinivas, Frede Donskov, Aristotelis Bamias, Lori Wood, D. Scott Ernst, Neeraj Agarwal, Ulka N. Vaishampayan, Sun Young Rha, Jenny J. Kim, Ravindran Kanesvaran, Toni K. Choueiri
Journal: Journal of Clinical Oncology (2014)

396 Background: The role of cytoreductive nephrectomy is unclear in patients with synchronous metastases from renal cell carcinoma (RCC) in the age of targeted therapy. Methods: Comparisons were made between patients treated with targeted therapy who had a CN versus not and adjusted using proportional hazards regression for known poor prognostic criteria (IMDC criteria Heng et al JCO 2009). Results: 2569/3245 (79%) mRCC patients received a nephrectomy. Patients who had nephrectomy before the diagnosis of metastatic disease were excluded (n=1634). Among the remaining patients, 935 patients had a CN and 676 patients did not have nephrectomy. All patients received targeted therapy with the majority receiving first-line sunitinib 72%, sorafenib 15%, temsirolimus 5%, bevacizumab 3%, pazopanib 3%. Patients who had CN had better IMDC prognostic profiles versus those without (favorable/intermediate/poor in 9%/63%/28% vs 1%/45%/54% p&lt;0.0001). The median overall survival of patients with CN vs without was 20.6 vs 9.5 months (p&lt;0.0001). When adjusted for IMDC criteria to correct for imbalances, the HR of death was 0.60 (95%CI 0.52-0.69, p&lt;0.0001). The Table demonstrates the increasing benefit of CN if a given patient has a longer survival time. Conclusions: CN can be beneficial in patients with synchronous metastatic RCC even after adjustment for prognostic factors. Patients who are estimated to survive less than 9-12 months may have a marginal benefit compared to those with longer estimated survival. This may aid in patient selection as we await results from randomized controlled trials. [Table: see text]
Illness perception and quality of life in patients with breast cancer.
Authors: D. Gercovich, P. Lopez, D. Bortolato, P. Margiolakis, M. Morgenfeld, M. Montiel, M. Abal, I. Danussi, S. Musini, E. Gil Deza, E. L. Morgenfeld, E. G. J. Rivarola, F. G. Gercovich
Journal: Journal of Clinical Oncology (2011)

e19567 Background: In the last decade the interest to know the modulating factors of the quality of life in oncological patients has grown. Previous researches suggest that the illness perception is closely related with the quality of life of these patients. The objective of our study is to assess the dimensions of illness perception that explain the quality of life of patients. Methods: Seventy five consecutive patients were evaluated by the Brief Illness Perception Questionnaire and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-30) at the admission interview of the mental health service of a specialized institute in oncological illness.A logistic regression analysis was calculated to assess the illness perception dimensions that explain the variance in the quality of life. Variables that showed significant association were included in the logistic regression model (Wald statistics). Results: Higher scores of Identity subscale were associated with lower probabilities to have a good quality of life (p=.027), role functioning (p=.042) and cognitive functioning (p=.004) and higher probabilities to have fatigue (p=.027). Additionally higher scores of Emotional Response subscale were associated with lower probabilities to have a good social functioning (p=.018) and finances (p=.009). Higher scores of Consequences subscale were associated with higher probabilities to have nausea and vomiting (p=.039). Higher scores of Preoccupation subscale were associated with higher probabilities to have diarrhea (p=.039). Finally, higher scores of Control of illness subscale were associated with higher probabilities to have dysnea (p=.048) Conclusions: The knowledge about the relation between the illness perception dimensions and the quality of life will allow the development of specific strategies that improve the daily functioning of the cancer patients, increasing the coping ability of the illness.
Long-term outcomes of induction chemotherapy and neoadjuvant stereotactic body radiotherapy for borderline resectable and locally advanced pancreatic adenocarcinoma.
Authors: Eric Albert Mellon, Sarah E. Hoffe, Gregory M. Springett, Pamela Joy Hodul, Mokenge Peter Malafa, Jessica M. Frakes, Michael D. Chuong, Tobin Joel Crill Strom, Ravi Shridhar
Journal: Journal of Clinical Oncology (2015)

360 Background: Limited data is available for neoadjuvant treatment of borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer. We update our institutional outcomes with a neoadjuvant chemotherapy and stereotactic body radiotherapy (SBRT) approach. Methods: We performed an IRB-approved analysis of all BRPC and LAPC patients treated with our departmental treatment protocol. After staging, medically fit patients underwent chemotherapy for 2-3 months, with regimen at the discretion of the treating medical oncologist (FOLFIRINOX, GTX, gem/abraxane, or gemcitabine alone). Patients then received SBRT delivered in 5 consecutive daily fractions with median radiation doses of 30 Gy to tumor and 40 Gy dose painted to tumor-vessel interfaces. This was followed by restaging imaging for possible resection. Overall survival (OS), event free survival (EFS), and locoregional control (LRC) rates were estimated and compared by Kaplan-Meier and log-rank methods. Results: We identified 159 patients, 110 BRPC and 49 LAPC, with 14.0 months median overall follow-up. The resection and margin negative (R0) rate for BRPC patients who completed neoadjuvant therapy was 50.9% and 96.4%, respectively. Estimated median OS was 14.4 months for BRPC patients and 11.3 months for LAPC patients (p=0.402). Median OS was 34.2 months for surgically resected patients vs 14.0 months for unresected patients (p&lt;0.001). Five of 21 (23.8%) LAPC patients receiving FOLFIRINOX chemotherapy underwent R0 resection. In LAPC, FOLFIRINOX recipients underwent R0 resection more often than other chemotherapy recipients (5 of 21 vs. 0 of 28, p=0.011). There was a trend for improved survival in those resected LAPC patients (p=0.09). For those not undergoing resection, one year LRC was 78.4%. Grade ≥3 potentially radiation related toxicity rate was 6.9%. Conclusions: This data underscores the feasibility, safety, and effectiveness of neoadjuvant SBRT and chemotherapy for BRPC and LAPC. Compared with other chemotherapies, FOLFIRINOX induced greater tumor response in LAPC, permitting for R0 resection in a subset of LAPC patients and trend towards improved OS.
No difference in emergency department visits before and after transition for coeliac disease
Authors: Norelle R Reilly, Peter H R Green, Jonas F Ludvigsson
Journal: Gut (2017)

In a recent consensus document, we and others presented recommendations for the transition of care from childhood to adulthood in coeliac disease (CD).1 Models of care transition share a goal of prevention of medical care lapses. Lower continuity of general paediatric care has been associated with greater risk of emergency department (ED) visits and hospitalisation.2 Yet patient vulnerability during and immediately following transition may be under-recognised. Poorer medical adherence has been noted for young adults with chronic illnesses during their transition to adult care.3 ,4 In a US study, ED visits comprised over 20% of the medical care of young adults, a significantly greater proportion than in other age groups.5 Young adults with sickle cell disease in the midst of transition to adult care had more ED visits when compared with those with stable paediatric care or who were able to successfully establish adult care.6

To assess the transition burden on young …
Computer simulation and stochastic programming to reduce patient wait times in an outpatient infusion center.
Authors: Autumn Heiney, Spyros Potiris, Brian T. Denton, Amy Cohn, Christopher Ryan Friese
Journal: Journal of Clinical Oncology (2013)

181 Background: As cancer treatment demand outpaces the capacity of outpatient facilities, providers are challenged to provide timely, cost-effective, safe, and patient-centered care. Reduction in patient wait times can help address these challenges through more efficient care delivery. Operations research techniques such as simulation and stochastic programming can inform more efficient patient scheduling. Methods: After 60 hours of observation by two students in one NCI-designated comprehensive cancer center's outpatient infusion center, 9 months of data from the electronic medical record and scheduling systems were used to calculate patient wait times, defined as the difference between scheduled time to begin infusion and actual time and actual administration time. After mapping the patient flow through the center, a computer simulation model was created to examine the effects on patient wait times and total hours of operation under different scheduling paradigms. To create different appointment schedules, both simple heuristic approaches and a more complex stochastic programming model were developed. These methods take into account the variability in infusion times. We generated 35 appointment schedules and evaluated their performance by running 100 replications for each one. Results: The baseline average patient wait time was 130.48 minutes (95% CI 122.38-138.68). Computer simulation results show that schedules generated by the stochastic programming model perform better than baseline and simple heuristics, reaching a 70% reduction in waiting times. Schedules that allocated patients with longer infusion times to earlier appointments resulted in both reduced average patient wait times and total hours of operation. Conclusions: Operations research techniques can improve care delivery in an outpatient infusion center. Based on our results from the computer simulation model, scheduling patients with longer infusion times earlier in the day results in shorter patient waiting times and total length of day of operations. Next steps include guideline development for appointment scheduling staff that attains maximal efficiency.
Cisplatin, gencitabine, and lapatinib in patients with HER2-positive metastatic breast cancer: An experience in routine clinical practice.
Authors: M. Valero, M. Ruiz-Borrego, J. Salvador, D. Vicente, M. L. Limon, J. Fuentes Pradera, A. Sabino, E. Calvo, L. Iglesias
Journal: Journal of Clinical Oncology (2011)

e11005 Background: The treatment of metastatic breast cancer HER-2 + is based on the use of chemotherapy plus trastuzumab in the first line and the use of lapatinib and capecitabine after trastuzumab progression. There is little evidence of the use of lapatinib with chemotherapy other than capecitabine. On the other hand, data about the best possible therapy after trastuzumab and lapatinib’s progression is limited, given that seems advisable to keep blocked the HER-2 pathway. Methods: We treated 19 patients diagnosed with metastatic breast cancer that had previously been treated with chemotherapy and trastuzumab and/or lapatinib and capecitabine, with cisplatinum 25 mg/m2 IV days 1 and 8, gemcitabine 1000 mg/m2 IV days 1 and 8 cycles each 21 days more daily oral lapatinib 1000 mg continuously. The primary endpoint was progression-free survival (PFS). Secondary efficacy endpoint was clinical benefit rate, defined as complete response, partial response and stable disease. Results: We administered a median of 5 cycles of treatment with cisplatinum-gemcitabine and lapatinib, range 1-12. Three patients continued treatment in December 2010. The median follow-up is 7 months, range 1-12 months. Patients received a median of 2 previous lines of chemotherapy for metastatic breast cancer, range 1-7, two patients didn't receive trastuzumab due to decreased FEVI and brain metastases disease at the moment of diagnosis, 12 patients recieved lapatinib previously, 6 patients had brain metastases. Median PFS was 4 months, range 1-12 months. CBR 44% (4 partial response and 4 stable disease). Five patients died. There were a total of 14 events of hematologic toxicity G3-4, (6 in one patient), 2 episodes of diarrhea G3-4, 1 event G3-4 of hepatic toxicity, and 1 event of mucositis G3-4. Conclusions: The schedule cisplatin-gemcitabine-lapatinib, 25 mg and 1000 mg/m2 days 1 and 8 every 21 and 1000 mg IV continuous oral, may be a reasonable therapeutic option in patients with metastatic breast cancer HER-2 + previously treated with chemotherapy and trastuzumab plus lapatinib plus capecitabine.
ACCORD12/0405-Prodige 2 phase III trial neoadjuvant treatment in rectal cancer: Results after 5 years of follow-up.
Authors: Eric Francois, Sophie Gourgou-Bourgade, David Azria, Thierry Conroy, Olivier Bouche, Jerome Doyen, Jean-François Seitz, Laurent Mineur, Pierre-Luc Etienne, Jean-Pierre Gerard
Journal: Journal of Clinical Oncology (2016)

490 Background: The ACCORD 12 randomized trial was aiming at improving ypCR by increasing the radiation dose and adding oxaliplatin (OX) to a standard RT 45 Gy with concurrent capecitabine. On short term benefit of OX was not demonstrated (Gérard JP et al. J Clin Oncol. 2010;28:1638-44) at 3 years no significant difference in clinical outcome was achieved (Gérard JP et al. J Clin Oncol. 2012;30:4558-65. François E et al. Radiother Oncol. 2014;110:144-9). This is an update of results at 5 years. Methods: Between 11/2005 and 07/2008, 598 patients were randomized. Inclusion criteria: adenocarcinoma of rectum accessible to digital examination, T3 Nx M0 (or T2 distal anterior rectum). Randomization was between two neoadjuvant treatments chemo radiotherapy: Cap45 (45 Gy + capecitabine) and Capox50 (50 Gy + cape. and oxaliplatin). Main end point was sterilization of the operative specimen. Bowel function for patients treated with anterior resection was analyzed with a global score (1 very poor to 7 excellent). A total of 253 patients received adjuvant chemotherapy usually with FOLFOX: 133 in Cap45, 120 in Capox50. Results: In the ITT population, with a median follow-up of 60 months, updated carcinologic results were calculated using the Kaplan-Meier method. Out of 299 pts randomized in CAP45 and 299 pts in CAPOX50 results were respectively the following 1) 5y-cumulative incidence of Loc. Recurrence : 8.8% vs 7.8% (p = 0.78 HR = 0.92 [0.51-1.66]) 2) 5y-cumulative incidence of dist metastasis : 29.3% vs 27.1% (p = 0.48 HR = 0.89 [0.62-1.54]) 3) 5y-disease free survival rate : 60.4% vs 64.7% (p = 0.25 HR = 0.86 [0.66-1.11]) 4) 5y-overall survival rate : 76.4% vs 81.9% (p = 0.06 HR = 0.71 [0.50-1.01]) 5) bowel function median score : 5.2 [1-7] vs 4.9 [1-7]. Conclusions: At 5 years there was no significant difference in terms of local recurrence or distant metastases rates between both regimens. The new finding is a trend for improved overall survival in the Capox 50 groups may be related to subsequent salvage secondary treatments. At time of meeting the prognostic factors will be available in details and these results put in perspective with other phase III trial testing the role of oxaliplatin in Europe and the US. Clinical trial information: NCT00227747.