bluuebunny/crossref_metadata_2025_split huggingface dataset:
Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer patients: Final analysis of the EORTC AMAROS trial (10981/22023).
Authors: Rutgers Emiel J. , Donker Mila , Straver Marieke Evelien , Meijnen Philip , Van De Velde Cornelis J. H. , Mansel Robert E. , Westenberg Helen , Orzalesi Lorenzo , Bouma Willem H. , van der Mijle Huub , Nieuwenhuijzen Grard A. P. , Veltkamp Sanne C. , Slaets Leen , Messina Carlo G. M. , Duez Nicole J. , Hurkmans Coen , Bogaerts Jan , van Tienhoven Geertjan 
Published: February 2017

LBA1001 Background: Sentinel node biopsy (SNB) is standard in assessing axillary lymph node status for cN0 breast cancer patients. In case of a positive SNB, if treatment is advised, axillary lymph node dissection (ALND) is the current standard. Although ALND provides excellent regional control, it may give harmful side effects. Axillary radiotherapy (ART) instead of ALND was hypothesized to provide comparable regional control and less side effects. Methods: From 2001 to 2010, patients with cT1E2N0 primary breast cancer were enrolled in the EORTC phase III non-inferiority AMAROS trial. Patients were randomized between ALND and ART in case of a positive SNB. Primary endpoint was 5-year axillary recurrence rate. Secondary endpoints were overall survival (OS), disease-free survival (DFS), quality of life (QOL), shoulder movement and lymphedema at 1 and 5 years. Results: Of the 4,806 patients entered in the trial, 744 in the ALND-arm and 681 in the ART-arm had a positive SNB, 60% with a macrometastasis. The two treatment-arms were comparable regarding age, tumor size, grade, tumor type, and adjuvant systemic treatment. With a median follow up of 6.1 years, the 5-year axillary recurrence rate after a positive SNB was 0.54% (4/744) after ALND versus 1.03% (7/681) after ART. The planned non-inferiority test was underpowered because of the unexpectedly low number of events. The axillary recurrence rate after a negative SNB was 0.8% (25/3131). There were no significant differences between treatment arms regarding OS (5 yr estimates: 93.27% ALND, 92.52% ART, p=0.3386) and DFS (5 yr estimates: 86.90% ALND, 82.65% ART, p=0.1788). Lymphedema was found significantly more often after ALND (1yr: 40% ALND, 22% ART, p<0.0001 and 5yr: 28% ALND, 14% ART, p<0.0001). There was a nonsignificant trend toward more early shoulder movement impairment after ART. These findings were compatible with a trend in two QOL items in the arm symptom scale: swelling (ART better) and movement (ALND better). There were no other differences in QOL. Conclusion: ALND and ART after a positive SNB provide excellent and comparable regional control. ART reduces the risk of short-term and long-term lymphedema compared to ALND. Clinical trial information: NCT00014612.
Clinical outcomes in patients with castrate-refractory prostate cancer (CRPC) metastatic to bone randomized in the factorial TRAPEZE trial to docetaxel (D) with strontium-89 (Sr89), zoledronic acid (ZA), neither, or both (ISRCTN 12808747).
Authors: James Nicholas David , Pirrie Sarah , Barton Darren , Brown Janet Elizabeth , Billingham Lucinda , Collins Stuart I. , Daunton Adam , Birtle Alison J. , Chakraborti Prabir Ranjan , Ford Daniel , Hussain Syed A. , Jones Helen , Pope Ann , Porfiri Emilio , Russell John Martin , Stanley Andrew , Staffurth John , McLaren Duncan , Parker Chris , Wylie James 
Published: February 2017

LBA5000 Background: Bony metastatic CRPC has a poor prognosis and high morbidity. TRAPEZE is a factorial RCT using three agents, D, ZA, and Sr89. All have palliative benefits and are used in bony metastatic CRPC to control bone symptoms and (for D) to prolong survival. ZA was approved on the basis of reducing skeletal related events (SRE). Sr89 was approved to control pain from metastases and to reduce the need for subsequent bone treatments. ZA is commonly combined with D in practice but evidence that the combination is effective is lacking and costs considerable. Sr89 is generally used as a palliative therapy in patients unfit for chemotherapy. Phase II analysis confirmed the safety and feasibility of combining these agents. TRAPEZE aimed to determine clinical and cost-effectiveness scheduling. Methods: Patients were randomised to receive 6 cycles of D plus prednisolone: alone; with ZA; with a single dose of Sr89 after cycle 6 or both. Primary outcomes were clinical progression-free survival (CPFS: pain progression, SRE or death) and cost-effectiveness. Secondary outcomes were SRE free interval (SREFI); total SREs, and overall survival (OS). The log rank test and Cox regression modelling were used to determine clinical effectiveness. Results: TRAPEZE randomised 757 patients; median age 68.7 yrs; ECOG 0: 40% 1: 52% 2: 8%; prior RT 45%; median PSA 144 (IQR 51, 354). Provisional stratified log rank analysis of CPFS did not reach statistical significance for either agent (Sr89 p=0.11, ZA p=0.45). Cox regression analysis adjusted for all stratification variables showed benefit of Sr89 on CPFS (HR=0.845; 95%CI 0.72, 0.99, p=0.036) and confirmed no effect of ZA (p=0.46). ZA did show a significant effect on SREFI (HR=0.76; 95%CI 0.63, 0.93, p=0.008). There was no effect of either agent on overall survival (Sr89 p=0.74, ZA p=0.91). Conclusions: Sr89 after six cycles of docetaxel improved CPFS but not OS. ZA did not improve CPFS or OS but did significantly improve median SREFI, mostly post progression, suggesting a role as post chemotherapy maintenance therapy. Further health economic and QoL analyses are pending. Clinical trial information: 12808747.
BOLERO-2: Efficacy and safety of first-line everolimus plus exemestane in advanced breast cancer.
Authors: Rugo Hope S. , Campone Mario , Gnant Michael , Neven Patrick , Pistilli Barbara , Baselga Jose , Bauly Hounayda , Taran Tanya , Sahmoud Tarek , Hortobagyi Gabriel N. 
Published: February 2017

152 Background: In the BOLERO-2 study, progression-free survival (PFS) was significantly longer with the combination of everolimus and exemestane (EVE + EXE) compared with placebo and exemestane (PBO + EXE; hazard ratio = 0.45; p < .0001). Consistent efficacy results were observed in all subgroup analyses, such as in patients with visceral metastases and patients with disease recurrence during/after adjuvant therapy. This analysis of BOLERO-2 examines the efficacy of EVE + EXE in the subgroup of patients who received treatment immediately after recurrence during adjuvant therapy (i.e., as first-line therapy in the advanced setting). Methods: BOLERO-2 enrolled patients with hormone receptor–positive (HR+) advanced breast cancer with disease recurrence or progression after prior nonsteroidal aromatase inhibitors and compared EVE (10 mg/d) + EXE (25 mg/d) vs PBO + EXE. The primary end point was PFS by local investigator review. Results: A total of 137 patients received first-line EVE + EXE (n = 100) or PBO + EXE (n = 37) in the advanced setting. Of these patients, 74% of the EVE + EXE arm and 76% of the PBO + EXE arm had recurred after adjuvant endocrine therapy plus chemotherapy; 26% and 24%, respectively, had recurred after adjuvant endocrine therapy alone. Also, approximately 20% of patients entered the trial after recurring during or within 12 months of adjuvant therapy (21% EVE + EXE vs 16% PBO + EXE). The EVE + EXE group had significantly longer PFS compared with the PBO + EXE group (11.50 vs 4.07 months, respectively; hazard ratio = 0.39; 95% confidence interval, 0.25-0.62). Median PFS remained longer with EVE + EXE versus PBO + EXE, regardless of whether chemotherapy was included with the prior adjuvant hormonal therapy. Similar results were obtained from the analyses based on central review. The safety profile was consistent with the known profiles of each agent. Conclusions: EVE + EXE prolonged PFS in patients with HR+ advanced breast cancer who received treatment as first-line therapy. These results support the combination of EVE + EXE in patients with recurrence after adjuvant therapy. The recently initiated BOLERO-4 study is also evaluating the efficacy of EVE as a first-line therapy in patients with HR+ advanced breast cancer. Clinical trial information: NCT00863655.
Growth of tumorspheres exhibiting stem cell features from peripherally circulating tumor cells.
Authors: Pachmann Katharina , Pizon Monica , Zimon Dorothea , Pachmann Ulrich A. 
Published: February 2017

32 Background: Even after the complete resection of a malignant tumor the menace remains, that cells that have dissociated from the tumor might resettle in distant organs and grow into life-threatening metastases. Therefore we have developed an approach (maintrac) to detect and monitor the circulating tumor suspect epithelial cells in blood. However, the question arises whether these cells have the potential to grow into metastases. Methods: Using a nondissipative approach with only one enrichment step of red blood cell lysis, the cells from the pellet, containing the white blood cells together with the putative tumor cells were cultured under conditions favoring the growth of epithelial cells. At 7, 14 and 21 days the cultured cells were stained with anti-EpCAM antibody and inspected for the appearance of epithelial antigen positive spheroids. Results: Peripherally circulating cells from patients with malignant tumors in different stages of disease were analyzed for the presence of circulating epithelial tumor suspect cells and the frequencies of tumorspheres. Tumorspheres could so far be grown from 79% of 36 patients in whom more than 1700/ml epithelial tumor suspect cells were detected. Numbers of tumorspheres varied from 1 to 29 /ml and correlated with the aggressiveness of the tumor. Surprsingly the numbers were highest in patients who had not yet received any systemic therapy after surgery. The size of the spheres increased from day 7 to day 21. The spheres were negative for CD24 and positive for CD44. They highly expressed ALDH1 and thus exhibited typical features of stem cells. Conclusions: Here, we demonstrate that the tumor suspect cells, detected in our approach contain a subpopulation with stem cell-like properties capable of growing into tumorspheres. The frequency and growth potential of cells capable of forming spheres seems to be dependent from the properties of the primary tumor. The possibility to grow tumorspheres from peripherally circulating tumor cells may open up a new field, where the relevant cells with stem cell properties from individual patients can now be specifically analysed further for genetic endowment, transcriptional activity, heterogeneity and stem cell markers.
Off-label prescribing of chemotherapy among older cancer patients.
Authors: Barcenas Carlos Hernando , Zhang Ning , Niu Jiangong , Zhang Yufeng , Zhao Hui , Giordano Sharon Hermes 
Published: February 2017

130 Background: Off-label chemotherapy prescribing is thought to be common, but little data exist on the current patterns and predictors of off-label treatments for cancer patients. Methods: Patients from the Surveillance Epidemiology and End Results-Medicare database with a first cancer diagnosis between 1995 and 2009, age >65 years, who had claims for intravenous chemotherapy were included. Off-label chemotherapy use was evaluated for the following invasive cancers: breast (BC), n=26,702; colorectal (CRC), n=37,727; non-small cell lung cancer (NSCLC), n=49,263; small cell lung cancer (SCLC), n=13,364; and ovarian cancer (OV), n=8,552. Patients were considered as having received off-label treatment if they had at least one claim for an intravenous chemotherapy drug that did not have a Food Drug Administration labeled indication for the specific cancer on the date of administration. Generalized estimating (GEE) multivariable models were created for each cancer site to evaluate predictors of off-label chemotherapy use. Results: Patients with OV and CRC were older compared to patients with other tumor types. Distant stage disease was present in 12.5% of patients with BC, 26.7% with CRC, 55.5% with NSCLC, 63.2% with SCLC, and 82.7% with OV. Off-label chemotherapy use varied widely across tumor types. Overall, 23.8% of patients with BC, 14.6% with CRC, 86.2% with NSCLC, 97.7% with SCLC, and 46.7% with OV had at least one claim for an off-label chemotherapy agent. The GEE models showed that distant stage disease was significantly associated with increased off-label use for patients with BC (odds ratio [OR] 1.72, 95% confidence interval [CI] 1.57-1.88), CRC (OR 1.44, 95% CI 1.32-1.58), OV (OR 1.85, 95% CI 1.54-2.21), and NSCLC (OR 1.07, 95% CI 1.00-1.14). Off-label use was more common among patients age >80 years with BC, but was significantly less common for older patients with CRC, NSCLC and OV. Conclusions: The use of off-label chemotherapy is common among patients with different cancer types, particularly among those patients with NSCLC and SCLC, but use varies between specific cancer types, stage of disease, and by age.
Developing CAHPS for cancer care prototype: Progress and next steps.
Authors: Garfinkel Steven , Frentzel Elizabeth , Evensen Christian , Keller San , Yost Kathleen J. , Sangl Judith , Arora Neeraj K. 
Published: February 2017

134 Background: The CAHPS Survey for Cancer Care Prototype (application for CAHPS trademark in process) represents a significant advancement towards helping cancer care providers understand patients’ experiences of care. Although a number of standard commercial surveys are in use, currently none are available that both (1) capture the aspects of care most important to patients and (2) allow comparisons of those aspects of care across treatment centers and modalities. Methods: We developed a survey instrument that incorporated patient, clinician, and other stakeholder input throughout the development process. The survey measures patients’ perceptions of observable provider behaviors that are indicative of high quality care. Field test data were collected from 1,367 of 2,826 eligible patients (48% response rate) treated with surgery, radiation, or medical oncology from 6 accredited cancer treatment centers across the US. Classical psychometric methods were used to evaluate the measurement properties of composite scales per standard CAHPS methodology. Results: Based on a priori conceptualization, patient and stakeholder input, and empirical analyses, we identified 5 composites measuring shared decision-making, exchanging information about treatment, affective communication, access to care, and patient self-management. A confirmatory factor analysis using structural equation modeling showed an excellent fit (CFI > 0.96; RMSEA < 0.05) between the observed data and the structure for these five composites. Cronbach’s alpha for these composites ranged from 0.71-0.88, discriminant validity was good for all scales, and correlations with overall ratings of cancer care providers were moderate (0.31) to high (0.69). Evaluation of the precision with which the composites distinguish among cancer centers indicated that the measures were reliable; however, a second field test with a greater number and variety of centers will be needed to establish a standard sampling approach and confirm these results. Conclusions: We anticipate wide-spread adoption of this measure by cancer care providers to direct quality improvement efforts due to great interest and involvement in this project on the part of stakeholders.
A single-center, retrospective chart review evaluating outpatient code status documentation in the EPIC electronic medical record for patients with advanced solid tumor cancer.
Authors: Horton John M. , Hwang Michael , Ma Joseph D. , Roeland Eric 
Published: February 2017

242 Background: A desired code status is a critical element of advance care planning ideally outlined in an advance directive. Preferably, advance care planning occurs in the non-emergent, outpatient setting. In the absence of a documented code status, full resuscitation is the default, which is not desired by all patients. Currently, unlike the inpatient setting, there is no single, convenient location for code status documentation in the outpatient EPIC electronic medical record (EMR). In order to propose a system-wide solution, a retrospective chart review was completed to assess the scope of the problem. Methods: 160 charts were randomly selected of advanced solid tumor cancer patients (stage III-IV) who received care by a medical oncologist at the UCSD Moores Cancer Center from 2008-2011. The primary objective was to determine the incidence of code status documentation. Secondary objectives included determining the clinical role of the documenter and the code status documentation location within the EMR. Results: 57 advanced cancer patients (36%) had code status documented in 9 different locations in the EMR. Of the 57 patients, only 4 (7%) had a code status documented in the outpatient setting. When documented, code status was located in the progress note (5%), demographics tab (26%), problem list (2%), and scanned media section (14%). Out of the 160 charts, the outpatient oncologist documented the code status in 1 chart. Inpatient EMR locations of the code status included the discharge summary (33%), history and physical (11%), and progress note (9%). Conclusions: In the absence of a standard EPIC outpatient code status documentation procedure, code status was infrequently and inconsistently documented. Consequently, a readily available and accurate code status is not present for emergencies in the outpatient setting. With this information, we will focus future efforts on a clearly defined, standard, and convenient location for outpatient code status documentation in the EPIC EMR.
Using IT solutions to empower your patients and improve quality and satisfaction scores.
Authors: Colman Gerard , Foster Todd L 
Published: February 2017

249 Background: Provider organizations are being bombarded from every direction with demands to better patient experience, engage patients, manage populations, implement or enhance implementations of EHRs…the list goes on. Dr. Charles Safran testified to Congress in 2004 that “patients are the most underutilized resource in the U.S. health system.” Taking this to heart, MD Anderson’s recognized their complex registration process was perceived as overwhelming and new patients were experiencing feelings of uncertainty and a lack of control. Patients translated this into poor quality of care. Patients and their caregivers needed to be engaged during this emotionally trying time. Methods: PreCare was born from the desire to use technology to place the first appointment process into the patients’ hands. PreCare is a web site that allows patients to drive the process to expedite their first appointment and track progress transparently. It gives the patients the appropriate information at the appropriate time during their first appointment process. No longer are they bombarded with all information all at once. They could not possibly process it all so vital information was missed, resulting in poor quality of care. Results: Obtaining medical records faster has increased the quality of patient care. Approximately 24% of previously diagnosed patient diseases are changed or refined from their original diagnosis. Accurate diagnosis is critical as cancer treatments become more targeted. MD Anderson has noted improvements in clinical operations, increases in patient retention, reducing dependence on staff, manual processes, print materials and phone calls. Presenters will demonstrate the self-driven tools, lessons learned and the impact of using IT such as: a 4% increase in new referrals, reduction in costs, improvements in efficiency and increased satisfaction for staff, patients and their families. A 47% reduction in patient anxiety has been demonstrated. Conclusions: The overall system utilization is well above national averages, with as high as 74% utilization in key areas. All cancer patients have very high expectations. Our patients using PreCare find their quality of care far exceeds their expectations.
Development and economic trends in cancer therapeutic drugs: An updated analysis of modern and historical treatment costs compared to the contemporary GDP per capita.
Authors: Savage Philip 
Published: February 2017

259 Background: Cancer drug development is a major industry and clincial success story with new cancer treatment drugs delivering improved healthcare for many more patients each year. Generally new cancer treatment drugs are viewed as being of 'high cost' and there is considerable debate as to how these new treatments can be funded for routine use. Accurate data on the trends of the relative costs of new treatments compared with earlier high cost cancer drugs is limited. In this sudy we have aimed to document all the newly licenced cancer drugs, by year of introduction, and compare the cost of a standard course of treatment relative to the current per capita GDP to allow an assessment of how relative costs of new drugs have changed over time. Methods: Drugs are classified by years of introduction, therapeutic classification, and an assessment of relative treatment cost using a contemporary 'standard' treatment compared with the relevant UK GDP per capita. Results: Prior to 1960, there were 5 cancer drugs available, 2 new drugs were introduced in the 1960s, 18 in the 1970s, 14 in the 1980s, 24 in the 1990s, 23 between 2000-2009 and 15 between 2010-12. Data will be presented on the cost relative to per capita GDP of a standard treatment for each new drug released from 1987 to current. The summary data indicates that the cost at introduction of an average new cancer drug treatment has increased from 33% of per capita GDP for 1995-99, 53% for 2000-2004, 67% for 2005-2009 and is now 114% for 2010-2012. Conclusions: The cost of new cancer drug treatments appears to be rising in absolute and relative terms. The data in this abstract may be of value to those interested in the history of cancer treatment development and the associated current economic issues.
Who is receiving survivorship care plans? Findings from the 2012 LIVESTRONG survey.
Authors: Rechis Ruth , Nutt Stephanie , Bann Carla , Squiers Linda , Rao Naveen 
Published: February 2017

26 Background: There are more than 14 million cancer survivors in the US – a number that is on the rise. Care coordination resources will be essential to provide support to this growing population. Key stakeholders, including the Commission on Cancer (CoC) and the Institute of Medicine, have proposed survivorship care plans (SCPs) as a way to extend support. However, limited research has been conducted to date on SCPs. Methods: In 2012, the LIVESTRONG Foundation (LIVESTRONG) administered a survey to understand the role of a treatment summary (TS) and SCPs and how they fit into survivors’ care. Logistic regression models were conducted to identify factors associated with receiving SCPs or TS. Results: 5,303 survivors responded to these questions. While 92% of these respondents received information about where to return to for cancer check-ups, only 51% reported receiving a TS and 17% reported receiving a SCP. Survivors who were more likely to receive SCPs if they had a navigator (p<.001) and if they were male, black, had finished treatment within the past year, or received care at a university-based medical center or community cancer center (p < 0.05). Also, those receiving a SCP were significantly more likely to have had a detailed discussion with a provider regarding long-term side effects, emotional needs, and lifestyle recommendations. Specifically, 60% of those with a SCP discussed long-term effects compared to 39% who did not. Conclusions: Results here indicate that few survivors receive SCPs but survivors reported benefits from receiving them. Currently many workflow barriers impede delivering SCPs, and LIVESTRONG is working with key stakeholders including the CoC to automate the LIVESTRONG Care Plan powered by Penn Medicine’s OncoLink through a registry and EMR system to understand how to address this issue.